The FDA issued a letter announcing that it revoked the emergency use authorization (EUA) for a COVID-19 test from Autobio Diagnostics.
Autobio’s SARS-CoV-2 rapid antibody test received EUA on April 24 for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood or serum.
Authorization for the test included clinical performance estimates of 85.43% positive percent agreement (PPA) for IgM and 86.17% PPA for IgG in all samples collected.
However, based on the results of new testing, the FDA determined that Autobio’s test does not meet current clinical performance estimates for serology tests, finding that it is unlikely that the test is effective in detecting SARS-CoV-2 IgM antibodies, according to a letter addressed to the company.
As a result of the findings, the FDA revoked the EUA, citing testing done at the National Institutes of Health’s Frederick National Laboratory for Cancer Research. That testing of 30 positive and 80 negative human samples found that Autobio’s test reported 50% sensitivity in testing for the IgM antibody, compared to the previously labeled 85.43% PPA.