In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
In Vitro Diagnostic EUAs: Overview and Templates
On This Page:
- Individual EUAs for Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
- Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2
Individual EUAs for Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
On August 6, 2020, based on the FDA's continued review of the scientific evidence available for Autobio Diagnostics Co. Ltd.'s Anti-SARS-CoV-2 Rapid Test for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin / EDTA / sodium citrate) or serum 2, including evidence from an NIH/NCI independent evaluation, the FDA determined that the statutory criteria for the authorization in Section 564(c)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act are no longer met. Specifically, the FDA determined that it is not reasonable to believe the product may be effective in detecting IgM antibodies against SARS-CoV-2 or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. The FDA also concluded that based on the risks to public health from false test results, revocation is appropriate to protect the public health or safety. Accordingly, the EUA was revoked under Section 564(g)(2)(B) & (C) of the FD&C Act.
On June 16, 2020, based on the FDA's continued review of the scientific evidence available for Chembio Diagnostic Systems, Inc.'s DPP COVID-19 IgM/IgG System for detection of IgM and IgG antibodies against SARS-CoV-2, including evidence from an NIH/NCI independent evaluation, the FDA determined that the statutory criteria for issuing an EUA in Section 564(c)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act are no longer met. Specifically, the FDA determined that it is not reasonable to believe the product may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. The FDA also concluded that based on the risks to public health from false test results, revocation is appropriate to protect the public health or safety. Accordingly, the EUA was revoked under Section 564(g)(2)(B) & (C) of the FD&C Act.
This table includes information about authorized SARS-CoV-2 serology/antibody tests and other adaptive immune response tests that have been authorized individually. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories.
For additional performance information about EUA authorized serology/antibody tests, please see the EUA Authorized Serology Test Performance page.
Date EUA Issued or Last Updated | Entity | Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued | Attributes3 | Authorized Setting(s)1 | Authorization Documents2 | Other Documents | Other Brand Name(s) |
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1/14/2021 | Abbott Laboratories Inc. | SARS-CoV-2 IgG assay 04/26/2020 |
IgG, CMIA | H, M | HCP, Recipients, IFU-ARCHITECT, IFU-Alinityi | None | |
06/12/2020 | Cellex Inc. | qSARS-CoV-2 IgG/IgM Rapid Test 04/01/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Patients, IFU | None | None |
03/29/2021 | Ortho Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack 04/14/2020 |
Total Antibody, CLIA | H, M | HCP, Recipients, IFU | None | |
04/15/2020 | Mount Sinai Laboratory | COVID-19 ELISA IgG Antibody Test 04/15/2020 |
IgG, ELISA | H | HCP, Patients, EUA Summary | None | None |
10/19/2020 | DiaSorin Inc. | LIAISON SARS-CoV-2 S1/S2 IgG 04/24/2020 |
IgG, CLIA | H, M | HCP, Recipients, IFU | None | |
02/12/2021 | Ortho-Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack 04/24/2020 |
IgG, CLIA | H, M | HCP, Recipients, IFU | None | |
10/30/2020 | Bio-Rad Laboratories, Inc. | Platelia SARS-CoV-2 Total Ab assay 04/29/2020 |
Total Antibody, ELISA | H | HCP, Recipients, IFU | None | |
04/30/2020 | Wadsworth Center, New York State Department of Health | New York SARS-CoV Microsphere Immunoassay for Antibody Detection 04/30/2020 |
Total Antibody, FMIA | H | HCP, Recipients, EUA Summary | None | None |
10/23/2020 | Roche Diagnostics | Elecsys Anti-SARS-CoV-2 05/02/2020 |
Total Antibody, ECLIA | H, M | HCP, Recipients, IFU | None | |
05/04/2020 | EUROIMMUN US Inc. | Anti-SARS-CoV-2 ELISA (IgG) 05/04/2020 |
IgG, ELISA | H | HCP, Recipients, IFU | None | None |
05/29/2020 | Healgen Scientific LLC | COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) 05/29/2020 |
IgM and IgG Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
05/29/2020 | Siemens Healthcare Diagnostics Inc. | Atellica IM SARS-CoV-2 Total (COV2T) 05/29/2020 |
Total Antibody, CLIA | H, M | HCP, Recipients, IFU | None | None |
05/29/2020 | Siemens Healthcare Diagnostics Inc. | ADVIA Centaur SARS-CoV-2 Total (COV2T) 05/29/2020 |
Total Antibody, CLIA | H, M | HCP, Recipients, IFU | None | None |
06/04/2020 | Vibrant America Clinical Labs | Vibrant COVID-19 Ab Assay 06/04/2020 |
IgM and IgG, CLIA | H | HCP, Recipients, EUA Summary | None | None |
12/21/2020 | Hangzhou Biotest Biotech Co., Ltd. | RightSign COVID-19 IgG/IgM Rapid Test Cassette 06/04/2020 |
IgM and IgG Lateral Flow, Fingerstick Whole Blood | H, M, W | HCP, Recipients, IFU |
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|
10/30/2020 | Siemens Healthcare Diagnostics Inc. | Dimension Vista SARS-CoV-2 Total antibody assay (COV2T) 06/08/2020 |
Total Antibody, CLIA | H, M | HCP, Recipients, IFU | None | |
10/30/2020 | Siemens Healthcare Diagnostics Inc. | Dimension EXL SARS-CoV-2 Total antibody assay (CV2T) 06/08/2020 |
Total Antibody, CLIA | H, M | HCP, Recipients, IFU | None | |
06/10/2020 | InBios International, Inc. | SCoV-2 Detect IgG ELISA 06/10/2020 |
IgG, ELISA | H | HCP, Recipients, IFU | None | None |
06/15/2020 | Emory Medical Laboratories | SARS-CoV-2 RBD IgG test 06/15/2020 |
IgG, ELISA | H | HCP, Recipients, EUA Summary | None | None |
10/17/2020 | Biohit Healthcare (Hefei) Co. Ltd. | Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit 06/18/2020 |
IgM and IgG Lateral Flow | H, M | HCP, Recipients, IFU | ThermoGenesis SARS-CoV-2 IgM/IgG Antibody Test Kit | |
12/02/2020 | Hangzhou Laihe Biotech Co., Ltd. | LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) 06/19/2020 |
IgM and IgG Lateral Flow | H, M | HCP, Recipients, IFU | QUICKKIT Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit | |
06/23/2020 | Babson Diagnostics, Inc. | Babson Diagnostics aC19G1 06/23/2020 |
IgG, CLIA | H | HCP, Recipients, EUA Summary | None | None |
06/26/2020 | Beckman Coulter, Inc. | Access SARS-CoV-2 IgG 06/26/2020 |
IgG, CLIA | H, M | HCP, Recipients, IFU | None | None |
03/25/2021 | InBios International, Inc. | SCoV-2 Detect IgM ELISA 06/30/2020 |
IgM, ELISA | H | HCP, Recipients, IFU | None | None |
09/23/2020 | Assure Tech. (Hangzhou Co., Ltd) | Assure COVID-19 IgG/IgM Rapid Test Device 07/06/2020 |
IgM and IgG, Lateral Flow, Fingerstick Whole Blood | H, M, W | HCP, Recipients, IFU | None |
|
03/22/2021 | Diazyme Laboratories, Inc. | Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit 07/08/2020 |
IgG, CLIA, Semi-quantitative | H, M | HCP, Recipients, IFU | None | None |
03/12/2021 | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | WANTAI SARS-CoV-2 Ab Rapid Test 07/10/2020 |
Total Antibody, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
01/05/2021 | Salofa Oy | Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette 07/13/2020 |
IgM and IgG, Lateral Flow, Fingerstick Whole Blood | H, M, W | HCP, Recipients, IFU | None |
|
07/16/2020 | Luminex Corporation | xMAP SARS-CoV-2 Multi-Antigen IgG Assay 07/16/2020 |
IgG, FMIA | H | HCP, Recipients, IFU | None | None |
04/22/2021 | Megna Health, Inc. | Rapid COVID-19 IgM/IgG Combo Test Kit 07/17/2020 |
IgM and IgG, Lateral Flow, Fingerstick Whole Blood | H, M, W | HCP, Recipients, IFU | None | None |
11/06/2020 | Xiamen Biotime Biotechnology Co., Ltd. | BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test 07/24/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU |
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04/22/2021 | Access Bio, Inc. | CareStart COVID-19 IgM/IgG 07/24/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU |
|
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07/31/2020 | Siemens Healthcare Diagnostics Inc. | Atellica IM SARS-CoV-2 IgG (COV2G) 07/31/2020 |
IgG, Semi-quantitative | H, M |
HCP, Recipients, IFU |
None | None |
07/31/2020 | Siemens Healthcare Diagnostics Inc. | ADVIA Centaur SARS-CoV-2 IgG (COV2G) 07/31/2020 |
IgG, Semi-quantitative | H, M | HCP, Recipients, IFU | None | None |
08/05/2020 | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | WANTAI SARS-CoV-2 Ab ELISA 08/05/2020 |
Total Antibody, ELISA | H | HCP, Recipients, IFU | None | None |
03/15/2021 | bioMérieux SA | VIDAS SARS-CoV-2 IgM 08/06/2020 |
IgM, ELFA | H, M | HCP, Recipients, IFU | None | None |
03/15/2021 | bioMérieux SA | VIDAS SARS-CoV-2 IgG 08/06/2020 |
IgG, ELFA | H, M | HCP, Recipients, IFU | None | None |
08/17/2020 | BioCheck, Inc. | BioCheck SARS-CoV-2 IgG and IgM Combo Test 08/17/2020 |
IgM and IgG, CLIA | H, M | HCP, Recipients, IFU | None | None |
08/17/2020 | Diazyme Laboratories, Inc. | Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit 08/17/2020 |
IgM, CLIA | H, M | HCP, Recipients, IFU | None | None |
08/25/2020 | Biocan Diagnostics Inc. | Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test - Letter of Authorization 08/25/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
08/31/2020 | TBG Biotechnology Corp. | TBG SARS-CoV-2 IgG / IgM Rapid Test Kit 08/31/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
08/31/2020 | University of Arizona Genetics Core for Clinical Services | COVID-19 ELISA pan-Ig Antibody Test 08/31/2020 |
Total Antibody, ELISA | H | HCP, Recipients, EUA Summary | None | None |
04/23/2021 | Sugentech, Inc. | SGTi-flex COVID-19 IgG 09/03/2020 |
IgG, Lateral Flow, Fingerstick Whole Blood | H, M, W | HCP, Recipients, IFU | None | None |
09/09/2020 | BioCheck, Inc. | BioCheck SARS-CoV-2 IgM Antibody Test Kit 09/09/2020 |
IgM, CLIA | H, M | HCP, Recipients, IFU | None | None |
09/09/2020 | BioCheck, Inc. | BioCheck SARS-CoV-2 IgG Antibody Test Kit 09/09/2020 |
IgG, CLIA | H, M | HCP, Recipients, IFU | None | None |
09/14/2020 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | MAGLUMI 2019-nCoV IgM/IgG 09/14/2020 |
IgM and IgG, CLIA | H, M | HCP, Recipients, IFU | None | None |
11/10/2020 | Jiangsu Well Biotech Co., Ltd. | Orawell IgM/IgG Rapid Test 09/23/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU |
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04/27/2021 | Quotient Suisse SA | MosaiQ COVID-19 Antibody Magazine 09/25/2020 |
Total Antibody, photometric immunoassay | H | HCP, Recipients, IFU | None | |
09/29/2020 | DiaSorin, Inc. | DiaSorin LIAISON SARS-CoV-2 IgM Assay 09/29/2020 |
IgM, Indirect CLIA | H, M | HCP, Recipients, IFU | None | None |
09/29/2020 | NanoEntek America, Inc. | FREND COVID-19 total Ab 09/29/2020 |
Total Antibody, FIA | H, M | HCP, Recipients, IFU | None | None |
09/29/2020 | Nirmidas Biotech, Inc. | Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit 09/29/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
10/06/2020 | Thermo Fisher Scientific | OmniPATH COVID-19 Total Antibody ELISA Test 10/02/2020 |
Total Antibody, ELISA | H, M | HCP, Recipients, IFU | None | None |
10/06/2020 | ZEUS Scientific, Inc. | ZEUS ELISA SARS-CoV-2 IgG Test System 10/06/2020 |
IgG, ELISA | H, M | HCP, Recipients, IFU | None | None |
10/08/2020 | Beckman Coulter, Inc. | Access SARS-CoV-2 IgM 10/08/2020 |
IgM, CLIA | H, M | HCP, Recipients, IFU | None | None |
10/08/2020 | Genalyte, Inc. | Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2 10/08/2020 |
Total Antibody, photonic ring immunoassay | H, M | HCP, Recipients, IFU | None | None |
10/09/2020 | Abbott Laboratories Inc. | AdviseDx SARS-CoV-2 IgM 10/09/2020 | IgM, CMIA | H, M | None | None | |
10/28/2020 | Quansys Biosciences, Inc. | Q-Plex SARS-CoV-2 Human IgG (4 Plex) 10/28/2020 | IgG, CLIA | H | HCP, Recipients, IFU | None | None |
11/06/2020 | GenScript USA Inc. | cPass SARS-CoV-2 Neutralization Antibody Detection Kit 11/06/2020 | Total Neutralizing Antibodies, Blocking ELISA | H | HCP, Recipients, IFU | None | None |
11/24/2020 | Kantaro Biosciences, LLC | COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit 11/24/2020 |
IgG, ELISA, Semi-quantitative | H | HCP, Recipients, IFU | None | None |
05/06/2021 | Roche Diagnostics, Inc. | Elecsys Anti-SARS-CoV-2 S 11/25/2020 |
Total Antibody, ECLIA, Semi-quantitative | H, M | HCP, Recipients, IFU | None | |
11/23/2020 | Innovita (Tangshan) Biological Technology Co., Ltd. | Innovita 2019-nCoV Ab Test (Colloidal Gold) 11/23/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
12/15/2020 | ACON Laboratories, Inc. | ACON SARS-CoV-2 IgG/IgM Rapid Test 12/15/2020 |
IgM and IgG, Lateral Flow | H, M | HCP, Recipients, IFU | None | None |
04/15/2021 | Quanterix Corporation | Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test 12/23/2020 |
IgG, Paramagnetic Microbead-based Sandwich ELISA, Semi-quantitative | H, M | HCP, Recipients, IFU | None | |
04/12/2021 | Nirmidas Biotech, Inc. | MidaSpot COVID-19 Antibody Combo Detection Kit 12/31/2020 |
IgM and IgG, lateral flow, Fingerstick Whole Blood | H, M, W | HCP, Recipients, IFU |
None |
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04/02/2021 | Siemens Healthcare Diagnostics Inc. | Dimension EXL SARS‑CoV‑2 IgG (CV2G) 01/08/2021 |
IgG, CLIA, Semi-quantitative | H, M | HCP, Recipients, IFU | None | |
04/02/2021 | Siemens Healthcare Diagnostics Inc. | Dimension Vista SARS‑CoV‑2 IgG (COV2G) 01/08/2021 |
IgG, CLIA, Semi-quantitative | H, M | HCP, Recipients, IFU | None | |
04/26/2021 | ADVAITE, Inc. | RapCov Rapid COVID-19 Test 01/11/2021 |
IgG, Lateral Flow, Fingerstick Whole Blood | H, M, W | HCP, Recipients, IFU | None | |
01/19/2021 | Phadia AB | EliA SARS-CoV-2-Sp1 IgG Test 01/11/2021 |
IgG, Fluoroenzyme Immunoassay, Semi-quantitative | H, M | HCP, Recipients, IFU | None | None |
01/15/2021 | United Biomedical, Inc. | UBI SARS-CoV-2 ELISA 01/15/2021 |
IgG, ELISA | H | HCP, Recipients, IFU | None | None |
02/10/2021 | Immunodiagnostic Systems Ltd. | IDS SARS-CoV-2 IgG 02/10/2021 |
IgG, CLIA | H, M | HCP, Recipients, IFU | None | None |
03/15/2021 | Abbott Laboratories Inc. | AdviseDx SARS-CoV-2 IgG II 03/01/2021 |
IgG, CMIA, Semi-quantitative | H, M | HCP, Recipients, IFU-ARCHITECT, IFU-Alinityi | None | None |
03/15/2021 | Adaptive Biotechnologies Corporation | T-Detect COVID Test 03/05/2021 |
T-cell receptor beta (TCR β), Sequencing | H | HCP, Recipients, EUA Summary | None | None |
03/25/2021 | Beckman Coulter, Inc. | Access SARS-CoV-2 IgG II 03/22/2021 |
IgG, CLIA, Semi-quantitative | H, M | HCP, Recipients, IFU | None | None |
04/01/2021 | Siemens Healthcare Diagnostics Inc. | Atellica IM SARS-CoV-2 IgG (sCOVG) 03/23/2021 |
IgG, CLIA, Semi-quantitative | H, M | HCP, Recipients, IFU | None | None |
04/05/2021 | Symbiotica, Inc. | COVID-19 Self-Collected Antibody Test System 04/05/2021 |
IgG, ELISA, Home Collection, Fingerstick Dried Blood Spot | H | HCP, Recipients, EUA Summary, IFU (Home Collect) | None | None |
04/19/2021 | Inova Diagnostics, Inc. | QUANTA Flash SARS-CoV-2 IgG 04/19/2021 |
IgG, CLIA, Semi-quantitative | H, M | HCP, Recipients, IFU | None | None |
05/11/2021 | ZEUS Scientific, Inc. | ZEUS ELISA SARS-CoV-2 Total Antibody Test System 05/11/2021 |
Total Antibody, ELISA | H, M | HCP, Recipients, IFU | None | None |
05/11/2021 | QIAGEN, GmbH | QIAreach Anti-SARS-CoV-2 Total Test 05/11/2021 |
Total Antibody, Digital Lateral Flow | H, M | HCP, Recipients, IFU | 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.
3 Abbreviations: CLIA = chemiluminescence immunoassay; ELISA = enzyme-linked immunosorbent assay; ECLIA = electrochemiluminescence immunoassay; FMIA = fluorescent microsphere Immunoassay, CMIA = chemiluminescent microparticle immunoassay; ELFA = enzyme-linked fluorescence assay
Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2
On April 28, 2020, FDA issued an umbrella EUA for SARS-CoV-2 Antibody Tests (Lateral flow or Enzyme-linked immunosorbent assay (ELISA) tests) that have been evaluated in an independent validation study performed at the National Institutes of Health's (NIH) National Cancer Institute (NCI), or by another government agency designated by the FDA, and are confirmed by the FDA to meet the criteria set forth in the Scope of Authorization of the EUA. To date, however, no device has been added to the list of authorized devices in Appendix A of the letter of authorization.
On July 21, 2020, FDA determined, based on information and experience since issuing this EUA, that circumstances support revocation of this umbrella EUA so that FDA may issue individual EUAs. Individual EUAs will allow for broader indications and scopes of authorization, individualized conditions of authorization to address any issue unique to a specific test, and more streamlined EUA amendments, such as additional uses that would not fall under this umbrella EUA.
Accordingly, the EUA was revoked under Section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act.