Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
This page provides answers to frequently asked questions related to Emergency Use Authorizations and Notifications under the policies outlined in the Policy for Coronavirus Disease-2019 Tests.
This section includes questions and answers regarding the policies outlined in the Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised). In this section, this guidance is referred to as the Policy for Coronavirus Disease-2019 Tests.
For a directory of FAQs related to SARS-CoV-2 testing, see FAQs on Testing for SARS-CoV-2.
A: All in vitro diagnostic tests that have been issued an Emergency Use Authorization (EUA) are listed on the In Vitro Diagnostics EUAs page. FDA has authorized molecular and antigen diagnostic tests for SARS-CoV-2, including multi-analyte tests that detect SARS-CoV-2 as well as other respiratory pathogens, and serology/antibody tests for SARS-CoV-2.
A: As stated in Section IV.A of the FDA's Policy for Coronavirus Disease-2019 Tests, for laboratories certified under CLIA to perform high-complexity testing and that seek to develop and perform diagnostic tests to detect the SARS-CoV-2 virus, the FDA does not intend to object to the use of validated tests for specimen testing for a reasonable period of time after validation while the laboratory is preparing an EUA request. As noted in the guidance, the FDA believes 15 business days is a reasonable period of time to prepare an EUA submission for a test that has already been validated.
Many commercial and healthcare system/academic laboratories have notified the FDA that they have validated their own COVID-19 test and have started patient testing as set forth in Section IV.A of the FDA's Policy for Coronavirus Disease-2019 Tests. The laboratories listed below have provided such notification. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the laboratory's validation and issued an EUA for the laboratory's test, and the test is included in this list to provide transparency regarding the notification submitted to FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing. Certain developers have completed the EUA process prior to offering a test for clinical use rather than notify FDA under this policy. Tests that have been issued an EUA can be found on the EUA page.
If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be addressed in a timely manner, the FDA intends to remove the laboratory from this list and may take additional actions as appropriate.
Note that many other laboratories, including public health, commercial, and healthcare system/academic laboratories, around the country are providing testing for COVID-19 using an EUA authorized test.
In addition, under the Policy for Coronavirus Disease-2019 Tests issued on March 16, States may choose to authorize high-complexity CLIA-certified laboratories within that State or territory to develop and perform tests for COVID-19. Such laboratories are not included in this list. The States that have chosen to use this authority are listed on this page under the question: Q: What States or territories have chosen to authorize laboratories within that State or territory to develop and perform a test for COVID-19 under the policy outlined in Section IV.B of the Policy for Diagnostic Tests for Coronavirus Disease-2019?
Laboratories that have notified the FDA that they have validated their own COVID-19 diagnostic test as set forth in Section IV.A:
Laboratory | Authorization Status | Settings for Use1 |
---|---|---|
Access Genetics, dba OralDNA Labs | FDA Authorized | H |
Access Medical Laboratories | Not FDA Authorized | H |
Accu Reference Medical Lab LLC | Not FDA Authorized | H |
Advanced Diagnostics Laboratory, National Jewish Health | Not FDA Authorized | H |
AdventHealth | Not FDA Authorized | H |
Aegis Sciences Corporation | Not FDA Authorized | H |
Aeon Global Health dba Peachstate Health Management LLC | FDA Authorized | H |
Alphadera Labs, LLC | Not FDA Authorized | H |
Altru Diagnostic, Inc. | FDA Authorized | H |
ARUP Laboratories | Not FDA Authorized | H |
Assurance Scientific | FDA Authorized | H |
Avellino Lab USA, Inc. | FDA Authorized | H |
Bako Pathology Associates/DBA Bako Diagnostics | Not FDA Authorized | H |
Baptist Hospital of Miami Clinical Lab | FDA Authorized | H |
Baylor College of Medicine (CMMR/HGSC) Clinical Laboratories | Not FDA Authorized | H |
Baylor Scott and White Medical Center - Temple | Not FDA Authorized | H |
Baystate Medical Center Whitney Ave Laboratories | Not FDA Authorized | H |
Bedford Research Foundation | Not FDA Authorized | H |
Beth Israel Deaconess Medical Center | Not FDA Authorized | H |
Boston Children's Hospital Infectious Diseases Diagnostics Laboratory | FDA Authorized | H |
Brigham and Women's Hospital | Not FDA Authorized | H |
Bryan Medical Center West | Not FDA Authorized | H |
Centogene | FDA Authorized | H |
The Children's Hospital of Philadelphia | FDA Authorized | H |
Children's National Hospital | Not FDA Authorized | H |
Clarity Lab Solutions | Not FDA Authorized | H |
Cleveland Clinic | FDA Authorized | H |
Clinical Laboratory University Hospital at University of Arkansas for Medical Sciences | Not FDA Authorized | H |
Clinical Pathology Laboratories | Not FDA Authorized | H |
Clinical Reference Laboratory, Inc. | FDA Authorized | H |
Clinical Research Sequencing Platform, LLC at the Broad Institute of MIT & Harvard | FDA Authorized | H |
Compass Laboratory Services, LLC | FDA Authorized | H |
Consolidated Medical Bio-Analysis, Inc. | Not FDA Authorized | H |
Coppe Laboratories | Not FDA Authorized | H |
CSI Laboratories | FDA Authorized | H |
Davis Medical Center | Not FDA Authorized | H |
Devansh Lab Werks Inc. | Not FDA Authorized | H |
Diagnostic Solutions Laboratory LLC | FDA Authorized | H |
Diatherix Eurofins | FDA Authorized | H |
Dynamic DNA Laboratories, LLC | Not FDA Authorized | H |
Eli Lilly Clinical Diagnostics Laboratory | FDA Authorized | H |
Emory Medical Laboratory, Emory Healthcare | Not FDA Authorized | H |
Ethos Laboratories | Not FDA Authorized | H |
Exact Sciences Laboratories | FDA Authorized | H |
Exact Sciences Laboratories | FDA Authorized | H |
Gene By Gene | FDA Authorized | H |
Genesys Diagnostics Inc. | Not FDA Authorized | H |
Gravity Diagnostics | FDA Authorized | H |
Henry Ford Health System | Not FDA Authorized | H |
HMH Hackensack University Medical Center | FDA Authorized | H |
Hospital of the University of Pennsylvania | Not FDA Authorized | H |
iGenomeDx | Not FDA Authorized | H |
Inform Diagnostics, Inc. | FDA Authorized | H |
Integrity Laboratories | FDA Authorized | H |
Ipsum Diagnostics LLC | FDA Authorized | H |
ISPM Labs, LLC DBA Capstone Healthcare | FDA Authorized | H |
J Randolph Schnitman MD Inc. | Not FDA Authorized | H |
Johns Hopkins Medical Microbiology Laboratory at Johns Hopkins Hospital | Not FDA Authorized | H |
Kansas State Veterinary Diagnostic Laboratory | Not FDA Authorized | H |
Korva-Labs Inc. | FDA Authorized | H |
Lehigh Valley Genomics | Not FDA Authorized | H |
Lexar Laboratories & Analysis, LLC | Not FDA Authorized | H |
MAWD Pathology Group | Not FDA Authorized | H |
Mayo Clinic - Rochester, MN | Not FDA Authorized | H |
MD Tox Laboratory DNA Innovative Health Diagnostics | Not FDA Authorized | H |
Medical College of Wisconsin | Not FDA Authorized | H |
Medical Diagnostic Laboratories LLC | Not FDA Authorized | H |
Molecular Diagnostics, Christiana Care Health Systems | Not FDA Authorized | H |
Montefiore Medical Center | Not FDA Authorized | H |
Nanticoke Memorial Hospital Laboratory | Not FDA Authorized | H |
Nebraska Medicine Clinical Laboratory | FDA Authorized | H |
New York Presbyterian Hospital - Weill Cornell Medicine (NYPH-WCM) | Not FDA Authorized | H |
Next Bio-Research Services LLC | Not FDA Authorized | H |
NIPD Genetics Public Company Limited | Not FDA Authorized | H |
North Central Florida Neurodiagnostic Services DBA: NCF Diagnostics & DNA Technologies | Not FDA Authorized | H |
NxGen MDx | Not FDA Authorized | H |
NYU Langone Medical Center | Not FDA Authorized | H |
Oklahoma University Medicine Laboratory | Not FDA Authorized | H |
OmniPathology Solutions Medical Corporation | FDA Authorized | H |
Opteo Laboratory, LLC | Not FDA Authorized | H |
Orig3n, Inc. | FDA Authorized | H |
Orlando Health | Not FDA Authorized | H |
Pathology Center, Nebraska Methodist Hospital | Not FDA Authorized | H |
Patriot Medical Laboratories LLC DBA CIAN Diagnostics | Not FDA Authorized | H |
Poplar Healthcare | Not FDA Authorized | H |
Primex Clinical Laboratories, Inc. | Not FDA Authorized | H |
Proteus Molecular and Clinical Lab LLC | Not FDA Authorized | H |
PTC Laboratories, Inc. | Not FDA Authorized | H |
Quest Diagnostics Infectious Disease, Inc. | FDA Authorized | H |
RCA Laboratory Services LLC DBA GENETWORx | Not FDA Authorized | H |
Real Diagnostics Laboratory | Not FDA Authorized | H |
ResourcePath, LLC | Not FDA Authorized | H |
Saint Mary's Medical Center | Not FDA Authorized | H |
Sandia National Laboratories | FDA Authorized | H |
Sciteck Clinical Laboratory | Not FDA Authorized | H |
Sharp Copley Laboratory | Not FDA Authorized | H |
Specialty Drug Testing | Not FDA Authorized | H |
Solaris Diagnostics | FDA Authorized | H |
Sonic Reference Laboratory | Not FDA Authorized | H |
Southwest Regional PCR Laboratory dba MicroGen DX | FDA Authorized | H |
Specialty Diagnostics Inc | FDA Authorized | H |
Stanford Health Care Clinical Laboratory | FDA Authorized | H |
Tampa General Hospital | Not FDA Authorized | H |
Texas Children's Hospital Department of Pathology | Not FDA Authorized | H |
TGen North, Clinical Laboratory | Not FDA Authorized | H |
Tide Laboratories, LLC | FDA Authorized | H |
UCSF-Health | Not FDA Authorized | H |
UC Berkeley Innovative Genomic Institute | Not FDA Authorized | H |
UltimateDx Laboratories | FDA Authorized | H |
University of North Carolina Medical Center McLendon Clinical Laboratories | FDA Authorized | H |
University of Minnesota Genomics Center | Not FDA Authorized | H |
University of Washington | Not FDA Authorized | H |
Viracor Eurofins Clinical Diagnostics | FDA Authorized | H |
WestPac Labs | Not FDA Authorized | H |
Wisconsin Diagnostic Laboratories | Not FDA Authorized | H |
Xymbio, LLC | Not FDA Authorized | H |
Yale Pathology Molecular Diagnostic Laboratory | Not FDA Authorized | H |
Virginia Tech Schiffert Health Center | Not FDA Authorized | H |
ASU Biodesign Clinical testing Laboratory, Center for Personalized Diagnostics | Not FDA Authorized | H |
Kashi Clinical Laboratories, Inc. | Not FDA Authorized | H |
DxTerity Diagnostics, Inc. | Not FDA Authorized | H |
Boston Heart Diagnostics | FDA Authorized | H |
Valley Medical and Wellness Laboratory | Not FDA Authorized | H |
Aperiomics Molecular Laboratory | Not FDA Authorized | H |
UniPath | Not FDA Authorized | H |
UCSC Molecular Diagnostic Lab | Not FDA Authorized | H |
Acupath Laboratories | FDA Authorized | H |
Color Genomics | FDA Authorized | H |
Banner-University Medical Center Tucson | Not FDA Authorized | H |
Eurofins Clinical Molecular Testing Services, LLC | Not FDA Authorized | H |
Physicians Laboratory Services, Inc. | Not FDA Authorized | H |
Essentia Health East- SMDC Laboratory | Not FDA Authorized | H |
PacGenomics Lab | Not FDA Authorized | H |
Northside Hospital | Not FDA Authorized | H |
Paradigm Laboratories | Not FDA Authorized | H |
Acutis Diagnostics | Not FDA Authorized | H |
Aspirus Riverview Hospital Laboratory | FDA Authorized | H |
North Shore Medical Center Clinical Lab | Not FDA Authorized | H |
River Road Testing Laboratory | Not FDA Authorized | H |
AKESOgen | Not FDA Authorized | H |
Texas Department of State Health Service Laboratory | FDA Authorized | H |
AdvaGenix | Not FDA Authorized | H |
Warrior Diagnostics | Not FDA Authorized | H |
Danner Laboratory | Not FDA Authorized | H |
MD Labs | Not FDA Authorized | H |
ApolloMDx Labs | Not FDA Authorized | H |
Helix | FDA Authorized | H |
Signal Diagnostics | Not FDA Authorized | H |
Women's Health Laboratory | Not FDA Authorized | H |
Lab Genomics LLC | Not FDA Authorized | H |
Pathlab Services Inc. | Not FDA Authorized | H |
Tempus Labs, Inc. | FDA Authorized | H |
Santa Clara Valley Medical Center Clinical Laboratory | Not FDA Authorized | H |
Rosalind Franklin University Clinical Immunology Laboratory | Not FDA Authorized | H |
Tribal Diagnostics, LLC | Not FDA Authorized | H |
BioReference Laboratories, Inc. | Not FDA Authorized | H |
Sun Clinical Laboratories | Not FDA Authorized | H |
CorePlus Servicios Clínicos y Patológicos, LLC | Not FDA Authorized | H |
FLO-MEDILAB SERVICES, LLC | Not FDA Authorized | H |
MedArbor Diagnostics | Not FDA Authorized | H |
Olin Health Center, Michigan State University | Not FDA Authorized | H |
George Washington University Hospital Laboratory | Not FDA Authorized | H |
NeoGenomics Laboratories, Inc. | Not FDA Authorized | H |
Guardant Health Clinical Laboratory, Inc. | FDA Authorized | H |
University of Illinois Veterinary Diagnostic Laboratory | Not FDA Authorized | H |
Sports Drug Testing Laboratory | Not FDA Authorized | H |
Genomic Expression | Not FDA Authorized | H |
Bandar Enterprises, LLC dba Cuur Diagnostics | FDA Authorized | H |
Sunpath-MDL | Not FDA Authorized | H |
Alimetrix, Inc. | FDA Authorized | H |
Ambry Genetics | Not FDA Authorized | H |
Cincinnati Children's Hospital Medical Center | Not FDA Authorized | H |
Tallahassee Memorial HealthCare | Not FDA Authorized | H |
Veritas Genetics | Not FDA Authorized | H |
Asante Rogue Regional Medical Center | Not FDA Authorized | H |
Southern Illinois Healthcare, Herrin Hospital | Not FDA Authorized | H |
Research Medical Center Laboratories | Not FDA Authorized | H |
Truman Medical Center | Not FDA Authorized | H |
University of Colorado School of Medicine Hospital | Not FDA Authorized | H |
Charles River Laboratories, Inc. Reno, Nevada | Not FDA Authorized | H |
Children's Hospital Los Angeles Clinical Virology Laboratory | Not FDA Authorized | H |
HFI Laboratory at Boston University dba Boston University Clinical Testing Laboratory | Not FDA Authorized | H |
University of Chicago Medical Center Main Clinical Laboratory | Not FDA Authorized | H |
Adventist Health Castle Laboratory | Not FDA Authorized | H |
OptimaLab, Inc. | Not FDA Authorized | H |
St. Joseph's Hospital and Medical Center | Not FDA Authorized | H |
Mayo Clinic Jacksonville Clinical Laboratory | Not FDA Authorized | H |
Alliance HealthCare System | Not FDA Authorized | H |
Ingenious Personalized Medicine | Not FDA Authorized | H |
Inno Diagnostics | Not FDA Authorized | H |
Columbia University Medical Center | Not FDA Authorized | H |
Transfusion Transmitted Viruses Lab NIH | Not FDA Authorized | H |
Avera Institute for Human Genetics | FDA Authorized | H |
303 Diagnostics, LLC. | Not FDA Authorized | H |
Innovative Genomics LLC. d/b/a Innovative Gx Laboratories | Not FDA Authorized | H |
Premier Medical, Inc. dba Premier Medical Laboratory Services | Not FDA Authorized | H |
CEDARS-SINAI MEDICAL CENTER | FDA Authorized | H |
UofSC College of Pharmacy Diagnostic Genomics Laboratory | Not FDA Authorized | H |
Lucence Diagnostics Pte Ltd | Not FDA Authorized | H |
Elite Medical Laboratory Solutions LLC dba Diax Labs | Not FDA Authorized | H |
Access Dx Laboratory, LLC | Not FDA Authorized | H |
ACL Laboratories | Not FDA Authorized | H |
Ascension Columbia St. Mary's Milwaukee | Not FDA Authorized | H |
Atrium Health Core Laboratory | Not FDA Authorized | H |
Baptist Medical Center | Not FDA Authorized | H |
Capital Digestive Care, LLC., Laboratory Services | Not FDA Authorized | H |
Diagnostic Laboratory Services, Inc. (HI) | Not FDA Authorized | H |
IDL Acquisition Co., LLC DBA MDx Laboratory Services | Not FDA Authorized | H |
INOVA Core Research Lab | Not FDA Authorized | H |
Weill Cornell Medicine | Not FDA Authorized | H |
Wise Diagnostic Systems | Not FDA Authorized | H |
P4 Clinical LLC | Not FDA Authorized | H |
Physician STAT Lab Molecular | Not FDA Authorized | H |
STS Lab Holdco LLC Kentucky | Not FDA Authorized | H |
STS Lab Holdco LLC California | Not FDA Authorized | H |
Molecular Diagnostics Laboratory, Department of Pathology, Yale School of Medicine | Not FDA Authorized | H |
Histogenetics | Not FDA Authorized | H |
LynxDx | Not FDA Authorized | H |
Kai Medical Laboratory | Not FDA Authorized | H |
Advanced Diagnostic Laboratory, LLC | Not FDA Authorized | H |
SummerBio Labs | Not FDA Authorized | H |
Saint Luke's Hospital of Kansas City | Not FDA Authorized | H |
Sutter Health Shared Laboratory (SHSL) | Not FDA Authorized | H |
Machaon Diagnostics, Inc. | Not FDA Authorized | H |
Kaiser Santa Clara Laboratory | Not FDA Authorized | H |
New Hampshire Public Health Laboratories | Not FDA Authorized | H |
Ome Ventures, Inc. | Not FDA Authorized | H |
BioBridge Global (BBG) | Not FDA Authorized | H |
NeoVect Technologies, LLC | Not FDA Authorized | H |
Loma Linda University Medical Center Clinical Laboratory | Not FDA Authorized | H |
NOAH Associates | Not FDA Authorized | H |
Curative, Inc. | Not FDA Authorized | H |
Arctic Medical Laboratories | Not FDA Authorized | H |
Alliance Laboratories | Not FDA Authorized | H |
Symbiotica, Inc. | Not FDA Authorized | H |
RAS Medical Solutions | Not FDA Authorized | H |
Telomere Diagnostics Inc. | Not FDA Authorized | H |
Pioneer Hi-Bred International, Inc. | Not FDA Authorized | H |
MOgene LC | Not FDA Authorized | H |
Raazi Clinical Laboratory LLC | Not FDA Authorized | H |
Northwestern Medicine Diagnostic Molecular Lab | Not FDA Authorized | H |
University of Maryland Baltimore | Not FDA Authorized | H |
1 Settings for use include the following:
- H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- W - Patient care settings operating under a CLIA Certificate of Waiver.
A: As stated in Section IV.B of the FDA's Policy for Coronavirus Disease-2019 Tests, a State or territory choosing to authorize laboratories within that State or territory to develop and perform a test for COVID-19 would do so under authority of its own State law, and under a process that it establishes. As noted in the guidance, FDA does not intend to object to the use of such tests for specimen testing where the notification of SARS-CoV-2 test validation is not submitted to FDA and the laboratory does not submit an EUA request to FDA, and where instead the State or territory takes responsibility for COVID-19 testing by laboratories in its State/territory during the COVID-19 outbreak.
The States and territories listed below have notified FDA that they choose to use this flexibility to expedite COVID-19 testing. As stated in the guidance, the FDA will not be reviewing the process adopted by the State or territory under this policy and is including this list here to provide transparency regarding the notifications submitted to FDA.
- Puerto Rico Department of Health
- State of Colorado
- State of Connecticut
- State of Maryland
- State of Mississippi
- State of Nevada
- State of New Jersey
- State of New York Department of Health Wadsworth Center
- Washington State Department of Health
A: As stated in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution to clinical laboratories of diagnostic test kits to perform assays to detect SARS-CoV-2 for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users. As noted in the guidance, the believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high-complexity testing, including testing at the point-of-care when the site is covered by the laboratory's CLIA certificate for high-complexity testing. This policy does not apply to at home testing, including at-home specimen collection.
The commercial manufacturers listed below have notified FDA that they have validated and intend to distribute diagnostic test kits as set forth in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the test, and the test is included in this list to provide transparency regarding the notification submitted to FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing. Certain developers have completed the EUA process prior to offering a test for clinical use rather than notify FDA under this policy. Tests that have been issued an EUA can be found on the EUA page.
If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be addressed in a timely manner, the FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution and conduct a recall of the test, and may take additional actions as appropriate.
Commercial Manufacturers that have notified the FDA that they have validated and intend to distribute diagnostic test kits as set forth in Section IV.C:
Manufacturer and Test | Authorization Status | Settings for Use1 |
---|---|---|
BD BioGx SARS-CoV-2 Reagents for BD MAX System | FDA Authorized | H, M |
Biomeme, Inc. Biomeme SARS-CoV-2 test kit | FDA Authorized | H |
BGI Genomics Co. Ltd | FDA Authorized | H |
ChromaCode, Inc. HDPCR SARS-CoV-2 Assay | FDA Authorized | H |
Co-Diagnostics, Inc. | FDA Authorized | H |
Genomictree, Inc. AccuraDTect SARS-CoV-2-qPCR Kit | Not FDA Authorized | H |
OPTOLANE Technologies Inc. Kaira 2019-nCoV Detection Kit | FDA Authorized | H |
OSANG Healthcare Co., Ltd, GeneFinder COVID-19 Plus RealAmp Kit | FDA Authorized | H |
QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel Assay | FDA Authorized | H, M |
YD Diagnostics Corp. MolecuTech Real-Time COVID-19 | Not FDA Authorized | H |
LabGenomics, Co., Ltd. LabGun™ COVID-19 Assay kit | FDA Authorized | H |
VelaDx ViroKey™ SARS-CoV-2 RT-PCR Test | FDA Authorized | H |
Hologic, Inc. Aptima SARS-CoV-2 assay | FDA Authorized | H |
GeneOne Diagnostics Corporation COVID-19 Nucleic Acid Diagnostic Kit | Not FDA Authorized | H |
RTA Labs DIAGNOVITAL SARS-CoV-2 | FDA Authorized | H |
Solgent Co. Ltd., COVID-19 DiaplexQ Diagnostic Kit | FDA Authorized | H |
ZhuHai Sinochips Bioscience Co., Ltd COVID-19 Real-time PCR Test Kit | FDA Authorized | H |
GeneReach Biotechnology Corporation POCKIT Central SARS-CoV-2 | Not FDA Authorized | H |
American BioSources Inc., DBA Genomic Diagnostics GDx GrandPerformance SARS-CoV-2 Detection Kit | Not FDA Authorized | H |
Taigen Bioscience Corporation LabTurbo AIO COVID-19 RNA Testing kit | Not FDA Authorized | H |
Gencurix Inc. GenePro SARS-CoV-2 Test | FDA Authorized | H |
ELITechGroup MDx LLC SARS-CoV-2 ELITe MGB Assay | Not FDA Authorized | H |
Agena Bioscience SA MassArray RS-CoV-2 Panel | FDA Authorized | H |
Grifols Diagnostic Solutions Inc. Procleix SARS-CoV-2 Assay | FDA Authorized | H |
MiCo BioMed Co., Ltd. Veri-Q COVID-19 Multiplex Detection Kit | Not FDA Authorized | H |
Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay | FDA Authorized | H |
SML GENETREE Co., Ltd. Ezplex SARS-CoV-2 G Kit | FDA Authorized | H |
Enzo Life Sciences, Inc. Enzo AMPIPROBE® SARS-CoV-2 Test System | FDA Authorized | H |
Vela Operations Singapore Pte Ltd. ViroKey SARS-CoV-2 RT-PCR Test v2.0 | FDA Authorized | H |
GenMark Diagnostics, Inc. ePlex Respiratory Pathogen Panel 2 (ePlex RP2 Panel) | FDA Authorized | H, M |
NovaTec Immundiagnosticsa GmBH GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR | Not FDA Authorized | H |
TAAG Genetics S.A. nPLEX SARS-CoV-2 Detection Kit | Not FDA Authorized | H |
Illucidx Inc., Illucidx COVID-19 Dx RT-LAMP | Not FDA Authorized | H |
BioZentech Co., Ltd., BZ QPCR COVID-19 Kit | Not FDA Authorized | H |
T2Biosystems, Inc., T2SARS-CoV-2 Panel | FDA Authorized | H |
Molecular Epidemiology Inc., IEH SARS-CoV-2 RT-PCR Test | Not FDA Authorized | H |
Suzhou PreciGenome, Ltd., Co., Fastplex Triplex SARS-CoV-2 Detection Kit (RT-PCR) | Not FDA Authorized | H |
GK Pharmaceuticals Contract Manufacturing Operations, ACCU-RIGHT SARS-COV-2 RT-PCR KIT | FDA Authorized | H |
Detectachem Inc., MD-Bio BCC19 | FDA Authorized | H |
GUANGDONG ARDENT BIOMED Co., Ltd, Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (PCR-fluorescent Probe) | Not FDA Authorized | H |
Nanjing Liming Bio-Products Co., Ltd., StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit | Not FDA Authorized | H |
Hologic Aptima SARS-CoV-2 Assay Pooled Samples Workflow | FDA Authorized | H |
Hologic Panther Fusion SARS-CoV-2 Assay Pooled Samples Workflow | FDA Authorized | H |
DowGene Co., Ltd., Dow QuickFinderTM 2019-nCov Real-Time PCR Kit | Not FDA Authorized | H |
Shimadzu Corporation, 2019 Novel Coronavirus Detection Kit | Not FDA Authorized | H |
ProteomeTech Inc. GENEdania COVID-19 qRT-PCR | Not FDA Authorized | H |
GenMark Diagnostics, Inc., eSensor SARS-CoV-2 Panel | Not FDA Authorized | H |
Genetic Signatures Limited, EasyScreen™ SARS-CoV-2 Detection Kit (RP011 and RP012) | Not FDA Authorized | H |
Eryigit medical Devices, Sentebiolab Senteligo SARS CoV-2 (COVID-19) Multiplex qPCR Detection Kit | Not FDA Authorized | H |
Clinomics USA Inc., TrioDx RT-PCR COVID-19 Test | FDA Authorized | H |
UStar Biotechnologies (Hangzhou) Ltd., EasyNAT® Diagnostic Kit for Novel-Coronavirus (COVID-19) RNA (Isothermal Amplification-Real Time Fluorescence Assay) | Not FDA Authorized | H |
Genrui Biotech Inc, Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) | Not FDA Authorized | H |
AMSBIOInc., A+CheQ COVID-19 High-Speed RT-qPCR Detection Kit | Not FDA Authorized | H |
TCM Bioscience, TCM-Q Corona III test | Not FDA Authorized | H |
Todos Medical USA Inc., TODOS 2019-nCoV RT-qPCR Detection Kit | Not FDA Authorized | H |
iCubate, Inc., iC-COVID-19 Assay | Not FDA Authorized | H |
Sacace Biotechnologies s.r.1., SARS-CoV-2 Real-TM | Not FDA Authorized | H |
Genes Laboratories, NEXdiaTM 2019-nCoV Detection Kit | Not FDA Authorized | H |
Roche Molecular Systems Pooling Sample Workflow for the cobas® SARS-CoV-2 for use on the cobas® 6800/8800 Systems | FDA Authorized | H, M |
Gerbion GmbH & Co. KG., Gerbion virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 | Not FDA Authorized | H |
General Biologicals Corporation, GB SARS-CoV-2 Real-Time RT-PCR | Not FDA Authorized | H |
Sanigen Co. Ltd., Genelix™ COVID-19 Real-Time PCR Kit | Not FDA Authorized | H |
Eurofins ARCA Technology, Inc., ARCA Straight Shot SARS-CoV-2 Extraction Free (EF) Assay | Not FDA Authorized | H |
Biopoa, Co. Ltd., Rapid COVID-19 PoaCheck | Not FDA Authorized | H |
RTA Laboratuvarlari Biyolojik Urunler Ilac ve Makine San. Tic. A.S., Diagnovital SARS-CoV-2 Multiplex | Not FDA Authorized | H |
BIONEER Corporation, AccuPower SARS-CoV-2 Multiplex Real-Time RT-PCR Kit | Not FDA Authorized | H |
Thermo Fisher Scientific, TaqPath™ COVID 19 High Throughput Combo Kit (also called "The Amplitude™ Solution with the TaqPath™ COVID 19 High Throughput Combo Kit") | Not FDA Authorized | H |
DiaSorin Inc. LIAISON SARS-CoV-2 Ag | FDA Authorized | H |
Ortho Clinical Diagnostics VITROS Immunodiagnostic Products SARS-CoV-2 Ag Assay (Reagent Pack / Calibrators) | FDA Authorized | H, M |
LMSI, LLC d/b/a Lighthouse Lab Services, CovidNow SARS-CoV-2 Assay Kit | Not FDA Authorized | H |
Ender diagnostics ag, Ender LAB COVID-19 isothermal PCR detection kit | Not FDA Authorized | H |
LuminUltra Technologies Ltd., GeneCount® COVID-19 RT-qPCR Assay Kit | Not FDA Authorized | H |
Biocartis NV, Idylla™ SARS-CoV-2 Test | Not FDA Authorized | H |
Jiangsu Code Biomedical Technology Co. Ltd., CodeCheckSARS-CoV-2 RT-PCR Kit | Not FDA Authorized | H |
Applied Biological Materials Inc. (abm), GenomeCoV19 Detection Kit | Not FDA Authorized | H |
BioGX Inc, Xfree COVID-19 Direct RT-PCR | Not FDA Authorized | H |
LGC Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test | FDA Authorized | H |
Merlin Biomedical (Xiamen) Co. Ltd., Novel Coronavirus (COVID-19) RT-PCR Kit | Not FDA Authorized | H |
Chai Inc., COVID-19 Saliva Dx Test Kit | Not FDA Authorized | H |
Genedrive Diagnostics Ltd., Genedrive ®96 SARS-CoV2 kit | Not FDA Authorized | H |
Tetracore, Inc., EZ-SARS-CoV-2 Real-Time RT-PCR | Not FDA Authorized | H |
BioGenex Laboratories, Inc., BGX COVID-19 RT-PCR | Not FDA Authorized | H |
Beckman Coulter Access SARS-CoV-2 Antigen | Not FDA Authorized | H |
GreenRoads Diagnostics LLC, GreenRoads Dx SARS-CoV-2™ Test | Not FDA Authorized | H |
MiRXES Pte Ltd, MiRXES Fortitude Kit 3.0 COVID-19 RT-PCR Test | Not FDA Authorized | H |
LMSI, LLC d/b/a Lighthouse Lab Services, SalivaNow SARS-CoV-2 Assay Kit | Not FDA Authorized | H |
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ, RevoDx SARS-CoV-2 qPCR Kit v2.2 | Not FDA Authorized | H |
Biotrack BV, Escher BT-MED® COV19 Test | Not FDA Authorized | H |
Siemens Healthcare Diagnostics Inc. Atellica® IM SARS-CoV-2 Antigen (CoV2Ag) | Not FDA Authorized | H |
Siemens Healthcare Diagnostics Inc. ADVIA Centaur® SARS-CoV-2 Antigen (CoV2Ag) | Not FDA Authorized | H |
Baebies Inc., FINDER SARS-CoV-2 Test (used with FINDER 1.5 instrument) | Not FDA Authorized | H |
Delphine Diagnostics Inc., Delphine PrecisQT™ COVID-19 Test Kit | Not FDA Authorized | H |
QIAGEN GmbH, artus® SARS-CoV-2 Prep&Amp UM Kit | Not FDA Authorized | H |
Bio Vision LLC, Bio Vision SARS-CoV-2 Rapid Molecular Test | Not FDA Authorized | H |
1 Settings for use include the following:
- H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- W - Patient care settings operating under a CLIA Certificate of Waiver.
A: As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, while laboratories are encouraged to submit EUA requests for serology tests, the FDA does not intend to object to the development and use of serology tests to identify antibodies to SARS-CoV-2 by laboratories that are certified under CLIA to perform high-complexity testing, where the test has been validated, notification is provided to FDA, and information that helps users and patients understand the test results, such as the following, is included in the test reports:
- This test has not been reviewed by the FDA.
- Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
- Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This policy does not apply to at-home testing, including at-home specimen collection.
The laboratories in the list below have notified FDA that they have validated and intend to offer serology tests as set forth in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not reviewed the laboratory's validation and issued an EUA for the laboratory's test, and the test is included in this list to provide transparency regarding the notifications submitted to FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing. Certain developers have completed the EUA process prior to offering a test for clinical use rather than notify FDA under this policy. Tests that have been issued an EUA can be found on the EUA page.
If FDA becomes aware of concerns about a laboratory developed serology test that cannot be or have not been addressed in a timely manner, FDA intends to remove the laboratory from this list and may take additional actions as appropriate.
Laboratories that have notified FDA that they have validated and intend to offer serology tests as set forth in Section IV.D:
Laboratory | Authorization Status | Settings for Use1 |
---|---|---|
BioDiagnostic Inc. | Not FDA Authorized | H |
EDP Biotech Corporation | Not FDA Authorized | H |
Emory Medical Laboratories | FDA Authorized | H |
Genalyte, Inc | Not FDA Authorized | H |
IMMYLabs | Not FDA Authorized | H |
University of Minnesota Advanced Research and Diagnostic Laboratory | Not FDA Authorized | H |
Vibrant America Clinical Labs | FDA Authorized | H |
White Coat Sciences | Not FDA Authorized | H |
KSL Diagnostics | Not FDA Authorized | H |
Enzo Clinical Labs | Not FDA Authorized | H |
University of Arizona Genetics Core for Clinical Services | Not FDA Authorized | H |
Center for Cellular Therapy Medical University of South Carolina | Not FDA Authorized | H |
IGeneX Inc. | Not FDA Authorized | H |
LabCorp Center for Esoteric Testing | Not FDA Authorized | H |
OneBlood, Inc. | Not FDA Authorized | H |
Ethos Laboratories | Not FDA Authorized | H |
Stanford Health Care | Not FDA Authorized | H |
Mayo Clinic | Not FDA Authorized | H |
Exsera Biolabs at the University of Colorado Anschutz Medical Campus | Not FDA Authorized | H |
CQuentia NGS, LLC | Not FDA Authorized | H |
Symbiotica, Inc | Not FDA Authorized | H |
Brigham and Women's Hospital | Not FDA Authorized | H |
Allermetrix, Inc. | Not FDA Authorized | H |
Cincinnati Children's Hospital Medical Center | Not FDA Authorized | H |
Phosphorus Diagnostics LLC | Not FDA Authorized | H |
Pan Laboratories | Not FDA Authorized | H |
ProterixBio, Inc | Not FDA Authorized | H |
Houston Methodist-Pathology | Not FDA Authorized | H |
1 Settings for use include the following:
- H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- W - Patient care settings operating under a CLIA Certificate of Waiver.
As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution of serology tests to identify antibodies to SARS-CoV-2 for a reasonable period of time, where the test has been validated and while the manufacturer is preparing its EUA request, where the manufacturer gives notification to the FDA and information that helps users and patients understand the test results, such as the following, is included in the instructions for use:
- This test has not been reviewed by the FDA.
- Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
- Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
As noted in the guidance, the FDA believes that 10 business days is a reasonable period of time to prepare an EUA submission for such tests. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.
This policy does not apply to at-home testing, including at-home specimen collection.
The commercial manufacturers in the list below have notified the FDA that they have validated and intend to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the manufacturer's test, and the test is included in this list to provide transparency regarding the notification submitted to the FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing. Certain developers have completed the EUA process prior to offering a test for clinical use rather than notify FDA under this policy. Tests that have been issued an EUA can be found on the EUA page.
If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution of the test, and may take additional actions as appropriate.
Manufacturers that have notified FDA that they have validated and intend to distribute serology tests as set forth in Section IV.D:
Manufacturer and Test | Authorization Status | Settings for Use1 |
---|---|---|
Abbott Laboratories SARS-CoV-2 IgG (for use on ARCHITECT) | FDA Authorized | H, M |
Access Bio, Inc. CareStart COVID-19 IgM/IgG | FDA Authorized | H, M |
Assure Tech (Hangzhou) Co., Ltd.'s COVID-19 IgG/IgM Rapid Test Device | FDA Authorized | H, M |
Beijing Wantai Biological Pharmaceutical Co., Ltd. TOTAL ANTIBODY WANTAI SARS-COV-2 Ab Rapid Test Kit | FDA Authorized | H, M |
Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Cassette Format) | FDA Authorized | H, M |
Biohit Healthcare (Hefei) Co., Ltd. SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) | FDA Authorized | H, M |
Diazyme Laboratories, Inc. Diazyme DZ-LITE SARS-CoV-2 IgG CLIA Kit | FDA Authorized | H, M |
Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-Cov-2 IgM CLIA Kit | FDA Authorized | H, M |
EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgG) | FDA Authorized | H |
Guangzhou Wondfo Biotech Co., Ltd. SARS-CoV-2 Antibody Test | Not FDA Authorized | H |
Hangzhou Clongene Biotech Co., Ltd. Clungene COVID-19 IgM/IgG Rapid Test Cassette | Not FDA Authorized | H |
Hangzhou Biotest Biotech's COVID-19 IgG/IgM Rapid Test Cassette | FDA Authorized | H, M, W |
Healgen Scientific, LLC. COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) | FDA Authorized | H, M |
INNOVITA (Tangshan) Biological Technology Co., Ltd. 2019-nCoV Ab Test (Colloidal Gold) | FDA Authorized | H, M |
Liming BioProducts Co. Ltd. SARS-CoV-2 lgM/lgG Antibody Rapid Test | Not FDA Authorized | H |
Nanjing Liming Bio-products Co.,Ltd SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit | Not FDA Authorized | H |
Nirmidas Biotech, Inc. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit | FDA Authorized | H, M |
Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator | FDA Authorized | H, M |
Quansys Biosciences Q-Plex™ SARS-CoV-2 Human IgG (4-Plex) | FDA Authorized | H |
Roche Diagnostics GmbH Elecsys Anti-SARS-CoV-2 | FDA Authorized | H, M |
Salofa Oy Clarity COVIBLOCK™ COVID-19 IgG/IgM Antibody Test | FDA Authorized | H, M |
Salofa Oy Sienna™ COVID-19 IgG/IgM Rapid Test Cassette | FDA Authorized | H, M |
Shenzhen Watmind Medical Co. SARS-CoV-2 IgG/IgM Ab Diagnostic Test Kit | Not FDA Authorized | H |
TBG Biotechnology Corp. SARS-CoV-2 IgG / IgM Rapid Test Kit | FDA Authorized | H, M |
United Biomedical, Inc. UBI® SARS-CoV-2 ELISA | FDA Authorized | H |
Xiamen Biotime Biotechnology Co., Ltd. Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test | FDA Authorized | H |
Zhejiang GENE SCIENCE Co., Ltd Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (Latex Chromatography) | Not FDA Authorized | H |
Boditech Med Inc AFIAS COVID-19 Ab serological tests | Not FDA Authorized | H |
HUMASIS Co., Ltd. Humasis COVID-19 IgG/IgM Test | Not FDA Authorized | H |
Jiangsu Well Biotech Co., Ltd. COVID-19 IgM/IgG Rapid Test (Colloidal Gold) | FDA Authorized | H, M |
Qingdao Hightop Biotech Co., Ltd. HIGHTOP 2019-nCoV IgM/IgG Rapid Test | Not FDA Authorized | H |
Türklab Tibbi Malzemeler San. ve Tic. A.Ş. INFO SARS-CoV-2 IgM/IgG Ab Test | Not FDA Authorized | H |
Türklab Tibbi Malzemeler San. ve Tic. A.Ş. TOYO SARS-CoV-2 IgM/IgG Ab Test | Not FDA Authorized | H |
Enable Biosciences Inc. ADAP SARS-CoV-2 Total Antibody Assay | Not FDA Authorized | H |
Virotech Diagnostics GmbH Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit | Not FDA Authorized | H |
Tetracore Inc. Tetracore FlexImmArray SARS-CoV-2 Human IgG Test | Not FDA Authorized | H |
Quotient Suisse SA MosaiQ COVID-19 Antibody Magazine | FDA Authorized | H |
Ansh Labs SARS-CoV2 IgM ELISA (μ-Capture) (AL-1002) | Not FDA Authorized | H |
bioMérieux SA VIDAS® SARS-COV-2 IgG | FDA Authorized | H, M |
bioMérieux SA VIDAS® SARS-COV-2 IgM | FDA Authorized | H, M |
Beckman Coulter Access SARS-CoV-2 IgG test (Catalog No. C58961), Access SARS-CoV-2 IgG Calibrators (Catalog No. C58963) and Access SARS-CoV-2 IgG QC (Catalog No. C58964) | FDA Authorized | H, M |
Megna Health Inc. Megna Rapid COVID-19 IgG/IgM Combo Test Kit | FDA Authorized | H, M |
Quanterix Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test | FDA Authorized | H, M |
Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 Total (COV2T) | FDA Authorized | H,M |
Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 Total (COV2T) | FDA Authorized | H, M |
Siemens Healthcare Diagnostics Dimension EXL SARS-CoV-2 Total antibody assay (CV2T) | FDA Authorized | H, M |
Siemens Healthcare Diagnostics Dimension Vista SARS-CoV-2 Total Antibody Assay (COV2T) | FDA Authorized | H, M |
BioCheck, Inc. BioCheck SARS-CoV-2 IgM Antibody Test | FDA Authorized | H, M |
ZEUS Scientific, Inc. ELISA SARS-CoV-2 IgG Test System | FDA Authorized | H, M |
ZEUS Scientific, Inc. ZEUS ELISA SARS-CoV-2 Total Antibody Test System | FDA Authorized | H, M |
Siemens Healthcare Diagnostics Inc. Atellica® IM SARS-CoV-2 IgG (COV2G) | FDA Authorized | H, M |
DiaSorin Inc. LIAISON SARS-CoV-2 IgM | FDA Authorized | H, M |
Shin Jin Medics Inc. DIAKEY COVID-19 IgM/IgG Rapid Test | Not FDA Authorized | H |
Biosynex SA Biosynex COVID-19 BSS | Not FDA Authorized | H |
Siemens Healthcare Diagnostics Inc. ADVIA Centaur® SARS-CoV-2 IgG (COV2G) | FDA Authorized | H, M |
Micropoint Biosciences, Inc. mLabs® SARS-CoV-2 IgG and IgM Assay | Not FDA Authorized | H |
Promega Corporation Lumit™ Dx SARS-CoV-2 Immunoassay | Not FDA Authorized | H |
AI DE Diagnostic Co., Ltd. SARS-CoV-2 IgG/IgM Antibody Test | Not FDA Authorized | H |
Qiagen GmbH Access Anti-SARS-CoV-2 Total Test | Not FDA Authorized | H |
LG Chem, Ltd., AdvanSure™ SARS-CoV-2 IgG(S1) ELISA | Not FDA Authorized | H |
Freedom For All Diagnostics™, Inc SARS-CoV-2 IgM/IgG Antibody Assay Kit | Not FDA Authorized | H |
Beckman Coulter, Inc. Access SARS-CoV-2 IgM test, Access SARS-CoV-2 IgM Calibrators, and Access SARS-CoV-2 IgM QC | FDA Authorized | H, M |
Excelsior Bio-System, Inc. EBSALERT SARS-CoV-2 Antibody Rapid test | Not FDA Authorized | H |
CareHealth America Corporation CoviCheck™ COVID-19 IgM/IgG Antibody Test | Not FDA Authorized | H |
Nirmidas Biotech, Inc. MidaSpot™ COVID-19 Antibody Combo Detection Kit | FDA Authorized | H, M, W |
Monarch Global Health LLC Magellan IgM and IgG Antibody Rapid Test Kit for Serum | Not FDA Authorized | H |
ProGnosis Biotech SA Rapid Test 2019-nCoV Total Ig S | Not FDA Authorized | H |
ADVAITE, Inc. RapCov™ COVID-19 Rapid Test | FDA Authorized | H, M, W |
Biomerica, Inc. COVID-19 IgG ELISA Test | Not FDA Authorized | H |
MBio Diagnostics, Inc. LightDeck® COVID-19 Total Antibody Test | Not FDA Authorized | H |
Qiagen GmbH QIAreach™ Anti-SARS-CoV-2 Total Test | FDA Authorized | H, M |
Phadia AB EliA SARS-CoV-2-Sp1 IgG Test | FDA Authorized | H, M |
NOW Diagnostics, Inc. ADEXUSDx® COVID-19 Test | Not FDA Authorized | H |
Leinco Technologies, Inc. COVID-19 Trace™ IgG MICRO-ELISA | Not FDA Authorized | H |
bioLytical Laboratories, Inc. INSTI® COVID-19 Antibody Test and INSTI® COVID-19 Test Controls | Not FDA Authorized | H |
LG Chem, Ltd AdvanSure™ SARS-CoV-2 IgG(RBD) ELISA | Not FDA Authorized | H |
Newscen Bio-Pharmaceutical Co., Ltd. COVID-19 Microfluidic IgG/IgM Test | Not FDA Authorized | H |
Beckman Coulter, Inc. Access SARS-CoV-2 IgG II test (Catalog No. C69057), Access SARS-CoV-2 IgG II Calibrators (Catalog No. C69058) and Access SARS-CoV-2 IgG II QC (Catalog No. C69059) | FDA Authorized | H, M |
Kantaro, Inc. COVID-Seroklir Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit | FDA Authorized | H |
Siemens Healthcare Diagnostics Inc. ADVIA Centaur® SARS-CoV-2 IgG (sCOVG), ADVIA Centaur® SARS-CoV-2 IgG Quality Control (sCOVG QC), and ADVIA Centaur® SARS-CoV-2 IgG Master Curve Material (sCOVG MCM) | Not FDA Authorized | H |
Siemens Healthcare Diagnostics Inc. Atellica® IM SARS-CoV-2 IgG (sCOVG), Atellica® IM SARS-CoV-2 IgG Quality Control (sCOVG QC), and Atellica® IM SARS-CoV-2 IgG Master Curve Material (sCOVG MCM) | FDA Authorized | H, M |
Agilent Technologies, Inc. Agilent Dako SARS-CoV-2 IgG ELISA kit | Not FDA Authorized | H |
Trinity Biotech USA Captia™ SARS-CoV-2 IgG Kit | Not FDA Authorized | H |
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Assay (Reagent Pack/ Calibrator/ Controls), short name CV2TN | Not FDA Authorized | H |
1 Settings for use include the following:
- H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- W - Patient care settings operating under a CLIA Certificate of Waiver.
A: No. FDA does not expect any notification or EUA request from laboratories that are performing testing using EUA-authorized test kits purchased from commercial manufacturers or their distributors. Facilities performing COVID-19 testing must be certified under the Clinical Laboratory Improvement Amendments, or CLIA, which is administered by CMS.
Laboratories authorized to use EUA-authorized tests are subject to various conditions that can be found in the EUA.
Each EUA also includes the settings in which the test is authorized. For ease of reference, the settings authorized in the EUAs are also noted in the EUA table on the In Vitro Diagnostics EUA page. Tests that are noted with an "H" in the Authorized Settings are limited to use in laboratories certified under CLIA that meet requirements to perform high-complexity tests. Tests that are noted with an "H" and "M" in the Authorized Settings may be performed in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests. Tests that are noted with a "W" in the Authorized Settings are deemed to be CLIA-waived for use in patient care settings operating under a CLIA Certificate of Waiver. Tests noted with an "H," "M," and "W may be used in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests and in patient care settings operating under a CLIA Certificate of Waiver.
A: No. FDA does not expect any notification or EUA request from laboratories that are performing testing using test kits purchased from commercial manufacturers or their distributors, where such tests are listed on a notification list.
Facilities performing COVID-19 testing must be certified under the Clinical Laboratory Improvement Amendments, or CLIA, which is administered by CMS.
Test kits on a notification list that are not identified as "Authorized" have not yet been reviewed by the FDA, are not FDA authorized, and have not received a CLIA categorization. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.
Laboratories offering such tests may be subject to additional requirements regarding establishment of performance specifications under the CLIA Regulations. Laboratories with questions about these requirements should contact CMS at LabExcellence@cms.hhs.gov.
As outlined in FDA's Guidance for Industry and Food and Drug Administration Staff: Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only, test kits that are intended for clinical use should not be labeled as "for research use only" (RUO).