FAQs on Testing for SARS-CoV-2

COVID-19 Resources for Laboratories and Manufacturers

• Emergency Use Authorizations for Medical Devices: Includes EUAs for In Vitro Diagnostics (molecular and serology tests)
• EUA Authorized Serology Test Performance: Includes summaries of test performance by test and a calculator for test performance.
• Independent Evaluations of COVID-19 Serological Tests
• SARS-CoV-2 Reference Panel Comparative Data
• Pooled Sample Testing and Screening Testing for COVID-19
• FAQs on Viral Transport Media During COVID-19: Includes questions and answers regarding the policies outlined in the Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
• Testing Supply Substitution Strategies: Includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some components of a molecular test. Download the slide show file (PPT - 1.5MB) and click Slide Show > From Beginning. (Release date: July 23, 2020)

Reporting Problems to the FDA

The sale of fraudulent COVID-19 products is a threat to the public health. Consumers and health care professionals can help by reporting suspected fraud to the FDA's Health Fraud Program or the Office of Criminal Investigations. You can also email FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.

If you think you had a problem with your diagnostic test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

This page provides answers to frequently asked questions relating to the development and performance of tests for SARS-CoV-2. These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify any existing policies. For general public and consumer FAQs on testing, please see FDA's COVID-19 Frequently Asked Questions.

The page includes questions and answers regarding the policies outlined in the Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised), originally introduced as Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff: Policy for Diagnostic Tests in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency on February 29, 2020 and updated on March 16, 2020, May 4, 2020, and May 11, 2020. On this page, this guidance is referred to as the Policy for Coronavirus Disease-2019 Tests.

Tests being offered prior to or without an EUA under a policy outlined in the Policy for Coronavirus Disease-2019 Tests, have not been reviewed or authorized by the FDA. As stated in the Policy for Coronavirus Disease-2019 Tests, all such tests should be validated by the developer prior to being offered for clinical use.

Note: Throughout this page and the Policy for Coronavirus Disease-2019 Tests, references to laboratories that are "certified to perform high complexity testing under CLIA" or to "high-complexity CLIA-certified laboratories" are referring to CLIA-certified laboratories that meet the regulatory requirements to perform high-complexity testing.

Get Updates: In Vitro Diagnostics

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On this page:

• What Laboratories and Manufacturers are Offering Tests for COVID-19?
• What Tests Should No Longer Be Used and/or Distributed for COVID-19?
• General FAQs
• Testing Supply FAQs
• 3D Printed Swab FAQs
• Test Validation FAQs
• COVID-19 Related Test Data and Reporting FAQs
• Clinical Laboratory Diagnostic Test FAQs
• Test Kit Manufacturer Diagnostic Test FAQs
• Serology/Antibody Test FAQs

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What Laboratories and Manufacturers are Offering Tests for COVID-19?

Q: What tests for COVID-19 have received Emergency Use Authorization?

A: All in vitro diagnostic tests that have received an Emergency Use Authorization (EUA) are listed on the EUA page.

Q: What laboratories are offering diagnostic tests under the policy outlined in Section IV.A of the Policy for Coronavirus Disease-2019 Tests? (Updated 10/20)

A: As stated in Section IV.A of the FDA's Policy for Coronavirus Disease-2019 Tests, for laboratories certified under CLIA to perform high-complexity testing and that seek to develop and perform diagnostic tests to detect the SARS-CoV-2 virus, the FDA does not intend to object to the use of validated tests for specimen testing for a reasonable period of time after validation while the laboratory is preparing an EUA request. As noted in the guidance, the FDA believes 15 business days is a reasonable period of time to prepare an EUA submission for a test that has already been validated.

Many commercial and healthcare system/academic laboratories have notified the FDA that they have validated their own COVID-19 test and have started patient testing as set forth in Section IV.A of the FDA's Policy for Coronavirus Disease-2019 Tests. The laboratories listed below have provided such notification. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the laboratory's validation and issued an EUA for the laboratory's test, and the test is included in this list to provide transparency regarding the notification submitted to FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing. Certain developers have completed the EUA process prior to offering a test for clinical use rather than notify FDA under this policy. Tests that have been issued an EUA can be found on the EUA page.

If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be addressed in a timely manner, the FDA intends to remove the laboratory from this list and may take additional actions as appropriate.

Note that many other laboratories, including public health, commercial, and healthcare system/academic laboratories, around the country are providing testing for COVID-19 using an EUA authorized test.

In addition, under the Policy for Coronavirus Disease-2019 Tests issued on March 16, States may choose to authorize high-complexity CLIA-certified laboratories within that State or territory to develop and perform tests for COVID-19. Such laboratories are not included in this list. The States that have chosen to use this authority are listed on this page under the question: Q: What States or territories have chosen to authorize laboratories within that State or territory to develop and perform a test for COVID-19 under the policy outlined in Section IV.B of the Policy for Diagnostic Tests for Coronavirus Disease-2019?

Laboratories that have notified the FDA that they have validated their own COVID-19 diagnostic test as set forth in Section IV.A:

Laboratory	Authorization Status	Settings for Use1
Access Genetics, dba OralDNA Labs	FDA Authorized	H
Access Medical Laboratories	Not FDA Authorized	H
Accu Reference Medical Lab LLC	Not FDA Authorized	H
Advanced Diagnostics Laboratory, National Jewish Health	Not FDA Authorized	H
AdventHealth	Not FDA Authorized	H
Aegis Sciences Corporation	Not FDA Authorized	H
Aeon Global Health dba Peachstate Health Management LLC	Not FDA Authorized	H
Alphadera Labs, LLC	Not FDA Authorized	H
Altru Diagnostic, Inc.	FDA Authorized	H
ARUP Laboratories	Not FDA Authorized	H
Assurance Scientific	FDA Authorized	H
Avellino Lab USA, Inc.	FDA Authorized	H
Bako Pathology Associates/DBA Bako Diagnostics	Not FDA Authorized	H
Baptist Hospital of Miami Clinical Lab	FDA Authorized	H
Baylor College of Medicine (CMMR/HGSC) Clinical Laboratories	Not FDA Authorized	H
Baylor Scott and White Medical Center - Temple	Not FDA Authorized	H
Baystate Medical Center Whitney Ave Laboratories	Not FDA Authorized	H
Bedford Research Foundation	Not FDA Authorized	H
Beth Israel Deaconess Medical Center	Not FDA Authorized	H
Boston Children's Hospital Infectious Diseases Diagnostics Laboratory	FDA Authorized	H
Brigham and Women's Hospital	Not FDA Authorized	H
Bryan Medical Center West	Not FDA Authorized	H
Centogene	FDA Authorized	H
The Children's Hospital of Philadelphia	FDA Authorized	H
Children's National Hospital	Not FDA Authorized	H
Clarity Lab Solutions	Not FDA Authorized	H
Cleveland Clinic	FDA Authorized	H
Clinical Laboratory University Hospital at University of Arkansas for Medical Sciences	Not FDA Authorized	H
Clinical Pathology Laboratories	Not FDA Authorized	H
Clinical Reference Laboratory, Inc.	FDA Authorized	H
Clinical Research Sequencing Platform, LLC at the Broad Institute of MIT & Harvard	FDA Authorized	H
Compass Laboratory Services, LLC	FDA Authorized	H
Consolidated Medical Bio-Analysis, Inc.	Not FDA Authorized	H
Coppe Laboratories	Not FDA Authorized	H
CSI Laboratories	FDA Authorized	H
Davis Medical Center	Not FDA Authorized	H
Devansh Lab Werks Inc.	Not FDA Authorized	H
Diagnostic Solutions Laboratory LLC	FDA Authorized	H
Diatherix Eurofins	FDA Authorized	H
Dynamic DNA Laboratories, LLC	Not FDA Authorized	H
Eli Lilly Clinical Diagnostics Laboratory	FDA Authorized	H
Emory Medical Laboratory, Emory Healthcare	Not FDA Authorized	H
Ethos Laboratories	Not FDA Authorized	H
Exact Sciences Laboratories	FDA Authorized	H
Exact Sciences Laboratories	FDA Authorized	H
Gene By Gene	FDA Authorized	H
Genesys Diagnostics Inc.	Not FDA Authorized	H
Gravity Diagnostics	FDA Authorized	H
Henry Ford Health System	Not FDA Authorized	H
HMH Hackensack University Medical Center	FDA Authorized	H
Hospital of the University of Pennsylvania	Not FDA Authorized	H
iGenomeDx	Not FDA Authorized	H
Inform Diagnostics, Inc.	FDA Authorized	H
Integrity Laboratories	FDA Authorized	H
Ipsum Diagnostics LLC	FDA Authorized	H
ISPM Labs, LLC DBA Capstone Healthcare	FDA Authorized	H
J Randolph Schnitman MD Inc.	Not FDA Authorized	H
Johns Hopkins Medical Microbiology Laboratory at Johns Hopkins Hospital	Not FDA Authorized	H
Kansas State Veterinary Diagnostic Laboratory	Not FDA Authorized	H
Korva-Labs Inc.	FDA Authorized	H
Lehigh Valley Genomics	Not FDA Authorized	H
Lexar Laboratories & Analysis, LLC	Not FDA Authorized	H
MAWD Pathology Group	Not FDA Authorized	H
Mayo Clinic - Rochester, MN	Not FDA Authorized	H
MD Tox Laboratory DNA Innovative Health Diagnostics	Not FDA Authorized	H
Medical College of Wisconsin	Not FDA Authorized	H
Medical Diagnostic Laboratories LLC	Not FDA Authorized	H
Molecular Diagnostics, Christiana Care Health Systems	Not FDA Authorized	H
Montefiore Medical Center	Not FDA Authorized	H
Nanticoke Memorial Hospital Laboratory	Not FDA Authorized	H
Nebraska Medicine Clinical Laboratory	Not FDA Authorized	H
New York Presbyterian Hospital - Weill Cornell Medicine (NYPH-WCM)	Not FDA Authorized	H
Next Bio-Research Services LLC	Not FDA Authorized	H
NIPD Genetics Public Company Limited	Not FDA Authorized	H
North Central Florida Neurodiagnostic Services DBA: NCF Diagnostics & DNA Technologies	Not FDA Authorized	H
NxGen MDx	Not FDA Authorized	H
NYU Langone Medical Center	Not FDA Authorized	H
Oklahoma University Medicine Laboratory	Not FDA Authorized	H
OmniPathology Solutions Medical Corporation	FDA Authorized	H
Opteo Laboratory, LLC	Not FDA Authorized	H
Orig3n, Inc.	FDA Authorized	H
Orlando Health	Not FDA Authorized	H
Pathology Center, Nebraska Methodist Hospital	Not FDA Authorized	H
Patriot Medical Laboratories LLC DBA CIAN Diagnostics	Not FDA Authorized	H
Poplar Healthcare	Not FDA Authorized	H
Primex Clinical Laboratories, Inc.	Not FDA Authorized	H
Proteus Molecular and Clinical Lab LLC	Not FDA Authorized	H
PTC Laboratories, Inc.	Not FDA Authorized	H
Quest Diagnostics Infectious Disease, Inc.	FDA Authorized	H
RCA Laboratory Services LLC DBA GENETWORx	Not FDA Authorized	H
Real Diagnostics Laboratory	Not FDA Authorized	H
ResourcePath, LLC	Not FDA Authorized	H
Saint Mary's Medical Center	Not FDA Authorized	H
Sandia National Laboratories	FDA Authorized	H
Sciteck Clinical Laboratory	Not FDA Authorized	H
Sharp Copley Laboratory	Not FDA Authorized	H
Specialty Drug Testing	Not FDA Authorized	H
Solaris Diagnostics	FDA Authorized	H
Sonic Reference Laboratory	Not FDA Authorized	H
Southwest Regional PCR Laboratory dba MicroGen DX	FDA Authorized	H
Specialty Diagnostics Inc	FDA Authorized	H
Stanford Health Care Clinical Laboratory	FDA Authorized	H
Tampa General Hospital	Not FDA Authorized	H
Texas Children's Hospital Department of Pathology	Not FDA Authorized	H
TGen North, Clinical Laboratory	Not FDA Authorized	H
Tide Laboratories, LLC	FDA Authorized	H
UCSF-Health	Not FDA Authorized	H
UC Berkeley Innovative Genomic Institute	Not FDA Authorized	H
UltimateDx Laboratories	FDA Authorized	H
University of North Carolina Medical Center McLendon Clinical Laboratories	FDA Authorized	H
University of Minnesota Genomics Center	Not FDA Authorized	H
University of Washington	Not FDA Authorized	H
Viracor Eurofins Clinical Diagnostics	FDA Authorized	H
WestPac Labs	Not FDA Authorized	H
Wisconsin Diagnostic Laboratories	Not FDA Authorized	H
Xymbio, LLC	Not FDA Authorized	H
Yale Pathology Molecular Diagnostic Laboratory	Not FDA Authorized	H
Virginia Tech Schiffert Health Center	Not FDA Authorized	H
ASU Biodesign Clinical testing Laboratory, Center for Personalized Diagnostics	Not FDA Authorized	H
Kashi Clinical Laboratories, Inc.	Not FDA Authorized	H
DxTerity Diagnostics, Inc.	Not FDA Authorized	H
Boston Heart Diagnostics	FDA Authorized	H
Valley Medical and Wellness Laboratory	Not FDA Authorized	H
Aperiomics Molecular Laboratory	Not FDA Authorized	H
UniPath	Not FDA Authorized	H
UCSC Molecular Diagnostic Lab	Not FDA Authorized	H
Acupath Laboratories	FDA Authorized	H
Color Genomics	FDA Authorized	H
Banner-University Medical Center Tucson	Not FDA Authorized	H
Eurofins Clinical Molecular Testing Services, LLC	Not FDA Authorized	H
Physicians Laboratory Services, Inc.	Not FDA Authorized	H
Essentia Health East- SMDC Laboratory	Not FDA Authorized	H
PacGenomics Lab	Not FDA Authorized	H
Northside Hospital	Not FDA Authorized	H
Paradigm Laboratories	Not FDA Authorized	H
Acutis Diagnostics	Not FDA Authorized	H
Aspirus Riverview Hospital Laboratory	FDA Authorized	H
North Shore Medical Center Clinical Lab	Not FDA Authorized	H
River Road Testing Laboratory	Not FDA Authorized	H
AKESOgen	Not FDA Authorized	H
Texas Department of State Health Service Laboratory	Not FDA Authorized	H
AdvaGenix	Not FDA Authorized	H
IGeneX, Inc.	Not FDA Authorized	H
Warrior Diagnostics	Not FDA Authorized	H
Danner Laboratory	Not FDA Authorized	H
MD Labs	Not FDA Authorized	H
ApolloMDx Labs	Not FDA Authorized	H
Helix	FDA Authorized	H
Signal Diagnostics	Not FDA Authorized	H
Women's Health Laboratory	Not FDA Authorized	H
Lab Genomics LLC	Not FDA Authorized	H
Pathlab Services Inc.	Not FDA Authorized	H
Tempus Labs, Inc.	Not FDA Authorized	H
Santa Clara Valley Medical Center Clinical Laboratory	Not FDA Authorized	H
Rosalind Franklin University Clinical Immunology Laboratory	Not FDA Authorized	H
Tribal Diagnostics, LLC	Not FDA Authorized	H
BioReference Laboratories, Inc.	Not FDA Authorized	H
Sun Clinical Laboratories	Not FDA Authorized	H
CorePlus Servicios Clínicos y Patológicos, LLC	Not FDA Authorized	H
FLO-MEDILAB SERVICES, LLC	Not FDA Authorized	H
MedArbor Diagnostics	Not FDA Authorized	H
Olin Health Center, Michigan State University	Not FDA Authorized	H
George Washington University Hospital Laboratory	Not FDA Authorized	H
NeoGenomics Laboratories, Inc.	Not FDA Authorized	H
Guardant Health Clinical Laboratory, Inc.	Not FDA Authorized	H
University of Illinois Veterinary Diagnostic Laboratory	Not FDA Authorized	H
Sports Drug Testing Laboratory	Not FDA Authorized	H
Genomic Expression	Not FDA Authorized	H
Bandar Enterprises, LLC dba Cuur Diagnostics	Not FDA Authorized	H
Sunpath-MDL	Not FDA Authorized	H
Alimetrix, Inc.	Not FDA Authorized	H
Ambry Genetics	Not FDA Authorized	H
Cincinnati Children's Hospital Medical Center	Not FDA Authorized	H
Tallahassee Memorial HealthCare	Not FDA Authorized	H
Veritas Genetics	Not FDA Authorized	H
Asante Rogue Regional Medical Center	Not FDA Authorized	H
Southern Illinois Healthcare, Herrin Hospital	Not FDA Authorized	H
Research Medical Center Laboratories	Not FDA Authorized	H
Truman Medical Center	Not FDA Authorized	H
University of Colorado School of Medicine Hospital	Not FDA Authorized	H
Charles River Laboratories, Inc. Reno, Nevada	Not FDA Authorized	H
Children's Hospital Los Angeles Clinical Virology Laboratory	Not FDA Authorized	H
HFI Laboratory at Boston University dba Boston University Clinical Testing Laboratory	Not FDA Authorized	H
University of Chicago Medical Center Main Clinical Laboratory	Not FDA Authorized	H
Adventist Health Castle Laboratory	Not FDA Authorized	H
OptimaLab, Inc.	Not FDA Authorized	H
St. Joseph's Hospital and Medical Center	Not FDA Authorized	H
Mayo Clinic Jacksonville Clinical Laboratory	Not FDA Authorized	H
Alliance HealthCare System	Not FDA Authorized	H
Ingenious Personalized Medicine	Not FDA Authorized	H
Inno Diagnostics	Not FDA Authorized	H
Columbia University Medical Center	Not FDA Authorized	H
Transfusion Transmitted Viruses Lab NIH	Not FDA Authorized	H
Avera Institute for Human Genetics	FDA Authorized	H
303 Diagnostics, LLC.	Not FDA Authorized	H
Innovative Genomics LLC. d/b/a Innovative Gx Laboratories	Not FDA Authorized	H
Premier Medical, Inc. dba Premier Medical Laboratory Services	Not FDA Authorized	H
CEDARS-SINAI MEDICAL CENTER	FDA Authorized	H
Pacific Toxicology Laboratories	Not FDA Authorized	H
UofSC College of Pharmacy Diagnostic Genomics Laboratory	Not FDA Authorized	H
Lucence Diagnostics Pte Ltd	Not FDA Authorized	H
Elite Medical Laboratory Solutions LLC dba Diax Labs	Not FDA Authorized	H
Access Dx Laboratory, LLC	Not FDA Authorized	H
ACL Laboratories	Not FDA Authorized	H
Ascension Columbia St. Mary's Milwaukee	Not FDA Authorized	H
Atrium Health Core Laboratory	Not FDA Authorized	H
Baptist Medical Center	Not FDA Authorized	H
Capital Digestive Care, LLC., Laboratory Services	Not FDA Authorized	H
Diagnostic Laboratory Services, Inc. (HI)	Not FDA Authorized	H
IDL Acquisition Co., LLC DBA MDx Laboratory Services	Not FDA Authorized	H
INOVA Core Research Lab	Not FDA Authorized	H
Weill Cornell Medicine	Not FDA Authorized	H
Wise Diagnostic Systems	Not FDA Authorized	H
P4 Clinical LLC	Not FDA Authorized	H
Physician STAT Lab Molecular	Not FDA Authorized	H
STS Lab Holdco LLC Kentucky	Not FDA Authorized	H
STS Lab Holdco LLC California	Not FDA Authorized	H
Molecular Diagnostics Laboratory, Department of Pathology, Yale School of Medicine	Not FDA Authorized	H
Histogenetics	Not FDA Authorized	H
LynxDx	Not FDA Authorized	H
Fosun Pharma USA Inc.	Not FDA Authorized	H
Kai Medical Laboratory	Not FDA Authorized	H
Advanced Diagnostic Laboratory, LLC	Not FDA Authorized	H
SummerBio Labs	Not FDA Authorized	H
Saint Luke's Hospital of Kansas City	Not FDA Authorized	H
Sutter Health Shared Laboratory (SHSL)	Not FDA Authorized	H
Machaon Diagnostics, Inc.	Not FDA Authorized	H
Kaiser Santa Clara Laboratory	Not FDA Authorized	H
New Hampshire Public Health Laboratories	Not FDA Authorized	H
Ome Ventures, Inc.	Not FDA Authorized	H
BioBridge Global (BBG)	Not FDA Authorized	H
NeoVect Technologies, LLC	Not FDA Authorized	H
Loma Linda University Medical Center Clinical Laboratory	Not FDA Authorized	H
NOAH Associates	Not FDA Authorized	H
Curative, Inc.	Not FDA Authorized	H
Pioneer Hi-Bred International, Inc.	Not FDA Authorized	H
Arctic Medical Laboratories	Not FDA Authorized	H
Alliance Laboratories	Not FDA Authorized	H

¹ Settings for use include the following:

• H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
• M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
• W - Patient care settings operating under a CLIA Certificate of Waiver.

Q: What States or territories have chosen to authorize laboratories within that State or territory to develop and perform a test for COVID-19 under the policy outlined in Section IV.B of the Policy for Coronavirus Disease-2019 Tests? (Updated 8/4)

A: As stated in Section IV.B of the FDA's Policy for Coronavirus Disease-2019 Tests, a State or territory choosing to authorize laboratories within that State or territory to develop and perform a test for COVID-19 would do so under authority of its own State law, and under a process that it establishes. As noted in the guidance, FDA does not intend to object to the use of such tests for specimen testing where the notification of SARS-CoV-2 test validation is not submitted to FDA and the laboratory does not submit an EUA request to FDA, and where instead the State or territory takes responsibility for COVID-19 testing by laboratories in its State/territory during the COVID-19 outbreak.

The States and territories listed below have notified FDA that they choose to use this flexibility to expedite COVID-19 testing. As stated in the guidance, the FDA will not be reviewing the process adopted by the State or territory under this policy and is including this list here to provide transparency regarding the notifications submitted to FDA.

• Puerto Rico Department of Health
• State of Colorado
• State of Connecticut
• State of Maryland
• State of Mississippi
• State of Nevada
• State of New Jersey
• State of New York Department of Health Wadsworth Center
• Washington State Department of Health

Q: What commercial manufacturers are distributing diagnostic test kits under the policy outlined in Section IV.C of the Policy for Coronavirus Disease-2019 Tests? (Updated 10/22)

A: As stated in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution to clinical laboratories of diagnostic test kits to perform assays to detect SARS-CoV-2 for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users. As noted in the guidance, the believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high-complexity testing, including testing at the point-of-care when the site is covered by the laboratory's CLIA certificate for high-complexity testing. This policy does not apply to at home testing, including at-home specimen collection.

The commercial manufacturers listed below have notified FDA that they have validated and intend to distribute diagnostic test kits as set forth in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the test, and the test is included in this list to provide transparency regarding the notification submitted to FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing. Certain developers have completed the EUA process prior to offering a test for clinical use rather than notify FDA under this policy. Tests that have been issued an EUA can be found on the EUA page.

If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be addressed in a timely manner, the FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution and conduct a recall of the test, and may take additional actions as appropriate.

Commercial Manufacturers that have notified the FDA that they have validated and intend to distribute diagnostic test kits as set forth in Section IV.C:

Manufacturer and Test	Authorization Status	Settings for Use1
BD BioGx SARS-CoV-2 Reagents for BD MAX System	FDA Authorized	H, M
Biomeme, Inc. Biomeme SARS-CoV-2 test kit	FDA Authorized	H
BGI Genomics Co. Ltd	FDA Authorized	H
ChromaCode, Inc. HDPCR SARS-CoV-2 Assay	FDA Authorized	H
Co-Diagnostics, Inc.	FDA Authorized	H
Genomictree, Inc. AccuraDTect SARS-CoV-2-qPCR Kit	Not FDA Authorized	H
OPTOLANE Technologies Inc. Kaira 2019-nCoV Detection Kit	FDA Authorized	H
OSANG Healthcare Co., Ltd, GeneFinder COVID-19 Plus RealAmp Kit	FDA Authorized	H
QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel Assay	FDA Authorized	H, M
YD Diagnostics Corp. MolecuTech Real-Time COVID-19	Not FDA Authorized	H
LabGenomics, Co., Ltd. LabGun™ COVID-19 Assay kit	FDA Authorized	H
VelaDx ViroKey™ SARS-CoV-2 RT-PCR Test	FDA Authorized	H
Hologic, Inc. Aptima SARS-CoV-2 assay	FDA Authorized	H
GeneOne Diagnostics Corporation COVID-19 Nucleic Acid Diagnostic Kit	Not FDA Authorized	H
RTA Labs DIAGNOVITAL SARS-CoV-2	FDA Authorized	H
Solgent Co. Ltd., COVID-19 DiaplexQ Diagnostic Kit	FDA Authorized	H
SA Scientific, SAS™ COVID-19 Antibody Detection Test	Not FDA Authorized	H
ZhuHai Sinochips Bioscience Co., Ltd COVID-19 Real-time PCR Test Kit	FDA Authorized	H
GeneReach Biotechnology Corporation POCKIT Central SARS-CoV-2	Not FDA Authorized	H
American BioSources Inc., DBA Genomic Diagnostics GDx GrandPerformance SARS-CoV-2 Detection Kit	Not FDA Authorized	H
Taigen Bioscience Corporation LabTurbo AIO COVID-19 RNA Testing kit	Not FDA Authorized	H
Gencurix Inc. GenePro SARS-CoV-2 Test	FDA Authorized	H
ELITechGroup MDx LLC SARS-CoV-2 ELITe MGB Assay	Not FDA Authorized	H
Melbourne Biotech MB QRT-PCR TEST SARS-COV2(COVID-19)	Not FDA Authorized	H
Agena Bioscience SARS-CoV-2 Panel	Not FDA Authorized	H
Grifols Diagnostic Solutions Inc. Procleix SARS-CoV-2 Assay	Not FDA Authorized	H
MiCo BioMed Co., Ltd. Veri-Q COVID-19 Multiplex Detection Kit	Not FDA Authorized	H
Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay	FDA Authorized	H
SML GENETREE Co., Ltd. Ezplex SARS-CoV-2 G Kit	Not FDA Authorized	H
BIONEER Corporation	Not FDA Authorized	H
AccuPower SARS-CoV-2 Multiplex Real-Time RT-PCR Kit	Not FDA Authorized	H
Enzo Biochem, Inc Enzo AMPIPROBE® SARS-CoV-2 Test System	FDA Authorized	H
Vela Operations Singapore Pte Ltd. ViroKey SARS-CoV-2 RT-PCR Test v2.0	FDA Authorized	H
GenMark Diagnostics, Inc. ePlex Respiratory Pathogen Panel 2 (ePlex RP2 Panel)	FDA Authorized	H, M
NovaTec Immundiagnosticsa GmBH GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR	Not FDA Authorized	H
TAAG Genetics S.A. nPLEX SARS-CoV-2 Detection Kit	Not FDA Authorized	H
Illucidx Inc., Illucidx COVID-19 Dx RT-LAMP	Not FDA Authorized	H
BioZentech Co., Ltd., BZ QPCR COVID-19 Kit	Not FDA Authorized	H
T2Biosystems, Inc., T2SARS-CoV-2 Panel	FDA Authorized	H
Molecular Epidemiology Inc., IEH SARS-CoV-2 RT-PCR Test	Not FDA Authorized	H
Suzhou PreciGenome, Ltd., Co., Fastplex Triplex SARS-CoV-2 Detection Kit (RT-PCR)	Not FDA Authorized	H
GK Pharmaceuticals Contract Manufacturing Operations, ACCU-RIGHT SARS-COV-2 RT-PCR KIT	Not FDA Authorized	H
Detectachem Inc., MD-Bio BCC19	FDA Authorized	H
GUANGDONG ARDENT BIOMED Co., Ltd, Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (PCR-fluorescent Probe)	Not FDA Authorized	H
Nanjing Liming Bio-Products Co., Ltd., StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit	Not FDA Authorized	H
Hologic Aptima SARS-CoV-2 Assay Pooled Samples Workflow	Not FDA Authorized	H
Hologic Panther Fusion SARS-CoV-2 Assay Pooled Samples Workflow	FDA Authorized	H
DowGene Co., Ltd., Dow QuickFinderTM 2019-nCov Real-Time PCR Kit	Not FDA Authorized	H
Shimadzu Corporation, 2019 Novel Coronavirus Detection Kit	Not FDA Authorized	H
ProteomeTech Inc. GENEdania COVID-19 qRT-PCR	Not FDA Authorized	H
GenMark Diagnostics, Inc., eSensor SARS-CoV-2 Panel	Not FDA Authorized	H
Genetic Signatures Limited, EasyScreen™ SARS-CoV-2 Detection Kit	Not FDA Authorized	H
Eryigit medical Devices, Sentebiolab Senteligo SARS CoV-2 (COVID-19) Multiplex qPCR Detection Kit	Not FDA Authorized	H
Clinomics USA Inc., TrioDx RT-PCR COVID-19 Test	Not FDA Authorized	H
UStar Biotechnologies (Hangzhou) Ltd., EasyNAT® Diagnostic Kit for Novel-Coronavirus (COVID-19) RNA (Isothermal Amplification-Real Time Fluorescence Assay)	Not FDA Authorized	H
Genrui Biotech Inc, Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR)	Not FDA Authorized	H
AMSBIOInc., A+CheQ COVID-19 High-Speed RT-qPCR Detection Kit	Not FDA Authorized	H
TCM Bioscience, TCM-Q Corona III test	Not FDA Authorized	H
Todos Medical USA Inc., TODOS 2019-nCoV RT-qPCR Detection Kit	Not FDA Authorized	H
iCubate, Inc., iC-COVID-19 Assay	Not FDA Authorized	H
Sacace Biotechnologies s.r.1., SARS-CoV-2 Real-TM	Not FDA Authorized	H
Genes Laboratories, NEXdiaTM 2019-nCoV Detection Kit	Not FDA Authorized	H
Roche Molecular Systems Pooling Sample Workflow for the cobas® SARS-CoV-2 for use on the cobas® 6800/8800 Systems	Not FDA Authorized	H
Caspr Biotech Corporation, Direct Caspr Lyo-CRISPR SARS-CoV-2	Not FDA Authorized	H
Gerbion GmbH & Co. KG., Gerbion virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0	Not FDA Authorized	H
Caspr Biotech Corporation, Caspr Lyo-CRISPR SARS-CoV-2	Not FDA Authorized	H
General Biologicals Corporation, GB SARS-CoV-2 Real-Time RT-PCR	Not FDA Authorized	H
Sanigen Co. Ltd., Genelix™ COVID-19 Real-Time PCR Kit	Not FDA Authorized	H
Eurofins ARCA Technology, Inc., ARCA Straight Shot SARS-CoV-2 Extraction Free (EF) Assay	Not FDA Authorized	H
Biopoa, Co. Ltd., Rapid COVID-19 PoaCheck	Not FDA Authorized	H
RTA Laboratuvarlari Biyolojik Urunler Ilac ve Makine San. Tic. A.S., Diagnovital SARS-CoV-2 Multiplex	Not FDA Authorized	H

¹ Settings for use include the following:

• H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
• M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
• W - Patient care settings operating under a CLIA Certificate of Waiver.

Q: What laboratories are offering serology tests under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests? (Updated 9/30)

A: As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, while laboratories are encouraged to submit EUA requests for serology tests, the FDA does not intend to object to the development and use of serology tests to identify antibodies to SARS-CoV-2 by laboratories that are certified under CLIA to perform high-complexity testing, where the test has been validated, notification is provided to FDA, and information that helps users and patients understand the test results, such as the following, is included in the test reports:

• This test has not been reviewed by the FDA.
• Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
• Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

This policy does not apply to at-home testing, including at-home specimen collection.

The laboratories in the list below have notified FDA that they have validated and intend to offer serology tests as set forth in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not reviewed the laboratory's validation and issued an EUA for the laboratory's test, and the test is included in this list to provide transparency regarding the notifications submitted to FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing. Certain developers have completed the EUA process prior to offering a test for clinical use rather than notify FDA under this policy. Tests that have been issued an EUA can be found on the EUA page.

If FDA becomes aware of concerns about a laboratory developed serology test that cannot be or have not been addressed in a timely manner, FDA intends to remove the laboratory from this list and may take additional actions as appropriate.

Laboratories that have notified FDA that they have validated and intend to offer serology tests as set forth in Section IV.D:

Laboratory	Authorization Status	Settings for Use1
BioDiagnostic Inc.	Not FDA Authorized	H
DLS Research & Ventures	Not FDA Authorized	H
EDP Biotech Corporation	Not FDA Authorized	H
Emory Medical Laboratories	FDA Authorized	H
Genalyte, Inc	Not FDA Authorized	H
IMMYLabs	Not FDA Authorized	H
University of Minnesota Advanced Research and Diagnostic Laboratory	Not FDA Authorized	H
Vibrant America Clinical Labs	FDA Authorized	H
White Coat Sciences	Not FDA Authorized	H
KSL Diagnostics	Not FDA Authorized	H
Enzo Clinical Labs	Not FDA Authorized	H
University of Arizona Genetics Core for Clinical Services	Not FDA Authorized	H
Center for Cellular Therapy Medical University of South Carolina	Not FDA Authorized	H
IGeneX Inc.	Not FDA Authorized	H
LabCorp Center for Esoteric Testing	Not FDA Authorized	H
OneBlood, Inc.	Not FDA Authorized	H
Ethos Laboratories	Not FDA Authorized	H
Otogenetics	Not FDA Authorized	H
Stanford Health Care	Not FDA Authorized	H
Sciteck Diagnostics	Not FDA Authorized	H
Mayo Clinic	Not FDA Authorized	H
Exsera Biolabs at the University of Colorado Anschutz Medical Campus	Not FDA Authorized	H
CQuentia NGS, LLC	Not FDA Authorized	H
Symbiotica, Inc	Not FDA Authorized	H
Brigham and Women's Hospital	Not FDA Authorized	H
Allermetrix, Inc.	Not FDA Authorized	H
Cincinnati Children's Hospital Medical Center	Not FDA Authorized	H
Phosphorus Diagnostics LLC	Not FDA Authorized	H
Pan Laboratories	Not FDA Authorized	H
ProterixBio, Inc	Not FDA Authorized	H

¹ Settings for use include the following:

• H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
• M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
• W - Patient care settings operating under a CLIA Certificate of Waiver.

Q: What commercial manufacturers are distributing serology test kits under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests? (Updated 10/23)

As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution of serology tests to identify antibodies to SARS-CoV-2 for a reasonable period of time, where the test has been validated and while the manufacturer is preparing its EUA request, where the manufacturer gives notification to the FDA and information that helps users and patients understand the test results, such as the following, is included in the instructions for use:

• This test has not been reviewed by the FDA.
• Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
• Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

As noted in the guidance, the FDA believes that 10 business days is a reasonable period of time to prepare an EUA submission for such tests. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.

This policy does not apply to at-home testing, including at-home specimen collection.

The commercial manufacturers in the list below have notified the FDA that they have validated and intend to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the manufacturer's test, and the test is included in this list to provide transparency regarding the notification submitted to the FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing. Certain developers have completed the EUA process prior to offering a test for clinical use rather than notify FDA under this policy. Tests that have been issued an EUA can be found on the EUA page.

If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution of the test, and may take additional actions as appropriate.

Manufacturers that have notified FDA that they have validated and intend to distribute serology tests as set forth in Section IV.D:

Manufacturer and Test	Authorization Status	Settings for Use1
Abbott Laboratories SARS-CoV-2 IgG (for use on ARCHITECT)	FDA Authorized	H, M
Access Bio, Inc. CareStart COVID-19 IgM/IgG	FDA Authorized	H, M
Assure Tech (Hangzhou) Co., Ltd.'s COVID-19 IgG/IgM Rapid Test Device	FDA Authorized	H, M
Beijing Beier Bioengineering Co., Ltd 2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P)	Not FDA Authorized	H
Beijing O&D BIOTECH Co., LTD. Coronavirus disease (COVID-19) Total Antibody Rapid Test (Colloidal Gold)	Not FDA Authorized	H
Beijing Wantai Biological Pharmaceutical Co., Ltd. TOTAL ANTIBODY WANTAI SARS-COV-2 Ab Rapid Test Kit	FDA Authorized	H, M
Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Cassette Format)	FDA Authorized	H, M
Biohit Healthcare (Hefei) Co., Ltd. SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method)	FDA Authorized	H, M
BTNX, Inc. Rapid Response™ COVID-19 IgG/IgM Test Cassette	Not FDA Authorized	H
ClearSign Diagnostics Co Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test	Not FDA Authorized	H
Core Technology Co., Ltd. CoreTest COVID-19 IgM/IgG Ab Test	Not FDA Authorized	H
CTK Biotech, Inc. OnSite® COVID-19 IgG/IgM Rapid Test	Not FDA Authorized	H
DIALAB(ZJG) Biotech Co., Ltd. Device Name: SARS-CoV-2 IgG/IgM Antibody Test (Fluorescence Immunoassay)	Not FDA Authorized	H
Diazyme Laboratories, Inc. Diazyme DZ-LITE SARS-CoV-2 IgG CLIA Kit	FDA Authorized	H, M
Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-Cov-2 IgM CLIA Kit	FDA Authorized	H, M
Epitope Diagnostics, Inc. KT-1032 EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit	Not FDA Authorized	H
Epitope Diagnostics, Inc. KT-1033 EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit	Not FDA Authorized	H
ET Healthcare Inc. Pylon COVID-19 IgM/IgG Assay	Not FDA Authorized	H
EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgG)	FDA Authorized	H
Genrui Biotech Inc. Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold)	Not FDA Authorized	H
Goldsite Diagnostics Inc SARS-CoV-2 IgG/IgM ki	Not FDA Authorized	H
Guangzhou Wondfo Biotech Co., Ltd. SARS-CoV-2 Antibody Test	Not FDA Authorized	H
Hangzhou AllTest Biotech Co., Ltd. AllTest 2019-nCoV IgG/IgM Rapid Test Cassette	Not FDA Authorized	H
Hangzhou AllTest Biotech Co., Ltd. AllTest COVID-19 IgG/IgM Rapid Test Strip	Not FDA Authorized	H
Hangzhou Clongene Biotech Co., Ltd. Clungene COVID-19 IgM/IgG Rapid Test Cassette	Not FDA Authorized	H
Hangzhou Biotest Biotech's COVID-19 IgG/IgM Rapid Test Cassette	FDA Authorized	H, M
Healgen Scientific, LLC. COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)	FDA Authorized	H, M
INNOVITA (Tangshan) Biological Technology Co., Ltd. 2019-nCoV Ab Test (Colloidal Gold)	Not FDA Authorized	H
Jiangsu Dablood Pharmaceutical Co, Ltd. AssuranceAB™ COVID-19 IgM/IgG Rapid Antibody Test	Not FDA Authorized	H
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. SARS-CoV-2 IgM/IgG Rapid Assay Kit (Colloidal Gold)	Not FDA Authorized	H
Liming BioProducts Co. Ltd. SARS-CoV-2 lgM/lgG Antibody Rapid Test	Not FDA Authorized	H
Maccura Biotechnology Co., Ltd. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method	Not FDA Authorized	H
Mokobio Biotechnology R&D Center Inc COVID-19 IgM & IgG Rapid Test (Colloidal Gold Assay)	Not FDA Authorized	H
Multi-G bvba COVID-19 IgG/IgM Rapid Test Cassette	Not FDA Authorized	H
Nanjing Liming Bio-products Co.,Ltd SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit	Not FDA Authorized	H
Nanjing SYNTHGENE Medical Technology Co., Ltd. SYNTHGENE COVID-19 IgM/IgG Rapid Detection Kit (Colloidal Gold Method)	Not FDA Authorized	H
NanoResearch, Inc. NanoMedicina™ SARS-COV-2 IgM/IgG Antibody Rapid Test	Not FDA Authorized	H
Nirmidas Biotech, Inc. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit	FDA Authorized	H, M
Nanjing Norman Biological Technology Co., Ltd Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold)	Not FDA Authorized	H
Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold)	Not FDA Authorized	H
Ortho Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack	Not FDA Authorized	H
Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator	FDA Authorized	H, M
Promedical Equipment Pty Ltd Promedical IgM/IgG Rapid Detection Kit	Not FDA Authorized	H
Quansys Biosciences Q-Plex™ SARS-CoV-2 Human IgG (4-Plex)	Not FDA Authorized	H
Roche Diagnostics GmbH Elecsys Anti-SARS-CoV-2	FDA Authorized	H, M
Salofa Oy Clarity COVIBLOCK™ COVID-19 IgG/IgM Antibody Test	Not FDA Authorized	H
Salofa Oy Sienna™ COVID-19 IgG/IgM Rapid Test Cassette	FDA Authorized	H, M
Shanghai Liangrun Biomedicine Technology Co., Ltd. Liangrun COVID-19 IgM/IgG Antibody Test	Not FDA Authorized	H
Shenzhen Watmind Medical Co. SARS-CoV-2 IgG/IgM Ab Diagnostic Test Kit	Not FDA Authorized	H
Singuway Biotech Inc. COVID-19 IgG/IgM Detection Kit (Colloidal Gold)	Not FDA Authorized	H
TBG Biotechnology Corp. SARS-CoV-2 IgG / IgM Rapid Test Kit	FDA Authorized	H, M
United Biomedical, Inc. UBI® SARS-CoV-2 ELISA	Not FDA Authorized	H
UC Berkeley Innovative Genomic Institute	Not FDA Authorized	H
VicTorch Meditek Inc. COVID-19 IgG/IgM Rapid test Cassette	Not FDA Authorized	H
VivaChek Biotech (Hangzhou) Co., Ltd. VivaDiag COVID-19 IgM/IgG Rapid Test	Not FDA Authorized	H
Wuhan UNscience Biotechnology Co., Ltd. Coronavirus-19 (COVID-19) Antibody (IgM/IgG) Rapid Test Kit (Colloidal gold immunochromatography)	Not FDA Authorized	H
Xiamen AmonMed Biotechnology Co., Ltd. COVID-19 IgM/IgG test kit (Colloidal Gold)	Not FDA Authorized	H
Xiamen Biotime Biotechnology Co., Ltd. Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test	FDA Authorized	H
Zhejiang GENE SCIENCE Co., Ltd Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (Latex Chromatography)	Not FDA Authorized	H
Zhejiang Orient Gene Biotech, Co., Ltd. COVID-19 IgG/IgM Rapid Test Cassette	Not FDA Authorized	H
Boditech Med Inc AFIAS COVID-19 Ab serological tests	Not FDA Authorized	H
Dynamiker Biotechnology (Tianjin) Co., Ltd. RapidCOV™ 2019-nCOV IgG/IgM Rapid Test	Not FDA Authorized	H
HUMASIS Co., Ltd. Humasis COVID-19 IgG/IgM Test	Not FDA Authorized	H
Jiangsu Well Biotech Co., Ltd. COVID-19 IgM/IgG Rapid Test (Colloidal Gold)	FDA Authorized	H, M
Qingdao Hightop Biotech Co., Ltd. HIGHTOP 2019-nCoV IgM/IgG Rapid Test	Not FDA Authorized	H
Spring Health Care AG COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)	Not FDA Authorized	H
Türklab Tibbi Malzemeler San. ve Tic. A.Ş. INFO SARS-CoV-2 IgM/IgG Ab Test	Not FDA Authorized	H
Türklab Tibbi Malzemeler San. ve Tic. A.Ş. TOYO SARS-CoV-2 IgM/IgG Ab Test	Not FDA Authorized	H
Zybio Inc. SARS-CoV-2 IgM/IgG Antibody Assay Kit (Colloidal Gold Method)	Not FDA Authorized	H
Enable Biosciences Inc. ADAP SARS-CoV-2 Total Antibody Assay	Not FDA Authorized	H
MedMira Inc. REVEALCOVID-19™ Total Antibody Test	Not FDA Authorized	H
Prometheus Bio Inc. 2019-nCoV IgG/IgM Test (Whole blood/Serum/Plasma) Colloidal Gold	Not FDA Authorized	H
Virotech Diagnostics GmbH Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit	Not FDA Authorized	H
Virotech Diagnostics GmbH Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit	Not FDA Authorized	H
Antagen Pharmaceuticals, Inc. COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold)	Not FDA Authorized	H
GeneOne Diagnostics Corporation COVID-19 Nucleic Acid Diagnostic Kit	Not FDA Authorized	H
Boston Bio Lab Inc. Boston Bio EZ Covid-19	Not FDA Authorized	H
Hangzhou Sejoy Electronics & Instrument Co., Ltd. COVID-19 IgG/IgM Rapid Test Cassette	Not FDA Authorized	H
Tetracore Inc. Tetracore FlexImmArray SARS-CoV-2 Human IgG Test	Not FDA Authorized	H
Quotient Suisse SA MosaiQ COVID-19 Antibody Magazine	Not FDA Authorized	H
Ansh Labs SARS-CoV2 IgG ELISA (AL-1001)	Not FDA Authorized	H
Ansh Labs SARS-CoV2 IgM ELISA (μ-Capture) (AL-1002)	Not FDA Authorized	H
Ring Biotechnology Co Ltd COVID-19 IgM/IgG Rapid Test Kit	Not FDA Authorized	H
SUREDX V-CHEK™ SARS-CoV-2 Antibody Rapid Test Kit	Not FDA Authorized	H
bioMérieux SA VIDAS® SARS-COV-2 IgG	FDA Authorized	H, M
bioMérieux SA VIDAS® SARS-COV-2 IgM	FDA Authorized	H, M
Core Technology Co., Ltd. RapidTest COVID-19 IgM/IgG Ab Test	Not FDA Authorized	H
H&Z Life Science Co. Ltd. Anti-COVID-19 Virus IgM/IgG Test Kit (lateral flow assay)	Not FDA Authorized	H
Beckman Coulter Access SARS-CoV-2 IgG test (Catalog No. C58961), Access SARS-CoV-2 IgG Calibrators (Catalog No. C58963) and Access SARS-CoV-2 IgG QC (Catalog No. C58964)	FDA Authorized	H, M
Megna Health Inc. Megna Rapid COVID-19 IgG/IgM Combo Test Kit	FDA Authorized	H, M
Quanterix Simoa Quantitative SARS-CoV-2 IgG Antibody Test	Not FDA Authorized	H
Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 Total (COV2T)	FDA Authorized	H,M
Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 Total (COV2T)	FDA Authorized	H, M
Siemens Healthcare Diagnostics Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)	FDA Authorized	H, M
Siemens Healthcare Diagnostics Dimension Vista SARS-CoV-2 Total Antibody Assay (COV2T)	FDA Authorized	H, M
Sunbeam Laboratories, LLC. Sunbeam Laboratories Covid-19 Rapid Test Kit	Not FDA Authorized	H
ALPCO SARS-CoV-2 IgG Chemiluminescence ELISA	Not FDA Authorized	H
ALPCO SARS-CoV-2 IgM Chemiluminescence ELISA	Not FDA Authorized	H
BioCheck, Inc. BioCheck SARS-CoV-2 IgM Antibody Test	FDA Authorized	H, M
ZEUS Scientific, Inc. ELISA SARS-CoV-2 IgG Test System	FDA Authorized	H, M
Vivera Pharmaceuticals, Inc. COVx-RT	Not FDA Authorized	H
SA Scientific SAS™ COVID-19 Antibody Detection test	Not FDA Authorized	H
Sciteck Diagnostics COVID19 Automated Antibody Assay	Not FDA Authorized	H
ZEUS Scientific, Inc. ZEUS ELISA SARS-CoV-2 Total Antibody Test System	Not FDA Authorized	H
Accel Diagnostics, LLC Rapid C2T Total Ab (IgG/IgM) Card	Not FDA Authorized	H
ALPCO SARS-CoV-2 IgG ELISA	Not FDA Authorized	H
ALPCO SARS-CoV-2 IgM ELISA	Not FDA Authorized	H
Akston Biosciences Corporation AntiCoV-ID IgG ELISA Test	Not FDA Authorized	H
Molecular Innovations SARS-CoV-2 IgG Seroconversion ELISA Kit	Not FDA Authorized	H
Siemens Healthcare Diagnostics Inc. Atellica® IM SARS-CoV-2 IgG (COV2G)	FDA Authorized	H, M
VicTorch Meditek Inc. COVID-19 Serology IgG ELISA	Not FDA Authorized	H
VicTorch Meditek Inc. COVID-19 Serology IgM ELISA	Not FDA Authorized	H
Plexense, Inc. ACCEL ELISA COVID-19	Not FDA Authorized	H
DiaSorin Inc. LIAISON SARS-CoV-2 IgM	FDA Authorized	H, M
Qualigen, Inc. FastPack® SARS-CoV-2 IgG Immunoassay	Not FDA Authorized	H
Genelogic Research Limited Genelogic COVID-19 IgM/IgG Antibody Rapid Test	Not FDA Authorized	H
SA Scientific Ltd. SAS™ COVID-19 Total Antibody Detection Test	Not FDA Authorized	H
Shin Jin Medics Inc. DIAKEY COVID-19 IgM/IgG Rapid Test	Not FDA Authorized	H
AnyGo Technology Co., Ltd: COVID-19 Capture ELISA Assay	Not FDA Authorized	H
Pharmact GmbH, BelTEST It SARS CoV-2 IgM/IgG Rapid Test (Pharmact CoV-2 Rapid Test)	Not FDA Authorized	H
Shandong ThinkLab Biotechnology Co., Ltd.: 2019-nCoV IgM/IgG antibody Test Kit (Colloidal-gold Assay)	Not FDA Authorized	H
Biosynex SA Biosynex COVID-19 BSS	Not FDA Authorized	H
Gold Standard Diagnostics INgezim® COVID 19 DR ELISA Test Kit	Not FDA Authorized	H
Siemens Healthcare Diagnostics Inc. ADVIA Centaur® SARS-CoV-2 IgG (COV2G)	FDA Authorized	H, M
Micropoint Biosciences, Inc. mLabs® SARS-CoV-2 IgG and IgM Assay	Not FDA Authorized	H
Promega Corporation Lumit™ Dx SARS-CoV-2 Immunoassay	Not FDA Authorized	H
AI DE Diagnostic Co., Ltd. SARS-CoV-2 IgG/IgM Antibody Test	Not FDA Authorized	H
Bethyl Laboratories, Inc. Bethyl SARS-CoV-2 IgG IVD ELISA	Not FDA Authorized	H
Epitope Diagnostics, Inc. EDI COVID-19 Nucleocapsid IgG Quantitative ELISA Kit	Not FDA Authorized	H
Newscen Coast Bio-Pharmaceutical Co., Ltd. COVID-19 Microfluidic Combo Test	Not FDA Authorized	H
VirIntel, LLC VirIntel COVID-19 Antibody Test	Not FDA Authorized	H
AdvanSure™ SARS-CoV-2 IgG (S1) ELISA	Not FDA Authorized	H
Victory Square Health Canada, Inc. Safetest-COVID19 IgG / IgM - Elisa Kit	Not FDA Authorized	H
Qiagen GmbH Access Anti-SARS-CoV-2 Total Test	Not FDA Authorized	H
LG Chem, Ltd., AdvanSure™ SARS-CoV-2 IgG(S1) ELISA	Not FDA Authorized	H
Freedom For All Diagnostics™, Inc SARS-CoV-2 IgM/IgG Antibody Assay Kit	Not FDA Authorized	H
Beckman Coulter, Inc. Access SARS-CoV-2 IgM test, Access SARS-CoV-2 IgM Calibrators, and Access SARS-CoV-2 IgM QC	Not FDA Authorized	H
ClearSign Diagnostics Co., LLC ClearSign Diagnostics SARS-CoV-2 Antibody (IgM and IgG) Test	Not FDA Authorized	H
Excelsior Bio-System, Inc. EBSALERT SARS-CoV-2 Antibody Rapid test	Not FDA Authorized	H
Horizon Pharmaceuticals, Inc. Horizon RDT SARS CoV-2 IgM/IgG Antibody Test	Not FDA Authorized	H
AESKU.DIAGNOSTICS GmbH & Co. KG AESKULISA® SARS-CoV-2 NP IgG	Not FDA Authorized	H
CareHealth America Corporation CoviCheck™ COVID-19 IgM/IgG Antibody Test	Not FDA Authorized	H
AESKU.DIAGNOSTICS GmbH & Co. KG AESKULISA® SARS-CoV-2 NP IgM	Not FDA Authorized	H
Gold Standard Diagnostics INgezim® COVID 19 CROM Rapid Test Kit	Not FDA Authorized	H
Nirmidas Biotech, Inc. MidaSpot™ COVID-19 Antibody Combo Detection Kit	Not FDA Authorized	H
Monarch Global Health LLC Magellan IgM and IgG Antibody Rapid Test Kit for Serum	Not FDA Authorized	H
ProGnosis Biotech SA Bio-Shield 2019-nCoV Total Ig ELISA	Not FDA Authorized	H
ProGnosis Biotech SA Rapid Test 2019-nCoV Total Ig S	Not FDA Authorized	H
Spartacus-Biomed LFA COVID-19 IgG & IgM Rapid Test Device	Not FDA Authorized	H
ADVAITE, Inc. RapCov™ COVID-19 Rapid Test	Not FDA Authorized	H
Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Strip Format)	Not FDA Authorized	H
One Lambda, Inc. LABScreen™ COVID Plus	Not FDA Authorized	H
Biomerica, Inc. COVID-19 IgG ELISA Test	Not FDA Authorized	H
Diabetomics, Inc CovAbScreen™ SARS-CoV-2 Ab Test	Not FDA Authorized	H
Absology Co., Ltd. Absoludy COVID-19 IgM/IgG RAPID	Not FDA Authorized	H
Absology Co., Ltd. INIST COVID-19 IgM/IgG RAPID	Not FDA Authorized	H
MBio Diagnostics, Inc. LightDeck® COVID-19 Total Antibody Test	Not FDA Authorized	H
Bloom Diagnostics AG Bloom COVID-19 Test	Not FDA Authorized	H
Absology Co., Ltd. Absoludy COVID-19 IgM/IgG Combo	Not FDA Authorized	H
DNALink, Inc. AccuFind COVID19 IgG	Not FDA Authorized	H
Medicon Company Limited Trueline COVID-19 IgG/IgM Rapid Test	Not FDA Authorized	H
Nanomix, Inc. Nanomix eLab® COVID-19 Rapid IgG/IgM Panel	Not FDA Authorized	H
Qiagen GmbH QIAreach™ Anti-SARS-CoV-2 Total Test	Not FDA Authorized	H
Phadia AB EliA SARS-CoV-2-Sp1 IgG Test	Not FDA Authorized	H
NOW Diagnostics, Inc. ADEXUSDx® COVID-19 Test	Not FDA Authorized	H
Victory Square Health, Inc. Safetest Covid-19 IgG/IgM Rapid Test	Not FDA Authorized	H
Top Biotech Sdn. Bhd TOP RAPID COVID-19 Rapid Antibody IgG/IgM Test Kit	Not FDA Authorized	H
Leinco Technologies, Inc. COVID-19 Trace™ IgG MICRO-ELISA	Not FDA Authorized	H
Shenzhen Kingfocus Biomedical Engineering Co., Ltd. True-Dot™ Novel Coronavirus (2019-nCoV) IgM/IgG Rapid Antibody Detection Kit (Quantum Dot Immunochromatography)	Not FDA Authorized	H
bioLytical Laboratories, Inc. INSTI® COVID-19 Antibody Test and INSTI® COVID-19 Test Controls	Not FDA Authorized	H
LG Chem, Ltd AdvanSure™ SARS-CoV-2 IgG(RBD) ELISA	Not FDA Authorized	H
Truvian Sciences Inc. Easy Check COVID-19 IgM/IgG™ POC Antibody Test	Not FDA Authorized	H
Newscen Bio-Pharmaceutical Co., Ltd. COVID-19 Microfluidic IgG/IgM Test	Not FDA Authorized	H

¹ Settings for use include the following:

• H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
• M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
• W - Patient care settings operating under a CLIA Certificate of Waiver.

Q: I am offering COVID-19 testing with an EUA-authorized test kit. Should I notify FDA? (Updated 6/1)

A: No. Notification is intended for tests being offered under certain policies in the FDA's Policy for Coronavirus Disease-2019 Tests. In those cases, FDA expects notification from laboratories intending to offer tests they have developed and commercial manufacturers intending to distribute test kits they have developed. FDA does not expect any notification or EUA request from laboratories that are performing testing using EUA-authorized test kits purchased from commercial manufacturers or their distributors. Facilities performing COVID-19 testing must be certified under the Clinical Laboratory Improvement Amendments, or CLIA, which is administered by CMS. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/

Laboratories authorized to use EUA-authorized tests are subject to various conditions that can be found in the EUA.

Each EUA also includes the settings in which the test is authorized. For ease of reference, the settings authorized in the EUAs are also noted in the EUA table on the EUA page. Tests that are noted with an "H" in the Authorized Settings are limited to use in laboratories certified under CLIA that meet requirements to perform high-complexity tests. Tests that are noted with an "H" and "M" in the Authorized Settings may be performed in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests. Tests that are noted with a "W" in the Authorized Settings are deemed to be CLIA-waived for use in patient care settings operating under a CLIA Certificate of Waiver. Tests noted with an "H," "M," and "W may be used in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests and in patient care settings operating under a CLIA Certificate of Waiver.

Q: I am offering COVID-19 testing with a test kit listed on the notification lists for tests being offered under the policy in Section IV.C or IV.D in the Policy for Coronavirus Disease-2019 Tests. Should I notify FDA? (Updated 6/1)

A: No. As stated in the Policy for Coronavirus Disease-2019 Tests, laboratories that are performing testing using the test kits of commercial manufacturers that have notified FDA as outlined in the guidance should not separately notify FDA.

Facilities performing COVID-19 testing must be certified under the Clinical Laboratory Improvement Amendments, or CLIA, which is administered by CMS. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/

Test kits being offered prior to an EUA under the policies outlined in the FDA's Policy for Coronavirus Disease-2019 Tests have not yet been reviewed by the FDA, are not FDA authorized, and have not received a CLIA categorization. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.

Laboratories offering such tests may be subject to additional requirements regarding establishment of performance specifications under the CLIA Regulations. Laboratories with questions about these requirements should contact CMS at LabExcellence@cms.hhs.gov.

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What Tests Should No Longer Be Used and/or Distributed for COVID-19?

Q: What laboratories that had previously provided notification to FDA that they had developed and validated a diagnostic SARS-CoV-2 test under the policy outlined in Section IV.A of the Policy for Coronavirus Disease-2019 Tests have now been removed from that notification list because FDA has determined the test should no longer be used? (Updated 9/25)

The laboratories in the list below provided notification to the FDA that they developed and validated a diagnostic SARS-CoV-2 test as set forth in Section IV.A of the Policy for Coronavirus Disease-2019 Tests. Although the FDA had previously included them on the website notification list of laboratories offering diagnostic tests under that policy, they have now been removed from that notification list and placed on the list below. As noted in the guidance, among other things, if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner, the FDA intends to remove the laboratory from the notification list. FDA has determined that there are significant problems with the tests being offered by the laboratories listed below that cannot be or have not been addressed in a timely manner. As such, these laboratories have now been removed from the notification list and placed on the removal list below.

The FDA expects that laboratories on this list will not offer or use their diagnostic SARS-CoV-2 laboratory developed test that was previously on the notification list. Other tests that are EUA authorized may be available for use by these laboratories, in accordance with those EUAs.

Laboratory	Status
ChemiSys Laboratories	Removed - Should Not Be Used
Mayo Clinic Arizona	Removed - Should Not Be Used

Q: What commercial manufacturers of diagnostic tests that had previously provided notification to FDA under the policy outlined in Section IV.C of the Policy for Coronavirus Disease-2019 Tests have now been removed from that notification list and should no longer be offering that test? (New 10/19)

The commercial manufacturers in the list below provided notification to the FDA that they validated and intended to distribute a diagnostic test as set forth in Section IV.C of the Policy for Coronavirus Disease-2019 Tests. The FDA had previously included them on the website notification list of commercial manufacturers distributing diagnostic test kits under that policy, but they have now been removed from that notification list and placed on the list below. As noted in the guidance, if an EUA request is not submitted by a commercial manufacturer of a diagnostic test within a reasonable period of time, or if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner, the FDA intends to remove the manufacturer and test from the notification list. Commercial manufacturers may also voluntarily withdraw their test notification, and such tests are noted with an asterisk.

The FDA expects that the tests on this list will not be distributed unless and until an EUA is issued for the test, and the FDA may take additional actions as appropriate.

Manufacturer	Test	Status
Advanced Biological Laboratories (ABL) S.A.	UltraGene Combo2Screen SARS-CoV-2 Assay	Removed - Should Not Be Distributed *
SUREDX	V-CHEK Coronavirus (SARS-CoV-2) Antigen Detection Kit	Removed - Should Not Be Distributed
MatMaCorp	MatMaCorp COVID-19 Test kit (used on the Solas 8)	Removed - Should Not Be Distributed *
Alpha Pharma Service srl	IRIS SARS-CoV-2 IgG/IgM Rapid Test	Removed - Should Not Be Distributed

Q: What commercial manufacturers of serological tests that had previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests have now been removed from that notification list and should no longer be offering that test? (Updated 10/21)

The commercial manufacturers in the list below provided notification to the FDA that they validated and intended to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. The FDA had previously included them on the website notification list of commercial manufacturers distributing serology test kits under that policy, but they have now been removed from that notification list and placed on the list below. As noted in the guidance, if an EUA request is not submitted by a commercial manufacturer of a serology test within a reasonable period of time, or if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner, the FDA intends to remove the manufacturer and test from the notification list. Commercial manufacturers may also voluntarily withdraw their test notification, and such tests are noted with an asterisk.

The FDA expects that the tests on this list will not be distributed unless and until an EUA is issued for the test, and the FDA may take additional actions as appropriate.

Recommendations for clinical laboratories and health care providers regarding these tests may be found in the FDA's June 19, 2020, Letter to Clinical Laboratory Staff and Health Care Providers.

Manufacturer	Test	Status
Anhui Deepblue Medical Technology Co., Ltd.	COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold)	Removed - Should Not Be Distributed
Artron BioResearch Inc./ Artron Laboratories Inc.	COVID-19 IgM/IgG Antibody Test	Removed - Should Not Be Distributed*
BestNovo (Jiangsu) Medical Technology Co., Ltd.	BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit	Removed - Should Not Be Distributed
Biobase Biodustry (Shandong) Co., Ltd.	SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)	Removed - Should Not Be Distributed
BioMedomics, Inc.	COVID-19 IgM-IgG rapid test	Removed - Should Not Be Distributed*
Bioscience(Chongqing) Diagnostic Technology Co., Ltd.	Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody	Removed - Should Not Be Distributed
Bioscience(Chongqing) Diagnostic Technology Co., Ltd.	Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody	Removed - Should Not Be Distributed
Bioscience(Tianjin) Diagnostic Technology Co., Ltd.	Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgM Antibody	Removed - Should Not Be Distributed
Bioscience(Tianjin) Diagnostic Technology Co., Ltd.	Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgG Antibody	Removed - Should Not Be Distributed
Pure Genetic Medical Ltd. (Distributed Boson Biotech Ltd. Co)	Rapid 2019-nCoV IgG/IgM Combo Test Card	Removed - Should Not Be Distributed
Changchun Wancheng Bio-Electron Co., Ltd.	COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography)	Removed - Should Not Be Distributed
Diazyme Laboratories, Inc.	Diazyme SARS-CoV-2 Antibody Rapid Test	Removed - Should Not Be Distributed*
Genlantis Diagnostics, Inc.	CovidQuik Coronavirus (COVID-19) IgM/IgG Antibody Test	Removed - Should Not Be Distributed*
Hangzhou Clongene Biotech Co., Ltd.	COMBRA COVID-19 IgM/IgG Rapid Test Cassette	Removed - Should Not Be Distributed
Hangzhou Testsea Biotechnology Co., Ltd.	One Step SARS-CoV2(COVID-19) IgG/IgM Test	Removed - Should Not Be Distributed*
Hunan RunKun Pharmaceutical Co., Ltd.	SARS-CoV-2 lgM/lgG Test Kit (Colloidal Gold)	Removed - Should Not Be Distributed*
Jiangsu Eubo Biotechnology Co., Ltd.	EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)	Removed - Should Not Be Distributed
Lifeassay Diagnostics (Pty) Ltd	Test-it COVID-19 IgM/IgG Lateral Flow Assay	Removed - Should Not Be Distributed
Phamatech	COVID19 IgG / IgM Rapid Test	Removed - Should Not Be Distributed*
Promedical	COVID-19 Rapid Test	Removed - Should Not Be Distributed
Saladax Biomedical	COVID-19 IgG/IgM Rapid Antibody Test	Removed - Should Not Be Distributed*
Shanghai Eugene Biotech Co., Ltd.	SARS-CoV2 (COVID-19) IgG/IgM Rapid Test	Removed - Should Not Be Distributed
Shenzen Landwind Medical Co., Ltd.	COVID-19 IgG/IgM Rapid Test	Removed - Should Not Be Distributed*
VITA Testing	COVID-19 IgM/IgG Antibody Rapid Test Kit	Removed - Should Not Be Distributed
Zhengzhou Fortune Bioscience Co., Ltd.	COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)	Removed - Should Not Be Distributed
Zhengzhou Fortune Bioscience Co., Ltd.	COVID-19 IgM Antibody Rapid Test Kit	Removed - Should Not Be Distributed
Zhengzhou Fortune Bioscience Co., Ltd.	COVID-19 IgG Antibody Rapid Test Kit	Removed - Should Not Be Distributed
Zhongshan Bio-Tech Co Ltd.	SARS-CoV-2 IgM/IgG (GICA)	Removed - Should Not Be Distributed*
Zhuhai Encode Medical Engineering Co., Ltd	Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device	Removed - Should Not Be Distributed*
IMMY, Inc.	clarus SARS-CoV-2 Total Antibody EIA	Removed - Should Not Be Distributed*
Beijing Decombio Biotechnology Co., Ltd.	Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood)	Removed - Should Not Be Distributed*
Beroni Group	SARS-CoV-2 IgG/IgM Antibody Detection Kit	Removed - Should Not Be Distributed
Tianjin Beroni Biotechnology Co. Ltd	SARS-CoV-2 IgG/IgM Antibody Detection Kit	Removed - Should Not Be Distributed
Calbiotech, Inc.	ErbaLisa® COVID-19 IgG	Removed - Should Not Be Distributed
ACCOBiotech SDN.BHD	ACCO COVID-19 IgM/IgG TEST	Removed - Should Not Be Distributed
Innovation Biotech (Beijing) Co., Ltd.	SARS-COV-2 IgM/IgG Antibody Rapid Test (Immunochromatographic Method)	Removed - Should Not Be Distributed
W.H.P.M., Inc.	COVID-19 IgM/IgG Rapid Test	Removed - Should Not Be Distributed
W.H.P.M., Inc.	COVISURE™ COVID-19 IgM/IgG Rapid Test	Removed - Should Not Be Distributed
Sure Bio-tech	API Covid-Rapid IgM/IgG Antibody Test Kit	Removed - Should Not Be Distributed
Nantong Egens Biotechnology Co., Ltd	EGENS COVID-19 IgG/IgM Rapid Test Kit	Removed - Should Not Be Distributed
Suzhou Kangheshun Medical Technology Co., Ltd	SARS-CoV-2 IgG/IgM Rapid Test Cassette	Removed - Should Not Be Distributed
Aurora Biomed Inc.	COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold)	Removed - Should Not Be Distributed
Chembio Diagnostic Systems, Inc.	DPP COVID-19 IgM/IgG System	Removed - Should Not Be Distributed
Getein Biotech Inc.	One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)	Removed - Should Not Be Distributed
Guangdong Hecin Scientific, Inc.	SARS-CoV-2 IgM Antibody Rapid Test Kit	Removed - Should Not Be Distributed*
Fosun Pharma USA Inc.	Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit	Removed - Should Not Be Distributed*
Atlas Link (Beijing)Technology Co., Ltd	NovaTest: One Step COVID-19 IgG/IgM rapid test	Removed - Should Not Be Distributed
SD Biosensor	STANDARD Q COVID-19 IgM/IgG Duo	Removed - Should Not Be Distributed
Audacia Bioscience	CMC-19D SARS-CoV2 (COVID-19) Rapid Antibody Test	Removed - Should Not Be Distributed
JOYSBIO (Tianjin) Biotechnology Co., Ltd.	COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)	Removed - Should Not Be Distributed
BioSys Laboratories, Inc.	BioSys Plus COVID-19 IgM/IgG Rapid Test	Removed - Should Not Be Distributed
ICT international	2019-nCoV IgG/IgM Rapid Test Cassette	Removed - Should Not Be Distributed*
One Milo, Inc.	InstantRapid® SARS CoV-2 IgG IgM Test	Removed - Should Not Be Distributed
Nanjing Vazyme Medical Technology Co., LTD.	2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based)	Removed - Should Not Be Distributed*
Zhuhai Livzon Diagnostics, Inc.	Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)	Removed - Should Not Be Distributed*
Alfa Scientific Designs, Inc.	Clarity COVID-19 IgG/IgM Antibody Test	Removed - Should Not Be Distributed
Alfa Scientific Designs, Inc.	Instant-view plus COVID-19 IgG/IgM Antibody Test	Removed - Should Not Be Distributed
Biolidics Limited	2019-nCoV IgG/IgM Detection Kit (Colloidal Gold)	Removed - Should Not Be Distributed*
Guangzhou Fenghua Bioengineering Co., Ltd.	SARS-CoV-2 IgG/IgM Rapid Test	Removed - Should Not Be Distributed
Guangzhou Decheng biotechnology	DOCHEK™ SARS-CoV-2 Antibody Rapid Test Kit	Removed - Should Not Be Distributed
Biomerica, Inc.	COVID-19 IgG/IgM Rapid Test	Removed - Should Not Be Distributed
Safecare Biotech (Hagzhou) Co., Ltd.	SAFECARE COVID-19 IgG/IgM Rapid Test Device	Removed - Should Not Be Distributed
RayBiotech Life, Inc.	Novel Coronavirus (SARS-CoV-2) IgM and IgG Antibody Detection Kits for Serum	Removed - Should Not Be Distributed
RayBiotech Life, Inc.	Novel Coronavirus (SARS-CoV-2) IgM and IgG Dual Combined Antibody Detection Kit for Serum	Removed - Should Not Be Distributed
Abbexa Ltd	abx294171 - COVID-19 IgG/IgM Rapid Test Kit	Removed - Should Not Be Distributed
H-Guard (China) Co., Ltd.	Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold)	Removed - Should Not Be Distributed*
Vivera Pharmaceuticals, Inc.	Vivera Pharma COVID-19 Rapid Test	Removed - Should Not Be Distributed*
Lepu Medical Technology (Beijing) Co., Ltd.	Lepu SARS-CoV-2 Antibody Rapid Test	Removed - Should Not Be Distributed
Camtech Diagnostics Pte Ltd	Camtech Covid-19 IgM/IgG 2C Rapid Test	Removed - Should Not Be Distributed
Camtech Diagnostics Pte Ltd	Camtech Covid-19 IgM/IgG 1C Rapid Test	Removed - Should Not Be Distributed
Discount Diagnostics	Global WholeHealth Partners RDT IgG/IgM Antibody test	Removed - Should Not Be Distributed
GenBody Inc.	GenBody COVID-19 IgM/IgG	Removed - Should Not Be Distributed
Invenio Medical	COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)	Removed - Should Not Be Distributed
Invenio Medical	COVID-19 IgG/IgM Ab Rapid Test	Removed - Should Not Be Distributed
Pinnacle Biolabs	SARS-CoV-2 IgG/IgM Rapid Test	Removed - Should Not Be Distributed
Universal Meditech Inc.	DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test	Removed - Should Not Be Distributed
Gold Standard Diagnostics	SARS-CoV-2 IgM ELISA Test Kit	Removed - Should Not Be Distributed
Edinburgh Genetics Limited	ActivXpress+ COVID-19 IgG/IgM Immunoassay Complete Testing Kit	Removed - Should Not Be Distributed
Sure Bio-Tech	API Pharma Covid-Rapid IgM/IgG Antibody Test	Removed - Should Not Be Distributed
Tianjin New Bay Bioresearch Co., Ltd.	Quikpac II COVID-19 IgG/IgM	Removed - Should Not Be Distributed
Boston Biopharma Inc.	BB Rapid-MT	Removed - Should Not Be Distributed*
Wuhan EasyDiagnosis	Ediagnosis COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test	Removed - Should Not Be Distributed
Leritas LLC	DualTec SARS-CoV-2 Test Kit	Removed - Should Not Be Distributed*
PCL Inc.	COVID19 IgG/IgM Rapid Gold	Removed - Should Not Be Distributed
Sugentech, Inc.	SGTi-flex COVID-19 IgM/IgG	Removed - Should Not Be Distributed*
NanoEntek, Inc.	FREND COVID-19 IgG/IgM Duo	Removed - Should Not Be Distributed*
Naturitious LLC	Viralert COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT	Removed - Should Not Be Distributed*
Jiangsu Dablood Pharmaceutical Co. Ltd.	COVID-19 IgM/IgG Rapid Test	Removed - Should Not Be Distributed
Xiamen AmonMed Biotechnology Co., Ltd.	Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold)	Removed - Should Not Be Distributed
Genobio Pharmaceutical Co., Ltd.	COVID-19 IgM/IgG Lateral Flow Assay	Removed - Should Not Be Distributed*
Arbor Vita Corporation	CoVisa IgG Test	Removed - Should Not Be Distributed
Shanghai Outdo Biotech Co., Ltd.	Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test	Removed - Should Not Be Distributed*
ZEUS Scientific, Inc.	ZEUS Rapid SARS-CoV-2 IgM/IgG Test System	Removed - Should Not Be Distributed*
Autobio Diagnostics Co. Ltd.	Anti-SARS-CoV-2 Rapid Test	Removed - Should Not Be Distributed
Beijing DiaGreat Biotechnologies Co. Ltd.	2019-nCoV IgM Antibody Determination Kit	Removed - Should Not Be Distributed*
Beijing DiaGreat Biotechnologies Co. Ltd.	2019-nCoV IgG/IgM Antibody Rapid Test Kit	Removed - Should Not Be Distributed*
Beijing DiaGreat Biotechnologies Co. Ltd.	2019-nCoV IgG Antibody Determination Kit	Removed - Should Not Be Distributed*
Chemtron Biotech, Inc.	Chemtrue®Rapid COVID-19 IgM/IgG Antibody Test	Removed - Should Not Be Distributed
Asan Pharmaceutical Co., Ltd.	Asan Easy Test COVID-19 IgG/IgM	Removed - Should Not Be Distributed*
Jiangsu Superbio Biomedical (Nanjing) Co., Ltd.	SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)	Removed - Should Not Be Distributed*
Jiangsu Superbio Biomedical (Nanjing) Co., Ltd.	ThermoGenesis SARS-CoV-2(COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)	Removed - Should Not Be Distributed*
Shanghai Fosun Long March Medical Science Co., Ltd.	Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit	Removed - Should Not Be Distributed*
GREEN ENERGY TECHNOLOGY SOLUTIONS, LLC	AMP Rapid Test SARS-CoV-2 IgG/IgM	Removed - Should Not Be Distributed*
Telepoint Medical Services	SARS-CoV-2 IgG/IgM Rapid Qualitative Test	Removed - Should Not Be Distributed
Vitro Diagnostics	Vitro Diagnostics COVID 19 IgG/IgM Rapid Test Cassette Serology Device	Removed - Should Not Be Distributed
Nano-Ditech Corporation	Nano-Check COVID-19 IgG/IgM Antibody Test	Removed - Should Not Be Distributed*
Melbourne Biotech	MB COVID-19 Antibody Detection Kit	Removed - Should Not Be Distributed
Wuhu 3H Biotechnology Co. Ltd.	COVID-19 IgG/IgM Test Kit (Colloidal Gold Method)	Removed - Should Not Be Distributed
Shijiazhuang Hipro Biotechnology Co., Ltd.	COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold)	Removed - Should Not Be Distributed
Sinocare, Inc.	SARS-CoV-2 Antibody Test Kit (Colloidal Gold Method)	Removed - Should Not Be Distributed
Antibody BioPharm, Inc.	COVID-19 IgM/IgG POCT Kit (Colloidal Gold)	Removed - Should Not Be Distributed*
Axium BioResearch, Inc.	AxiumHealth COVID-19 IgG/IgM Antibody Test	Removed - Should Not Be Distributed*
PerGrande BioTech Development Co., Ltd.	SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay)	Removed - Should Not Be Distributed*
Beijing Kewei Clinical Diagnostic Reagent Inc.	Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit	Removed - Should Not Be Distributed
Pacific Connect Group LLC (US)	SARS-CoV-2 IgG/IgM Rapid Test Kit	Removed - Should Not Be Distributed
Sober Holdings, LLC	ProMed Rapid Testing - COVID-19 IgG/IgM Test Kit	Removed - Should Not Be Distributed
Arbor Assays	DetectX SARS-CoV-2 IgG ELISA Kit	Removed - Should Not Be Distributed*
TM Testing, Inc.	TM Test Kits, CoVID-19 Rapid Antibody Serology Test	Removed - Should Not Be Distributed
Genesprint Group, Ltd.	Genesprint Diagnostic Kit for IgG/IgM Antibody to SARS-CoV-2 test	Removed - Should Not Be Distributed*
Reszon Diagnostics International Sdn. Bhd.	RESZON (COVID-19) (Sars-Cov-2) IgG/IgM Antibody Test	Removed - Should Not Be Distributed*
Reszon Diagnostics International Sdn. Bhd.	Reszon COVID-19 Rapid IgG/IgM Test	Removed - Should Not Be Distributed*
Sober Holdings, LLC	ProMed Rapid Test	Removed - Should Not Be Distributed
Zalgen Labs, LLC.	ReSARS CoV-2 (N) IgG ELISA	Removed - Should Not Be Distributed*
Nanjing Weiyun Biotechnology Co., Ltd.	SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)	Removed - Should Not Be Distributed
Zhuhai Keyu Biological Engineering Co., Ltd.	SARS-CoV-2 IgG/IgM Rapid Test Kit	Removed - Should Not Be Distributed
LumiQuick Diagnostics, Inc.	QuickProfile™ 2019-nCoV IgG/IgM Antibody Test	Removed - Should Not Be Distributed
MedicalSystem Biotechnology Co., Ltd.	Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit	Removed - Should Not Be Distributed*
GeneScan Diagnostics, LLC	AmeriDx® SARS-CoV-2 IgG/IgM Rapid Test Kit	Removed - Should Not Be Distributed
GeneScan Diagnostics, LLC	AmeriDx® SARS-CoV-2 IgG/IgM-T Antibody Rapid Test Kit	Removed - Should Not Be Distributed
Hangzhou Realy Tech Co Ltd.	2019-nCOV IgG/IgM Rapid Test	Removed - Should Not Be Distributed
Shenzhen Lvshiyuan Biotechnology Co., Ltd	COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit	Removed - Should Not Be Distributed
Sensing Self Pte. Ltd.	COVID-19 Rapid IgM/IgG Combined Antibody Assay Pre-Screening Kit	Removed - Should Not Be Distributed
EpiGentek	SeroFlash SARS-CoV-2 IgM/IgG Antibody Detection Kit	Removed - Should Not Be Distributed*
CoreMedica Laboratories, Inc.	Capillary Blood Collection Kit & Laboratory Analysis for SARS-CoV-2 ELISA IgG and IgM	Removed - Should Not Be Distributed
Oncosem Onkolojik Sistemler San.ve Tic. A.S	CRT (COVID-19 Rapid Test)	Removed - Should Not Be Distributed*
TheraTest Laboratories, Inc.	EL-Anti-SARS-CoV-2 IgG	Removed - Should Not Be Distributed*
Mokobio Biotechnology R&D Center	SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay	Removed - Should Not Be Distributed*
ProteomeTech Inc.	KOVIcheck COVID-19 IgG/IgM	Removed - Should Not Be Distributed*
BreviTest Technologies, LLC	Brevitest SARS-CoV-2 IgG Test	Removed - Should Not Be Distributed*
Cell ID Pte Ltd	Smart COVID-19 IgM/IgG Rapid Diagnostic Test (RDT)	Removed - Should Not Be Distributed*
Profarma, UAB	ProRapid Coronavirus Disease (SARS-CoV-2) IgG/IgM Rapid Test Cassette Single Use Kit	Removed - Should Not Be Distributed
EACHY Biopharmaceuticals Co., Ltd.	AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay)	Removed - Should Not Be Distributed
EACHY Biopharmaceuticals Co., Ltd.	AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)	Removed - Should Not Be Distributed
Xiamen Wiz Biotech Co., Ltd.	Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2	Removed - Should Not Be Distributed
EUROIMMUN AG	Anti-SARS-CoV-2 ELISA (IgA)	Removed - Should Not Be Distributed*
EACHY Biopharmaceuticals Co., Ltd.	SmartScreen COVID-19 IgM/IgG Test Kit	Removed - Should Not Be Distributed
AngelWorld Biotech Manufacturing FZ LLC	AngelWorld V2.0 COVID-19 IgG/IgM Antibody Rapid Test	Removed - Should Not Be Distributed
Bioscience(Tianjin) Diagnostic Technology Co., Ltd.	Novel Coronavirus (2019-nCoV) Antibody Rapid Test	Removed - Should Not Be Distributed
ScheBo® • Biotech AG ScheBo®	SARS-CoV-2 Quick	Removed - Should Not Be Distributed*
Newscen Coast Bio-Pharmaceutical Co., Ltd.	COVID-19 Microfluidic Combo Test	Removed - Should Not Be Distributed
Nantong Diagnos Biotechnology Co., Ltd.	(2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)	Removed - Should Not Be Distributed

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General FAQs

Q: What are FDA's priorities with respect to review of EUA requests for COVID-19 tests? (New 10/7)

A: We are currently in a different phase of the pandemic with respect to tests than we were previously, where many COVID-19 tests are now authorized to be run in labs.  We prioritize review of EUA requests for tests taking into account a variety of factors, including those discussed in the Emergency Use Authorization of Medical Products and Related Authorities Guidance, such as the public health need for the product and the availability of the product. We have, for example, prioritized review of EUA requests for tests where authorization would increase testing accessibility (e.g., point of care (POC) tests, home collection tests, at-home tests) or would significantly increase testing capacity (e.g., tests that reduce reliance on test supplies, high-throughput, widely distributed tests). In light of this and the recent HHS announcement that FDA will not require premarket review of LDTs, to make the best use of our resources for the greatest public health benefit, FDA is  declining to review EUA requests for LDTs at this time. FDA continues to prioritize review of EUA requests for POC tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, widely distributed tests.

Q: I submitted a pre-EUA or EUA request for a COVID-19 test. How long will the review take? (New 6/17)

A: During this unprecedented public health emergency, the Agency has received an exceedingly high volume of EUA requests and is working as quickly as possible to review each request. There are hundreds of pre-EUA and EUA requests for COVID-19 tests under review and FDA continues to receive new submissions on a daily basis. To address this high volume of work, we have brought in additional scientific review staff to double the number of teams working on submissions; and we have implemented a triage program to prioritize submissions based on several factors. As a result of these efforts, by June 1, 2020, FDA had authorized over 125 diagnostic and serological tests, far exceeding the number of test EUAs issued during previous emergencies.

As explained in FDA's guidance "Emergency Use Authorization of Medical Products and Related Authorities," starting on page 18, FDA prioritizes EUA requests based on several factors that include, but are not limited to, the public health need of the product (e.g., point-of-care; high throughput), the extent to which the product would serve a significant unmet medical need (e.g., at-home specimen collection; at-home testing), and the availability and adequacy of the information concerning the likelihood that the product may be safe and effective in preventing, treating, or diagnosing the condition, as well as the availability of the product (e.g., the quantity and manufacturing capacity).

FDA strives to review Pre-EUA and EUA requests as quickly as we can. FDA will communicate with each sponsor regarding its pre-EUA or EUA request as soon as possible. The review team will be in contact with you when their review is complete or if there are questions. If you have not yet been assigned a lead reviewer for your pre-EUA or EUA request, we recommend that you refer to the available resources to help you with your planning and submitting your EUA request:

• SARS-CoV-2 IVD EUAs (Letters of Authorization and Instructions for Use/EUA Summaries)
• EUA Templates with recommendations to help facilitate EUA requests, as explained in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
• FAQs on Testing for SARS-CoV-2

Additionally, FDA's Policy for Coronavirus Disease-2019 Tests guidance includes recommendations intended to help accelerate the availability of COVID-19 tests in the United States for the duration of the public health emergency under certain circumstances. As explained in this policy, FDA does not intend to object to the development, distribution, and use of some tests prior to or without an EUA, as outlined in the guidance. Please refer to this policy for more information.

Q: When FDA authorizes under an EUA a SARS-CoV-2 test for use at the point of care, does that mean it is CLIA waived? (Updated 5/9)

A: Yes. The settings in which an EUA-authorized test may be used are described in the Letter of Authorization. As discussed in the Guidance for Industry and Other Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities, when the FDA authorizes tests for use at the point of care (including SARS-CoV-2 point of care test systems) under an EUA, such tests are deemed to be CLIA waived tests. Accordingly, for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

We note that the term point of care in the EUAs may include settings such as hospitals, physician offices, urgent care, outreach clinics, pharmacies, and temporary patient care settings that have appropriately trained personnel to perform the test and are operating under a CLIA Certificate of Waiver or Certificate of Compliance. These terms generally do not apply to home specimen collection or at home testing unless otherwise specified.

Q: When tests are offered prior to or without an EUA under the FDA's Policy for Coronavirus Disease-2019 Tests, what is their CLIA categorization?

A: Tests being offered prior to or without an EUA under the policies outlined in the FDA's Policy for Coronavirus Disease-2019 Tests have not yet been reviewed by the FDA, are not FDA authorized, and have not received a CLIA categorization. While FDA has indicated that such tests may be appropriate for use in clinical laboratories and by healthcare workers at the point of care, the policies in the Policy for Coronavirus Disease-2019 Tests do not provide a CLIA categorization and do not override any CLIA requirements. Therefore, in accordance with CLIA, tests offered under these policies are considered high complexity by default until or unless they are authorized and deemed to be appropriate, through an EUA authorization or general FDA review processes, to be performed as moderate or waived complexity tests.

Laboratories using tests being marketed under the FDA's EUA policy should be mindful of CLIA requirements which are enforced by CMS and certain State authorities, and CMS guidance for laboratories during the COVID-19 public health emergency. Under CMS guidance, if a facility has the appropriate CLIA certificates and follows applicable CLIA regulations, state regulations and guidelines, the laboratory's CLIA certificate can be extended to cover testing in areas outside of the designated primary site or home base such as contiguous buildings, or any other designated temporary overflow location in its facility or temporary remote location, such as a parking lot. https://www.cms.gov/files/document/qso-20-21-clia.pdf-0

Q: What is the difference between surveillance, screening, and diagnostic testing for COVID-19 testing? (New 7/2)

A: Surveillance for COVID-19 includes ongoing systematic activities, including collection, analysis, and interpretation of health-related data, essential to planning, implementing, and evaluating public health practice. It is generally used to monitor for an occurrence, such as an infectious disease outbreak, in a population or community, or to characterize the occurrence once detected, such as looking at the incidence and prevalence of the occurrence. Surveillance testing is primarily used to gain information at a population level, rather than an individual level. Surveillance testing may be random sampling of a certain percentage of a specific population to monitor for increasing or decreasing prevalence and determining the population effect from community interventions such as social distancing. FDA generally does not regulate surveillance testing. An example of surveillance testing is a testing plan developed by a State Public Health Department to randomly select and sample 1% of all individuals in a city on a rolling basis to determine local infection rates and trends.

If at any time a patient specific result is to be reported by a facility, it must first obtain a CLIA certificate and meet all requirements to perform testing. For more information, see: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/Research-Testing-and-CLIA.pdf and https://www.cms.gov/files/document/06-19-2020-frequently-asked-questions-covid-surveillance-testing.pdf

Screening for COVID-19 is looking for occurrence at the individual level even if there is no individual reason to suspect infection such as a known exposure. This includes broad screening of asymptomatic individuals without known exposure with the intent of making individual decisions based on the test results. Screening tests are intended to identify infected individuals prior to development of symptoms or those infected individuals without signs or symptoms who may be contagious, so that measures can be taken to prevent those individuals from infecting others. FDA regulates screening tests as in vitro diagnostic devices and has provided recommendations and information regarding EUA requests for COVID-19 screening tests in the Policy for Coronavirus Disease-2019 Tests and the EUA templates referenced in that Policy. Examples of screening include testing plans developed by a workplace to test all employees returning to the workplace regardless of exposure or signs and symptoms and testing plans developed by a school to test all students and faculty returning to the school regardless of exposure or signs and symptoms, with the intent of using those results to determine who may return or what protective measures to take on an individual basis.

If at any time a patient specific result is to be reported by a facility, it must first obtain a CLIA certificate and meet all requirements to perform testing. For more information, see: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/Research-Testing-and-CLIA.pdf and https://www.cms.gov/files/document/06-19-2020-frequently-asked-questions-covid-surveillance-testing.pdf

Diagnostic testing for COVID-19 is also looking for occurrence at the individual level but is performed when there is a particular reason to suspect that an individual may be infected. Diagnostic tests are intended to diagnose an infection in patients suspected of COVID-19 by their healthcare provider such as in symptomatic individuals, individuals who have had a recent exposure, individuals who are in a high-risk group such as healthcare providers with known exposure, or testing to determine resolution of infection. Diagnostic tests may also be appropriate in areas of high community spread, at the discretion of the ordering healthcare provider. FDA regulates diagnostic tests as in vitro diagnostic devices and has provided recommendations and information regarding EUA requests for COVID-19 diagnostic tests in the Policy for Coronavirus Disease-2019 Tests and the EUA templates referenced in that Policy. Examples of diagnostic testing include testing symptomatic individuals presenting to their healthcare provider, testing individuals who indicate that they were exposed to an individual with a confirmed or suspected case of COVID-19, and testing all individuals present at an event where an attendee was later confirmed to have COVID-19.

If at any time a patient specific result is to be reported by a facility, it must first obtain a CLIA certificate and meet all requirements to perform testing. For more information, see: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/Research-Testing-and-CLIA.pdf and https://www.cms.gov/files/document/06-19-2020-frequently-asked-questions-covid-surveillance-testing.pdf

Q: Are EUA-authorized SARS-CoV-2 diagnostic tests limited to use in individuals who are symptomatic for COVID-19? (Updated 6/16)

A: No. Most EUA-authorized SARS-CoV-2 diagnostic tests have been authorized for use in individuals suspected of COVID-19 by their healthcare providers. Individuals suspected of COVID-19 infection or exposure can be symptomatic, pre-symptomatic, or asymptomatic. Testing of any of these individuals is at the discretion of the healthcare provider ordering the test.

Q: I am a commercial test kit manufacturer or clinical laboratory offering a SARS-CoV-2 diagnostic test. Can I offer it for screening of asymptomatic individuals for COVID-19? (Updated 8/14)

A: If you would like to develop and offer a diagnostic test for testing any individual regardless of whether they are suspected of COVID-19 by a healthcare provider -- including the screening of asymptomatic individuals without known exposure with the intent of making decisions based on the test results -- please see the Molecular Diagnostic Template for Commercial Manufacturers or Molecular Diagnostic Template for Laboratories for recommendations on how to validate the test for this intended use and submit your EUA request to the FDA. As outlined in the Policy for Coronavirus Disease-2019 Tests, the FDA is providing regulatory flexibility for developers that offer validated diagnostic tests, including for screening of asymptomatic individuals, while the developers pursue an EUA from the FDA.

Diagnostic tests that are authorized for use on individuals suspected of COVID-19 by their healthcare provider are authorized for use on symptomatic individuals and asymptomatic individuals suspected of having COVID-19, such as because they have been exposed to an infected individual. Diagnostic tests offered by the test developer for the screening of any asymptomatic individual, however, are to be validated by their developers and authorized by the FDA specifically for screening purposes.

The FDA recognizes that the CDC has issued guidance relating to screening and that organizations may want to conduct screening of asymptomatic individuals as part of a strategy to assure the safety of their employees, patients, students, and others. Screening using a highly sensitive test, especially given the asymptomatic testing population, leads to the most accurate results when rapid turnaround times are available. The FDA has provided validation recommendations designed to establish high sensitivity for tests intended for screening in the templates referenced above. We encourage developers who want to offer a less sensitive test for screening to discuss validation approaches with us.

The FDA's EUA webpage provides information on the performance of each EUA-authorized test. However, available performance data may vary depending on how the test was validated. At the beginning of the pandemic, there were few patient specimens available and developers validated their tests using contrived specimens spiked with SARS-CoV-2 viral RNA in different amounts. Doing so allowed tests to be validated quickly while providing a measure of confidence in test performance appropriate at that point in the public health emergency. However, validation with contrived specimens instead of patient samples does not provide a true determination of clinical performance (sensitivity and specificity) and, therefore, comparing the performance of tests using these different specimens, and identifying which ones are more sensitive, is difficult. As the pandemic progressed and more patient specimens became available, the FDA began recommending that developers validate their tests with actual patient specimens. Now, the FDA has developed a reference panel to use with EUA-authorized tests which will identify which tests are more sensitive than others. The FDA will make this information available on our website as it becomes available.

Q: Does the FDA have recommendations for health care providers using SARS-CoV-2 diagnostic tests for screening asymptomatic individuals for COVID-19? (Updated 9/2)

A: An asymptomatic individual may be suspected of COVID-19 by their health care provider for various reasons, such as known exposure or working in a high-risk environment. Such use is within the authorized indications for use of tests intended for individuals suspected of COVID-19 by their health care provider. For licensed health care practitioners who are prescribing or administering an authorized SARS-CoV-2 diagnostic test to be used off-label (outside the authorization) to screen asymptomatic individuals not suspected of having COVID-19, we recommend they consider the information below, as well as the HHS guidance on PREP Act coverage.

Although the current available literature suggests that symptomatic individuals with COVID-19 and asymptomatic individuals without known exposure may have similar levels of viral genetic material, there is limited data on the distribution of viral loads in individuals with and without symptoms across demographics, different settings, and specimen types. Therefore, when screening asymptomatic individuals, health care providers should consider using a highly sensitive test, especially if rapid turnaround times are available. If highly sensitive tests are not feasible, or if turnaround times are prolonged, health care providers may consider use of less sensitive point-of-care tests, even if they are not specifically authorized for this indication (commonly referred to as "off-label"). For congregate care settings, like nursing homes or similar settings, repeated use of rapid point-of-care testing may be superior for overall infection control compared to less frequent, highly sensitive tests with prolonged turnaround times.

If less sensitive tests, such as some rapid point-of-care tests, are used, health care providers should be aware of the performance of the tests and may want to consider different testing approaches, such as serial testing. "Negative" results should be considered as "presumptive negative," and health care providers should consider them in the context of clinical observations, patient history, and epidemiological information. Thus, if there is a significant new outbreak in a congregate care facility or high clinical suspicion of an infection in an individual resident, a negative point-of-care test should be confirmed with a highly sensitive molecular test (refer to CDC guidelines). It is not necessary to perform confirmatory high-sensitivity molecular tests on individuals with negative antigen test or other point-of-care test results if they are obtained during routine screening or surveillance.

Commercial manufacturers and laboratories submitting an EUA request to the FDA for tests to screen asymptomatic individuals should consider the validation recommendations outlined in the EUA templates for such use.

Q: Does FDA have validation or other recommendations regarding SARS-CoV-2 diagnostic/screening tests for use with sample pooling? (Updated 7/28)

A: With appropriate mitigations and validation, FDA believes that sample pooling can be safely implemented for use in certain diagnostic and screening tests. If you would like to develop and offer a test for use with sample pooling, please see the Molecular Diagnostic Template for Commercial Manufacturers or Molecular Diagnostic Template for Laboratories for recommendations on how to validate the test for this use and submit your EUA request to the FDA.

As outlined in the Policy for Coronavirus Disease-2019 Tests, the FDA is providing regulatory flexibility for developers that offer validated diagnostic tests, including for use with sample pooling, while the developers pursue an EUA from the FDA. This flexibility, including discussion of notification to FDA, is outlined in the guidance.

As discussed in the templates, there are currently two approaches to patient specimen pooling: 1) pooling aliquots of transport media each containing a single patient sample (sample/media pooling) or 2) adding swabs from multiple patients into a single volume of transport media (swab pooling). These templates include validation recommendations for both types of pooling approaches.

Generally, FDA recommends validating your test with either pooling approach in a way that preserves the sensitivity of your test as much as possible; that is, it is preferable to use an approach where all specimens identified as positive when tested individually are also identified as positive when tested using the pooled testing approach. However, a decrease in performance is likely with pooling strategies, due to dilution of the primary clinical sample. As discussed in the templates, since, sample pooling will greatly increase the number of individuals that can be tested using existing resources, a small reduction in sensitivity may be acceptable depending on the pooling efficiency and other mitigations in place. Therefore, FDA generally recommends that, after pooling, test performance includes ≥85% percent positive agreement (PPA) when compared with the same test performed on individual samples. Additional limitations, such as considering negative results from pooled samples to be presumptive negatives, may be recommended based on the patient population included in your clinical evaluation and the performance data submitted in your EUA request.

As discussed in the templates, laboratories should incorporate ongoing monitoring of the positivity rate and of the performance of their test with their pooling strategy. Commercial manufacturers should include a monitoring plan in their Instructions for Use and laboratories should include one in their procedures. As data become available and new approaches are identified, our recommendations in these templates may evolve.

Q: Does the Policy for Coronavirus Disease-2019 Tests apply to my SARS-CoV-2 diagnostic/screening test for use at the Point-of-Care (POC)? (New 7/28)

A: As outlined in the Policy for Coronavirus Disease-2019 Tests, the FDA is providing regulatory flexibility for developers that offer validated diagnostic tests while the developers pursue an EUA from the FDA. Tests being offered prior to an EUA under the policies outlined in the FDA's Policy for Coronavirus Disease-2019 Tests have not yet been reviewed by the FDA, are not FDA authorized, and have not received a CLIA categorization or deemed categorization. Therefore, in accordance with CLIA, tests offered under these policies are considered high complexity by default until or unless they are authorized and deemed to be appropriate, through an EUA authorization or general FDA review processes, to be performed as moderate or waived complexity tests.

If you would like to develop and offer a test for use at the point-of-care (POC), please see the Molecular Diagnostic Template for Commercial Manufacturers for recommendations on how to validate the test for this use and submit your EUA request to the FDA. As discussed in the EUA template, an EUA request for a POC test should include data to demonstrate that non-laboratory personnel can perform the test accurately in the intended use environment, as well as data to demonstrate the robustness of the device for near patient testing, i.e., that the device is not sensitive to environmental and usage variation. For assays intended for use with a test system that was previously reviewed and CLIA waived by the FDA, testing is generally only needed to establish the performance of the SARS-CoV-2 assay. If your test system is CLIA waived, please reference the data submitted in a previous CLIA waiver submission in your EUA request (i.e., provide your previous 510(k) or CLIA waiver submission number). In general, since the information provided for the previous CLIA waiver categorization can be leveraged, additional test data may not be needed to demonstrate that the system is simple enough for use at the POC, unless there is a feature of the SARS-CoV-2 assay that would make performing the test more complicated than assays previously cleared for use on the test system.

As discussed in the EUA template, diagnostic POC tests are generally expected to demonstrate positive and negative agreement of ≥ 95%. However, positive agreement of ≥ 80% may be appropriate with appropriate limitations added to the intended use that would mitigate the risk of false negative results. For example, negative results may be considered presumptive negative if the demonstrated PPA is lower than 95%.

Q: Can I request an EUA for my multi-analyte respiratory panel that includes SARS-CoV-2? (Updated 9/9)

A: Yes. Given the overlap in signs and symptoms between SARS-CoV-2 and other respiratory viral infections, including influenza, FDA has authorized multi-analyte respiratory panels for the qualitative detection and differentiation of nucleic acid from multiple pathogens, including the SARS-CoV-2 virus. These panels are useful when multiple respiratory pathogens are circulating at the same time, as is expected with the upcoming flu season. The ability to run one test to identify which pathogen is present provides faster results overall and more efficient use of resources.

When determining whether to issue an EUA for a multi-analyte respiratory panel, FDA considers, among other things, the use of the test (multi-analyte pathogen detection as an aid in differential diagnosis), clearance/approval status of IVDs for the other panel members, whether the proposed Intended Use fits within the HHS emergency declaration and how the panel test would fit into current recommendations of public health authorities regarding patient testing.

If you would like to develop and offer a multi-analyte respiratory panel that includes SARS-CoV-2, please see the Molecular Diagnostic Template for Commercial Manufacturers or Molecular Diagnostic Template for Laboratories for recommendations on how to validate the test for this use and for recommendations on what to include in your EUA request to the FDA.

Please note that the policies in the Policy for Coronavirus Disease-2019 Tests do not apply to multi-analyte respiratory panels, and the FDA expects developers of such tests to request and receive an EUA prior to offering or marketing their test.

The CDC has granted a right of reference to the performance data contained in the CDC's EUA request for their Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay (FDA submission number EUA201781) to any entity requesting an FDA EUA for a multi-analyte respiratory panel that includes SARS-CoV-2. CDC has published the primer and probe sequences for the Influenza SARS-CoV-2 Multiplex Assay on the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/lab/multiplex-primer-probes.html.

Q: Can an EUA-authorized SARS-CoV-2 diagnostic test be used for surveillance for COVID-19? (New 6/16)

A: The FDA does not generally regulate the use of a test for surveillance purposes, such as determining the prevalence of acute infections in a population. The FDA understands that results have been returned to individuals tested for COVID-19 surveillance purposes. If surveillance testing is performed by a non-CLIA certified laboratory, an individual who tests positive for SARS-CoV-2 should have a confirmatory test performed by a CLIA-certified laboratory. Surveillance with return of results and surveillance with pooled or batched testing should be validated on a test platform and test of high sensitivity and positive tests should have a confirmatory test.

Q: Does FDA have validation or other recommendations regarding tests for use at home or other non-laboratory settings, where the collection of a specimen, testing, and interpreting results are all completed outside of a laboratory? (Updated 7/29)

A: As noted in the Policy for Coronavirus Disease-2019 Tests, the policies outlined in the guidance do not apply to at-home testing or testing at other non-laboratory settings, including the collection of a specimen at home. Developers of COVID-19 tests for at-home testing, with or without the use of telemedicine, are expected to request and receive an EUA for their test prior to offering or distributing the test.

The FDA is supportive of testing for COVID-19 that can be performed at home or in other non-laboratory settings, such as offices or schools, provided there is data and science to support consumer safety and test accuracy.

FDA has provided a Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use to help facilitate the preparation and submission of EUA requests, and the authorization of these types of tests. The template includes recommendations about what testing should be performed to demonstrate that a COVID-19 test for home/non-lab use has been validated, recommendations for generally expected performance metrics, and recommendations for demonstrating the ability of a lay user to collect their specimen, run the test, and interpret their results accurately. Additionally, this template provides information about what safety considerations should be considered in an EUA request, including safety from any exposure to toxic chemicals that may be used in the reaction. Due to the benefits of broader access to simple and fast testing options from tests that can be performed completely outside of a laboratory, a lower sensitivity of such tests, when compared to tests run in a laboratory, may be appropriate.

As explained in the template, when FDA receives an EUA submission with validation to support consumer safety and test reliability and accuracy for COVID-19 tests for non-laboratory use, FDA will generally evaluate and may issue EUAs for such tests when the criteria for authorization are met. All such authorizations will include, among other conditions, any necessary conditions of authorization to address different risks presented by specimen collection outside healthcare settings versus collection in a healthcare setting, as well as testing and interpreting results by a lay consumer rather than a healthcare professional.

Q: Can I offer my test for self-collection of a specimen at home and shipping to a laboratory for testing? (Updated 5/29)

A: Yes, you can offer your COVID-19 test for at-home self-collection if at-home self-collection is specifically authorized under the EUA for the test. In addition COVID-19 tests for at-home self-collection may be used as part of an Institutional Review Board (IRB)-approved study.

The FDA is supportive of at-home self-collection and has authorized several COVID-19 tests for home collection of specimens to be sent to a laboratory for processing and test reporting. These authorizations are specific to the home collection kit and test pairs identified in those EUAs. All tests that have received an EUA, including any authorizations for home collection of a specimen, can be found on our Emergency Use Authorizations page. If you are developing a home specimen collection kit or are interested in adding home collection to your authorized assay, we recommend using the Home Specimen Collection Molecular Diagnostic Template to help facilitate the preparation, submission, and authorization of an EUA. We encourage you to reach out to us at CDRH-EUA-Templates@fda.hhs.gov if you wish to discuss an alternate approach.

As noted in the Policy for Coronavirus Disease-2019 Tests, the policies outlined do not apply to at-home testing, which includes self-collection of a specimen at home, with or without the use of telemedicine, that is then sent to a clinical laboratory.

Home collection raises several issues of importance, including whether the lay user can safely and properly collect the specimen, whether the components of the specimen transport media are safe for use in the home environment (since some may be toxic), proper shipment, and adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions (such as, if the specimen sits in a hot truck).

A healthcare provider watching the collection by way of telemedicine may address the issue of proper specimen collection (if the self-collection method does not raise safety concerns) but it does not address the other issues, and specimen stability and shipping conditions are still of concern.

To address the concerns regarding specimen stability and shipping conditions for foam or polyester nasal swabs shipped dry (in an empty tube) or in saline (0.9%), FDA has reviewed analytical validation data from a swab stability study conducted by Quantigen Biosciences, with support from The Gates Foundation and UnitedHealth Group, that can be used, in conjunction with other data from the sponsor, to support sample stability of foam or polyester nasal swabs shipped dry (in an empty tube) or in saline (0.9%) for testing with authorized SARS-CoV-2 molecular diagnostic assays. Quantigen Biosciences has granted a right of reference to any sponsor wishing to pursue an EUA to leverage their COVID-19 swab stability data as part of that sponsor's EUA request. This data addresses specimen stability and shipping questions but may not address usability questions. At this time, FDA would need to review clinical data supporting dry swab transport (swabs transported in a tube with no media) to better understand its impact on test validity.

Distributors of home collection systems should contact the Pipeline and Hazardous Materials Safety Administration (PHMSA) within the Department of Transportation (DOT) to confirm their packaging and shipping instructions will ensure users are in compliance with the hazardous materials regulations for shipping medical material. PHMSA can be contacted at HMInfo@dot.gov.

COVID-19 tests for self-collection of a specimen at home are not eligible to be added to the umbrella EUA for molecular-based laboratory developed tests (LDTs) or the umbrella EUA for SARS-CoV-2 antibody tests. Instead, FDA would authorize individual EUAs for such tests when the criteria for authorization are met and would include any necessary conditions of authorization to address different risks presented by specimen collection at home versus collection in a health care setting.

Q: Do all COVID-19 tests require a prescription? Do they need to be ordered by a physician? (Updated 5/9)

A: Each EUA-authorized test has a Letter of Authorization (LOA) and Instructions for Use (or an EUA Summary for tests performed in a single laboratory) available on the EUA page. These documents include FDA requirements regarding ordering the test. For example, there is a condition in the LOAs that the manufacturer comply with 21 CFR 809.10(a)(4), which states that, among other things, the label of an in vitro diagnostic product shall include certain references to: (1) "Rx," (2) a statement regarding the restriction to sale by or on the order of a physician, dentist, veterinarian or (3) with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device. As such, State licensing laws may need to be consulted to determine exactly who can use or order an EUA-authorized COVID-19 test.

Tests offered prior to or without an EUA, under the policies in the Policy for Coronavirus Disease-2019 Tests, are performed in laboratories certified to perform high-complexity testing. Under CLIA regulatory requirements, such laboratories must have a written or electronic request for patient testing from an individual authorized under State law to order tests and/or receive test results. See 42 CFR 493.1241(a); 42 CFR 493.2. State laws should be consulted to see exactly who can order a COVID-19 test and whether the authorized person must be a healthcare provider.

Q: I operate a pharmacy and would like to offer COVID-19 testing. What tests are available for use? Where do I get test kits? (Updated 5/9)

A: Facilities performing COVID-19 testing must be certified under the Clinical Laboratory Improvement Amendments, or CLIA, which is administered by CMS. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/

FDA has issued a number of Emergency Use Authorizations for COVID-19 tests. All COVID-19 tests that are authorized under an EUA can be found on our EUA website. Laboratories authorized to use such tests are subject to various conditions that can be found in the EUA.

Each EUA also includes the settings in which the test is authorized. For ease of reference, the settings authorized in the EUAs are also noted in the EUA table on the EUA page. Tests that are noted with an "H" in the Authorized Settings are limited to use in laboratories certified under CLIA that meet requirements to perform high-complexity tests. Tests that are noted with an "H" and "M" in the Authorized Settings may be performed in laboratories certified under CLIA to perform high complexity and/or moderate complexity tests. Tests that are noted with a "W" in the Authorized Settings are deemed to be CLIA-waived for use in patient care settings operating under a CLIA Certificate of Waiver. Tests noted with an "H," "M," and "W may be used in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests and in patient care settings operating under a CLIA Certificate of Waiver.

Test kits being offered prior to an EUA under the policies outlined in the FDA's Policy for Coronavirus Disease-2019 Tests have not yet been reviewed by the FDA, are not FDA authorized, and have not received a CLIA categorization. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.

FDA is not involved in the distribution or allocation of tests. Facilities qualified to offer tests should reach out to their usual purchasers and distributors.

Q: I am developing a new COVID-19 diagnostic test and need assistance with funding to complete test development. Are there any resources available to me? (New 5/26)

A: The Rapid Acceleration of Diagnostics (RADx) program, supported by the National Institutes of Health (NIH) National Institute of Biomedical Imaging and Bioengineering (NIBIB), is currently soliciting proposals for projects to rapidly produce innovative SARS-CoV-2 diagnostic tests. Interested test developers may reach out to the RADx program directly. Additional information on this project can be found on the RADx website: https://www.poctrn.org/radx

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Testing Supply FAQs

Q: I am having trouble obtaining testing supplies for specimen collection, transport, and testing. Are there alternatives that I can use? (Updated 7/20)

A: On July 20, 2020, FDA issued the Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, to help address transport media availability concerns resulting from the COVID-19 public health emergency. Additional information about the policies in this guidance can be found on FDA's FAQs on Viral Transport Media During COVID-19 webpage.

We note that, as outlined in the Policy for Coronavirus Disease-2019 Tests, FDA does not intend to object to the use of a test, without notification to FDA or a new or amended EUA, where the test is a modification (other than a new specimen type modification) of an EUA-authorized test and the modified test is validated using a bridging study to the EUA-authorized test. (Note that such modifications are generally outside the scope of the EUA and are not authorized under the EUA.) This policy does not apply to home collection of specimens.

The FAQs in this section explain FDA's guidance policy on VTM and, along with the Testing Supply Substitution Strategies slides, provide additional information about validated supply alternatives for labs to perform testing when there is a supply issue with some components of a molecular test. Download the slide show file (PPT - 1.5MB) and click Slide Show > From Beginning. (Release date: July 23, 2020)

The factual information in these slides and FAQs is being provided in the context of limited quantities of testing supplies during this public health crisis, based on the best available evidence at this time and in consultation with outside experts.

We note that the information below provided about testing supply alternatives is not intended to alter any already issued EUA for a COVID-19 diagnostic test nor is it intended to speak to any specific FDA regulatory requirement. Rather, as stated above, the information is being provided to help address availability concerns regarding certain critical components of COVID-19 diagnostic tests during this pandemic.

Q: Which alternative specimen types and swab types can I use for COVID-19 diagnostic testing? (Updated 10/7)

Based on the available evidence at this time, the FDA believes that the following specimen types are appropriate for swab-based SARS-CoV-2 testing:

• Nasopharyngeal (NP) specimen collected by a healthcare professional (HCP) using a specialized mini-tip swab;
• Oropharyngeal (OP) specimen collected by an HCP using a swab with a full-sized tip;
• Mid-turbinate specimen collected by an HCP or by onsite self-collection using a specialized, flocked tapered swab; or
• Anterior nares specimen collected by an HCP or by onsite self-collection using a flocked swab, round foam swab, or spun fiber swab. For anterior nares specimen collection, a swab with a full-sized tip (OP-type swab) is generally preferred over a swab with a mini-tip (NP-type swab). See additional notes on the performance of anterior nares swabbing, below.

Although all of the above options are appropriate for clinical testing, nasopharyngeal specimens are generally considered to yield the most sensitive test results and are therefore the preferred choice as a reference (comparator) for clinical investigations and validating new methodology. Nasopharyngeal and oropharyngeal specimens are not appropriate for self-collection. For patients with productive cough, a sputum sample is an acceptable lower respiratory specimen.

Other specimen types (for example, specimens collected using buccal and tongue swabs) may decrease the sensitivity of a test, so caution should be exercised when interpreting negative results. More data are necessary to better understand the performance when using specific saliva collection devices or other specimen types for COVID-19 testing.

It is important that the person performing the specimen collection, whether an HCP or self-swabbing individual in a health care setting, have a clear and appropriate set of written or electronic instructions to help them perform the task correctly, for example, from the CDC or the lower nasal swab collection instructions developed by Audere, a Washington State nonprofit corporation. Audere has granted a general Right of Reference to any organization who wishes to access and use Audere's "Lower nasal swab collection" instructions for lower nasal swabs administered at a testing site. 

For anterior nares specimen collection, the entire tip of the swab (usually ½ to ¾ of an inch) should be placed inside the nose, and the side of the swab tip should be rubbed with moderate pressure against as much of the wall of nares region as possible, moving the tip through a large circle path inside the nose. At least four of these sweeping circular motions should be performed in each nostril. Simply twirling the swab against one part of the inside of the nose or leaving it in the nares region may not produce an adequate sample for testing, and therefore may decrease the sensitivity of the test.  For additional information, see the FDA's Letter to Health Care Providers, issued October 7, 2020, on providing clear instructions to patients who self-collect an anterior nares nasal sample in a health care setting for SARS-CoV-2 testing.

Multiple specimens from the same patient may be taken with a single swab. If a separate swab is used for collecting specimens from two different locations in the same patient, both swabs may be placed in the same vial in order to conserve collection and assay supplies.

The FDA believes that sample collection with a flocked swab, when available, is preferred. When traditional swabs (such as spun fiber, foam, or flocked) are not available, 3D printed swabs may also be considered (see additional FAQ). The FDA is aware that some users have reported concerns of brittle 3D printed swabs that have broken into multiple sharp pieces as well as non-traditional capture geometries that may not sufficiently capture the sample. These concerns should be considered in the evaluation of 3D printed swabs for use in COVID-19 testing.

All specimen collection should be conducted with a sterile swab. If the applicator handle requires additional trimming, it is also important to perform the trimming with a sterile pair of scissors to prevent contamination of the sample.

Please be aware that the CDC does not recommend use of calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and inhibit PCR testing. Additionally, rayon swabs may not be compatible with all molecular testing platforms. As noted above, analytical testing can be performed to confirm compatibility with individual platforms.

Due to concerns with specimen stability, transport, and appropriate collection materials, self-collection at home or at sites other than designated collection sites staffed by HCPs is currently only permitted with tests authorized explicitly for use in these settings in the EUA. Home specimen collection methods may also be used as part of an IRB approved study. All authorized tests can be found on the EUA page and authorizations for self-collection at home are noted in the test's Letter of Authorization.

The information about swabs provided above is based on limited available evidence, and further research is needed in this area.

To avoid specimens being wasted, if a lab is presented with a specimen that was collected or identified in a sub-optimal manner (for example, with a swab type for which there is less evidence of its effectiveness than the swab types listed in this FAQ), it may be appropriate for the lab to accept the specimen for analysis and note the circumstances on the report. These specimens may have decreased sensitivity, so caution should be exercised when interpreting negative results. Lab personnel should also exercise caution if you cannot identify the type of transport media in the specimen collection tubes or if you do not know whether the transport media contains guanidine thiocyanate or similar chemicals as an ingredient, since warnings apply and special precautions should be taken for such ingredients (see the answer to the question regarding alternative types of transport media below).

Q: Is there an example of anterior nares swabbing instructions that I could provide to my patients? (New 10/7)

For anterior nares specimen collection, the entire tip of the swab should be placed inside the nose, and the side of the swab tip should be rubbed with moderate pressure against as much of the wall of nares region as possible, moving the tip through a large circle path inside the nose. At least four of these sweeping circular motions should be performed in each nostril. Simply twirling the swab or leaving it in the nares region may not produce an adequate sample for testing, and therefore may decrease the sensitivity of the test.

It is important to have a clear and appropriate set of written or electronic instructions as a reference during sample collection to ensure an optimal sample is obtained.

For examples of anterior nares swabbing instructions, refer to the CDC instructions or the lower nasal swab collection instructions developed by Audere, a Washington State nonprofit corporation. Audere has granted a general Right of Reference to any organization who wishes to access and use Audere's "Lower nasal swab collection" instructions for lower nasal swabs administered at a testing site.

For additional information, see the FDA's Letter to Health Care Providers, issued October 7, 2020, on providing clear instructions to patients who, in a health care setting, self-collect an anterior nares nasal sample for SARS-CoV-2 testing.

Q: What alternative transport media can I use to transport patient specimens for COVID-19 diagnostic testing? (Updated 7/20)

Please be aware that some transport media and SARS-CoV-2 testing platforms are not compatible. There is a risk of exposure to harmful cyanide gas, a by-product of a reaction between guanidine thiocyanate and similar chemicals used in certain transport media and bleach (sodium hypochlorite) used in certain SARS-CoV2 testing platforms or laboratory processes.

In general, Viral Transport Media (VTM) and Inactivating Transport Media (ITM) are the preferred transport media. Universal Transport Media (UTM) is a type of VTM. Additionally, all transport media should be sterile to avoid contamination of the specimen.

Please refer to FDA's guidance, Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency for FDA's policy regarding VTM during the COVID-19 public health emergency. As explained in this guidance, FDA does not intend to object to the distribution and use of commercial VTM under certain circumstances. This guidance was issued on July 20, 2020, to help address transport media availability concerns resulting from the COVID-19 public health emergency. Additional information about the policies in this guidance can be found on FDA's FAQs on Viral Transport Media During COVID-19 webpage.

Inactivating transport media (ITM), which are not included in the scope of the guidance, are intended to inactivate virus and stabilize nucleic acids in the sample. There is not a single formulation that these types of media use, and they can consist of proprietary formulations intended to enhance inactivation and stabilization performance. Users of ITM should carefully read the warnings and precautions noted in the labeling and confirm that each ITM is compatible with the test kits and procedures used in the laboratory. Many ITM contain guanidine thiocyanate or similar chemicals making them incompatible with certain in vitro diagnostic platforms, including those that use bleach (sodium hypochlorite), and with laboratory processes that use bleach. See warning below.

Please refer to the COVID-19 Transport Media Policy and FDA's Policy for Coronavirus Disease-2019 Tests for FDA's policies concerning alternative types of sterile transport media intended for use with molecular RT-PCR SARS-CoV-2 assays. These policies apply to swab-based specimen collection by healthcare providers (HCP), and to anterior nares (nasal) and mid-turbinate specimen collection onsite by self-collection. The best available evidence at this time indicates that the following types of transport media will stabilize the SARS-CoV-2 RNA without meaningful degradation:

• Liquid Amies - Specimens can be stored in liquid Amies media for up to 72 hours at 4°C.
• Phosphate buffered saline and normal saline solution - Phosphate buffered saline (PBS), including molecular grade PBS when available, and other similar formulations including Dulbecco's PBS, can be used to collect and transport samples for molecular RT-PCR SARS-CoV-2 assays. If PBS is not available, normal saline may be used. FDA believes that a sterile glass or plastic vial containing between 1mL and 3mL of PBS or normal saline is appropriate. Specimens can be stored up to 72 hours at 4°C.

There is limited data available on test performance with specimens which have been frozen in any transport media; therefore, specimen stability should be investigated if freezing is necessary.

At this time, FDA would need to review clinical data supporting dry swab transport (swabs transported in a tube with no media) to better understand its impact on test validity.

WARNING: Media containing guanidine thiocyanate or similar chemicals, including Longhorn PrimeStore MTM, Zymo DNA/RNA Shield, as well as that found in the Spectrum Solutions Saliva Collection Device, should not be used with in vitro diagnostic platforms that use bleach (sodium hypochlorite) in the testing platform or during laboratory processes. Media containing guanidine thiocyanate or similar chemicals produce a potentially hazardous chemical reaction that releases cyanide gas when exposed to bleach. Many laboratories may use bleach in their cleaning or decontamination processes in response to laboratory spills. If you cannot identify the type of transport media in the specimen collection tubes or if you do not know if the transport media contains guanidine thiocyanate or similar chemicals as an ingredient, handle tubes as if they contain guanidine thiocyanate or similar chemicals.

Labs should be aware that inaccurate or invalid results may occur when using media containing guanidine thiocyanate or similar chemicals with tests which are not designed for use with such chemicals. If you have questions about compatibility with guanidine thiocyanate media and your EUA test or test platform, please contact the manufacturer for further recommendations.

WARNING: Do not use Longhorn PrimeStore MTM, Zymo DNA/RNA Shield, or Spectrum Solutions Saliva Collection Device or other media containing guanidine thiocyanate or similar chemicals with the Hologic Panther or Panther Fusion Systems due to a disinfecting step involving bleach that is specific to the platform. When the bleach interacts with the guanidine thiocyanate in the transport media, it produces dangerous cyanide gas.

Q: I am considering offering clinical testing using the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. What are the considerations I should be aware of regarding extraction platforms? (Updated 9/9)

A: Following initial authorization of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC), several EUA amendments have been granted that include additional extraction options. All authorizations, including updates, are listed on FDA's EUA page. 

Below is information regarding extraction platforms that the FDA understands  have been validated for use with the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel.  As noted in the footnotes below, some uses of certain extraction platforms are authorized under the CDC's EUA and others are not. 

• Roche MagNA Pure LC*
  Kit: Roche MagNA Pure Total Nucleic Acid Kit
  Protocol: Total NA External_lysis
  • Add 100 μL of sample to 300 μL of pre-aliquoted TNA isolation kit lysis buffer (total input sample volume is 400 μL). Elution volume is 100 μL.
• Roche MagNA Pure Compact*
  Kit: Roche MagNA Pure Nucleic Acid Isolation Kit I
  Protocol: Total_NA_Plasma100_400
  • Add 100 μL of sample to 300 μL of pre-aliquoted TNA isolation kit lysis buffer (total input sample volume is 400 μL). Elution volume is 100 μL.
• Roche MagNA Pure 96*
  Kit: Roche MagNA Pure 96 DNA and Viral NA Small Volume Kit
  Protocol: Viral NA Plasma Ext LysExt Lys SV 4.0 Protocol or Viral NA Plasma Ext Lys SV Protocol
  • Add 100 μL of sample to 350 μL of pre-aliquoted External Lysis Buffer (supplied separately) (total input sample volume is 450 μL). Proceed with the extraction on the MagNA Pure 96. (Note: Internal Control = None). Elution volume is 100 μL.
• Roche MagNA Pure 24*
  Kit: Roche MagNA Pure 24 Total NA Isolation Kit
  Protocol: Pathogen 1000 2.0 Protocol
  • Add 100 µL of sample to 400 µL of pre-aliquoted External Lysis Buffer (supplied separately) (total input sample volume is 500 µL). Proceed with the extraction on the MagNA Pure 24. (Internal Control = None). Elution volume is 100 µL.
• QIAGEN QIAcube*
  Kit: QIAGEN QIAamp® DSP Viral RNA Mini Kit or QIAamp® Viral RNA Mini Kit
  • Utilize 140 μL of sample and elute with 100 μL of buffer.
• QIAGEN*
  Kit: QIAGEN QIAamp® DSP Viral RNA Mini Kit or QIAamp® Viral RNA Mini Kit
  • Utilize 100 μL of sample and elute with 100 μL of buffer or utilize 140 μL of sample and elute with 140 μL of buffer.
• QIAGEN EZ1 Advanced XL*
  Kit: QIAGEN EZ1 DSP Virus Kit and Buffer AVL (supplied separately) for offboard lysis
  Card: EZ1 Advanced XL DSP Virus Card
  • Add 120 μL of sample to 280 μL of pre-aliquoted Buffer AVL (total input sample volume is 400 μL). Proceed with the extraction on the EZ1 Advanced XL. Elution volume is 120 μL.
• QIAGEN EZ1 Advanced XL*
  Kit: QIAGEN EZ1 Virus Mini Kit v2.0 and Buffer AVL (supplied separately) for offboard lysis
  Card: EZ1 Advanced XL Virus Card v2.0
  • Add 120 μL of sample to 280 μL of pre-aliquoted Buffer AVL (total input sample volume is 400 μL). Proceed with the extraction on the EZ1 Advanced XL. Elution volume is 120 μL.
• bioMérieux NucliSENS easyMAG Instrument*
  Protocol: General protocol (not for blood) using "Off-board Lysis" reagent settings.
  • Add 100 μL of sample to 1000 μL of pre-aliquoted easyMAG lysis buffer (total input sample volume is 1100 μL). Incubate for 10 minutes at room temperature. Elution volume is 100 μL.
• bioMérieux EMAG Instrument*
  Protocol: Custom protocol: CDC Flu V1 using "Off-board Lysis" reagent settings.
  • Add 100 μL of samples to 2000 μL of pre-aliquoted easyMAG lysis buffer (total input sample volume is 2100 μL). Incubate for 10 minutes at room temperature. Elution volume is 100 μL. The custom protocol, CDC Flu V1, is programmed on the bioMérieux EMAG instrument with the assistance of a bioMérieux service representative. Installation verification is documented at the time of installation. Laboratories are recommended to retain a record of the step-by-step verification of the bioMérieux custom protocol installation procedure.
• KingFisher Flex Nucleic Acid Extraction System˜
  Kit: Omega Bio-Tek Mag-Bind Viral DNA/RNA 96 Kit
  Protocol: Please contact product_support@omegabiotek.com for instructions to upload the script and protocols for viral RNA extraction.
  • Add 200 μL of patient sample and elute with 60 μL. Use 5 μL of eluant in a 20 μL final amplification reaction volume.
• Applied Biosystems MagMAX™ Express-96 Magnetic Particle Processor˜
  Kit: Applied Biosystems MagMAX™ Viral/Pathogen Ultra Nucleic Acid Isolation Kit
  Protocol: MVP_Ultra_MMe96
  • Add 400 μL of sample and 50 μL of enzyme in a 96-well plate. Proceed with the extraction on the MagMAX Express-96 instrument. Elute with 100 μL TE buffer.
• Promega Maxwell RSC 48 Instrument^
  Kit: Maxwell RSC Viral Total Nucleic Acid Purification Kit
  Protocol: AS1330
  • Add 200 μL of sample and 30 μL of enzyme in a 96-well plate. Proceed with the extraction on the Maxwell RSC 48 instrument. Elute with 50 μL TE buffer.
• Promega Maxwell RSC 48 Instrument*
  Kit: Promega Maxwell Viral Total Nucleic Acid Purification Kit
  Protocol: Total Nucleic Acid
  • Add 120 μL of sample to 330 µL of pre-aliquoted External Lysis Buffer (300 µL Lysis Buffer plus 30 µL Proteinase K; supplied within the kit) (total input volume is 450 µL). Proceed with the extraction on the Maxwell® RSC 48. Elution volume is 75 µL.
• Beckman RNAdvance Viral XP˜
  Kit: RNAdvance Viral XP extraction kit
  • Add 200 μL of sample and 150 μL of lysis buffer (LBF). After mixing, add 350 μL of binding buffer (VBE) (total input sample volume is 700 μL). Proceed with RNAdvanced magnetic capture protocol with 70% ethanol washes. Elution volume is 40 μL in nuclease-free water.

* Use of these extraction methods with the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel as set forth above is authorized under the CDC's EUA.

^ The instruments in these extraction methods are referenced in the instructions for use for the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel, but the methods described above vary from the methods described in those instructions.  Thus, such uses are outside the scope of and not authorized under the EUA. 

˜ Use of these extraction methods with the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel is not authorized under the CDC's EUA.  

Q: What if I do not have the instruments referenced in the authorization of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel? (Updated 9/9)

A: Below is information regarding certain instruments and the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel.  We note that use of these instruments with the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel is not authorized, but FDA understands that there is information available to support use of these instruments with this test.

The following instruments are designed to detect RNA viruses, and are FDA cleared in K190302 for the CDC's RNA-based influenza panel:

• Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument with SDS software version 1.4
• Applied Biosystems™ QuantStudio™ Dx with version 1.0.3 software
• QIAGEN Rotor-Gene Q MDx with AssayManager version 1.0.4.1 and Epsilon version 1.0.1 software

Independent validation studies were conducted on the following instruments with the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel:

• Applied Biosystems™ 7500 Fast Real-Time PCR Instrument with SDS software version 1.4
• Applied Biosystems™ QuantStudio™ 6 Flex Real-Time PCR System with version 1.1 software

Q: If I do not have assay positive control material, how can I obtain it? (Updated 6/5)

A: Below is information regarding positive control material. Links provided are for information purposes only and not a recommendation by FDA to use that product. FDA encourages other suppliers of test materials to email COVID19DX@fda.hhs.gov to discuss whether materials they have available may also be appropriate for use.

Control material specific for the CDC EUA is available from the following resources.

• N1/N2 Positive Controls, for the CDC EUA design:
  • Novel Coronavirus extracted RNA is available from BEI. To create N1/N2 positive controls from BEI's concentrated RNA, dilute the concentrated RNA into extracted nucleic acid to approximately 2 to 3 times the assay LOD per reaction.
    or
  • IDT sells a DNA plasmid control (2019-nCoV_N_Positive Control #10006625). To create N1/N2 positive controls from IDT's plasmid control, dilute the plasmid into extracted nucleic acid to approximately 2 to 3 times the assay LOD per reaction.
• RNase P (RP) Control, for the CDC EUA design:
  • Human RNA can be extracted from human specimens or cultured human cells and used directly as the RP positive control
    or
  • IDT sells a plasmid control (Hs_RPP30 Positive Control #10006626). Dilute the plasmid into extracted nucleic acid to approximately 2 to 3 times the assay LOD per reaction.

In addition to the materials listed for assay validation (please see Test Validation FAQs), control material for other EUA RT-PCR tests is available from the following resources:

• Non-encapsulated synthetic RNA:
  • Twist Bioscience: Order following the instructions on the product page
    • Upon request, Twist Bioscience can manufacture synthetic SARS-CoV-2 RNA controls for any new strains as they evolve.
  • Codex DNA: Order by emailing covid19@codexdna.com
    • Upon request, Codex DNA can manufacture desired synthetic DNA and RNA constructs to support customers' COVID-19 related needs.
  • Microbiologics: Order by emailing INFO@microbiologics.com OR through their website [https://www.microbiologics.com/Sars-cov-2-quality-control]
    • Product # HE0060S: Helix Elite SARS-CoV-2 Synthetic RNA (N-gene targets)
    • Product # 9006 or 9009: SARS-CoV-2 Synthetic RNA (N-gene targets)
    • Product # 9019VP: SARS-CoV-2 Synthetic RNA (E/RdRp gene targets)
    • Product # 9029VP: SARS-CoV-2 Synthetic RNA (S-gene targets)
  • ATCC: Order through their website [https://www.atcc.org/Landing_Pages/Coronavirus_Resources]
    • Product # VR-3276SD: Quantitative Synthetic SARS-CoV-2: ORF, E, N
    • Product # VR-3277SD: Quantitative Synthetic SARS-CoV-2 RNA: Spike 5'
    • Product # VR-3278SD: Quantitative Synthetic SARS-CoV-2 RNA: Spike 3'
  • Exact Diagnostics: Order through their website [http://www.exactdiagnostics.com/sars-cov-2-standard.html]
    • Product # COV019: Exact Diagnostics SARS-CoV-2 Standard
      • This product contains targets within the E/N/S/ORF1ab/RdRp regions.
  • European Commission: Order through their website [https://crm.jrc.ec.europa.eu/p/EURM-019]
    • Product # EURM-019: Single stranded RNA (ssRNA) fragments of SARS-CoV-2
      • Please note this product sequence has been verified for use with the N1 and N2 gene targets developed by the Centers for Disease Control and Prevention (USA), the E gene and the RdRP gene targets developed by the Charité, and the S gene target developed by the Joint Research Centre of the European Commission.
  • Thermo Fisher Scientific: Order through their website [https://www.thermofisher.com/order/catalog/product/954519#/954519]
    • Product # 954519: AcroMetrix™ Coronavirus 2019 (COVID-19) RNA Control
      • This control plasmid contains in vitro transcribed RNA containing the N, S, E and Orf1ab regions.
  • Main Molecular Quality Controls: Order by emailing info@mmqci.com OR through their website [https://www.mmqci.comr]
    • Product M441: BioFire RP2.1/RP2.1plus Control Panel M441
      • This product is intended for use with BioFire RP2.1 and BioFire RP2.1plus assays. It contains gene segments from the S, E, M, ORF8, and N genes.
• DNA plasmid: Please note that if a DNA plasmid control is used, a method to evaluate performance of the reverse transcription step should be included.
  • IDT: Order through their website [https://www.idtdna.com/pages/landing/coronavirus-research-reagents]
    • Product # 10006625: 2019-nCoV_N_Positive Control
      • This product contains the nucleocapsid (N) region, including the N1/N2 targets for the CDC EUA design.
• RNase P controls:
  • Human RNA can be extracted from human specimens or cultured human cells and used directly as the RP positive control.
  • Microbiologics: Order by emailing INFO@microbiologics.com OR through their website [https://www.microbiologics.com/Sars-cov-2-quality-control]
    • Product # HE0058N: Helix Elite Inactivated Standard (Negative Cellularity Control)
      • Each pellet contains A549 lung epithelial cells.
  • Asuragen: Order by emailing armored@asuragen.com OR through their website [https://asuragen.com/portfolio/custom-reagents/]
    • Product # 52031: Armored RNA Quant® RNAase P
      • This is an encapsulated product (phage-based). This is also available in its non-encapsulated form upon request.
  • IDT Order through their website [https://www.idtdna.com/pages/landing/coronavirus-research-reagents]
    • Product # 10006626: Hs_RPP30 Positive Control
      • This product is a DNA plasmid containing a portion of the RPP30 gene.

Q: If I do not have human extraction control material, how can I obtain it? (Updated 4/22)

A: Human RNA can be extracted from human specimens or cultured human cells and used directly as the Human Specimen Control (HSC) control. This RNA extraction procedural control is used to demonstrate successful recovery of RNA as well as extraction reagent integrity. The HSC should yield a positive result with the RP primer and probe set and negative results with all 2019-nCoV markers.

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3D Printed Swab FAQs

Q: What are the regulatory requirements for 3D printed swabs, whether fabricated by a commercial manufacturer or at a hospital, laboratory, or other facility? (Updated 10/7)

A: Absorbent tipped applicators (i.e., swabs), whether produced through traditional manufacturing or other means such as additive manufacturing (i.e., 3D printing), are generally Class I medical devices regulated under 21 CFR 880.6025. Swabs used for specimen collection for diagnostic testing are generally sterile to preserve both patient safety and specimen integrity. These swabs fall under the product code KXG, whether they are marketed as sterile or intended to be sterilized by the end user. Sterile swabs that are exempt from premarket notification requirements do not need an emergency use authorization (EUA) to be distributed. However, manufacturers are responsible for ensuring their products' performance is appropriate for its intended use.

Any facility (including a hospital, laboratory, or other site) that manufactures sterile swabs is responsible for Registering and Listing their product and is expected to meet applicable medical device regulatory requirements, including those relating to the quality system regulation (21 CFR Part 820), medical device reporting (21 CFR Part 803), and reports of corrections and removals (21 CFR Part 806).  For more information on Registration and Listing, please contact the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov or see the How to Register and List page.

Q: How should I evaluate my 3D printed swab? (New 10/7)

A: As a general matter, 3D printing can introduce certain challenges not seen with conventional manufacturing. FDA is aware that some users have reported concerns of brittle 3D printed swabs that have broken into multiple sharp pieces, and non-traditional capture geometries that may not capture the sample sufficiently. While FDA and the clinical community have vast experience with traditional swabs, there is limited prior experience with the use of 3D printed swabs for specimen collection for diagnostic testing. Therefore, it is important that 3D printed swabs be assessed to ensure they are appropriately characterized for the end use to determine if they meet the clinical need.
It may be possible to leverage some data provided by the swab designer or other facilities; however, appropriate controls must be in place, and data validation should demonstrate applicability of such data. The Agency is aware that devices produced at different 3D printing facilities can have different characteristics that may affect safety and effectiveness even when using the same printers, resin, and design. Notably, the finishing and sterilization processes, and printer software updates, are among the factors that may have a significant impact on the functionality of 3D printed devices including swabs.

FDA has published a guidance on technical considerations for additive manufactured medical devices, Technical Considerations for Additive Manufactured Medical Devices, and has a webpage on 3D printed devices, accessories, components, and parts relating to the COVID-19 Public Health Emergency Response.

Manufacturers may also wish to consider resources available through the NIH's 3D Print Exchange.

Q: Are there quality system requirements for 3D printing of sterile swabs? (New 6/4)

A: Yes. Manufacturers of 3D printed, sterile swabs are required to comply with quality system regulation (21 CFR Part 820).

Q: How should I label my 3D printed swabs? (New 6/4)

A: 3D printed swabs are required to meet the general labeling requirements for medical devices. More information on labeling requirements can be found at on the General Device Labeling Requirements page.

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Test Validation FAQs

Q: Can I leverage validation data that has already been reviewed by the FDA for another test? (New 9/9)

A: Yes. FDA values collaboration between developers to reduce the burden for test validation.  A developer that has provided data to the FDA may grant a right of reference to other developers, either broadly or to individual developers, to leverage that data. In these cases, if the data is applicable to the new developer's test, they would generally not have to repeat that validation for their submission to the FDA.  For example, if a new developer's test is similar to the CDC assay, they may be able to leverage the CDC's in silico and cross reactivity data, rather than repeating it.  Further, as discussed in another FAQ on this page (Can I offer my test for self-collection of a specimen at home and shipping to a laboratory for testing?), FDA has reviewed analytical validation data from a swab stability study conducted by Quantigen Biosciences, with support from The Gates Foundation and UnitedHealth Group, that can be used, in conjunction with other data from the developer, to support sample stability of foam or polyester nasal swabs shipped dry or in saline for testing with authorized SARS-CoV-2 molecular diagnostic assays.

Any developer seeking to leverage data from an EUA-authorized assay must obtain a right of reference from the sponsor of that EUA.

The CDC has granted a right of reference to the performance data contained in the CDC's EUA request for the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.

The CDC has granted a right of reference to the performance data contained in the CDC's EUA request for their Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay (FDA submission number EUA201781) to any entity seeking an FDA EUA for a multi-analyte respiratory panel that includes SARS-CoV-2. CDC has published the primer and probe sequences for the Influenza SARS-CoV-2 Multiplex Assay on the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/lab/multiplex-primer-probes.html.

Q: Are two or more viral targets needed to validate an RT-PCR SARS-CoV-2 assay?

A: Based on evidence that has become recently available, and with the increased spread of COVID-19, FDA believes an appropriately validated single viral target SARS-CoV-2 assay could provide acceptable performance. Please refer to the policy outlined in Policy for Coronavirus Disease-2019 Tests, which includes recommendations regarding the minimum testing to be performed to ensure analytical and clinical validity for COVID-19 diagnostic assays, as well as the templates for EUA submissions provided on FDA's website.

Q: What are the current validation study recommendations for a new COVID-19 assay? (Updated 6/24)

A: Please refer to Section V of the Policy for Coronavirus Disease-2019 Tests, where we have provided recommendations regarding the testing to be performed to demonstrate that a SARS-CoV-2 test is validated based upon the underlying technological principles of the test. These recommendations for testing apply to tests for which an EUA request is submitted to FDA as well as tests claiming to be validated and offered under the policies in the Policy for Coronavirus Disease-2019 Tests prior to submission of an EUA request. Depending on the characteristics of your test, additional validation studies may be recommended. FDA encourages test developers to discuss any alternative approaches to validating their test with FDA through CDRH-EUA-templates@FDA.HHS.GOV.

As discussed in the Policy for Coronavirus Disease-2019 Tests, the availability of positive samples has increased as the pandemic has progressed. As such, FDA now recommends that developers use positive clinical samples for clinical validation. Moreover, due to the increased availability of clinical samples, FDA recommends that laboratories confirm performance of their assay by testing a minimum of 30 positive specimens and 30 negative specimens as determined by an authorized assay. If you do not have access to clinical samples as determined by an authorized assay, contrived clinical specimens may be considered, and we recommend that you contact FDA to discuss.

Additional information on the FDA's recommendations for validation testing, as well as generally expected performance metrics, can be found in the EUA templates. Templates for laboratories and commercial manufacturers are available at:

• Molecular Diagnostic Template for Commercial Manufacturers
• Molecular Diagnostic Template for Laboratories
• Serology Template for Commercial Manufacturers
• Serology Template for Laboratories
• Antigen Template for Test Developers
• Home Specimen Collection Molecular Diagnostic Template

These templates are part of the FDA's Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff. The templates reflect FDA's current thinking on the data and information that developers should submit to facilitate the EUA process. The templates provide information and recommendations, and we plan to update them as appropriate as we learn more about the COVID-19 disease and gain experience with the EUA process for the various types of COVID-19 tests.

Developers can use alternative approaches. Developers who intend to use alternative approaches should consider seeking FDA's feedback or recommendations to help them through the EUA process. FDA encourages developers to discuss any alternative technological approaches to validating their test with FDA through CDRH-EUA-Templates@fda.hhs.gov.

Q: I am developing a SARS-CoV-2 test and want to pursue an EUA. Do I need to have all of my validation and documentation completed and submitted in an EUA request to FDA before engaging with the FDA? (Updated 5/4)

A: No. The FDA is interested in early interactions with test developers and will review data on a rolling basis. We encourage you to reach out to us at CDRH-EUA-Templates@fda.hhs.gov to begin pre-EUA discussions, even if you do not have your validation and/or documentation completed. We can work with you on the best approach for completing your validation, documentation, and submission of your EUA request.

Q: I am developing a SARS-CoV-2 test. What test materials are appropriate for assay validation? (Updated 6/5)

A: Below is information regarding various test materials for assay validation. Links provided are for information purposes only and not a recommendation by FDA to use that product. FDA encourages other suppliers of test materials to email COVID19DX@fda.hhs.gov to discuss whether materials they have available may also be appropriate for use.

As noted in the molecular diagnostics templates, FDA recommends using natural clinical specimens in the clinical evaluation for those tests. Please refer to those templates for information regarding clinical study design for molecular diagnostic tests (https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd). If you do not have access to positive clinical samples from a clinical laboratory, these are available commercially:

• Boca Biolistics: Order by emailing COVID19support@BocaBio.com
  • Product # C0040-0001: SARS-COV-2 Validation Panel
    • This product includes 30 positive patient samples and 30 negative patient samples, as determined by CLIA-certified labs.
• Discovery Life Sciences: Order by emailing sales@dls.com OR following the instructions on their website [https://www.dls.com/covid-19]
  • Product: Discovery COVID-19 Biospecimen Sets
    • Discovery Life Sciences has positive and negative patient samples, as determined by CLIA-certified labs, for several biospecimen types. Contact them to discuss options.

As also noted in the molecular diagnostic templates, in the absence of known positive samples, Limit of Detection (LoD) validation studies may also be performed with contrived clinical specimens. Inactivated virus (e.g., heat treated or irradiated virus) is the preferred material to generate contrived specimens since this most closely reflects live virus in a clinical sample. You may request inactivated virus directly from:

• BEI Resources: Order through BEI Resources website [https://www.beiresources.org]
  • Product # NR-52286: SARS-Related Coronavirus 2, Isolate USA-WA1/2020, Heat inactivated
  • Product # NR-52287: SARS-Related Coronavirus 2, Isolate USA-WA1/2020, Gamma-Irradiated
• ATCC: Order through their website [https://www.atcc.org/Landing_Pages/Coronavirus_Resources]
  • Product # VR-1986HK: Heat-inactivated SARS-CoV-2 (strain 2019-nCoV/USA-WA1/2020)
• ZeptoMetrix: Order by emailing custserv@zeptometrix.com OR calling customer service at 1-800-274-5487 OR through their website [https://www.zeptometrix.com]
  • Product # NATSARS(COV2)-ERC: NATtrol™ SARS-Related Coronavirus 2 (SARS-CoV-2) External Run Control (6X0.5mL)
    • This product contains approximately 50,000 copies/mL. The isolate is USA-WA1/2020.
  • Product # NATSARS(COV2)-ST: NATtrol SARS-Related Coronavirus 2 (SARS-CoV-2) Stock (1mL)
    • This product contains approximately 1,000,000 copies/mL. The isolate is USA-WA1/2020.

If you are unable to acquire inactivated virus, the templates note that FDA believes that viral genomic RNA is the next best material for LoD validation studies. Potential sources for this material include:

• Viral genomic RNA may be acquired through extraction of SARS-CoV-2 positive patient samples. FDA believes that quantifying extracted material (i.e., copies/mL) prior to use in an LoD study is an important step.
• RNA commercial sources:
  • BEI: Order through BEI Resources website [https://www.beiresources.org]
    • Product # NR-52285: Genomic RNA from SARS-Related Coronavirus 2, Isolate USA-WA1/2020
  • ATCC: Order through their website [https://www.atcc.org/Landing_Pages/Coronavirus_Resources]
    • Product # VR-1986D: Genomic RNA from Severe acute respiratory syndrome-related coronavirus 2 (strain 2019-nCoV/USA-WA1/2020)

If you are unable to obtain any of the above mentioned materials and have not used live or inactivated organisms for validation, it would be helpful to indicate this when submitting your validation data to FDA. Synthetic nucleic acid material could be used for analytical validation, provided that the product contains assay appropriate targets.

Please be aware of potential differences between the sequences these synthetic genomic materials are based on and the current circulating SARS-CoV-2 in the US. These differences could impact the performance of an assay and users should take this into consideration when selecting this material for test validation. To promote RNA stability, steps can be taken to minimize exposure to degrading conditions for instance by spiking test material into a lysis buffer prior to adding negative clinical matrix.

Products that span a larger portion of the genome are preferable:

• Twist Bioscience: Order following the instructions on the product page
  • Product SKU 102019: Twist Synthetic SARS-CoV-2 RNA Control 1 (MT007544.1)
    • This is a non-encapsulated product consisting of 6 non-overlapping 5 kb synthetic RNA fragments spanning near the entire viral genome (>99.9%).
  • Product SKU 102024: Twist Synthetic SARS-CoV-2 RNA Control 2 (MN908947.3)
    • This is a non-encapsulated product consisting of 6 non-overlapping 5 kb synthetic RNA fragments spanning near the entire viral genome (>99.9%).
• Codex DNA: Order by emailing covid19@codexdna.com OR following the instructions on their product page [https://codexdna.com/products/synthetic-sars-cov-2-rna-controls]
  • Product # SC2-RNAC-0100: Synthetic SARS-CoV-2 RNA Controls
    • This is a non-encapsulated product consisting of 6 non-overlapping 5 kb synthetic RNA fragments spanning near the entire viral genome (>99.9%, reference NC_045512).

Encapsulated products with shorter fragments of the genome with specific targets may be considered in the context of your assay design:

• Encapsulated synthetic RNA:
  • SeraCare: Order through their website [https://www.seracare.com/SARS-CoV-2/]
    • Products # 0505-0129 OR # 0505-0132: AccuPlex SARS-CoV-2 Verification Panels
      • These products contain recombinant Alphavirus encapsulating synthetic SARS-CoV-2 RNA targets (#0505-0129 contains ORF1a/RdRp/E/N; #0505-0132 contains ORF1a/RdRp/E/N/S). This feature more closely resembles the conditions of live virus in clinical samples.
      • From the product sheet: "Note that the positive reference material may contain traces of RNase P and therefore generate a positive RNase P result; it is not designed or intended to be used as an RNase P reference material."
    • Products # 0505-0126 OR # 0505-0133: AccuPlex SARS-CoV-2 Reference Material Kits
      • These products contains recombinant Alphavirus encapsulating synthetic SARS-CoV-2 RNA targets (#0505-0126 contains ORF1a/RdRp/E/N; #0505-0133 contains ORF1a/RdRp/E/N/S). This feature more closely resembles the conditions of live virus in clinical samples.
      • From the product sheet: "Note that the positive reference material may contain traces of RNase P and therefore generate a positive RNase P result; it is not designed or intended to be used as an RNase P reference material."
  • Asuragen: Order by emailing armored@asuragen.com OR through their website [https://asuragen.com/portfolio/custom-reagents/]
    • Product # 52030: Armored RNA Quant® SARS-CoV-2
    • This is an encapsulated product (phage-based), containing targets within the nucleocapsid (N) region. This is also available in its non-encapsulated form upon request.

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COVID-19 Related Test Data and Reporting FAQs

Q: I am a laboratory performing COVID-19 testing. Do I need to report COVID-19 test results to public health authorities? (New 6/17)

A: Laboratories are required to report to state and local public health authorities in accordance with applicable state or local law.

In addition, under section 18115 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Public Law 116-136), laboratories, including those in patient care settings operating under a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation, must report the results of COVID-19 tests to the Department of Health and Human Services (HHS) or its designee, in such form and manner as the Secretary may prescribe, during the declared public health emergency.

For additional information on the laboratory data reporting guidance and FAQs from the Department of Health and Human Services (HHS), please see: https://www.hhs.gov/about/news/2020/06/04/hhs-announces-new-laboratory-data-reporting-guidance-for-covid-19-testing.html

When FDA issues an Emergency Use Authorization (EUA) for a COVID-19 test, the letter of authorization includes a condition that requires authorized laboratories performing COVID-19 testing to have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate. FDA considers this condition to include authorized laboratories reporting test results to HHS in accordance with section 18115 of the CARES Act.

Q: When reporting COVID-19 related test results to appropriate public health authorities, should I use standard terminology (i.e., LOINC and SNOMED-CT)? (New 5/27)

A: In order to reduce reporting burdens for testing facilities and ensure that the core COVID-19 related test data is accurate and meaningful, pre-harmonized terminology standards -- LOINC and SNOMED-CT codes -- are available. Using this basic and simple approach to ensuring the same test is described the same way can help establish infrastructure needed to accomplish our mission of protecting and promoting public health.

Testing facilities' use of LOINC and SNOMED-CT terminology standards, when available, should help improve the accuracy of reporting of their SARS-CoV-2 and COVID-19 related test results. As noted on the CDC's Reporting COVID-19 Laboratory Data page, standard use of these laboratory terminology codes ensures that the same type of test is represented uniformly across the United States.

For IVD tests, LOINC codes can be used to represent the "question" a diagnostic test asks of a specimen (e.g., does this specimen have SARS-CoV-2 RNA?), and SNOMED-CT codes can be used to represent the diagnostic "answer" (e.g., SARS-CoV-2 RNA was detected). For more information on laboratory data reporting, and these terminology standards please refer to:

• CDC COVID-19 Data and Reporting Q & A
• SARS-CoV-2 LOINC codes and Basics
• SNOMED CT Basics

For assistance in the assignment of LOINC and SNOMED codes, please refer to the LIVD mapping catalog for available SARS-CoV-2 tests and/or contact:

• Test developers: SHIELD-LabCodes@fda.hhs.gov.
• Test users (e.g., laboratories/healthcare providers): dlsinquiries@cdc.gov.

Q: I have developed a SARS-CoV-2 test kit for distribution to clinical laboratories that are required to report test results to appropriate public health authorities. How can I assist laboratories to meet their reporting obligations? (New 5/27)

A: Assistance from test developers can be invaluable in harmonizing the application of terminology standards (i.e., LOINC, SNOMED-CT and UCUM) and helping ensure that the same type of test is described the same way. This helps to enable Real-World Evidence (RWE) aggregation and analysis. For all SARS-CoV-2 tests, developers can supply pre-harmonized LOINC codes representing the "question" a diagnostic test asks of a specimen (e.g., does this specimen have SARS-CoV-2 RNA?), and SNOMED-CT codes representing the diagnostic "answer" (e.g., SARS-CoV-2 RNA was detected).

For support in the assignment of appropriate LOINC and SNOMED-CT codes or to request modification of your test in the LIVD mapping catalog for SARS-CoV-2 tests, SARS-CoV-2 test developers can contact SHIELD-LabCodes@fda.hhs.gov.

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Clinical Laboratory Diagnostic Test FAQs

Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA. I am developing a molecular SARS-CoV-2 diagnostic test and preparing to submit an EUA request. What template should I use? (Updated 5/11)

A: If you are developing a molecular SARS-CoV-2 diagnostic test, we recommend using the Molecular Diagnostic Template for Laboratories to help facilitate the preparation, submission, and authorization of an EUA. We encourage you to reach out to us at CDRH-EUA-Templates@fda.hhs.gov if you wish to discuss an alternate approach.

Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA and am offering my own diagnostic test under the new policy outlined in the Policy for Coronavirus Disease-2019 Tests. Do I report all my results as presumptive? (Updated 5/4)

A: Under the policy outlined in the Policy for Coronavirus Disease-2019 Tests, the first five positive and first five negative results should be reported as presumptive and confirmed by an EUA authorized test. If all ten of these results are confirmed by an EUA authorized test, confirmatory testing for subsequent results is not recommended in the guidance.

Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA. I have developed a SARS-CoV-2 diagnostic test and want to begin accepting patient samples. What should I do? (Updated 5/4)

A: Please refer to the Policy for Coronavirus Disease-2019 Tests.

The FDA encourages such laboratories developing diagnostic tests to consider the validation recommendations in the guidance as they seek to validate their tests. If you pursue an alternate approach, we recommend discussing plans with us early, through the pre-EUA program. Please contact us at CDRH-EUA-Templates@fda.hhs.gov.

As noted in the guidance, once your test is validated and you are ready to begin clinical testing, labs should notify the FDA at CDRH-EUA-Templates@fda.hhs.gov and provide the name of the lab, lab director, address, and contact person. In the guidance, we recommend that you confirm the first five positive and the first five negative samples with an EUA-authorized test and include in your test report a statement that the FDA review of the validation is pending.

As stated in the guidance, the FDA does not intend to object to the use of validated diagnostic tests for specimen testing for a reasonable period of time after validation while the laboratory is preparing an EUA request. The FDA believes 15 business days is a reasonable period of time to prepare an EUA submission for a diagnostic test that has already been validated.

We strongly encourage laboratories testing under this policy to contact their state public health department as early as possible in the process (perhaps even before receipt of any orders or samples) to help ensure they have capacity for the validation testing described in the guidance and have the information necessary to support case investigations. We also encourage laboratories to be sure they are familiar with state and local laws mandating reporting of diseases and conditions of public health significance.

Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA. Do I need an EUA if I purchase a CDC-qualified lot of SARS-CoV-2 test kit reagents and follow the CDC's protocol?

A: No, you do not need your own EUA if you use reagents from a lot that has been qualified by the CDC and follow the CDC's EUA-authorized protocol. Testing using the CDC's EUA-authorized protocol and CDC-qualified lots of reagents is considered to be testing done under the CDC's EUA. Labs performing such testing under the CDC's EUA should be aware of any applicable conditions set forth in the EUA.

Currently, reagents qualified by the CDC are being sold through:

• Integrated DNA Technologies (IDT)
• Biosearch Technologies

Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA. Do I need an EUA if I purchase a CDC-qualified lot of SARS-CoV-2 test kit reagents and develop my own protocol?

A: Yes. Laboratories that wish to develop their own protocol should refer to the streamlined EUA policy outlined in the Policy for Coronavirus Disease-2019 Tests.

FDA encourages laboratories to discuss their plans with us early, through the pre-EUA program. Please contact us at CDRH-EUA-Templates@fda.hhs.gov.

Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA and am interested in developing a SARS-CoV-2 diagnostic test. What do I need to do if I make my own primers/probes or order the individual components? (Updated 5/4)

A: Please refer to the Policy for Coronavirus Disease-2019 Tests.

The FDA encourages such laboratories developing diagnostic tests, whether using purchased components or making their own primers/probes, to consider the validation recommendations in the guidance as they seek to validate their tests. If you pursue an alternate approach, we recommend discussing plans with us early, through the pre-EUA program. Please contact us at CDRH-EUA-Templates@fda.hhs.gov.

As noted in the guidance, once your test is validated and you are ready to begin clinical testing, labs should notify the FDA at CDRH-EUA-Templates@fda.hhs.gov and provide the name of the lab, lab director, address, and contact person. In the guidance, we recommend that you confirm the first five positive and the first five negative samples with an EUA-authorized test and include in your test report a statement that the FDA review of the validation is pending.

As stated in the guidance, the FDA does not intend to object to the use of validated diagnostic tests for specimen testing for a reasonable period of time after validation while the laboratory is preparing an EUA request. The FDA believes 15 business days is a reasonable period of time to prepare an EUA submission for a diagnostic test that has already been validated.

Q: I am a high-complexity CLIA-certified laboratory developing a COVID-19 assay that is a modification of a previously EUA authorized COVID-19 assay. Do I need to start from scratch with my validation or can I validate my test with a bridging study? (Updated 6/24)

A: The approach to modifications depends on the type of modification, as described below.

As discussed in the Policy for Coronavirus Disease-2019 Tests, when a laboratory makes a modification to an EUA authorized test for use of a new specimen type, FDA does not intend to object to the use of such a modified test without notification to FDA or a new or amended EUA where the new specimen type has been previously authorized for another test of the same technology and where the EUA-authorized test is validated for the new specimen type. Note that for all current EUAs for COVID-19 tests, such modifications would be outside the scope of and not authorized under the EUA. The Policy for Coronavirus Disease-2019 Tests does not include validation using a bridging study when validating a modification involving a new specimen type. The Molecular Diagnostic Templates referenced in the guidance and linked from FDA's webpage include recommendations for validation of a new specimen type (i.e., alternative, non-respiratory specimens).

Modifications to an EUA-authorized test for use of a new specimen type that has not been previously authorized for another test of the same technology must be authorized under a new or amended EUA prior to clinical use.

For all other types of modifications, FDA does not intend to object to the use of a test (despite that the modification is outside the scope of the EUA), without notification to the FDA or a new or amended EUA, where the test is a modification of an EUA-authorized test and the modified test is validated using a bridging study to the EUA-authorized test. Note that such modifications are outside the scope of the EUA and are not authorized under the EUA. One way to bridge to a new component is to establish equivalent performance between parallel testing of the same specimens with the new and original components. We recommend testing 3-fold serial dilutions of SARS-CoV-2 viral materials (e.g., whole genomic viral RNA or inactivated virus, etc.) in a pooled respiratory sample matrix in triplicate until you achieve a hit rate of <100%. If the resultant Limit of Detection (LoD) is the same as the LoD for the unmodified authorized test (i.e., ≤3xLOD), then FDA believes the two tests can be considered to have equivalent performance. As noted in the guidance, validation using this bridging approach is for modifications other than adding a new specimen type.

As noted in the guidance, in these cases, while the FDA does not intend to object where no EUA request is submitted, FDA would like to see your validation data through an email to CDRH-EUA-Templates@FDA.HHS.GOV to see if the bridged validation data could be applicable to modifications of other tests with an EUA, or to other laboratories modifying the same authorized tests. If it could be, and the laboratory agrees to FDA sharing that information on our website for use by other laboratories, the FDA intends to update our FAQs for other laboratories who want to refer to the validation for their testing, without conducting their own study for the same modification. This sharing of data is not considered to be a notification, a pre-EUA submission or EUA request. FDA is looking at this data only for the reasons set forth above. If you intend to pursue an EUA for modifications to an EUA-authorized test, please refer to the applicable EUA template for information on the data for a submission, including appropriate validation data, which may include bridging studies in lieu of independent validation.

The CDC has granted a right of reference to the performance data contained in the CDC's EUA request for the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device. Laboratories bridging to another EUA-authorized assay must obtain a right of reference to leverage the performance data for that EUA-authorized assay.

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Test Kit Manufacturer Diagnostic Test FAQs

Q: I am developing a SARS-CoV-2 diagnostic test kit for distribution to clinical laboratories. Can I follow the policy outlined in the Policy for Coronavirus Disease-2019 Tests? (Updated 5/4)

A: The Policy for Coronavirus Disease-2019 Tests includes information applicable to manufacturers developing diagnostic test kits for distribution. As stated in the guidance, the FDA does not intend to object to a commercial manufacturer's development and distribution of SARS-CoV-2 diagnostic test kits for specimen testing for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users. The FDA believes 15 business days is a reasonable period of time to prepare an EUA submission for a diagnostic test whose performance characteristics have already been validated.

Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high-complexity testing, including testing at the point-of-care when the site is covered by the laboratory's CLIA certificate for high-complexity testing.

This policy does not apply to at-home testing, including at-home specimen collection.

Q: I am developing a molecular SARS-CoV-2 diagnostic test kit for distribution to clinical laboratories and preparing to submit an EUA request. What template should I use? (Updated 5/4)?

A: If you are developing a molecular SARS-CoV-2 diagnostic test, we recommend using the Molecular Diagnostics Template for Commercial Manufacturers to help facilitate the preparation, submission, and authorization of an EUA. We encourage you to reach out to us at CDRH-EUA-Templates@fda.hhs.gov if you wish to discuss an alternate approach.

If you are developing an antigen SARS-CoV-2 diagnostic test, we recommend using the Antigen Template for Test Developers to help facilitate the preparation, submission, and authorization of an EUA. We encourage you to reach out to us at CDRH-EUA-Templates@fda.hhs.gov if you wish to discuss an alternate approach.

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Serology/Antibody Test FAQs

Q: Are antibody, or serology, tests used to diagnose SARS-CoV-2 infection? (Updated 5/4)

A: The terms "serological" or "antibody" tests are generally used to refer to tests that detect antibodies to the SARS-CoV-2 virus. Because the antibodies are part of the body's immune response to exposure and not the virus itself, such testing cannot be used for diagnosis of infection. Based on the underlying scientific principles of antibody tests, we do not expect that an antibody test can be shown to definitively diagnose or exclude COVID-19 infection. SARS-CoV-2 antibody tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, by detecting antibodies to SARS-CoV-2 in human blood specimens.

As stated in the Policy for Coronavirus Disease-2019 Tests, validated antibody tests offered under the policy in that guidance should, among other things, include in instructions for use and test reports information to convey that negative results do not preclude acute SARS-CoV-2 infection and that, if acute infection is suspected, direct testing for SARS-CoV-2 is necessary. SARS-CoV-2 serology tests should be ordered only by clinicians who are familiar with the use and limitations of the test.

Q: If antibody tests are not used for diagnosis or exclusion of COVID-19 infection, what is their purpose? (Updated 5/4)

A: Serology (antibody) tests may detect different types of antibodies. The most common are IgM and IgG. High quality serological tests can help us understand whether a person or population of people have developed antibodies indicative of an adaptive immune response to COVID-19.

Because a serology test can yield a negative test result even in infected patients (e.g., if antibody has not yet developed in response to the virus) or may be falsely positive (e.g., if antibody to a coronavirus type other than the current pandemic novel strain is present), antibody tests should not be used in the immediate diagnosis of a patient where COVID-19 infection is suspected. That is, these tests should not be used to diagnose acute COIVD-19 infection. Using this type of test on many patients may help the medical community better understand how the immune response against the SARS-CoV-2 virus develops in patients over time and how many people may have been infected. While there is a lot of uncertainty with this new virus, it is also possible that, over time, broad use of antibody tests and clinical follow-up will provide the medical community with more information on whether or not, and how long, a person who has recovered from the virus is at lower risk of infection if they are exposed to the virus again.

Positive results from appropriately validated serology tests that are designed to be very specific to the SARS-CoV-2 virus can indicate whether a patient has had recent or prior COVID-19 infection. In addition, although not everyone who is infected will develop an antibody response, appropriately validated serology tests, when used broadly, can be useful in understanding how many people have developed an adaptive immune response to the virus and how far the pandemic has progressed.

Serology tests can play a critical role in the fight against COVID-19 by helping healthcare professionals identify individuals who have antibodies to SARS-CoV-2 virus and have developed an adaptive immune response. In the future, this may potentially be used to help determine, together with other clinical data, whether these individuals may be less susceptible to infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. In addition, these test results can aid in determining who may be eligible to donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19.

Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA. Does FDA expect my SARS-CoV-2 antibody test to have an EUA if I offer it in the United States? (Updated 5/4)

A: As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, while laboratories are encouraged to submit EUA requests for serology tests, the FDA does not intend to object to the development and use of serology tests to identify antibodies to SARS-CoV-2 by laboratories that are certified under CLIA to perform high-complexity testing, where the test has been validated, notification is provided to the FDA, and information that helps users and patients understand the test results, such as the following, is included in the test reports:

• This test has not been reviewed by the FDA.
• Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
• Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

This policy does not apply to at-home testing, including at-home specimen collection.

The laboratories that have notified the FDA that they have validated and intend to offer serology tests as set forth in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests are listed on this FAQ page under What laboratories are offering serology tests under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests?.

Q: I am a commercial manufacturer. Does FDA expect my SARS-CoV-2 antibody test kit to have an EUA if I distribute it in the United States? (Updated 5/4)

A: As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution of serology tests to identify antibodies to SARS-CoV-2 for a reasonable period of time, where the test has been validated and while the manufacturer is preparing its EUA request, where the manufacturer gives notification to the FDA and information along the lines of the following is included in the instructions for use:

• This test has not been reviewed by the FDA.
• Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
• Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

As noted in the guidance, FDA believes that 10 business days is a reasonable period of time to prepare an EUA submission for such tests. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.

This policy does not apply to at-home testing, including at-home specimen collection.

The commercial manufacturers that have notified FDA that they have validated and intend to distribute serology tests as set forth in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests are listed on this FAQ page under What commercial manufacturers are distributing serology test kits under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests?.

In reviewing tests that are imported into the United States, the FDA will consider whether they have an EUA, as well as whether they fall within the recommendations in the FDA's Policy for Coronavirus Disease-2019 Tests.

Q: I am developing a SARS-CoV-2 antibody test and want to pursue an EUA. Do I need to have all of my validation and documentation completed and submitted in an EUA request to FDA before engaging with the FDA? (Updated 5/4)

A: If you are interested in pursuing an EUA, the FDA is interested in early interactions with test developers and will review data on a rolling basis. We encourage you to reach out to us at CDRH-EUA-Templates@fda.hhs.gov to begin pre-EUA discussions, even if you do not have your validation and/or documentation completed. We can work with you on the best approach for completing your validation, documentation, and submission of your EUA request.

As noted above, if you intend to submit a notification and begin offering your validated test before FDA issues an EUA, please refer to Section IV.D of the Policy for Coronavirus Disease-2019 Tests.

Q: I am developing a SARS-CoV-2 antibody test and want to pursue an EUA. What is FDA's policy if my validation is complete, and I notify FDA and begin offering my test for patient testing while I prepare and submit an EUA? (Updated 5/4)

A: As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, while laboratories are encouraged to submit EUA requests for serology tests, the FDA does not intend to object to the development and use of serology tests to identify antibodies to SARS-CoV-2 by laboratories that are certified under CLIA to perform high-complexity testing, where the test has been validated, notification is provided to the FDA, and certain information (as described below) is included in the test reports.

As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution of serology tests to identify antibodies to SARS-CoV-2 for a reasonable period of time, where the test has been validated and while the manufacturer is preparing its EUA request, where the manufacturer gives notification to the FDA and certain information (as described below) is included in the instructions for use. As noted in the guidance, the FDA believes that 10 business days is a reasonable period of time to prepare an EUA submission for such tests.

For serology tests offered prior to an EUA for commercial manufacturers, or prior to or without an EUA for laboratories, under the policies in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, information that helps users and patients understand the test results, such as the following, should be included in the test reports and/or the instructions for use:

• This test has not been reviewed by the FDA.
• Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
• Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.

This policy does not apply to at-home testing, including at-home specimen collection.

Q: I am developing a SARS-CoV-2 antibody test and preparing to submit an EUA request. Is there an EUA template for SARS-CoV-2 antibody tests? (Updated 5/11)

A: Yes. The FDA has developed EUA templates to help facilitate the preparation, submission, and authorization of an EUA.

• Serology Template for Commercial Manufacturers
• Serology Template for Laboratories

We encourage you to reach out to us at CDRH-EUA-Templates@fda.hhs.gov if you wish to discuss an alternate approach or to discuss any additional questions regarding performance and validation issues.

Q: What are the current validation study recommendations for a new SARS-CoV-2 antibody assay? (Updated 5/11)?

A: Please refer to Section V.C. of the FDA guidance Policy for Coronavirus Disease-2019 Tests, where we have provided recommendations regarding the testing to be performed to demonstrate that a SARS-CoV-2 antibody test is validated based upon the underlying technological principles of the test. As stated in the guidance, FDA recommends the following studies be performed for serology tests: cross-reactivity, class specificity, and clinical agreement. Depending on the characteristics of your test, such as what specimen types you are claiming, additional validation studies may be recommended in the guidance, e.g., matrix equivalency.

Additional information on the FDA's recommendations for validation testing can be found in the EUA templates provided to help facilitate the preparation, submission, and authorization of an EUA.

• Serology Template for Commercial Manufacturers
• Serology Template for Laboratories

As noted in the guidance, we encourage you to reach out to us at CDRH-EUA-Templates@fda.hhs.gov if you wish to discuss an alternate approach or to discuss any additional questions regarding performance and validation issues.

Q: I have developed a serology test kit for SARS-CoV-2 antibodies. Is there an opportunity to have my serology test independently validated? Can I use this for an EUA request? (Updated 5/4)

A: All clinical tests should be validated prior to use. Tests, including serology tests, being offered prior to or without an EUA under a policy outlined in the Policy for Coronavirus Disease-2019 Tests, have not been reviewed or authorized by the FDA. As stated in the guidance, all such tests should be validated by the developer prior to being offered for clinical use. The FDA has provided regulatory flexibility regarding the timing of the independent check by the FDA for certain tests used during the public health emergency, but still expects all developers to validate their tests prior to offering them for limited clinical uses.

The FDA is working with the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA) to assess the performance of serological tests for detection of SARS-CoV-2 antibodies. This project is intended to complement and inform FDA review as needed. As part of this project, the FDA, working with partnering agencies, has designed a performance assessment protocol that offers a mechanism for an independent evaluation of lateral flow and certain enzyme-linked immunosorbent assay (ELISA) SARS-CoV-2 antibody tests in a laboratory environment. Under this protocol, each test submitted to the National Cancer Institute (NCI)/NIH will be evaluated with a well-characterized sample panel consisting of positive and negative plasma and/or serum samples. The NIH/NCI validation project is an important resource to independently validate tests that are on the market but have not come in through the EUA process for FDA review. Performance results can be included by the test developer in an EUA submission. As stated in the guidance, FDA may leverage data from testing at the NCI/NIH, or at another federal government laboratory designated by FDA, to inform decisions on EUA requests and other actions.

If you are interested in participating in this validation project, please send an email to CDRH-OIR-POPS@fda.hhs.gov. Include the following information in your email:

• Manufacturer and test name as provided in your notification to FDA,
• Volume of tests currently available to distribute in the United States,
• Weekly production volume available to distribute in the United States,
• Test technology,
• Sample type, and
• Pre-EUA (PEUA) or EUA number if you have been assigned one.

Q: If I send my tests to NCI for evaluation, can I use the data they collect to support an EUA request? (Updated 5/5)

A: Yes. On April 28, 2020, FDA issued an umbrella Emergency Use Authorization for SARS-CoV-2 Antibody Tests (Lateral flow or Enzyme-linked immunosorbent assay (ELISA) tests) that have been evaluated in an independent validation study performed at the National Institutes of Health's (NIH) National Cancer Institute (NCI), or by another government agency designated by FDA, and are confirmed by FDA to meet the criteria set forth in the Scope of Authorization (Section II) in the Letter of Authorization. Under this EUA, authorized devices are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, by detecting antibodies (IgG, or IgG and IgM, or total), as specified in each authorized device's instructions for use, to SARS-CoV-2 in human plasma and/or serum. Emergency use of devices authorized under the umbrella EUA is limited to laboratories certified under CLIA to perform moderate or high complexity tests.

FDA will inform developers of their tests' potential eligibility for inclusion in the umbrella EUA when sharing the results of the testing with developers. The developer may request that their test be added to Appendix A of the umbrella EUA upon submission of the information set forth in the Scope of Authorization (Section II) of the EUA to CDRH-EUA-Templates@fda.hhs.gov. In order to streamline the submission and review process, FDA recommends manufacturers use the Serology Template for Commercial Manufacturers to submit the information described in the Scope of Authorization (Section II) of the EUA. FDA will issue a letter to developers notifying them of their addition to Appendix A of the umbrella EUA after confirmation that the applicable performance and labeling criteria set forth in the Scope of Authorization (Section II) of the EUA have been met.

If the test is not eligible for inclusion in the umbrella EUA, for example because the test is for use only in laboratories certified by CLIA to perform high complexity tests or the manufacturer has additional validation data, and intends to seek authorization for specimen types in addition to plasma and serum, manufacturers can still use the data in support of an individual EUA request.

Q: How is FDA using NCI validation data for SARS-CoV-2 serology (antibody) tests? (New 5/30)

A. The capability to evaluate SARS-CoV-2 serology (antibody) tests at NCI was established to enhance the U.S. Government's ability to conduct an independent evaluation of serology tests and inform FDA recommendations and decision making. Since the program began, we have seen some inconsistent performance between the clinical validation performed by the sponsor and the independent evaluation performed at NCI for several serology tests evaluated to date, particularly lateral flow tests. We have also received reports of under-performing serology tests in clinical use and there have been several reports published in the scientific literature suggesting that some lateral flow tests, in particular, have clinically unacceptable performance. In light of these findings, lateral flow serology tests are generally undergoing independent evaluation performed by NCI, or by another government agency designated by FDA, prior to EUA authorization. FDA may also leverage this independent evaluation for serology tests that use other technologies, such as chemiluminescence or ELISA, to inform regulatory decision making on EUA requests and other actions. This may be particularly helpful when data in submissions raise questions. FDA will continue to decide whether to authorize a test based on the totality of scientific evidence available. As the pandemic progresses and FDA continues to learn through real world experience with SARS-CoV-2 antibody tests, FDA will continue to adapt to the rapidly evolving circumstances as public health needs warrant.

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For More Information

If you need additional information for completing an EUA template, would like to know how to submit your Pre-EUA/EUA submission to FDA, or wish to consider use of alternative approaches to validating your test, please email CDRH-EUA-Templates@fda.hhs.gov.

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Virtual Town Hall Meeting Materials

• Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
• March 6, 2020 - Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency - Immediately in Effect Guidance
• March 2, 2020 - Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency