FDA pulls plug on wayward coronavirus antibody tests

By Emily Hayes, LabPulse.com editor in chief

May 22, 2020 -- The U.S. Food and Drug Administration (FDA) has published the names of 28 coronavirus antibody tests that may no longer be marketed or distributed, as part of its crackdown on the quality of products introduced on an emergency basis during the pandemic.

The names of the products and their manufacturers are now on a "removal list" as they are not in compliance with new regulatory requirements announced by the agency this month. It includes products that have been voluntarily withdrawn and products that have not been cleared through the FDA's emergency use authorization (EUA) pathway. Critics have been alarmed at what they saw as a lax regulatory approach during the pandemic, resulting in the market entry of many tests for immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies that had never been validated or reviewed. The agency responded by changing its policy to require commercial manufacturers to submit EUA requests within 10 business days from the date that they notified the agency of their validation testing. The FDA also now has specific performance thresholds that testing products must meet.

In a statement about its publication of the removal list, which was published May 21 on a section of the FDA website pertaining to the availability of tests, the agency said that it is "providing promised transparency for antibody tests."

The products on the list are as follows:

  • Artron BioResearch/Artron Laboratories, COVID-19 IgM/IgG Antibody Test
  • BestNovo (Jiangsu) Medical Technology, BestNovo COVID-19 IgM/IgG Antibody Rapid Test kit
  • Biobase Biodustry (Shandong), SARS-CoV-2 IgM/IgG Antibody Test kit (colloidal gold)
  • BioMedomics, COVID-19 IgM-IgG rapid test
  • Bioscience (Chongqing) Diagnostic Technology, Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody
  • Bioscience (Chongqing) Diagnostic Technology, Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody
  • Bioscience (Tianjin) Diagnostic Technology, Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody
  • Bioscience (Tianjin) Diagnostic Technology, Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody
  • Boson Biotech (Distributed by Pure Genetic Medical), Rapid 2019-nCoV IgG/IgM Combo Test Card
  • Changchun Wancheng Bio-Electron, COVID-19 IgG/IgM Antibody Rapid Test kit (colloidal gold immunochromatography)
  • Diazyme Laboratories, Diazyme SARS-CoV-2 Antibody Rapid Test
  • Genlantis Diagnostics, CovidQuik Coronavirus (COVID-19) IgM/IgG Antibody Test
  • Hangzhou Clongene Biotech, COMBRA COVID-19 IgM/IgG Rapid Test Cassette
  • Hangzhou Testsea Biotechnology, One Step SARS-CoV2 (COVID-19) IgG/IgM Test
  • Hunan RunKun Pharmaceutical, SARS-CoV-2 lgM/lgG Test kit (colloidal gold)
  • IMMY, clarus SARS-CoV-2 Total Antibody EIA
  • Jiangsu Eubo Biotechnology, EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)
  • Lifeassay, Test-it COVID-19 IgM/IgG Lateral Flow Assay
  • Phamatech, COVID-19 IgG / IgM Rapid Test
  • Promedical, COVID-19 Rapid Test
  • Saladax Biomedical, COVID-19 IgG/IgM Rapid Antibody Test
  • Shanghai Eugene Biotech, SARS-CoV2 (COVID-19) IgG/IgM Rapid Test
  • Shenzen Landwind Medical, COVID-19 IgG/IgM Rapid Test
  • Vita Testing, COVID-19 IgM/IgG Antibody Rapid Test Kit
  • Zhengzhou Fortune Bioscience, COVID-19 Antibody Rapid Test Kit (colloidal gold immunochromatography method)
  • Zhengzhou Fortune Bioscience, COVID-19 IgM Antibody Rapid Test kit
  • Zhengzhou Fortune Bioscience, COVID-19 IgG Antibody Rapid Test kit
  • Zhongshan Bio-Tech, SARS-CoV-2 IgM/IgG (GICA)

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