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 healthcare providers and laboratories using 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 23, 2020, the FDA has contacted developers of 186 authorized assays for shipping information and has sent the reference panel to developers of 161 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 28, 2020, the FDA has contacted developers of 165 authorized assays for shipping information and by August 31, 2020 sent the reference panel to developers of 147 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 September 11, 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 September 11, 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 studies are performed by diluting the panel material in "negative patient clinical matrix" acquired and prepared by individual developers. 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 | Results in Table 2A |
| 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 | Under interactive review |
| 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 | Results in Table 2A |
| 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 SARS-CoV-2 Reagents for BD MAX System1 | Results in Table 2A |
| Becton, Dickinson & Company (BD) | BioGX 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 | Under interactive review |
| 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*** |
| Biomeme, Inc. | Biomeme SARS-CoV-2 Real-Time RT-PCR Test | Under interactive review |
| BioMérieux SA | SARS-COV-2 R-GENE | Results in Table 2A |
| Bio-Rad Laboratories, Inc | Bio-Rad SARS-CoV-2 ddPCR Test | Results in Table 2A |
| BioSewoom, Inc. | Real-Q 2019-nCoV Detection Kit | Under interactive review |
| Boston Heart Diagnostics | Boston Heart COVID-19 RT-PCR Test | Results in Table 2A |
| Boston Medical Center | BMC-CReM COVID-19 Test | Results in Table 2A |
| Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine | SARS-CoV-2-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 |
| Centers for Disease Control and Prevention (CDC) | Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay | 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 |
| 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 | Results in Table 2C |
| 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 Assay2 | Results in Table 2A |
| Columbia University Laboratory of Personalized Genomic Medicine | TRIPLEX CII-SARS-CoV-2 rRT-PCR TEST | 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 uninterpretable*** |
| Cue Health Inc. | Cue COVID-19 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 |
| 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 uninterpretable |
| 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 |
| 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 |
| George Washington University Public Health Laboratory | GWU SARS-CoV-2 RT-PCR Test | 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 |
| Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory | CDI Enhanced COVID-19 Test | 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 |
| Hologic, Inc. | Panther Fusion SARS-CoV-2 Assay | Results in Table 2A |
| Hologic, Inc. | Aptima SARS-CoV-2 assay | Results in Table 2A |
| Illumina, Inc. | Illumina COVIDSeq Test | Results in Table 2A |
| InBios International, Inc | Smart Detect SARS-CoV-2 rRT-PCR Kit | Under interactive review |
| Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia | SARS-CoV-2 RT-PCR test | Data not returned |
| Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital | Childrens-Altona-SARS-CoV-2 Assay | Results in Table 2A |
| Infinity BiologiX LLC (formerly Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University) | Infinity BiologiX TaqPath SARS-CoV-2 Assay (formerly Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay) | Data not returned |
| 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 assay3 | Results in Table 2A |
| 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 | Results in Table 2A |
| 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 | Results in Table 2A |
| LIFE TECHNOLOGIES (A PART OF THERMO FISHER SCIENTIFIC, INC.) | TAQPATH COVID-19 COMBO KIT, 100 RXN, TAQPATH COVID-19 COMBO KIT, 1,000 RXN | Results in Table 2A |
| 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 |
| LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 RNA STAR | Data not returned |
| 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 |
| Nebraska Medicine Clinical Laboratory | NEcov19 RT-PCR Assay | Did not provide shipping information |
| NeuMoDx Molecular, Inc. | NeuMoDx SARS-CoV-2 Assay | Results in Table 2A |
| 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 | Under interactive review |
| OPTI Medical Systems, Inc. | OPTI SARS-COV-2 RT PCR Test | Results in Table 2A |
| 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 | Results in Table 2A |
| 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) | Results in Table 2A |
| 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 |
| Pro-Lab Diagnostics | Pro-AmpRT SARS-CoV-2 Test | Did not provide shipping information |
| Psomagen, Inc. | Psoma COVID-19 RT Test | Results in Table 2A |
| QIAGEN GmbH | QIAstat-Dx Respiratory SARS-CoV-2 Panel | Results in Table 2A |
| Quadrant Biosciences Inc. | Clarifi COVID-19 Test Kit | Data not returned |
| Quest Diagnostics Infectious Disease, Inc. | Quest SARS-CoV-2 rRT-PCR | Results in Table 2A |
| Quidel Corporation | Lyra SARS-CoV-2 Assay | Results in Table 2A |
| Quidel Corporation | Lyra Direct SARS-CoV-2 Assay | Results in Table 2B |
| Rheonix, Inc. | Rheonix COVID-19 MDx Assay | Results in Table 2A |
| Roche Molecular Systems, Inc. | cobas SARS-CoV-2 & Influenza A/B | Results in Table 2A |
| Roche Molecular Systems, Inc. (RMS) | cobas SARS-CoV-2 | Results in Table 2A |
| RTA Laboratories Biological Products Pharmaceutical and Machinery Industry | Diagnovital SARS-CoV-2 Real-Time PCR Kit | Did not provide shipping information |
| Sandia National Laboratories | SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay | Under interactive review |
| 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 |
| Solaris Diagnostics | Solaris Multiplex SARS-CoV-2 Assay | Data not returned |
| SolGent Co., Ltd | DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit | Under interactive review |
| Southwest Regional PCR Laboratory LLC. dba MicroGen DX | COVID-19 Key | Results in Table 2A |
| Specialty Diagnostic (SDI) Laboratories | SDI SARS-CoV-2 Assay | Results in Table 2A |
| 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 | Results in Table 2A |
| University of Alabama at Birmingham Fungal Reference Lab | FRL SARS CoV-2 Test | Data not returned |
| 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 | Under interactive review |
| Wadsworth Center, New York State Department of Public Health | New York SARS-CoV-2 Real-time Reverse Transcriptase (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 |
| Yale School of Public Health, Department of Epidemiology of Microbial Diseases | SalivaDirect | Results in Table 2C |
| ZhuHai Sinochips Bioscience Co., Ltd | COVID-19 Nucleic Acid RT-PCR Test Kit | Results in Table 2A |
| 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 8/28/2020 for panel shipping no later than 8/31/20.
** Status of "Did not provide shipping information" indicates that no shipping information was received by 8/28/2020. Status of "Data not returned" indicates that no data was received as of 9/11/2020.
*** No patient matrix was used
**** Nasal swab
1 Results were obtained with the version of the test authorized on 9/23/2020
2 Results were obtained with the version of the test authorized on 8/28/2020
3 Results were obtained with the version of the test authorized on 4/01/2020
FDA SARS-CoV-2 Reference Panel Results
Confirmed results from reference data sets received as of September 11, 2020, are shown in Table 2. No cross-reactivity with MERS-CoV has been observed unless otherwise specified.
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, healthcare 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 | Bio-Rad Laboratories, Inc | Bio-Rad SARS-CoV-2 ddPCR Test |
| 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 | Altru Diagnostics, Inc. | Altru Dx SARS-CoV-2 RT-PCR assay |
| 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 | OPTI Medical Systems, Inc. | OPTI SARS-COV-2 RT PCR Test |
| 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. | cobas SARS-CoV-2 & Influenza A/B |
| 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 System1 |
| 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 | Illumina, Inc. | Illumina COVIDSeq Test |
| 5400 | KogeneBiotech Co., Ltd. | PowerChek 2019-nCoV Real-time PCR Kit |
| 5400 | Luminex Molecular Diagnostics, Inc. | NxTAG CoV Extended Panel Assay |
| 5400 | NeuMoDx Molecular, Inc. | NeuMoDx SARS-CoV-2 Assay |
| 5400 | Patients Choice Laboratories, LLC | PCL SARS-CoV-2 Real-Time RT-PCR Assay |
| 5400 | ZhuHai Sinochips Bioscience Co., Ltd | COVID-19 Nucleic Acid RT-PCR Test Kit |
| 18000 | Centers for Disease Control and Prevention (CDC) | CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) |
| 6000 | Columbia University Laboratory of Personalized Genomic Medicine | TRIPLEX CII-SARS-CoV-2 rRT-PCR TEST |
| 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 |
| 6025 | Exact Sciences Laboratories | SARS-CoV-2 (N gene detection) Test |
| 720 | PrivaPath Diagnostics, Inc.**** | LetsGetChecked Coronavirus (COVID-19) Test |
| 18000 | 1drop Inc. | 1copy COVID-19 qPCR Multi Kit |
| 18000 | Acupath Laboratories, Inc | Acupath COVID-19 Real-Time (RT-PCR) Assay |
| 18000 | Avellino Lab USA, Inc. | AvellinoCoV2 test |
| 18000 | BioMérieux SA | SARS-COV-2 R-GENE |
| 18000 | Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine | SARS-CoV-2-Assay |
| 5700 | Centers for Disease Control and Prevention (CDC) | Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay |
| 18000 | Color Genomics, Inc.**** | Color Genomics SARS-CoV-2 RT-LAMP Diagnostic Assay2 |
| 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 | Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital | Childrens-Altona-SARS-CoV-2 Assay |
| 18000 | KorvaLabs Inc. | Curative-Korva SARS-Cov-2 Assay |
| 18000 | Pathology/Laboratory Medicine Lab of Baptist Hospital Miami | COVID-19 RT-PCR Test |
| 18000 | Phosphorus Diagnostics LLC | Phosphorus COVID-19 RT-qPCR Test3 |
| 18000 | Psomagen, Inc. | Psoma COVID-19 RT Test |
| 18000 | Ultimate Dx Laboratory | UDX SARS-CoV-2 Molecular Assay |
| 180000 | Diatherix Eurofins Laboratory | SARS-CoV-2 PCR Test |
| 180000 | Ipsum Diagnostics, LLC | COV-19 IDx assay4 |
| 180000 | Laboratory Corporation of America (LabCorp) | COVID-19 RT-PCR Test |
| 180000 | LIFE TECHNOLOGIES (A PART OF THERMO FISHER SCIENTIFIC, INC.) | TAQPATH COVID-19 COMBO KIT, 100 RXN, TAQPATH COVID-19 COMBO KIT, 1,000 RXN |
| 180000 | Luminex Corporation | ARIES SARS-CoV-2 Assay |
| 180000 | PreciGenome LLC***** | FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR) |
| 180000 | QIAGEN GmbH | QIAstat-Dx Respiratory SARS-CoV-2 Panel |
| 180000 | Southwest Regional PCR Laboratory LLC. dba MicroGen DX | COVID-19 Key |
| 180000 | Specialty Diagnostic (SDI) Laboratories | SDI SARS-CoV-2 Assay |
| 600000 | Boston Medical Center | BMC-CReM COVID-19 Test |
* The current performance reflects the extraction/ instrument combination with the least sensitive LoD. For additional information please refer to the Instructions for Use of the assay.
** 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
***** Oropharyngeal swabs
1 Results were obtained with the version of the test authorized on 9/23/2020
2 Results were obtained with the version of the test authorized on 8/28/2020
3 Cross-reactivity with MERS-CoV was observed
4 Results were obtained with the version of the test authorized on 4/01/2020
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 |
| 18000 | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | SalivaDirect |
| 5400 | Clinical Reference Laboratory, Inc. | CRL Rapid Response |
*** NAAT Detectable Units / mL