Many tests for immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies have been introduced, some of which have received emergency use authorization (EUA) from the FDA. Recently, the FDA has tightened its policies and published a list of products that have been removed from eligibility to market.
The FDA has also been assessing tests in conjunction with other U.S. government agencies. As part of this cross-government process, to date the agency has published performance data -- sensitivity, specificity, positive and negative predictive value -- for the following products, noting market status:
- Euroimmun's SARS-CoV-2 ELISA (IgG): EUA authorized
- Healgen's IgG/IgM rapid test cassette: EUA authorized
- Tianjin Beroni Biotechnology's IgG/IgM antibody detection kit: Should not be distributed, removed
- Phamatech's COVID-19 rapid test: Should not be distributed, voluntarily withdrawn
- BioMedomics' COVID-19 IgM/IgG rapid test kit: Should not be distributed, voluntarily withdrawn
As of June 3, the agency had granted 120 EUAs -- for 104 molecular tests, 15 antibody tests, and one antigen test. The agency also has published an educational video explaining tests for COVID-19, including molecular, IgG/IgM, and antigen tests.
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