Certain COVID-19 Serology/Antibody Tests Should Not Be Used – Letter to Clinical Laboratory Staff and Health Care Providers

The U.S. Food and Drug Administration (FDA) recommends that clinical laboratories and health care providers stop using COVID-19 antibody tests that are listed on FDA’s “removed” test list, found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage.  The “removed” test list includes tests where significant clinical performance problems were identified that cannot be or have not been addressed by the commercial manufacturer in a timely manner, tests for which an Emergency Use Authorization request has not been submitted by a commercial manufacturer of a serology test within a reasonable period of time as outlined in FDA’s guidance, and tests voluntarily withdrawn by the respective commercial manufacturers.

Although tests on the “removed” test list should no longer be distributed, laboratories and health care providers may still have these tests within their stock, or may have used these tests in the past. The FDA is therefore providing additional information and recommendations to laboratories and health care providers regarding these tests.

ManufacturerTestStatus
ACCOBiotech SDN.BHDACCO COVID-19 IgM/IgG TESTRemoved – Should Not Be Distributed
Anhui Deepblue Medical Technology Co., Ltd.COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold)Removed – Should Not Be Distributed
Artron BioResearch Inc./ Artron Laboratories Inc.COVID-19 IgM/IgG Antibody TestRemoved – Should Not Be Distributed*
Atlas Link (Beijing)Technology Co., LtdNovaTest: One Step COVID-19 IgG/IgM rapid testRemoved – Should Not Be Distributed
Audacia BioscienceCMC-19D SARS-CoV2 (COVID-19) Rapid Antibody TestRemoved – Should Not Be Distributed
Aurora Biomed Inc.COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold)Removed – Should Not Be Distributed
Beijing Decombio Biotechnology Co., Ltd.Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood)Removed – Should Not Be Distributed
Beroni GroupSARS-CoV-2 IgG/IgM Antibody Detection KitRemoved – Should Not Be Distributed
BestNovo (Jiangsu) Medical Technology Co., Ltd.BestNovo COVID-19 IgM/IgG Antibody Rapid Test KitRemoved – Should Not Be Distributed
Biobase Biodustry (Shandong) Co., Ltd.SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)Removed – Should Not Be Distributed
BioMedomics, Inc.COVID-19 IgM-IgG rapid testRemoved – Should Not Be Distributed*
Bioscience(Chongqing) Diagnostic Technology Co., Ltd.Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM AntibodyRemoved – Should Not Be Distributed
Bioscience(Chongqing) Diagnostic Technology Co., Ltd.Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG AntibodyRemoved – Should Not Be Distributed
Bioscience(Tianjin) Diagnostic Technology Co., Ltd.Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgM AntibodyRemoved – Should Not Be Distributed
Bioscience(Tianjin) Diagnostic Technology Co., Ltd.Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgG AntibodyRemoved – Should Not Be Distributed
Boson Biotech Ltd. Co (Distributed by Pure Genetic Medical Ltd.)Rapid 2019-nCoV IgG/IgM Combo Test CardRemoved – Should Not Be Distributed
Calbiotech, Inc.ErbaLisa® COVID-19 IgGRemoved – Should Not Be Distributed
Changchun Wancheng Bio-Electron Co., Ltd.COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography)Removed – Should Not Be Distributed
Chembio Diagnostic Systems, Inc.DPP COVID-19 IgM/IgG SystemRemoved – Should Not Be Distributed
Diazyme Laboratories, Inc.Diazyme SARS-CoV-2 Antibody Rapid TestRemoved – Should Not Be Distributed*
Fosun Pharma USA Inc.Fosun COVID-19 IgG/IgM Rapid Antibody Detection KitRemoved – Should Not Be Distributed*
Genlantis Diagnostics, Inc.CovidQuik Coronavirus (COVID-19) IgM/IgG Antibody TestRemoved – Should Not Be Distributed*
Getein Biotech Inc.One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)Removed – Should Not Be Distributed
Guangdong Hecin Scientific, Inc.SARS-CoV-2 IgM Antibody Rapid Test KitRemoved – Should Not Be Distributed
Hangzhou Clongene Biotech Co., Ltd.COMBRA COVID-19 IgM/IgG Rapid Test CassetteRemoved – Should Not Be Distributed
Hangzhou Testsea Biotechnology Co., Ltd.One Step SARS-CoV2(COVID-19) IgG/IgM TestRemoved – Should Not Be Distributed*
Hunan RunKun Pharmaceutical Co., Ltd.SARS-CoV-2 lgM/lgG Test Kit (Colloidal Gold)Removed – Should Not Be Distributed*
IMMY, Inc.clarus SARS-CoV-2 Total Antibody EIARemoved – Should Not Be Distributed*
Innovation Biotech (Beijing) Co., Ltd.SARS-COV-2 IgM/IgG Antibody Rapid Test (Immunochromatographic Method)Removed – Should Not Be Distributed
Jiangsu Eubo Biotechnology Co., Ltd.EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)Removed – Should Not Be Distributed
JOYSBIO (Tianjin) Biotechnology Co., Ltd.COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)Removed – Should Not Be Distributed
LifeassayTest-it COVID-19 IgM/IgG Lateral Flow AssayRemoved – Should Not Be Distributed
Nantong Egens Biotechnology Co., LtdEGENS COVID-19 IgG/IgM Rapid Test KitRemoved – Should Not Be Distributed
PhamatechCOVID19 IgG / IgM Rapid TestRemoved – Should Not Be Distributed*
PromedicalCOVID-19 Rapid TestRemoved – Should Not Be Distributed
Saladax BiomedicalCOVID-19 IgG/IgM Rapid Antibody TestRemoved – Should Not Be Distributed*
SD BiosensorSTANDARD Q COVID-19 IgM/IgG DuoRemoved – Should Not Be Distributed
Shanghai Eugene Biotech Co., Ltd.SARS-CoV2 (COVID-19) IgG/IgM Rapid TestRemoved – Should Not Be Distributed
Shenzen Landwind Medical Co., Ltd.COVID-19 IgG/IgM Rapid TestRemoved – Should Not Be Distributed*
Sure Bio-techAPI Covid-Rapid IgM/IgG Antibody Test KitRemoved – Should Not Be Distributed
Suzhou Kangheshun Medical Technology Co., LtdSARS-CoV-2 IgG/IgM Rapid Test CassetteRemoved – Should Not Be Distributed
Tianjin Beroni Biotechnology Co. LtdSARS-CoV-2 IgG/IgM Antibody Detection KitRemoved – Should Not Be Distributed
VITA TestingCOVID-19 IgM/IgG Antibody Rapid Test KitRemoved – Should Not Be Distributed
W.H.P.M., Inc.COVID-19 IgM/IgG Rapid TestRemoved – Should Not Be Distributed
W.H.P.M., Inc.COVISURE™ COVID-19 IgM/IgG Rapid TestRemoved – Should Not Be Distributed
Zhengzhou Fortune Bioscience Co., Ltd.COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)Removed – Should Not Be Distributed
Zhengzhou Fortune Bioscience Co., Ltd.COVID-19 IgM Antibody Rapid Test KitRemoved – Should Not Be Distributed
Zhengzhou Fortune Bioscience Co., Ltd.COVID-19 IgG Antibody Rapid Test KitRemoved – Should Not Be Distributed
Zhongshan Bio-Tech Co Ltd.SARS-CoV-2 IgM/IgG (GICA)Removed – Should Not Be Distributed*
Zhuhai Encode Medical Engineering Co., LtdNovel Coronavirus (COVID-19) IgG/IgM Rapid Test DeviceRemoved – Should Not Be Distributed*

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Source: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#nolonger-ivd