DETROIT – The U.S. Food and Drug Administration is tightening the rules on coronavirus (COVID-19) antibody testing.
Officials have issued a new policy requiring manufacturers to apply for Emergency Use Authorization within 10 days of when a test is validated.
The former policy, which was issued in March, allowed companies to validate their own tests and sell them, as long as they had a disclaimer that they hadn’t been approved by the FDA.
But FDA officials have since learned of companies making false claims about tests and their accuracy.
So far, 12 antibody tests have been issued Emergency Use Authorization from the FDA. You can see the full list, along with the dates of authorization, below.
- April 1: Cellex Inc. -- qSARS-CoV-2 IgG/IgM Rapid Test
- April 14: Ortho Clinical Diagnostics, Inc. -- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack
- April 14: Chembio Diagnostic System, Inc -- DPP COVID-19 IgM/IgG System
- April 15: Mount Sinai Laboratory -- COVID-19 ELISA IgG Antibody Test Serology IgG
- April 24: Autobio Diagnostics Co. Ltd. -- Anti-SARS-CoV-2 Rapid Test
- April 24: Ortho-Clinical Diagnostics, Inc. -- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
- April 24: DiaSorin Inc. -- LIAISON SARS-CoV-2 S1/S2 IgG
- April 26: Abbott Laboratories Inc. -- SARS-CoV-2 IgG assay
- April 29: Bio-Rad Laboratories, Inc. -- Platelia SARS-CoV-2 Total Ab assay
- April 30: Wadsworth Center, New York State Department of Health -- New York SARS-CoV Microsphere Immunoassay for Antibody Detection
- May 2: Roche Diagnostics -- Elecsys Anti-SARS-CoV-2
- May 4: EUROIMMUN US Inc. -- Anti-SARS-CoV-2 ELISA (IgG)