In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2
In Vitro Diagnostic EUAs: Overview and Templates
On This Page:
- Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
- Revision Concerning Viral Mutation
- Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2
- Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
- EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests
Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
This table includes information about authorized SARS-CoV-2 molecular diagnostic tests. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. Test attributes are listed in the "Attributes" column. For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with "screening" in the attribute column; pooling, multi-analyte, saliva, home collection, and home testing are similarly listed. Tests available without a prescription include the attribute "DTC" (for direct-to-consumer home collection tests) or "OTC" (for over-the-counter at-home tests). To see additional authorization documents, such as letters granting EUA amendments or revisions, and a list of other brand names authorized under a specific EUA, select the plus (+) button beside the "Date EUA Issued or Last Updated" for the EUA.
For information on tests that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD)
Molecular SARS-CoV-2 Diagnostic Tests for COVID-19 that have been granted a De Novo, 510(k) clearance or PMA
- BioFire Respiratory Panel 2.1 (RP2.1) - On March 17, 2021, FDA granted the first marketing authorization using the De Novo review pathway for the BioFire Respiratory Panel 2.1 (RP2.1) (PDF - 630 KB). The BioFire RP2.1 is for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections, including COVID-19. Also see the FDA news release: FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process. With granting of the De Novo for the BioFire RP2.1, the FDA revoked the EUA for this device, which was initially authorized for emergency use in May 2020.
The BioFire Respiratory Panel 2.1 (RP2.1) was reviewed under the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria, called special controls, that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA's 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
Tests with "single target" in the attribute column are:
- designed to detect only one viral target on the SARS-CoV-2 genome;
- more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.
Tests with "multiple targets" in the attribute column are:
- designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome;
- more likely to continue to perform well when new variants emerge.
EUAs for standalone specimen collection devices, including home collection kits which do not include an assay in the EUA, will not have a target designation in the attribute column.
Authorized Molecular Diagnostic Tests for SARS-CoV-2 are assigned the QJR product code.
Authorized Home Collection Kits are assigned the QLW product code. Authorized EUAs for Multi-analyte Respiratory Panel Tests are assigned the QLT product code.
Date EUA Issued or Last Updated | Entity | Diagnostic (Most Recent Letter of Authorization) and Date EUA Original Issue | Attributes3 | Authorized Setting(s)1 | Authorization Documents2 | Other Documents | Other Brand Name(s) |
---|---|---|---|---|---|---|---|
11/08/2022 | Nanobiosym Precision Testing Services | The Nano Test for COVID-19 11/08/2022 | Real-time RT-PCR, Home Collection, Saliva, Multiple Targets | H | HCP, Patients, EUA Summary, IFU | None | None |
10/18/2022 | Aptitude Medical Systems Inc. | Metrix COVID-19 Test 10/18/2022 | RT, LAMP, Over the Counter (OTC) Home Testing, Saliva, Screening, Multiple Targets | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
09/13/2022 | Predicine, Inc. | Predicine SARS-CoV-2 RT-PCR Test 07/19/2022 | Real-time RT-PCR, Home Collection, Multiple Targets, Screening, Pooling | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
07/28/2022 | Laboratory Corporation of America (Labcorp) | Labcorp Seasonal Respiratory Virus RT-PCR DTC Test 05/16/2022 | Direct to Consumer (DTC), Real-time RT-PCR, Multi-analyte, Home Collection, Single Target | H | HCP, Individuals, EUA Summary, IFU (Home Collect) | None | |
05/02/2022 | LGC, Biosearch Technologies |
Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test |
End-Point RT-PCR, Screening, Multiple Targets | H | HCP, Patients, IFU | None | None |
04/26/2022 | Audere | HealthPulse@home Fusion 04/26/2022 | Home Collection Kit, Screening, Single Target | N/A | EUA Summary, IFU | None | None |
12/17/2021 | UCSD BCG EXCITE Lab | UCSD EXCITE COVID-19 Test 12/17/2021 | Real-time RT-PCR, Home Collection, Screening, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
08/24/2022 | Applied BioCode, Inc. | BioCode CoV-2 Flu Plus Assay 12/15/2021 |
RT-PCR, Multi-analyte, Single Target | H | HCP, Patients, IFU | None | |
07/21/2022 | Meridian Bioscience, Inc. | Revogene SARS-CoV-2 11/09/2021 |
Real time RT-PCR, Single Target | H, M | HCP, Patients, IFU | None | None |
08/17/2022 | Detect, Inc. | Detect Covid-19 Test 10/28/2021 |
RT, LAMP, Lateral Flow Strips, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, Individuals, IFU, IFU (Home Test) | None | |
07/21/2022 |
PerkinElmer, Inc. | PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 10/06/2021 |
Real-time RT-PCR, Multi-analyte, Multiple Targets | H | HCP, Patients, IFU | None | |
10/19/2022 | Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute | SelfCheck cobas SARS-CoV-2 Assay 09/29/2021 |
Real-time RT-PCR, Home Collection, Screening, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
12/14/2021 | Quest Diagnostics Nichols Institute | Quest Diagnostics Collection Kit for COVID-19 10/08/2021 |
Home Collection Kit | N/A | EUA Summary, IFU | None | None |
07/28/2022 | Laboratory Corporation of America (Labcorp) | Labcorp SARS-CoV-2 & Influenza A/B Assay 9/30/2021 |
Real-time RT-PCR, Multi-analyte, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
10/20/2021 | Cepheid | Xpert Xpress CoV-2/Flu/RSV plus 09/10/2021 | Real-time RT-PCR, Multi-analyte, Multiple Targets | H, M, W | HCP, Patients, IFU for Labs, IFU for Point-of-Care | None | |
12/14/2022 | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | SalivaDirect for use with DTC Kits 08/27/2021 | Direct to Consumer (DTC), Real-time RT-PCR, Saliva, Home Collection, Screening, Pooling, Single Target | H | HCP, Individuals, EUA Summary | None | |
12/01/2022 | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | SalivaDirect DTC Saliva Collection Kit 08/27/2021 |
Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening | N/A | Individual, IFU-1, IFU-2, EUA Summary | None | None |
08/25/2021 | Empire City Laboratories | ECL COVID TEST SYSTEM-1 08/25/2021 | Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, IFU (Home Collect), EUA Summary | None | None |
08/25/2021 | Empire City Laboratories | ECL COVID TEST SYSTEM 08/25/2021 | Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, IFU (Home Collect), EUA Summary | None | None |
08/23/2021 | The Mount Sinai Hospital, Center for Clinical Laboratories | Mount Sinai SARS-CoV-2 Assay 08/23/2021 | Real-time RT-PCR, Home Collection, Saliva, Screening, Multiple Targets | H | HCP, Patients, IFU (Home Collect), EUA Summary | None | None |
01/11/2022 | SEASUN BIOMATERIALS | U-TOP COVID-19 Detection Kit 04/27/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
04/23/2020 | SD Biosensor, Inc. | STANDARD M nCoV Real-Time Detection Kit 04/23/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
11/15/2022 | altona Diagnostics GmbH | RealStar SARS-CoV02 RT-PCR Kits U.S. 04/22/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
07/21/2021 | Centers for Disease Control and Prevention's (CDC) | CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) 02/04/2020 |
Real-time RT-PCR, Pooling, Multiple Targets | H | HCP, Patients, IFU | None | |
05/20/2021 | Wadsworth Center, New York State Department of Public Health | New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel 02/29/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
04/26/2022 | BGI Genomics Co. Ltd | Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 03/26/2020 |
Real-time RT-PCR, Single Target | H | HCP, Patients, IFU | None | |
04/26/2022 | Cepheid | Xpert Xpress SARS-CoV-2 test 03/20/2020 |
Real-time RT-PCR, Multiple Targets | H, M, W | HCP, Patients, IFU for Labs, IFU for Point-of-Care |
None | |
01/05/2021 | Primerdesign Ltd. | Primerdesign Ltd COVID-19 genesig Real-Time PCR assay 03/20/2020 |
Real-time RT-PCR, Single Target | H | HCP, Patients, IFU | None | |
08/18/2020 | GenMark Diagnostics, Inc. | ePlex SARS-CoV-2 Test 03/19/2020 |
RT-PCR and electrochemical detection, Single Target | H, M | HCP, Patients, IFU | None | |
07/22/2021 | DiaSorin Molecular LLC | Simplexa COVID-19 Direct assay 03/19/2020 |
Real-time RT-PCR, Multiple Targets | H, M | HCP, Patients, IFU | None | |
06/28/2022 | Abbott Molecular Inc. | Abbott RealTime SARS-CoV-2 assay 03/18/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
12/14/2021 | Quest Diagnostics Nichols Institute | Quest SARS-CoV-2 rRT-PCR 03/17/2020 |
Real-time RT-PCR, Home Collection, Pooling, Multiple Targets | H | HCP, Patients, IFU | None | |
09/29/2022 | Quidel Corporation | Lyra SARS-CoV-2 Assay 03/17/2020 |
Real-time RT-PCR, Single Target | H | HCP, Patients, IFU | None | |
06/21/2022 | Laboratory Corporation of America (Labcorp) | COVID-19 RT-PCR Test 03/16/2020 |
Real-time RT-PCR, Home Collection, Pooling, Screening, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) |
None | |
03/23/2022 | Hologic, Inc. | Panther Fusion SARS-CoV-2 Assay 03/16/2020 |
Real-time RT-PCR, Pooling, Screening, Multiple Targets | H | HCP, Patients, IFU | None | |
08/31/2022 | Thermo Fisher Scientific, Inc. | TaqPath COVID-19 Combo Kit 03/13/2020 |
Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, IFU |
|
None |
02/08/2023 | Roche Molecular Systems, Inc. (RMS) | cobas SARS-CoV-2 03/12/2020 |
Real-time RT-PCR, Pooling, Screening, Multiple Targets | H, M, H-Pooling | HCP, Patients, IFU | None | |
08/17/2022 | Mesa Biotech Inc. | Accula SARS-Cov-2 Test 03/23/2020 |
RT and amplification, Single Target | H, M, W | HCP, Patients, IFU | None | |
05/31/2022 | BioFire Defense, LLC | BioFire COVID-19 Test 03/23/2020 |
RT, Nested multiplex PCR, Pooling, Saliva, Multiple Targets | H, M | HCP, Patients, IFU | None | |
09/12/2022 | PerkinElmer, Inc. | PerkinElmer New Coronavirus Nucleic Acid Detection Kit 03/24/2020 |
Real-time RT-PCR, Pooling, Screening, Saliva, Multiple Targets | H | HCP, Patients, IFU | None | |
10/04/2022 | Avellino Lab USA, Inc. | AvellinoCoV2 test 03/25/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
10/19/2022 | Luminex Molecular Diagnostics, Inc. | NxTAG CoV Extended Panel Assay 03/27/2020 |
RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
08/27/2021 | Abbott Diagnostics Scarborough, Inc. | ID NOW COVID-19 03/27/2020 |
RT, Isothermal amplification, Single Target | H, M, W | HCP, Patients, IFU | None | |
07/29/2021 | QIAGEN GmbH | QIAstat-Dx Respiratory SARS-CoV-2 Panel 03/30/2020 |
Real-time RT-PCR, Multi-analyte, Multiple Targets | H, M | HCP, Patients, IFU | None | None |
01/22/2021 | NeuMoDx Molecular, Inc. | NeuMoDx SARS-CoV-2 Assay 03/30/2020 |
RT-PCR, Collection Kit, Saliva, Multiple Targets | H, M | HCP, Patients, IFU, IFU (Collect) | None | |
04/01/2020 | Ipsum Diagnostics, LLC | COV-19 IDx assay 04/01/2020 |
Real-time RT-PCR, Single Target | H | HCP, Patients, EUA Summary | None | |
04/03/2020 | Co-Diagnostics, Inc. | Logix Smart Coronavirus Disease 2019 (COVID-19) Kit 04/03/2020 |
RT-PCR, CoPrimer technology, Single Target | H | HCP, Patients, IFU | None | |
10/28/2020 | Luminex Corporation | ARIES SARS-CoV-2 Assay 04/03/2020 |
RT-PCR, Multiple Targets | H, M | HCP, Patients, IFU | None | |
04/28/2020 | Gnomegen LLC | Gnomegen COVID-19 RT-Digital PCR Detection Kit 04/06/2020 |
Real-time RT-digital PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
05/21/2021 | InBios International, Inc | Smart Detect SARS-CoV-2 rRT-PCR Kit 04/07/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
01/11/2022 | DiaCarta, Inc | QuantiVirus SARS-CoV-2 Test kit 04/08/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
07/14/2022 | Becton, Dickinson and Company (BD) | BD SARS-CoV-2 Reagents for BD MAX System 04/08/2020 |
Real-time RT-PCR, Screening, Multiple Targets | H, M | HCP, Patients, IFU | None | |
12/28/2020 | Atila BioSystems, Inc. | iAMP COVID-19 Detection Kit 04/10/2020 |
RT, Isothermal amplification, Multiple Targets | H | HCP, Patients, IFU | None | |
12/28/2020 | Maccura Biotechnology (USA) LLC | SARS-CoV-2 Fluorescent PCR Kit 04/15/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
04/16/2020 | GenoSensor, LLC | GS"¢ COVID-19 RT-PCR KIT 04/16/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
12/28/2020 | Fosun Pharma USA Inc. | Fosun COVID-19 RT-PCR Detection Kit 04/17/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
06/24/2021 | OSANG Healthcare | GeneFinder COVID-19 Plus RealAmp Kit 04/18/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
08/08/2020 | Trax Management Services Inc. | PhoenixDx 2019-CoV 04/20/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
12/13/2022 | Seegene, Inc. | Allplex 2019-nCoV Assay 04/21/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
09/22/2020 | LabGenomics Co., Ltd. | LabGun COVID-19 RT-PCR Kit 04/29/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
09/13/2022 | Rheonix, Inc. | Rheonix COVID-19 MDx Assay 04/29/2020 |
RT-PCR, Home Collection, Saliva, Single Target | H, M | HCP, Patients, IFU, IFU (Home Collect) | None | |
03/15/2022 | Bio-Rad Laboratories, Inc | Bio-Rad SARS-CoV-2 ddPCR Test 05/01/2020 |
RT-droplet PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
03/25/2022 | Sansure BioTech Inc. | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) 05/04/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
01/19/2022 | Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) | FTD SARS-CoV-2 05/05/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
11/01/2022 | OPTI Medical Systems, Inc. | OPTI SARS-CoV-2 RT PCR Test 05/06/2020 |
Real-time RT-PCR, Screening, Pooling, Multiple Targets | H | HCP, Patients, IFU | None | |
02/18/2022 | Sherlock BioSciences, Inc. | Sherlock CRISPR SARS-CoV-2 Kit 05/06/2020 |
RT-LAMP, CRISPR, Multiple Targets | H | HCP, Patients, IFU | None | |
08/18/2021 | Infinity BiologiX LLC | Infinity BiologiX TaqPath SARS-CoV-2 Assay 04/10/2020 |
Real-time RT-PCR, Home Collection, Saliva, Pooling, Multiple Targets | H |
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02/14/2022 | Zymo Research Corporation | Quick SARS-CoV-2rRT-PCR Kit 05/07/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
05/08/2020 | Gnomegen LLC | Gnomegen COVID-19-RT-qPCR Detection Kit 05/08/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
12/09/2022 | 1drop Inc. | 1copy COVID-19 qPCR Multi Kit 05/11/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
06/28/2022 | Abbott Molecular Inc. | Alinity m SARS-CoV-2 assay 05/11/2020 |
Real-time RT-PCR, Pooling, Screening, Multiple Targets | H, M | HCP, Patients, IFU | None | |
03/23/2022 | Hologic, Inc. | Aptima SARS-CoV-2 assay 05/14/2020 |
TMA, chemiluminescent, Pooling, Screening, Multiple Targets | H | HCP, Patients, IFU | None | |
10/12/2022 | GeneMatrix, Inc. | NeoPlex COVID-19 Detection Kit 05/14/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
06/22/2021 | Fulgent Therapeutics | Fulgent COVID-19 by RT-PCR Test 05/15/2020 |
Real-time RT-PCR, Home Collection, Screening, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
06/03/2021 | Everlywell, Inc. | Everlywell COVID-19 Test Home Collection Kit 05/15/2020 |
Home Collection Kit | N/A | IFU, EUA Summary | None | |
02/23/2022 | Assurance Scientific Laboratories | Assurance SARS-CoV-2 Panel 05/15/2020 |
Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
05/25/2021 | Quidel Corporation | Lyra Direct SARS-CoV-2 Assay 05/18/2020 |
Real-time RT-PCR, Single Target | H | HCP, Patients, IFU | None | |
04/01/2021 | P23 Labs, LLC. | P23 Labs TaqPath SARS-CoV-2 Assay 05/21/2020 |
Real-time RT-PCR, Home Collection, Saliva, Multiple Targets | H | HCP, Patients, IFU1 (Home Collect), IFU2 (Home Collect) EUA Summary |
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01/05/2022 | Seasun Biomaterials, Inc. | AQ-TOP COVID-19 Rapid Detection Kit 05/21/2020 |
RT-LAMP, Single Target | H | HCP, Patients, IFU | None | |
12/28/2020 | SolGent Co., Ltd | DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit 05/21/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
08/18/2021 | INVITES BIOCORE CO., LTD. | BioCore 2019-nCoV Real Time PCR Kit 05/21/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
08/11/2020 | dba SpectronRX | Hymon SARS-CoV-2 Test Kit 05/22/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
02/01/2022 | LetsGetChecked, Inc. | LetsGetChecked Coronavirus (COVID-19) Test 05/28/2020 |
Direct to Consumer (DTC), TMA, chemiluminescent, Home Collection, Screening, Pooling, Multiple Targets | H | HCP, Individuals, EUA Summary, IFU (Home Collect) | None | |
05/17/2021 | Phosphorus Diagnostics LLC | Phosphorus COVID-19 RT-qPCR Test 06/04/2020 |
Real-time RT-PCR, Home Collection, Saliva, Screening, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect), IFU (Clinic) |
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05/20/2021 | Genetron Health (Beijing) Co., Ltd. | Genetron SARS-CoV-2 RNA Test 06/05/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
04/13/2022 | Euroimmun US, Inc. | EURORealTime SARS-Cov-2 06/08/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
01/19/2022 | Illumina, Inc. | Illumina COVIDSeq Test 06/09/2020 |
Sequencing, Multiple Targets | H | HCP, Patients, IFU | None | |
12/22/2021 | Tide Laboratories, LLC | DTPM COVID-19 RT-PCR Test 06/10/2020 |
Real-time RT-PCR, Single Target | H | HCP, Patients, EUA Summary | None | |
08/27/2021 | TBG Biotechnology Corp. | ExProbe SARS-CoV-2 Testing Kit 06/10/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
03/01/2022 | Cue Health Inc. | Cue COVID-19 Test 06/10/2020 |
RT, Isothermal amplification, Screening, Single Target | H, M, W | HCP, Patients, IFU | None | |
06/08/2021 | Applied BioCode, Inc. | BioCode SARS-CoV-2 Assay 06/15/2020 |
RT-PCR, Pooling, Multiple Targets | H | HCP, Patients, IFU | None | |
01/13/2022 | Kaiser Permanente Mid-Atlantic States | KPMAS COVID-19 Test 06/13/2020 |
Real-time RT-PCR, Home Collection, Screening, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
05/10/2021 | Jiangsu Bioperfectus Technologies Co., Ltd. | COVID-19 Coronavirus Real Time PCR Kit 06/18/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
06/17/2020 | The Ohio State University Wexner Medical Center | OSUWMC COVID-19 RT-PCR test 06/17/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
06/24/2021 | 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd. | TRUPCR SARS-CoV-2 Kit 06/18/2020 |
Real-time RT-PCR, Saliva, Multiple Targets | H | HCP, Patients, IFU | None | |
09/21/2020 | HealthQuest Esoterics | HealthQuest Esoterics TaqPath SARS-CoV-2 Assay 06/23/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
06/23/2020 | University of Alabama at Birmingham Fungal Reference Lab | FRL SARS CoV-2 Test 06/23/2020 |
Real-time RT-PCR, Single Target | H | HCP, Patients, EUA Summary | None | |
08/26/2021 | Gencurix, Inc. | GenePro SARS-CoV-2 Test 06/23/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | None |
01/29/2021 | Diagnostic Solutions Laboratory, LLC | DSL COVID-19 Assay 06/25/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
01/06/2022 | PreciGenome LLC | FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR) 06/25/2020 |
RT-digital droplet PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
04/26/2022 | PlexBio Co., Ltd. | IntelliPlex SARS-CoV-2 Detection Kit 06/25/2020 |
RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
06/26/2020 | Inform Diagnostics, Inc. | Inform Diagnostics SARS-CoV-2 RT-PCR Assay 06/26/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
09/24/2020 | Acupath Laboratories, Inc. | Acupath COVID-19 Real-Time (RT-PCR) Assay 06/29/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
01/26/2022 | Psomagen, Inc. | Psoma COVID-19 RT Test 06/30/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
05/28/2021 | BioTNS Co. Ltd. | COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit 06/30/2020 |
RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
05/19/2021 | The Kroger Co. | Kroger Health COVID-19 Test Home Collection Kit 06/30/2020 |
Home Collection Kit, Direct to Consumer (DTC), Screening | N/A | Individuals, IFU, EUA Summary | None | |
08/05/2021 | Centers for Disease Control and Prevention (CDC) | Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay 07/02/2020 |
Real-time RT-PCR, Multi-analyte, Single Target | H | HCP, Patients, IFU | None | |
07/16/2021 | Enzo Life Sciences, Inc. | AMPIPROBE SARS-CoV-2 Test System 07/07/2020 |
Real-time RT-PCR, Pooling, Multiple Targets | H | HCP, Patients, IFU |
None |
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02/05/2021 | Access Bio, Inc. | CareStart COVID-19 MDx RT-PCR 07/07/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU |
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12/28/2020 | Gene By Gene | Gene By Gene SARS-CoV-2 Detection Test 07/07/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
07/09/2020 | UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin | SARS-CoV-2 RNA DETECTR Assay 07/09/2020 |
RT-LAMP, Single Target | H | HCP, Patients, EUA Summary | None | |
12/28/2020 | BioSewoom, Inc. | Real-Q 2019-nCoV Detection Kit 07/09/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
01/04/2022 | KogeneBiotech Co., Ltd. | PowerChek 2019-nCoV Real-time PCR Kit 07/13/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | None |
11/01/2022 | Trax Management Services Inc. | PhoenixDx SARS-CoV-2 Multiplex 07/13/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
07/13/2020 | Compass Laboratory Services, LLC | Compass Laboratory Services SARS-CoV2 Assay 07/13/2020 |
Real-time RT-PCR, Home Collection, Single Target | H | HCP, Patients, EUA Summary | None | |
12/14/2021 | Quest Diagnostics Nichols Institute | Quest Diagnostics PF SARS-CoV-2 Assay 07/15/2020 |
Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
12/14/2021 | Quest Diagnostics Nichols Institute | Quest Diagnostics RC SARS-CoV-2 Assay 07/15/2020 |
Real-time RT-PCR, Home Collection, Pooling, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
12/14/2021 | Quest Diagnostics Nichols Institute | Quest Diagnostics HA SARS-CoV-2 Assay 07/15/2020 |
TMA, chemiluminescent, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
09/21/2020 | Boston Heart Diagnostics | Boston Heart COVID-19 RT-PCR Test 07/16/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
07/28/2021 | Access Genetics, LLC | OraRisk COVID-19 RT-PCR 07/17/2020 |
Real-time RT-PCR, Home Collection, Single Target | H | HCP, Patients, EUA Summary | None | None |
01/20/2022 | DiaCarta, Inc. | QuantiVirus SARS-CoV-2 Multiplex Test Kit 07/21/2020 |
Real-time RT-PCR, Single Target | H | HCP, Patients, IFU | None | |
10/22/2020 | Helix OpCo LLC | Helix COVID-19 Test 07/23/2020 |
Real-time RT-PCR, Home Collection, Screening, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
07/24/2020 | Jiangsu CoWin Biotech Co., Ltd. | Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 07/24/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
07/09/2021 | Color Health, Inc. | Color SARS-CoV-2 RT-LAMP Diagnostic Assay 05/18/2020 |
RT, LAMP, Home Collection, Screening, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
09/21/2020 | Eli Lilly and Company | Lilly SARS-CoV-2 Assay 07/27/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
01/29/2021 | Sandia National Laboratories | SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay 07/27/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
07/30/2020 | Clinical Reference Laboratory, Inc. | CRL Rapid Response 07/30/2020 |
Real-time RT-PCR, Home Collection, Saliva, Single Target | H | None | ||
11/10/2020 | Xiamen Zeesan Biotech Co., Ltd. | SARS-CoV-2 Test Kit (Real-time PCR) 07/31/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
07/31/2020 | University of California San Diego Health | UCSD RC SARS-CoV-2 Assay 07/31/2020 |
Real-time RT-PCR, Pooling, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
06/17/2021 | WREN Laboratories LLC | WREN Laboratories COVID-19 PCR Test 08/03/2020 |
Real-time RT-PCR, Home Collection, Saliva, Screening, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
09/21/2020 | Ethos Laboratories | Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay 08/03/2020 |
RT-PCR and MALDI-TOF Mass Spec., Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
08/03/2020 | Poplar Healthcare | Poplar SARS-CoV-2 TMA Pooling assay 08/03/2020 |
TMA, chemiluminescent, Pooling, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
04/28/2022 | Exact Sciences Laboratories | SARS-CoV-2 (N gene detection) Test 05/22/2020 |
Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
07/14/2021 | ISPM Labs, LLC dba Capstone Healthcare | Genus SARS-CoV-2 Assay 08/03/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | None |
08/06/2020 | Helix OpCo LLC (dba Helix) | Helix COVID-19 NGS Test 08/06/2020 |
Sequencing, Single Target | H | HCP, Patients, EUA Summary | None | |
06/24/2021 | Vela Operations Singapore Pte Ltd | ViroKey SARS-CoV-2 RT-PCR Test 08/05/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
01/06/2022 | George Washington University Public Health Laboratory | GWU SARS-CoV-2 RT-PCR Test 08/07/2020 |
Real-time RT-PCR, Multiple Targets, Home Collection | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
12/28/2020 | Solaris Diagnostics | Solaris Multiplex SARS-CoV-2 Assay 08/10/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
01/28/2021 | Alpha Genomix Laboratories | Alpha Genomix TaqPath SARS-CoV-2 Combo Assay 08/10/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
04/05/2022 | Biomeme, Inc. | Biomeme SARS-CoV-2 Real-Time RT-PCR Test 08/11/2020 |
Real-time RT-PCR, Pooled Serial Screening - Swab, Pooled Serial Screening - Media, Multiple Targets | H | HCP, Patient, IFU | None | |
12/28/2020 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 RNA STAR 08/11/2020 |
RT, non-isothermal nucleic acid amplification qSTAR, Single Target | H | HCP, Patient, IFU | None | |
05/28/2021 | Pro-Lab Diagnostics | Pro-AmpRT SARS-CoV-2 Test 08/13/2020 |
RT, Isothermal amplification, Single Target | H | HCP, Patient, EUA Summary | None | |
12/14/2022 | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | SalivaDirect 08/15/2020 |
Real-time RT-PCR, Saliva, Home Collection, Screening, Pooling, Single Target | H | HCP, Patients, EUA Summary | None | |
08/17/2020 | ZhuHai Sinochips Bioscience Co., Ltd. | COVID-19 Nucleic Acid RT-PCR Test Kit 08/17/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
12/09/2020 | DxTerity Diagnostics, Inc. | DxTerity SARS-CoV-2 RT-PCR Test 08/21/2020 |
Real-time RT-PCR, Saliva, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
12/28/2020 | Texas Department of State Health Services, Laboratory Services Section | Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay 08/21/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
02/08/2021 | QDx Pathology Services | QDX SARS-CoV-2 Assay 08/25/2020 |
Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
10/02/2020 | Cuur Diagnostics | Cuur Diagnostics SARS-CoV-2 Molecular Assay 08/26/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
09/21/2020 | Patients Choice Laboratories, LLC | PCL SARS-CoV-2 Real-Time RT-PCR Assay 08/28/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
04/27/2021 | DxTerity Diagnostics, Inc. | DxTerity SARS-CoV-2 RT PCR CE Test 08/28/2020 |
RT-PCR, Home Collection, Saliva, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
12/28/2020 | T2 Biosystems, Inc. | T2SARS-CoV-2 Panel 08/31/2020 |
RT, amplification, T2 Magnetic resonance, Single Target | H, M | HCP, Patients, IFU | None | |
05/27/2022 | MiraDx | MiraDx SARS-CoV-2 RT-PCR assay 08/31/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
01/28/2021 | BayCare Laboratories, LLC | BayCare SARS-CoV-2 RT PCR Assay 08/31/2020 |
Real-time RT-PCR, Pooling, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
06/17/2021 | MobileDetect Bio Inc. | MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit 09/01/2020 |
RT-LAMP, Multiple Targets | H, M | HCP, Patients, IFU | None | |
12/28/2020 | OPTOLANE Technologies, Inc. | Kaira 2019-nCoV Detection Kit 09/01/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
07/21/2022 | Color Health, Inc. | Color COVID-19 Self-Swab Collection Kit 08/31/2020 |
Home Collection Kit, Screening, Multiple Targets | N/A | EUA Summary, IFU | None | |
07/15/2022 | Bioeksen R&D Technologies Inc. | Bio-Speedy Direct RT-qPCR SARS-CoV-2 09/02/2020 |
Real-time RT-PCR, Single Target | H | HCP, Patients, IFU |
|
|
02/10/2023 | Roche Molecular Systems, Inc. | cobas SARS-CoV-2 & Influenza A/B 09/03/2020 |
Real-time RT-PCR, Multi-analyte, Multiple Targets | H, M | HCP, Patients, IFU | None | |
11/15/2022 | Verily Life Sciences | Verily COVID-19 RT-PCR Test 09/08/2020 |
Real-time RT-PCR, Pooling, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
10/31/2020 | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | Wantai SARS-CoV-2 RT-PCR Kit 09/09/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
10/26/2022 | Roche Molecular Systems, Inc. | cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System 09/14/2020 |
Real-time RT-PCR, Multi-analyte, Multiple Targets | H, M, W | HCP, Patients, IFU |
|
None |
08/27/2021 | GK Pharmaceuticals Contract Manufacturing Operations | GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT 09/18/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
07/15/2021 | KimForest Enterprise Co., Ltd. | KimForest SARS-CoV-2 Detection Kit v1 09/21/2020 |
Real-time RT-PCR, Single Target | H | HCP, Patients, IFU | None | |
05/06/2021 | Quadrant Biosciences Inc. | Clarifi COVID-19 Test Kit 09/22/2020 |
Real-time RT-PCR, Saliva, Pooling, Multiple Targets | H | HCP, Patients, IFU | None | |
01/28/2022 | Vela Operations Singapore Pte. Ltd. | ViroKey SARS-CoV-2 RT-PCR Test v2.0 09/22/2020 |
Real-time RT-PCR, Multiple Targets, Pooled Serial Screening – Media | H | HCP, Patients, IFU |
|
None |
03/24/2022 | Clear Labs, Inc. | Clear Dx SARS-CoV-2 Test 09/23/2020 |
RT-PCR and Sequencing, Multiple Targets | H | HCP, Patients, IFU | None | |
01/27/2021 | Cepheid | Xpert Xpress SARS-CoV-2/Flu/RSV 09/24/2020 |
Real-time RT-PCR, Multi-analyte, Multiple Targets | H, M, W | HCP, Patients, IFU for Labs, IFU for Point-of-Care | None | |
04/27/2021 | Genetrack Biolabs, Inc. | Genetrack SARS-CoV-2 Molecular Assay 09/25/2020 |
Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
11/19/2021 | Aeon Global Health | Aeon Global Health SARS-CoV-2 Assay 09/30/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
01/28/2022 | National Jewish Health | SARS-CoV-2 MassArray Test 09/29/2020 |
RT-PCR and MALDI-TOF Mass Spec. , Multiple Targets | H | HCP, Patients, EUA Summary | None | |
04/02/2021 | Alimetrix, Inc. | Alimetrix SARS-CoV-2 RT-PCR Assay 09/30/2020 |
RT-PCR, Microarray Hybridization, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
03/18/2022 | Tempus Labs, Inc. | iC SARS-CoV2 Test 10/01/2020 |
Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
12/28/2020 | UMass Memorial Medical Center | UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel 10/01/2020 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
04/26/2022 | BioFire Diagnostics, LLC | BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) 10/02/2020 |
RT, Nested multiplex PCR, Multi-analyte, Multiple Targets | H, M, W | HCP, Patients, IFU | None | |
01/11/2022 | SEASUN BIOMATERIALS, Inc. | AQ-TOP COVID-19 Rapid Detection Kit PLUS 10/05/2020 |
RT-LAMP, Multiple Targets | H | HCP, Patients, IFU | None | |
10/08/2020 | University of California, Los Angeles (UCLA) | UCLA SwabSeq COVID-19 Diagnostic Platform 10/06/2020 |
RT-PCR and Sequencing, Single Target | H | HCP, Patients, EUA Summary | None | |
07/28/2021 | GenMark Diagnostics, Inc. | ePlex Respiratory Pathogen Panel 2 10/07/2020 |
RT-PCR and electrochemical detection, Multi-analyte, Single Target | H, M | HCP, Patients, IFU | None | None |
08/04/2021 | Spectrum Solutions LLC | SDNA-1000 Saliva Collection Device 10/08/2020 |
Saliva Collection Device | N/A | EUA Summary, IFU | None | None |
09/15/2022 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 RNA STAR Complete 10/14/2020 |
RT, qSTAR amplification, Home Collection, Screening, Pooling, Single Target | H | HCP, Patients, IFU | None | |
06/10/2021 | Clinical Enterprise, Inc. | EmpowerDX COVID-19 Home Collection Kit DTC 10/15/2020 |
Home Collection Kit, Direct to Consumer (DTC), Screening | N/A | EUA Summary, Individuals, IFU | None | None |
01/12/2022 | Viracor Eurofins Clinical Diagnostics | Viracor SARS-CoV-2 assay 04/06/2020 |
Real-Time RT-PCR, Pooling, Screening, Pooled Serial Screening - Swab, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
08/13/2021 | binx health, Inc. | binx health At-Home Nasal Swab COVID-19 Sample Collection Kit 10/20/2020 |
Home Collection Kit | N/A | EUA Summary, IFU | None | |
05/04/2021 | Agena Bioscience, Inc. | MassARRAY SARS-CoV-2 Panel 10/26/2020 |
RT-PCR, chip array and MALDI-TOF Mass Spec, Multiple Targets | H | HCP, Patients, IFU | None | |
10/28/2020 | DNA Genotek Inc. | ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices 10/28/2020 |
Saliva Collection Device | N/A | EUA Summary, IFU | None | None |
10/28/2020 | DNA Genotek Inc. | OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices 10/14/2020 |
Saliva Collection Device | N/A | EUA Summary, IFU | None | None |
11/15/2022 | Lucira Health, Inc. | Lucira COVID-19 All-In-One Test Kit 11/17/2020 |
Prescription Home Testing, Multiple Targets | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
01/22/2021 | Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory | Express Gene 2019-nCoV RT-PCR Diagnostic Panel 05/22/2020 |
Real-time RT-PCR, Collection Kit, Saliva, Multiple Targets | H | HCP, Patients, EUA Summary, IFU | None | |
03/03/2022 | Diversified Medical Healthcare | RapidRona Self-Collection Kit 11/23/2020 |
Home Collection Kit, Screening | N/A | EUA Summary, IFU (Collection) | None | |
10/15/2021 | Gravity Diagnostics, LLC | Gravity Diagnostics SARS-CoV-2 RT-PCR Assay 11/23/2020 |
Real-time RT-PCR, Home Collection, Saliva, Screening, Multiple Targets | H | HCP, Patients, EUA Summary | None | None |
11/24/2020 | Stanford Health Care Clinical Virology Laboratory | SARS-CoV-2 RT-PCR Assay 04/08/2020 |
Real-time RT-PCR, Home Collection, Single Target | H | HCP, Patients, EUA Summary, IFU (Home Collection) | None | |
12/14/2021 | Quest Diagnostics Nichols Institute | Quest Diagnostics RC COVID-19+Flu RT-PCR 12/04/2020 |
Real-time RT-PCR, Multi-analyte, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collection) | None | |
11/01/2022 | Laboratory Corporation of America (LabCorp) | Pixel by LabCorp COVID-19 Test Home Collection Kit 12/09/2020 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening, Multiple Targets | H | HCP, Individuals, EUA Summary, IFU (Home Collect) | None | |
08/12/2022 | RCA Laboratory Services LLC dba GENETWORx | GENETWORx Covid-19 Nasal Swab Test 12/15/2020 |
Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
12/11/2020 | ResearchDx, Inc., DBA Pacific Diagnostics | PacificDx Covid-19 12/11/2020 |
TMA, chemiluminescent, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
03/23/2022 | Hologic, Inc. | Aptima SARS-CoV-2/Flu assay 12/16/2020 |
Real-time TMA, chemiluminescent, Multi-analyte, Multiple Targets | H | HCP, Patients, IFU | None | |
05/05/2022 | Quidel Corporation | Solana SARS-CoV-2 Assay 12/23/2020 |
Isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA), Single Target | H, M | HCP, Patients, IFU | None | |
10/11/2022 | Cepheid | Xpert Xpress SARS-CoV-2 DoD 12/23/2020 |
Real-time RT-PCR, Pooling, Multiple Targets | H, M, W | HCP, Patients, EUA Summary | None | |
06/08/2022 | SML GENETREE Co., Ltd. | Ezplex SARS-CoV-2 G Kit 01/13/2021 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
10/25/2022 | Bio-Rad Laboratories, Inc. | Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit 01/15/2021 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
07/16/2021 | Ambry Genetics Laboratory | Ambry COVID-19 RT-PCR Test 01/22/2021 |
Real-time RT-PCR, Home Collection, Saliva, Multiple Targets | H | HCP, Patients, IFU (Home Collect), EUA Summary | None | |
01/19/2021 | Hospital of the University of Pennsylvania | BD MAX COVID-19 ASSAY (Authorized by HHS/OASH) 01/19/2021 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
09/06/2022 | INNO Diagnostics Reference Laboratory, Ponce Medical School | PMSF-INNO SARS-CoV-2 RT-PCR Test (Authorized by HHS/OASH) 01/19/2021 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
06/24/2021 | Clinomics USA Inc. | Clinomics TrioDx RT-PCR COVID-19 Test 02/04/2021 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
03/04/2022 | Thermo Fisher Scientific | TaqPath COVID-19, FluA, FluB Combo Kit 02/10/2021 |
Real-time RT-PCR, Multi-analyte, Multiple Targets | H | HCP, Patients, IFU | None | |
07/07/2022 | Grifols Diagnostic Solutions Inc. | Procleix SARS-CoV-2 Assay 02/10/2021 |
TMA, Single Target | H | HCP, Patients, IFU | None | |
08/07/2022 | Gravity Diagnostics, LLC | Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits 02/13/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets | H | HCP, Individuals, EUA Summary | None | |
02/23/2022 | Assurance Scientific Laboratories | Assurance SARS-CoV-2 Panel DTC 02/13/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Single Target | H | HCP, Individuals, EUA Summary, IFU (Home Collect) | None
|
|
07/01/2021 | Everlywell, Inc. | Everlywell COVID-19 Test Home Collection Kit DTC 02/13/2021 |
Home Collection Kit, Direct to Consumer (DTC), Screening | N/A | Individuals, EUA Summary, IFU (Home Collect) | None | None |
01/14/2022 | University of Illinois Office of the Vice President for Economic Development and Innovation | covidSHIELD 02/24/2021 |
Real-time RT-PCR, Saliva, Serial Screening, Home Collection, Pooling, Multiple Targets | H | HCP, Patients, EUA Summary IFU (Home Collect) | None | None |
01/19/2022 | Viracor Eurofins Clinical Diagnostics | Viracor SARS-CoV-2 assay DTC 02/26/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets | H | HCP, Individuals, EUA Summary | None | |
04/29/2022 | Cue Health Inc. | Cue COVID-19 Test for Home and Over The Counter (OTC) Use 03/05/2021 |
RT, Isothermal amplification, Over the Counter (OTC) Home Testing, Screening, Single Target | Home, H, M, W | HCP, Individuals, IFU, IFU (Home Test), FAQ | None | |
06/28/2022 | Abbott Molecular Inc. | Alinity m Resp-4-Plex 03/04/2021 |
Real-time RT-PCR, Multi-analyte, Multiple Targets | H, M | HCP, Patients, IFU | None | |
01/04/2023 | Luminex Molecular Diagnostics, Inc. | NxTAG Respiratory Pathogen Panel + SARS-CoV-2 03/03/2021 |
RT-PCR, Multi-analyte, Multiple Targets | H | HCP, Patients, IFU | None | |
06/03/2022 | 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 (Version 3) 03/05/2021 |
Real-time RT-PCR, Home Collection, Pooled Serial Screening - Swab, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
08/07/2022 | Gravity Diagnostics, LLC | Gravity Diagnostics COVID-19 Test Home Collection Kit 03/09/2021 |
Home Collection Kit, Direct to Consumer (DTC), Screening | N/A | EUA Summary, Individuals, IFU | None | None |
01/26/2022 | Color Health, Inc. | Color COVID-19 Self-Swab Collection Kit DTC 03/19/2021 |
Home Collection Kit, Direct to Consumer (DTC), Screening | N/A | EUA Summary, Individuals, IFU | None | |
09/03/2021 | Color Health, Inc. | Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC 03/19/2021 |
Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening, Multiple Targets | H | EUA Summary, Individuals, HCP | None | None |
07/28/2022 | Twist Bioscience Corporation | SARS-CoV-2 NGS Assay 03/23/2021 |
Next Generation Sequencing (NGS), PANGO lineage, Mutation identification, Multiple Targets | H | HCP, Patients, IFU | None | |
04/23/2021 | NeuMoDx Molecular, Inc. | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay 03/25/2021 |
Real-time RT-PCR, Multi-analyte, Single Target | H, M | HCP, Patients, IFU | None | |
01/26/2022 | STS Lab Holdco (a subsidiary of Amazon.com Services LLC) | Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 03/25/2021 |
Real-time RT-PCR, Home Collection, Pooling, Screening, Single Target | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
08/31/2022 | University of Louisville Infectious Diseases Laboratory | SARS-CoV-2 real time RT-PCR test (Authorized by HHS/OASH) 01/19/2021 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
12/12/2022 | Lucira Health, Inc. | Lucira CHECK-IT COVID-19 Test Kit 04/09/2021 |
RT, LAMP, Over the Counter (OTC) Home Testing, Screening, Multiple Targets | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
11/04/2022 | Thermo Fisher Scientific Inc. | Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit 04/09/2021 |
Real-time RT-PCR, Saliva, Multiple Targets | H | HCP, Patients, IFU | None | |
04/12/2021 | PerkinElmer Genomics | PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit 04/12/2021 |
Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
06/24/2021 | Clinical Enterprise, Inc. | Clinical Enterprise SARS-CoV-2 RT-PCR Assay 04/13/2021 |
Real-time RT-PCR, Screening, Pooled Serial Screening - Swab, Multiple Targets | H | HCP, Patients, EUA Summary | None | |
04/13/2021 | Clinical Enterprise, Inc. | Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC 04/13/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets | H | HCP, Individuals, EUA Summary | None | |
12/01/2022 | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | SalivaDirect At-Home Collection Kit 04/09/2021 |
Home Collection Kit, Saliva, Screening | N/A | EUA Summary, IFU-1, IFU-2 | None | |
06/15/2022 | Color Health, Inc. | Color COVID-19 Self-Swab Collection Kit with Saline 04/14/2021 |
Home Collection Kit, Screening | N/A | EUA Summary, IFU | None | |
05/03/2022 | LGC, Biosearch Technologies | Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test 04/15/2021 |
Real-Time and End-Point RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | |
06/02/2021 | Synergy Diagnostic Laboratory, Inc., DBA SynergyDx | SynergyDx SARS-CoV-2 RNA Test DTC 04/16/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets | H | HCP, Individuals, EUA Summary, IFU (Home Collect) | None | |
06/02/2021 | Synergy Diagnostic Laboratory, Inc., DBA SynergyDx | SynergyDx SARS-CoV-2 RNA Test 04/16/2021 |
Real-time RT-PCR, Home Collection, Screening, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
09/22/2021 | Southern California Permanente Medical Group | Kaiser Permanente High Throughput SARS-CoV-2 Assay 04/19/2021 |
Real-Time RT-PCR, Saliva, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
07/22/2021 | PathogenDx, Inc. | DetectX-Rv 04/20/2021 |
RT-PCR, DNA Microarray Hybridization, Multiple Targets | H | HCP, Patients, IFU | None | None |
05/17/2021 | Phosphorus Diagnostics LLC | Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC 05/17/2021 |
Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening, Multiple Targets | N/A | Individual, EUA Summary, IFU | None | None |
05/17/2021 | Phosphorus Diagnostics LLC | Phosphorous COVID19 RT-qPCR Test DTC 05/17/2021 |
Real-time RT-PCR, Direct to Consumer (DTC), Screening, Salvia, Home Collection, Multiple Targets | H | HCP, Individuals, EUA Summary | None | |
07/08/2021 | Harvard University Clinical Laboratory (HUCL) | Quaeris SARS-CoV-2 Assay 05/21/2021 |
Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
05/25/2021 | Thermo Fisher Scientific Inc. | TaqPath COVID-19 Pooling Kit 05/25/2021 |
Real-time RT-PCR, Pooling, Multiple Targets | H | HCP, Patients, IFU | None | |
06/17/2021 | WREN Laboratories LLC | WREN Laboratories COVID-19 PCR Test DTC 06/17/2021 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Saliva Screening, Multiple Targets | H | HCP, Individuals, EUA Summary | None | |
06/17/2021 | WREN Laboratories LLC | WREN Laboratories COVID-19 Saliva Test Collection Kit DTC 06/17/2021 |
Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening, Multiple Targets | N/A | Individuals, EUA Summary, IFU | None | None |
10/26/2022 | Roche Molecular Systems | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) 06/17/2021 |
Real-time RT-PCR, Screening, Multiple Targets | H, M, W | HCP, Patients, IFU | None | |
11/01/2022 | BioGX, Inc. | BioGX Xfree COVID-19 Direct RT-PCR 06/29/2021 |
Real-time RT-PCR, Single Target | H | HCP, Patients, IFU | None | |
08/02/2022 | Exact Sciences Laboratories | COVID-Flu Multiplex Assay 07/01/2021 |
Real-time RT-PCR, Multi-analyte, Home Collection, Single Target | H | None | ||
07/01/2021 | Everlywell, Inc. | Everlywell COVID-19 & Flu Test Home Collection Kit 07/01/2021 |
Home Collection Kit, Multi-analyte | N/A | IFU, EUA Summary | None | None |
09/21/2022 | Thermo Fisher Scientific Inc. | TaqPath COVID-19 RNase P Combo Kit 2.0 07/08/2021 |
Real-time RT-PCR, Screening, Home Collection, Multiple Targets | H | HCP, Patients, IFU | None | |
10/22/2021 | Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.) | TaqPath COVID-19 Fast PCR Combo Kit 2.0 07/30/2021 |
Real-time RT-PCR, Saliva, Multiple Targets | H | HCP, Patients, IFU | None | |
11/29/2021 | Kwokman Diagnostics, LLC | Kwokman Diagnostics COVID-19 Home Collection Kit 08/13/2021 |
Home Collection Kit | N/A | IFU, EUA Summary | None | None |
09/22/2021 | Life Sciences Testing Center | Life Sciences Testing Center COVID-19 Test 09/22/2021 |
Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
10/14/2021 | LMSI, LLC (dba Lighthouse Lab Services) | CovidNow SARS-CoV-2 Assay 10/14/2021 |
Real-time RT-PCR, Home Collection, Screening, Single Target | H | HCP, Patients, IFU, IFU (Home Collect) | None | None |
07/19/2022 | Audere | HealthPulse@home 11/30/2021 |
Home Collection Kit, Screening, Single Target | N/A | EUA Summary, IFU | None | None |
04/21/2022 | Premier Medical Laboratory Services | PMLS SARS-CoV-2 Assay 01/07/2022 |
Real-time RT-PCR, Home Collection, Screening, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
11/08/2022 | Uh-Oh Labs Inc. | UOL COVID-19 Test 02/08/2022 |
RT-LAMP, Single Target | H, M, W | HCP, Patients, IFU | None | |
07/28/2022 | Minute Molecular Diagnostics, Inc. | DASH SARS-CoV-2/S Test 03/15/2022 |
Real-time RT-PCR, Multiple Targets | H, M, W | HCP, Patients, IFU | None | |
07/14/2022 | Helix OpCo LLC (dba Helix) | Helix SARS-CoV-2 Test 03/17/2022 |
Real-time RT-PCR, Home Collection, Multiple Targets, Screening | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
07/07/2022 | Quest Diagnostics Nichols Institute | Quest COVID-19 PCR Test Home Collection Kit 03/21/2022 |
Direct to Consumer (DTC), Home Collection Kit, Screening | N/A | EUA Summary, IFU, Individuals | None | |
03/21/2022 | Quest Diagnostics Nichols Institute | Quest RC COVID-19 PCR DTC 03/21/2022 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening | H | HCP, Individuals, EUA Summary | None | None |
03/21/2022 | Quest Diagnostics Nichols Institute | Quest PF COVID-19 PCR DTC 03/21/2022 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening | H | HCP, Individuals, EUA Summary | None | None |
10/06/2022 | Quest Diagnostics Nichols Institute | Quest COVID-19 PCR DTC 03/21/2022 |
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening | H | HCP, Individuals, EUA Summary | None | |
04/06/2022 | DC Department of Health | Test Yourself DC At-Home COVID-19 Collection Kit 04/06/2022 | Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening, Multiple Targets | H | HCP, Individuals, EUA Summary, IFU (Home Collect) | None | None |
05/25/2022 | UCSD BCG EXCITE Lab | UCSD EXCITE COVID-19 EL Test 04/07/2022 | Real-time RT-PCR, Home Collection, Screening, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
08/17/2022 | Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute | SelfCheck cobas SARS-CoV-2 + Flu Assay 04/11/2022 | Real-time RT-PCR, Home Collection, Multi-analyte, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
08/24/2022 | MicroGEM U.S., Inc. | MicroGEM Sal6830 SARS-CoV-2 Saliva Test 04/14/2022 |
Real-time RT-PCR, Saliva, Multiple Targets | H, M, W | HCP, Patients, IFU | None | |
04/21/2022 | OPTI Medical Systems, Inc. | OPTI SARS-CoV-2/ Influenza A/B RT-PCR Test (Version 1 and Version 2) 04/21/2022 |
Real-time RT-PCR, Multi-analyte, Multiple Targets | H | HCP, Patients, IFU | None | None |
10/05/2022 | Abbott Diagnostics Scarborough, Inc. | ID NOW COVID-19 2.0 05/06/2022 |
RT, Isothermal amplification, Single Target | H, M, W | HCP, Patients, IFU | None | None |
11/07/2022 | Cepheid | Xpert Xpress CoV-2 plus 05/10/2022 |
Real-time RT-PCR, Screening, Multiple Targets | H, M, W | HCP, Patients, IFU for Labs, IFU for Point-of-Care | None | None |
07/28/2022 | Laboratory Corporation of America (Labcorp) | Labcorp Seasonal Respiratory Virus RT-PCR Test 05/17/2022 |
Real-time RT-PCR, Multi-analyte, Home Collection, Single Target | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
07/21/2022 | Nexus Medical Labs, LLC | Nexus High Throughput SARS-CoV-2 Assay 05/17/2022 |
Real-time RT-PCR, Home Collection, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | |
11/23/2022 | DxLab Inc. | DxLab COVID-19 Test 06/01/2022 |
RT-LAMP, Serial Screening, Multiple Targets | H, M, W | HCP, Patients, IFU | None | |
06/14/2022 | Roche Molecular Systems, Inc. | cobas SARS-CoV-2 Duo for use on the cobas 6800/8800 Systems 06/14/2022 |
Real-time RT-PCR, Quantitative, Multiple Targets | H, M | HCP, Patients, IFU | None | None |
11/18/2022 | Premier Medical Laboratory Services | Diversified Medical Healthcare SARS-CoV-2 Assay 11/18/2022 |
Real-time RT-PCR, Home Collection, Screening, Multiple Targets | H | HCP, Patients, EUA Summary, IFU (Home Collect) | None | None |
11/22/2022 | Lucira Health, Inc. | Lucira COVID-19 & Flu Test 11/22/2022 | RT-LAMP, Multiple Targets, Multi-analyte | H, M, W | HCP, Patients, IFU | None | None |
12/19/2022 | OnsiteGene, Inc. | Hi-Sense COVID-19 Molecular Testing Kit 1.0 12/19/2022 |
Real-time RT-PCR, Multiple Targets | H | HCP, Patients, IFU | None | None |
12/23/2022 | Visby Medical, Inc. | Visby Medical Respiratory Health Test 12/23/2022 |
RT-PCR, Multi-analyte, Multiple Targets | H, M, W | HCP, Patients, IFU | None | None |
02/03/2023 | Becton, Dickinson and Company (BD) | BD Respiratory Viral Panel for BD MAX System 02/03/2023 |
Real-time RT-PCR, Multi-analyte, Multiple Targets | M, H | HCP, Patients, IFU | None | None |
02/03/2023 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete Assay 02/03/2023 |
RT, Non-isothermal Nucleic Acid Amplification qSTAR, Multi-analyte, Single Target | H | HCP, Patients, IFU | None | None |
02/08/2023 | ADL Diagnostics, Inc., dba Anavasi Diagnostics | The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector 02/08/2023 |
RT-LAMP, Multiple Targets | H, M, W | HCP, Patients, IFU | None | None |
02/08/2023 | The HFI Laboratory at Boston University (dba the BU Clinical Testing Laboratory) | BU SARS-CoV-2 Test 02/08/2023 |
real-time RT-PCR, Multiple Targets | H | HCP, Patients, EUA Summary | None | None |
1 Authorized settings 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.
2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.
- RT-PCR = reverse transcriptase polymerase chain reaction;
- RT = reverse transcriptase;
- LAMP = loop-mediated isothermal amplification;
- MALDI-TOF = Matrix Assisted Laser Desorption/Ionization - Time of Flight;
- TMA = Transcription Mediated Amplification;
- qSTAR = Selective Temperature Amplification Reaction;
- CRISPR = clustered regularly interspaced short palindromic repeats;
Revision Concerning Viral Mutations
On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. The revision requires test developers to update their authorized labeling and evaluate the impact of SARS-CoV-2 viral mutations on their test's performance as outlined in the letter. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. This revision does not apply to EUAs for authorized IL-6 assays or standalone specimen collection devices and does not apply to EUAs that include substantially equivalent viral mutation conditions of authorization.
The FDA has determined that establishing additional conditions is necessary to mitigate the potential risk of false negative results due to either decreased sensitivity or non-reactivity associated with SARS-CoV-2 viral mutations. As set forth in the September 23, 2021 letter, developers of authorized tests that are within the scope of the revision are now required to routinely monitor emerging viral mutations and their potential impact on the performance of the authorized SARS-CoV-2 test(s). If potential impacts are identified, the EUA holder must communicate with the FDA and end users about the potential risk that presence of the mutations may have on test performance. The EUA holder must also update their authorized labeling consistent with the revision letter and submit the labeling to the FDA within 3 months of September 23, 2021. By taking these steps, the FDA and the test developer can quickly act in response to the potential risks identified and, when applicable, share the findings on SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.
Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2
On April 20, 2021, the FDA issued an amendment allowing certain authorized molecular diagnostic SARS-CoV-2 tests to be distributed and used to pool anterior nasal respiratory specimens from asymptomatic individuals as part of a serial testing program after developers submit a complete notification, including meeting required validation data, as set forth in the letter. Use of tests for these indications is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, except that tests authorized for use in specific named or designated high complexity laboratories can only be used in such laboratories.
This means that tests with EUAs that are amended by this authorization may be used with pooled anterior nasal specimens from individuals without known or suspected COVID-19 when such individuals are tested as part of a testing program that includes testing at regular intervals, at least once per week. The indications in each appendix (A-H) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10) and the type of pooling that can be done (media pooling or swab pooling).
Prior to a test being distributed or used for any new indication, the developer must submit a notification to the FDA with the information required by the amendment, including self-certifying that the applicable validation has been completed. Tests will be added to Exhibit 1 once FDA confirms that the required documentation has been submitted. Please note that being added to Exhibit 1 does not necessarily mean that the FDA has reviewed the underlying validation data submitted or confirmed that the test is appropriately validated.
- Amendment Letter
- Appendix J - Sample Updated Fact Sheet for Health Care Providers
- Appendix K - Sample Updated Fact Sheet for Patients
Exhibit 1 of the Pooling and Serial Testing Amendment
The table below includes information for the authorized RT-PCR molecular diagnostic tests for SARS-CoV-2 amended by this Pooling and Serial Testing Amendment. For authorization documents for each test, see Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2 above.
Date Added to Exhibit 1 | EUA Holder | Test Name | Indication(s)* |
---|---|---|---|
06/24/2021 | Clinical Enterprise, Inc. | Clinical Enterprise SARS-SoV-2-RT-PCR Assay | Swab: Up to 10 (Appendix C) |
06/15/2021 | 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 (Version 3) | Swab: Up to 10 (Appendix C) |
06/22/2021 | Biomeme, Inc. | Biomeme SARS-CoV-2 Real-Time RT-PCR Test | Swab: Up to 10 (Appendix C) Media: Up to 10 (Appendix H) |
06/23/2021 | Viracor Eurofins Clinical Diagnostics | Viracor SARS-CoV-2 assay | Swab: Up to 10 (Appendix C) |
01/28/2022 | Vela Operations Singapore Pte. Ltd | ViroKey SARS-CoV-2 RT-PCR Test v2.0 | Media: Up to 3 (Appendix D) |
* The indications in each appendix (A-H) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10) and the type of pooling that can be done (media or swab pooling).
Tests authorized for Swab Pooling are authorized for:
- Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swabs placed in a single vial containing transport media after being collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from any individual, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week as part of a serial testing program.
This indication is authorized for use in laboratories certified under CLIA to perform high complexity tests except tests authorized for use in specific named or designated laboratories can only be used in such laboratories.
Tests authorized for Media Pooling are authorized for:
- Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing aliquots of transport media from up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swab specimens that were collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from any individual and placed in individual vials containing transport media, including individuals without symptoms or other reasons to suspect COVID-19, when tested as part of a serial testing program including testing at least once per week.
This indication is authorized for use in laboratories certified under CLIA to perform high complexity tests except tests authorized for use in specific named or designated laboratories can only be used in such laboratories.
Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
On November 15, 2021, the FDA issued an umbrella EUA for certain RT-PCR molecular-based tests, developed by laboratories, for detection of nucleic acid from SARS-CoV-2 from anterior nasal respiratory specimens for use as part of a serial testing program, that meet certain criteria for eligibility specified in the EUA. Under this EUA, authorized tests can be used with individual or pooled anterior nasal specimens for testing individuals, including individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least once per week. This means that tests authorized by this EUA may be used with individual or pooled anterior nasal respiratory specimens from individuals with or without known or suspected exposure to COVID-19 when such individuals are tested at least once per week, such as testing at regular intervals as part of a testing program implemented by schools, workplaces, or community groups. The indications in each appendix (A-K) differ in the number of specimens that can be pooled (1, up to 3, up to 5, or up to 10), the type of pooling that can be done (media pooling or swab pooling), and whether the test can be used with home collected specimens.
Use of tests authorized by this EUA is limited to use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high complexity tests.
Tests will be added to Exhibit 1 of this EUA following submission of a complete notification to the FDA with the information required by the EUA, including self-certifying that the applicable validation has been completed, and confirmation by the FDA that the required documentation has been submitted. Being added to Exhibit 1 does not necessarily mean that the FDA has reviewed the underlying validation data submitted or confirmed that the test is appropriately validated.
- EUA Letter of Authorization - Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
- Appendix L - Fact Sheet for Health Care Providers (Template)
- Appendix M - Fact Sheet for Patients (Template)
- Appendix N - Test Summary (Template)
Exhibit 1 of the Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
This exhibit includes information for the RT-PCR molecular diagnostic tests for SARS-CoV-2 authorized by this umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing. All tests authorized by this umbrella EUA are required to have at least two viral targets on the SARS-CoV-2 genome. Tests with multiple targets are more likely to continue to perform well when new variants emerge.
Date Added to Exhibit 1 |
EUA Holder | Test Name | Additional Indication(s)* | Authorization Documents** |
---|---|---|---|---|
02/17/2022 | Applied DNA Clinical Labs, LLC. | Linea 2.0 COVID-19 Assay | Media: Up to n=5 (Appendix H) | Test Summary, HCP, Patients |
08/01/2022 | Helix Diagnostics | Helix Diagnostics SARS nCoV-2019 Multiplexed Assay | None | Test Summary, HCP, Patients |
11/02/2022 | Rize Laboratory | Rize Laboratory SARS nCoV-2019 Multiplexed Assay | None | Test Summary, HCP, Patients |
01/05/2023 | Scope Molecular Laboratory | Scope Molecular Laboratory SARS nCoV-2019 Multiplexed Assay | None | Test Summary, HCP, Patients |
* All tests authorized under this Umbrella EUA are authorized for (as described in appendix A):
- Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swab samples collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week.
Each test is authorized for use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high complexity tests.
Additional indications included in appendices (B-K) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10), the type of pooling that can be done (media or swab pooling), and the inclusion of use with home collected specimens.
Tests authorized for Swab Pooling (appendices B-D) are authorized for:
- Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swabs or pooled samples containing up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swabs placed in a single vial after being collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week.
This test is authorized for use in the single laboratory that developed the test and that is certified under CLIA and meets requirements to perform high complexity tests.
Tests authorized for Media Pooling (appendices E-I) are authorized for:
- Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swabs or pooled samples containing aliquots of media from up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swab specimens that were collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19 and placed in individual vials when tested at least once per week.
This test is authorized for use in the single laboratory that developed the test and that is certified under CLIA and meets requirements to perform high complexity tests.
Tests authorized for Home Specimen Collection (appendices J-K) are authorized for the applicable above indications with the following addition regarding specimen collection:
- {or self-collected at home using the following authorized home collection kit(s): [specific named home collection kit(s) with which the test was validated] when used consistent with the home collection kit's authorization for individuals tested at least once per week}
** Authorization Documents include the Test Summary, Fact Sheet for Healthcare Providers (HCP) and Fact Sheet for Patients.
EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests
On March 31, 2020, the FDA issued an umbrella EUA for molecular laboratory developed tests (LDTs) for detection of SARS-CoV-2 that meet certain criteria for eligibility described in the EUA. Under this EUA, authorized tests are authorized for use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests. Tests authorized under this umbrella EUA were added to Appendix A in the table below.
On November 15, 2021, the FDA reissued this EUA such that only tests that are listed in Appendix A are authorized for use as described in the EUA, and no additional tests will be authorized by this EUA. The reissued EUA also includes updated Conditions of Authorization and Fact Sheets to reflect the most up-to-date information.
- EUA Letter of Authorization - Laboratories Who Have Developed a Molecular-Based Test (LDTs) for Coronavirus Disease 2019 (COVID-19)
- Fact Sheet for Healthcare Providers
- Fact Sheet for Patients
- See Appendix A table below for a list of tests authorized under this EUA
Appendix A: Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2
The table below includes information for the high complexity molecular-based laboratory developed SARS-CoV-2 assays authorized by this EUA during the COVID-19 public health emergency.
To see additional authorization documents, such as letters granting EUA amendments or revisions, for a specific test, select the plus (+) button beside the "Date Last Updated" for each test.
All tests in this table are multiple target tests unless noted with an asterisk (*). Multiple target tests are designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome. Tests with an asterisk are single target tests. Single target tests are designed to detect only one viral target on the SARS-CoV-2 genome. Tests with multiple targets are more likely to continue to perform well when new variants emerge. Tests with single targets are more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.
All authorized devices in the table below are assigned the QJR product code.
1 The tests listed in this table are all molecular-based tests for COVID-19 and the authorized setting is for use in the identified laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.