Q: What serology tests are being offered under the policy outlined in Section IV.D of the Policy for Diagnostic Tests for Coronavirus Disease-2019?
A: As stated in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, the FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:
This test has not been reviewed by the FDA.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
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.
The commercial manufacturers and laboratories listed below have notified FDA that they have validated and are offering serology tests as set forth in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019. The FDA has not reviewed the validation of tests offered by these developers, who may not be pursuing EUAs, and is including this list here to provide transparency regarding the notifications submitted to FDA.
Laboratory Notifications:
Arrayit Corporation
Beaumont Health
Boston Heart Diagnostics
DLS Research & Ventures
EDP Biotech Corporation
Emory Medical Laboratories
IMMYLabs
Mayo Clinic
Michigan Health Clinics
Otogenetics
Roseland Community Hospital/American Medical Lab
University of Minnesota Advanced Research and Diagnostic Laboratory
Vibrant America Clinical Labs
Manufacturer Notifications:
Abbott Laboratories SARS-CoV-2 IgG (for use on ARCHITECT)
Alfa Scientific Designs, Inc. Instant-view plus COVID-19 IgG/IgM Antibody Test
Alfa Scientific Designs, Inc. Clarity COVID-19 IgG/IgM Antibody Test
Assure Tech (Hangzhou) Co., Ltd.'s COVID-19 IgG/IgM Rapid Test Device
Atlas Link (Beijing)Technology Co., Ltd NovaTest: One Step COVID-19 IgG/IgM rapid test
Autobio Diagnostics' Anti-SARS-CoV-2 Rapid Test
Beijing Beier Bioengineering Co., Ltd 2019-New Coronavirus IgG/IgM Rapid Test Cassette (WB/S/P)
Beijing Decombio Biotechnology Co., Ltd. Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood)
Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgG Antibody Determination Kit
Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgM Antibody Determination Kit
Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgG/IgM Antibody Rapid Test Kit
Beijing Kewei Clinical Diagnostic Reagent Inc. Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit
Beijing O&D BIOTECH Co., LTD. Coronavirus disease(COVID-19) Total Antibody Rapid Test (Colloidal Gold)
Beijing Wantai Biological Pharmaceutical Co., Ltd. TOTAL ANTIBODY WANTAI SARS- COV-2 Ab Rapid Test Kit
Beroni Group SARS-CoV-2 IgG/IgM Antibody Detection Kit
Biobase Biodustry (Shandong) Co., Ltd SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)
Biohit Healthcare (Hefei) Co., Ltd. SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method)
Biolidics Limited 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold)
BioMedomics, Inc. COVID-19 IgM-IgG Rapid Test
BioSys Laboratories, Inc. BioSys Plus COVID-19 IgM/IgG Rapid Test
BTNX, Inc. Rapid Response™ COVID-19 IgG/IgM Test Cassette
Chembio Diagnostic Systems, Inc. DPP COVID-19 IgM/IgG System
Core Technology Co., Ltd. CoreTest COVID-19 IgM/IgG Ab Test
Core Technology Co., Ltd. RapidTest COVID-19 IgM/IgG Ab Test
Coronacide™ COVID-19 IgM/IgG Rapid Test
CTK Biotech, Inc. OnSite® COVID-19 IgG/IgM Rapid Test
DIALAB(ZJG) Biotech Co., Ltd. Device Name: SARS-CoV-2 IgG/IgM Antibody Test (Fluorescence Immunoassay)
Diazyme Laboratories, Inc. Diazyme DZ-LITE SARS-CoV-2 IgG CLIA Kit
Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-Cov-2 IgM CLIA Kit
Diazyme Laboratories, Inc. Diazyme SARS-CoV-2 Antibody Rapid Test
Eachy Biopharmaceuticals Co., Ltd. AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)
Eachy Biopharmaceuticals Co., Ltd. SmartScreen COVID-19 IgM/IgG Test Kit
EpiGentek SeroFlash SARS-CoV-2 IgM/IgG Antibody Detection Kit
Epitope Diagnostics, Inc. KT-1032 EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit
Epitope Diagnostics, Inc. KT-1033 EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit
ET Healthcare Inc. Pylon COVID-19 IgM/IgG Assay
EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgA)
EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgG)
GenBody Inc. GenBody COVID-19 IgM/IgG
Genrui Biotech Inc. Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold)
Getein Biotech Inc. One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)
Goldsite Diagnostics Inc SARS-CoV-2 IgG/IgM ki
Guangzhou Fenghua Bioengineering Co., Ltd. SARS-CoV-2 IgG/IgM Rapid Testt
Guangzhou Wondfo Biotech Co., Ltd. SARS-CoV-2 Antibody Test
Hangzhou AllTest Biotech Co., Ltd. AllTest 2019-nCoV IgG/IgM Rapid Test Cassette
Hangzhou AllTest Biotech Co., Ltd. AllTest COVID IgG/IgM Rapid Test Dipstick
Hangzhou Clongene Biotech Co., Ltd. Clungene COVID-19 IgM/IgG Rapid Test Cassette
Hangzhou Clongene Biotech Co., Ltd. COMBRA COVID-19 IgM/IgG Rapid Test Cassette
Hangzhou Biotest Biotech's COVID-19 IgG/IgM Rapid Test Cassette
Hangzhou Realy Tech Co Ltd. 2019-nCOV IgG/IgM Rapid Test
Hangzhou Testsealabs Biotecnology Co., Ltd One Step SARS-CoV2 (COVID-19) IgG/IgM Test
Healgen Scientific, LLC. COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)
Hunan RunKun Pharmaceutical Co., Ltd SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)
INNOVITA (Tangshan) Biological Technology Co., Ltd. 2019-nCoV Ab Test (Colloidal Gold)
Jiangsu Dablood Pharmaceutical Co, Ltd. AssuranceAB™ COVID-19 IgM/IgG Rapid Antibody Test
Jiangsu Dablood Pharmaceutical Co. Ltd. COVID-19 IgM/IgG Rapid Test
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. SARS-CoV-2 IgM/IgG Rapid Assay Kit (Colloidal Gold)
Lepu Medical Technology (Beijing) Co., Ltd. Lepu SARS-CoV-2 Antibody Test (colloidal gold immunochromatography)
Lifeassay Diagnostics (Pty) Ltd Test-it COVID-19 IgM/IgG Lateral Flow Assay
Liming BioProducts Co. Ltd. SARS-CoV-2 lgM/lgG Antibody Rapid Test
Maccura Biotechnology Co., Ltd. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method
Medical Systems Biotechnology Co., Ltd. Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit
Mokobio Biotechnology R&D Center SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay
Nanjing Liming Bio-products Co.,Ltd SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit
NanoResearch, Inc. NanoMedicina™ SARS-COV-2 IgM/IgG Antibody Rapid Test
Nantong Diagnos Biotechnology Co., Ltd. (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)
Nirmidas Biotech, Inc. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
PCL Inc. COVID19 IgG/IgM Rapid Gold
Phamatech Inc. COVID19 IgG/IgM Rapid Test
RayBiotech, Inc. Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method)
RayBiotech, Inc. Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method)
Safecare Biotech (Hangzhou) Co., Ltd SAFECARE COVID-19 IgG/IgM Rapid Test Device
SD Biosensor STANDARD Q COVID-19 IgM/IgG Duo
Shanghai Eugene Biotech Co., Ltd. SARS-CoV2 (COVID-19) IgG/IgM Rapid Test
Shanghai Liangrun Biomedicine Technology Co., Ltd. Liangrun COVID-19 IgM/IgG Antibody Test
Shenzhen Landwind Medical Co., Ltd COVID-19 IgG/IgM Rapid Test Device
Shenzhen Watmind Medical Co. SARS-CoV-2 IgG/IgM Ab Diagnostic Test Kit
Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG
Sure Bio-tech API Covid-Rapid IgM/IgG Antibody Test Kit
Suzhou Kangheshun Medical Technology Co., Ltd SARS-CoV-2 IgG/IgM Rapid Test Cassette
Telepoint Medical Services SARS-CoV-2 IgG/IgM Rapid Qualitative Test
Tianjin Beroni Biotechnology Co. Ltd SARS-CoV-2 IgG/IgM Antibody Detection Kit
United Biomedical, Inc. UBI® SARS-CoV-2 ELISA
VivaChek Biotech (Hangzhou) Co., Ltd. VivaDiag COVID-19 IgM/IgG Rapid Test
W.H.P.M. Inc., COVID-19 IgM/IgG Rapid Test
W.H.P.M. Inc., COVISURE™ COVID-19 IgM/IgG Rapid Test
Wuhu 3H Biotechnology Co. Ltd. COVID-19 IgG/IgM Test Kit (Colloidal Gold Method)
Xiamen AmonMed Biotechnology Co. Ltd Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold)
Zhejiang GENE SCIENCE Co., Ltd Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (Latex Chromatography)
Zhejiang Orient Gene Biotech, Co., Ltd. COVID-19 IgG/IgM Rapid Test Cassette
Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 IgG Antibody Rapid Test Kit (Colloidal Gold Immunochromatography method)
Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 IgM Antibody Rapid Test Kit (Colloidal Gold Immunochromatography method)
Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography method)
Zhongshan Bio-Tech Co. Ltd SARS-CoV-2 IgM/IgG (GICA)
Zhuhai Encode Medical Engineering Co., Ltd Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device
Zhuhai Livzon Diagnostics, Inc. Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)
