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  1. Coronavirus (COVID-19) and Medical Devices

SARS-CoV-2 Reference Panel Comparative Data

The FDA SARS-CoV-2 Reference Panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2. The Reference Panel contains common, independent, and well-characterized reference material that is available to developers of SARS-CoV-2 nucleic acid-based amplification tests (NAATs) for which Emergency Use Authorization (EUA) was requested.


On this page:

  • Background
  • Development of the FDA SARS-CoV-2 Reference Panel
  • Distribution and Testing of the Reference Panel
  • Results

Background

During the early months of the Coronavirus Disease 2019 (COVID-19) pandemic, clinical specimens were not readily available to developers of IVDs to detect SARS-CoV-2. Therefore, the FDA authorized IVDs based on available data from  contrived samples generated from a range of SARS-CoV-2 material sources (for example, gene specific RNA, synthetic RNA, or whole genome viral RNA) for analytical and clinical performance evaluation. While validation using these contrived specimens provided a measure of confidence in test performance at the beginning of the pandemic, it is not feasible to precisely compare the performance of various tests that used contrived specimens because each test validated performance using samples derived from different gene specific, synthetic, or genomic nucleic acid sources.

From February through the middle of May, the FDA issued a total of 59 EUAs for IVDs for the qualitative detection of nucleic acid from SARS-CoV-2 based on validation data using contrived specimens derived from SARS-CoV-2 viral RNA. As the pandemic progressed and more patient specimens became available, on May 11, 2020, the FDA recommended in the Policy for Coronavirus Disease-2019 Tests that developers obtain and use patient specimens to validate their tests.

Recognizing the value to healthcare professionals, laboratories, and patients in understanding the relative performance of NAATs for SARS-CoV-2, the FDA obtained live virus in February to develop a reference panel. Reference panels are a fundamental tool for performance assessment of molecular tests, and the use of the same reference material across different tests allows a direct comparison of analytical sensitivity performance across these tests. As was done for the evaluation of NAATs for Zika, the FDA is again providing a tool for a comparative analysis of the performance of different tests. Such comparison has shown to be useful to health care providers and laboratories implementing these tests.

The FDA SARS-CoV-2 Reference Panel is shared with developers who have interacted with FDA through the review process.

Development of the FDA SARS-CoV-2 Reference Panel

To more precisely compare the performance of NAAT SARS-CoV-2 assays, through a collaboration between the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), the FDA established a Reference Panel composed of standardized material, suitable for the determination and direct comparison of analytical sensitivity and cross-reactivity of nucleic acid-based SARS-CoV-2 assays.

The panel contains one heat-inactivated SARS-CoV-2 strain and one heat-inactivated MERS-CoV strain in cell culture media. The panel is composed of five tubes (T1 to T5): T1 contains the SARS-CoV-2 strain (2019-nCoV/USA-WA1/2020) at a concentration of ~1.8x108 RNA NAAT detectable units/mL (NDU/mL); T2, T3, T4, and T5 contain blinded samples, meaning that, although the FDA knows the concentration, the developer testing the samples does not. Based on a standard protocol provided by the FDA for T1, the developers are asked to perform a range finding Limit of Detection (LoD) study followed by a confirmatory study to further define and corroborate the LoD of their assay. The blinded samples (T2 to T5) are also tested per a protocol provided by the FDA, to confirm the LoD determined for T1 and evaluate cross-reactivity with MERS-CoV virus. Depending on the test, the number of tests performed on different amounts of viral replicates can range from over 40 to over 150.

The FDA SARS-CoV-2 Reference Panel was first provided to all developers of authorized IVD EUAs that used contrived samples to validate their assay and is provided to all developers who request an EUA for SARS-CoV-2 NAATs. In general, FDA’s EUAs require developers to evaluate and submit the analytical limit of detection and assess traceability of their product with any FDA-recommended reference material as a condition of the authorization. As explained above, assessment of assay performance using the FDA SARS-CoV-2 Reference Panel allows for a consistent determination of the relative sensitivity of these tests and cross-reactivity with MERS-CoV virus.

While the FDA SARS-CoV-2 Reference Panel helps determine the comparative performance among authorized tests, the panel is not a replacement for the analytical and clinical validation recommendations the FDA has provided in the EUA templates.  For example, the panel only includes one strain of SARS-CoV-2 and one cross-reactant, MERS-CoV. Recent mutations reported for SARS-CoV-2 (e.g., D614G), which may impact molecular testing, are not included.

Distribution and Testing of the FDA SARS-CoV-2 Reference Panel

FDA began distribution of the FDA SARS-CoV-2 Reference Panel in May 2020.  As of September 10, 2020, the FDA has contacted developers of 176 authorized assays for shipping information and has sent the reference panel to developers of 152 authorized assays. The FDA is reviewing results as they are returned, and continues to send the reference panel out to additional developers.

As of  August 15, 2020, the FDA has contacted developers of 154 authorized assays for shipping information and by August 17, 2020 sent the reference panel to developers of 137 authorized assays which are included in the tables below. Developers who received the reference panel were asked to conduct testing and return results within two weeks of receiving the panel. Many developers returned data to the FDA by August 31, 2020, but in some cases, FDA did not receive the data, or the data was uninterpretable, or is still under interactive review. All contacted developers are listed in Table 1 along with the current status of their Reference Panel testing. Confirmed results of the relative sensitivity of EUA authorized assays provided by developers as of August 31, 2020, are displayed in Tables 2A, 2B, and 2C. The results are presented in three tables according to the clinical matrix used in the study: swab in transport media, direct swabs (dry swabs), or saliva.

Following a protocol provided by the FDA with the reference panel, developers conducted testing with 3 replicates of serial dilutions of the SARS-CoV-2 virus provided in T1 in clinical negative specimens. The developers identified a provisional LoD and then performed confirmatory testing. To corroborate the LoD identified from testing T1, developers then diluted in clinical negative specimens and tested the blinded samples (T2-T5) according to the protocol provided by the FDA.

Table 1.  Status of Developers of Authorized EUAs contacted for distribution of the FDA SARS‑CoV‑2 Reference Panel*

Developer Authorized Test Status**
1drop Inc. 1copy COVID-19 qPCR Multi Kit Data not returned
3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd. TRUPCR SARS-CoV-2 Kit Did not provide shipping information
Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19 Results in Table 2B
Abbott Molecular Abbott RealTime SARS-CoV-2 assay Results in Table 2A
Abbott Molecular Inc. Alinity m SARS-CoV-2 assay Data not returned
Access Bio, Inc. CareStart COVID-19 MDx RT-PCR Results in Table 2A
Access Genetics, LLC OraRisk COVID-19 RT-PCR Data not returned
Acupath Laboratories, Inc Acupath COVID-19 Real-Time (RT-PCR) Assay Results in Table 2A
AIT Laboratories SARS-CoV-2 Assay Data not returned
altona Diagnostics GmbH REALSTAR SARS-COV-2 RT-PCR KIT U.S. Under interactive review
Altru Diagnostics, Inc. Altru Dx SARS-CoV-2 RT-PCR assay Data not returned
Applied BioCode, Inc. BioCode SARS-CoV-2 Assay Results in Table 2A
Applied DNA Sciences, Inc. Linea COVID-19 Assay Kit Results in Table 2A
Aspirus Reference Laboratory Aspirus SARS-CoV rRT Assay Data not returned
Assurance Scientific Laboratories Assurance SARS-CoV-2 Panel Results in Table 2A
Atila BioSystems, Inc. iAMP COVID-19 Detection Kit Data not returned
Avellino Lab USA, Inc. AvellinoCoV2 test Results in Table 2A
Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD MAX System Results in Table 2A
Becton, Dickinson & Company BD SARS-CoV-2 Reagents for BD MAX System Results in Table 2A
BGI Genomics Co. Ltd Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 Data not returned
Biocerna SARS-CoV-2 Test Data not returned
Biocollections Worldwide, Inc. Biocollections Worldwide SARS-Co-V-2 Assay Data not returned
BioCore Co., Ltd. BioCore 2019-nCoV Real Time PCR Kit Results in Table 2A
BioFire Defense, LLC BioFire COVID-19 Test Results in Table 2A
BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 (RP2.1) Data uninterpretable***
BioMérieux SA SARS-COV-2 R-GENE Data not returned
BioSewoom, Inc. Real-Q 2019-nCoV Detection Kit Data not returned
Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital Childrens-Altona-SARS-CoV-2 Assay Results in Table 2A
Boston Heart Diagnostics Boston Heart COVID-19 RT-PCR Test Results in Table 2A
Boston Medical Center BMC-CReM COVID-19 Test Under interactive review
Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine SARS-CoV-2-Assay  Data not returned
Centers for Disease Control and Prevention (CDC) Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay Results in Table 2A
Centers for Disease Control and Prevention (CDC) CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) Results in Table 2A
CENTOGENE US, LLC CentoFast-SARS-CoV-2 RT-PCR Assay Data not returned
Cepheid Xpert Xpress SARS-CoV-2 test Results in Table 2A
Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia SARS-CoV-2 RT-PCR test Data not returned
ChromaCode Inc. HDPCR SARS-CoV-2 Assay Results in Table 2A
CirrusDx Laboratories CirrusDx SARS-CoV-2 Assay Results in Table 2A
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute Cleveland Clinic SARS-CoV-2 Assay Data not returned
Clinical Reference Laboratory, Inc. CRL Rapid Response Data not returned
Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay Under interactive review
Co-Diagnostics, Inc. Logix Smart Coronavirus Disease 2019 (COVID-19) Kit Data not returned
Color Genomics, Inc.**** Color Genomics SARS-CoV-2 RT-LAMP Diagnostic Assay Results in Table 2A
Compass Laboratory Services, LLC Compass Laboratory Services SARS-CoV2 Assay Data not returned
Cormeum Laboratory Services Cormeum SARS-CoV-2 Assay Under interactive review
CSI Laboratories CSI SARS-CoV-2 RT PCR Test Data not returned
dba SpectronRX Hymon SARS-CoV-2 Test Kit Did not provide shipping information
DiaCarta, Inc QuantiVirus SARS-CoV-2 Test kit Results in Table 2A
DiaCarta, Inc QuantiVirus SARS-CoV-2 Multiplex Test Kit Results in Table 2A
Diagnostic Molecular Laboratory - Northwestern Medicine SARS-COV-2 Assay Did not provide shipping information
Diagnostic Solutions Laboratory, LLC DSL COVID-19 Assay Under interactive review
DiaSorin Molecular LLC Simplexa COVID-19 Direct assay Results in Table 2A
Diatherix Eurofins Laboratory SARS-CoV-2 PCR Test Results in Table 2A
Eli Lilly and Company Lilly SARS-CoV-2 Assay Results in Table 2A
Enzo Life Sciences, Inc. AMPIPROBE SARS-CoV-2 Test System Results in Table 2A
Ethos Laboratories Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay Results in Table 2A
Euroimmun US, Inc. EURORealTime SARS-Cov-2 Results in Table 2A
Exact Sciences Laboratories SARS-CoV-2 (N gene detection) Test Results in Table 2A
Exact Sciences Laboratories SARS-CoV-2 (E, N and RdRP gene detection) Test Under interactive review
Express Gene LLC (dba Molecular Diagnostics Laboratory) Express Gene 2019-nCoV RT-PCR Diagnostic Panel Under interactive review
Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) FTD SARS-COV-2 Data not returned
Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay Results in Table 2C
Fosun Pharma USA Inc.. Fosun COVID-19 RT-PCR Detection Kit Data not returned for review
Fulgent Therapeutics, LLC Fulgent COVID-19 by RT-PCR Test Results in Table 2A
Gene By Gene Gene By Gene SARS-CoV-2 Detection Test Did not provide shipping information
GeneMatrix, Inc NeoPlex COVID-19 Detection Kit Results in Table 2A
Genetron Health (Beijing) Co., Ltd. Genetron SARS-CoV-2 RNA Test Data not returned
GenMark Diagnostics, Inc. ePlex SARS-CoV-2 Test Data uninterpretable***
GenoSensor, LLC GS COVID-19 RT-PCR KIT Data not returned
Gnomegen LLC Gnomegen COVID-19 RT-Digital PCR Detection Kit Data not returned
Gnomegen LLC Gnomegen COVID-19-RT-qPCR Detection Kit Data not returned
Gravity Diagnostics, LLC Gravity Diagnostics COVID-19 Assay (370KB) Results in Table 2A
HealthQuest Esoterics HealthQuest Esoterics TaqPath SARS-CoV-2 Assay Results in Table 2A
Helix OpCo LLC (dba Helix) Helix COVID-19 Test Results in Table 2A
Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory CDI Enhanced COVID-19 Test Results in Table 2A
Hologic, Inc. Panther Fusion SARS-CoV-2 Assay Results in Table 2A
Hologic, Inc. Aptima SARS-CoV-2 assay Results in Table 2A
InBios International, Inc Smart Detect SARS-CoV-2 rRT-PCR Kit Under interactive review
Inform Diagnostics, Inc. Inform Diagnostics SARS-CoV-2 RT-PCR Assay Data not returned
Integrity Laboratories SARS-COV-2 ASSAY Data uninterpretable***
Ipsum Diagnostics, LLC COV-19 IDx assay Data uninterpretable
Jiangsu Bioperfectus Technologies Co., Ltd. COVID-19 Coronavirus Real Time PCR Kit Did not provide shipping information
Jiangsu CoWin Biotech Co., Ltd. Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) Did not provide shipping information
Kaiser Permanente Mid-Atlantic States KPMAS COVID-19 Test (104KB) Data not returned
KogeneBiotech Co., Ltd. PowerChek 2019-nCoV Real-time PCR Kit Results in Table 2A
KorvaLabs Inc. Curative-Korva SARS-Cov-2 Assay Under interactive review
LabGenomics Co., Ltd. LabGun COVID-19 RT-PCR Kit Results in Table 2A
Laboratorio Clinico Toledo Laboratorio Clinico Toledo SARS-CoV-2 Assay Under interactive review
Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test Under interactive review
LIFE TECHNOLOGIES (A PART OF THERMO FISHER SCIENTIFIC, INC.) TAQPATH COVID-19 COMBO KIT, 100 RXN, TAQPATH COVID-19 COMBO KIT, 1000 RXN Under interactive review
LifeHope Labs LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel Data not returned
Luminex Corporation ARIES SARS-CoV-2 Assay Results in Table 2A
Luminex Molecular Diagnostics, Inc. NxTAG CoV Extended Panel Assay Results in Table 2A
Maccura Biotechnology (USA) LLC SARS-CoV-2 Fluorescent PCR Kit Under interactive review
Massachusetts General Hospital MGH COVID-19 qPCR assay Data not returned
Mesa Biotech Inc Accula SARS-Cov-2 Test Under interactive review
Nationwide Children's Hospital SARS-CoV-2 Assay Data not returned
NeuMoDx Molecular, Inc. NeuMoDx SARS-CoV-2 Assay Data not returned
Omnipathology Solutions Medical Corporation Omni COVID-19 Assay by RT-PCR Did not provide shipping information
One Health Laboratories, LLC SARS-CoV-2 Real-Time RT-PCR-Test Data not returned
OPTI Medical Systems, Inc. OPTI SARS-COV-2 RT PCR Test Data not returned
Orig3n, Inc. Orig3n 2019 Novel Coronavirus (COVID-19) Test Did not provide shipping information
OSANG Healthcare GeneFinder COVID-19 Plus RealAmp Kit Did not provide shipping information
P23 Labs, LLC. P23 Labs TaqPath SARS-CoV-2 Assay Data uninterpretable
Pathology/Laboratory Medicine Lab of Baptist Hospital Miami COVID-19 RT-PCR Test Results in Table 2A
Patients Choice Laboratories, LLC PCL SARS-CoV-2 Real-Time RT-PCR Assay Results in Table 2A
PerkinElmer, Inc. PerkinElmer New Coronavirus Nucleic Acid Detection Kit Results in Table 2A
Phosphorus Diagnostics LLC Phosphorus COVID-19 RT-qPCR Test Data uninterpretable
PlexBio Co., Ltd. IntelliPlex SARS-CoV-2 Detection Kit Did not provide shipping information
PreciGenome LLC FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR) Data not returned
Primerdesign Ltd. Primerdesign Ltd COVID-19 genesig Real-Time PCR assay Under interactive review
PrivaPath Diagnostics, Inc.**** LetsGetChecked Coronavirus (COVID-19) Test Results in Table 2A
Psomagen, Inc. Psoma COVID-19 RT Test Results in Table 2A
QIAGEN GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel Results in Table 2A
Quest Diagnostics Infectious Disease, Inc. Quest SARS-CoV-2 rRT-PCR Results in Table 2A
Quidel Corporation Lyra Direct SARS-CoV-2 Assay Results in Table 2B
Quidel Corporation Lyra SARS-CoV-2 Assay Results in Table 2A
Rheonix, Inc. Rheonix COVID-19 MDx Assay Results in Table 2A
Roche Molecular Systems, Inc. (RMS) cobas SARS-CoV-2 Results in Table 2A
Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Data not returned
RTA Laboratories Biological Products Pharmaceutical and Machinery Industry Diagnovital SARS-CoV-2 Real-Time PCR Kit Did not provide shipping information
Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay Data not returned
Sandia National Laboratories SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay Data not returned
Sansure BioTech Inc. Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) Did not provide shipping information
ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit Results in Table 2A
SD Biosensor, Inc. STANDARD M nCoV Real-Time Detection Kit Did not provide shipping information
SEASUN BIOMATERIALS U-TOP COVID-19 Detection Kit Results in Table 2A
Seasun Biomaterials, Inc AQ-TOP COVID-19 Rapid Detection Kit Results in Table 2A
Seegene, Inc. Allplex 2019-nCoV Assay Data not returned
Sherlock BioSciences, Inc. Sherlock CRISPR SARS-CoV-2 Kit Results in Table 2A
SolGent Co., Ltd DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit Under interactive review
Southwest Regional PCR Laboratory LLC. dba MicroGen DX COVID-19 Key Under interactive review
Specialty Diagnostic (SDI) Laboratories SDI SARS-CoV-2 Assay Data not returned
Stanford Health Care Clinical Virology Laboratory Stanford SARS-CoV-2 assay Data not returned
TBG Biotechnology Corp. ExProbe SARS-CoV-2 Testing Kit Under interactive review
The Ohio State University Wexner Medical Center OSUWMC COVID-19 RT-PCR test Data not returned
Tide Laboratories, LLC DTPM COVID-19 RT-PCR Test Data not returned
TNS Co., Ltd (Bio TNS) COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit Did not provide shipping information
Trax Management Services Inc. PhoenixDx SARS-CoV-2 Multiplex Data not returned
Trax Management Services Inc. PhoenixDx 2019-CoV Data not returned
UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin SARS-CoV-2 RNA DETECTR Assay Data not returned
Ultimate Dx Laboratory UDX SARS-CoV-2 Molecular Assay Under interactive review
University of Alabama at Birmingham Fungal Reference Lab FRL SARS CoV-2 Test Data not returned
Nebraska Medicine Clinical Laboratory NEcov19 RT-PCR Assay Did not provide shipping information
University of North Carolina Medical Center UNC Health SARS-CoV-2 real-time RT-PCR test Results in Table 2A
University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay Data not returned
UTMG Pathology Laboratory UTHSC/UCH SARS-CoV-2-RT-PCR Assay Data not returned
Vela Operations Singapore Pte Ltd ViroKey SARS-CoV-2 RT-PCR Test Data not returned
Wadsworth Center, New York State Department of Public Health New York SARS-CoV-2 Real-time RT-PCR Diagnostic Panel Under interactive review
Warrior Diagnostics, Inc. Warrior Diagnostics SARS-CoV-2 Assay Data not returned
Wren Laboratories LLC Wren Laboratories COVID-19 PCR Test Data not returned
Xiamen Zeesan Biotech Co., Ltd. SARS-CoV-2 Test Kit (Real-time PCR) Did not provide shipping information
Yale New Haven Hospital, Clinical Virology Laboratory SARS-CoV-2 PCR Test Did not provide shipping information
Zymo Research Corporation Quick SARS-CoV-2rRT-PCR Kit Under interactive review

* Developers who were contacted for distribution of the FDA SARS-CoV-2 Reference Panel as of 8/15/2020 for panel shipping no later than 8/17/20. 
**Status of “Did not provide shipping information” indicates that no shipping information was received by 8/15/2020.  Status of “Data not returned” indicates that no data was received as of 8/31/2020.
*** No patient matrix was used
**** Nasal swab

FDA SARS-CoV-2 Reference Panel Results

Confirmed results from reference data sets received as of August 31, 2020, are shown in Table 2. No cross-reactivity with MERS-CoV has been observed.

Note: In the data in Table 2, a lower LoD represents a test’s ability to detect a smaller amount of viral material in a given sample, signaling a more sensitive test. The FDA will continue to update the table as it receives results to provide laboratories, health care providers, and patients with a resource they can use to better inform which tests they select to use.

Table 2. Sensitivity* Mean Estimates of the EUA authorized SARS-CoV-2 molecular diagnostic tests using the FDA SARS CoV-2 Reference Panel

A - Swabs in Transport Media**
Swabs are collected and transported in media as per the Instructions for Use of each EUA. If several specimen types are authorized, nasopharyngeal (NP) swabs were recommended to use. The clinical matrix is spiked following the FDA-proposed dilution protocol and tested.

Product LoD (NDU/mL***) Developer Test
180 PerkinElmer, Inc. PerkinElmer New Coronavirus Nucleic Acid Detection Kit
540 ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit
600 BioCore Co., Ltd. BioCore 2019-nCoV Real Time PCR Kit
600 DiaCarta, Inc QuantiVirus SARS-CoV-2 Test kit
600 DiaCarta, Inc QuantiVirus SARS-CoV-2 Multiplex Test Kit
600 Hologic, Inc. Panther Fusion SARS-CoV-2 Assay
600 Hologic, Inc. Aptima SARS-CoV-2 assay
600 SEASUN BIOMATERIALS U-TOP COVID-19 Detection Kit
1800 Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD MAX System
1800 CirrusDx Laboratories CirrusDx SARS-CoV-2 Assay
1800 Euroimmun US, Inc. EURORealTime SARS-Cov-2
1800 Helix OpCo LLC (dba Helix) Helix COVID-19 Test
1800 LabGenomics Co., Ltd. LabGun COVID-19 RT-PCR Kit
1800 Quest Diagnostics Infectious Disease, Inc. Quest SARS-CoV-2 rRT-PCR
1800 Rheonix, Inc. Rheonix COVID-19 MDx Assay
1800 Roche Molecular Systems, Inc. (RMS) cobas SARS-CoV-2
2500 Applied DNA Sciences, Inc. Linea COVID-19 Assay Kit
3600 Fulgent Therapeutics, LLC Fulgent COVID-19 by RT-PCR Test
5400 Abbott Molecular Abbott RealTime SARS-CoV-2 assay
5400 Access Bio, Inc. CareStart COVID-19 MDx RT-PCR
5400 Applied BioCode, Inc. BioCode SARS-CoV-2 Assay
5400 Assurance Scientific Laboratories Assurance SARS-CoV-2 Panel
5400 Becton, Dickinson & Company BD SARS-CoV-2 Reagents for BD MAX System
5400 BioFire Defense, LLC BioFire COVID-19 Test
5400 Boston Heart Diagnostics Boston Heart COVID-19 RT-PCR Test
5400 Cepheid Xpert Xpress SARS-CoV-2 test
5400 ChromaCode Inc. HDPCR SARS-CoV-2 Assay
5400 Ethos Laboratories Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay
5400 GeneMatrix, Inc NeoPlex COVID-19 Detection Kit
5400 Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory CDI Enhanced COVID-19 Test
5400 KogeneBiotech Co., Ltd. PowerChek 2019-nCoV Real-time PCR Kit
5400 Luminex Molecular Diagnostics, Inc. NxTAG CoV Extended Panel Assay
5400 Patients Choice Laboratories, LLC PCL SARS-CoV-2 Real-Time RT-PCR Assay
5700 Centers for Disease Control and Prevention (CDC) Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay
6000 DiaSorin Molecular LLC Simplexa COVID-19 Direct assay
6000 Quidel Corporation Lyra SARS-CoV-2 Assay
6000 Seasun Biomaterials, Inc AQ-TOP COVID-19 Rapid Detection Kit
6000 Sherlock BioSciences, Inc. Sherlock CRISPR SARS-CoV-2 Kit
6000 University of North Carolina Medical Center UNC Health SARS-CoV-2 real-time RT-PCR test
6030 Exact Sciences Laboratories SARS-CoV-2 (N gene detection) Test
7200 PrivaPath Diagnostics, Inc.**** LetsGetChecked Coronavirus (COVID-19) Test
18000 Acupath Laboratories, Inc Acupath COVID-19 Real-Time (RT-PCR) Assay
18000 Avellino Lab USA, Inc. AvellinoCoV2 test
18000 Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital Childrens-Altona-SARS-CoV-2 Assay
18000 Centers for Disease Control and Prevention (CDC) CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)
18000 Color Genomics, Inc.**** Color Genomics SARS-CoV-2 RT-LAMP Diagnostic Assay
18000 Eli Lilly and Company Lilly SARS-CoV-2 Assay
18000 Enzo Life Sciences, Inc. AMPIPROBE SARS-CoV-2 Test System
18000 Gravity Diagnostics, LLC Gravity Diagnostics COVID-19 Assay (370KB)
18000 HealthQuest Esoterics HealthQuest Esoterics TaqPath SARS-CoV-2 Assay
18000 Pathology/Laboratory Medicine Lab of Baptist Hospital Miami COVID-19 RT-PCR Test
18000 Psomagen, Inc. Psoma COVID-19 RT Test
180000 Diatherix Eurofins Laboratory SARS-CoV-2 PCR Test
180000 Luminex Corporation ARIES SARS-CoV-2 Assay
180000 QIAGEN GmbH

QIAstat-Dx Respiratory SARS-CoV-2 Panel

*The current performance reflects the extraction/ instrument combination with the least sensitive LoD.
**Nasopharyngeal swabs, unless otherwise noted.  Transport media refers to Viral Transport Media (VTM), Universal Transport Media (UTM), phosphate-buffered saline (PBS), saline, etc.
***NAAT Detectable Units/ mL
**** Nasal swab

B-Direct Swabs (Dry Swabs) **
For devices authorized for use with dry swab specimens only, mock swabs are prepared by pipetting 50 μL of each diluted virus stock onto a swab. Dry swabs are let to dry for a minimum of 20 minutes, and the swab is tested following the Instructions for Use for the device.

Product LoD (NDU/mL***) Developer Test
300000 Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19
540000 Quidel Corporation Lyra Direct SARS-CoV-2 Assay

**Nasopharyngeal swabs, unless otherwise noted
***NAAT Detectable Units/ mL

C-Saliva
Corroborated negative saliva is pooled. The volume of saliva that goes into the collection device is then spiked with the material at the same dilution as indicated for NP swabs (considering the replicates needed and an excess volume for the serial dilution). If the collection device is a dry container with nothing in it, the saliva is spiked and tested. However, if the collection device contains liquid, the saliva is mixed with virus and then the normal volume of collected saliva is added to the container to mimic the workflow. The volumes in the FDA-proposed dilution protocol may need to be adjusted to follow the device Instructions for Use.

Product LoD (NDU/mL***) Developer Test
54000 Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay

***NAAT Detectable Units/ mL 

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