The FDA announced that it revoked the emergency use authorization (EUA) of the Chembio DPP COVID-19 antibody test due to accuracy concerns.
Chembio’s IgM/IgG SARS-CoV-2 serological antibody test received EUA in March as a fingerstick-style test designed to use the company’s MicroReader 1 and MicroReader 2 analyzers to detect IgM and IgG antibodies and offer results within 15 minutes.
As it was one of the first antibody tests authorized by the FDA during the COVID-19 pandemic, the agency concluded at the time that it met the statute’s “may be effective” standard for EUA, with the test’s known and potential benefits outweighing its known and potential risks.
However, the agency has since learned more regarding performance capabilities for SARS-CoV-2 serology tests, according to a news release, and developed general performance expectations for these tests.
Data submitted by Chembio showed that its test generates a…