FDA has given emergency use authorization (EUA) to yet another rapid COVID-19 antibody test. The assay is being distributed by Virality Diagnostics and is manufactured by Finland-based Biohit.
New Haven, CT-based Virality Diagnostics said the test is a rapid SARS-CoV-2 lateral flow immunoassay (LFA) which detects both IgG and IgM antibodies with 98.5% accuracy.
The test will require a simple finger-prick and only one drop of blood, obviating the need for a venous blood draw, and delivers easily interpreted results within 15 minutes.
Recent studies involving over 1,500 patients were conducted at multiple sites, including Yale University and the National Cancer Institute (NCI). These studies independently validated that Virality's tests exhibit near perfect (98.8%) specificity for the novel coronavirus and extremely high sensitivity (94.9%) for patients tested at least 2-weeks from symptom onset.
Studies also show that the accuracy of Virality's test is not only better than most other rapid LFA tests currently authorized by the FDA, but also performs as well as, or better than, some ELISA tests, which are currently considered the gold-standard for SARS-CoV-2 antibody detection.
Antibody testing has been controversial in the U.S. About a week ago, Chembio Diagnostics’s EUA for its antibody test was revoked. The San Clemente, CA-based company was one of the first firms to get EUA for an antibody test during the pandemic.
FDA took action in early May and revised its March 16 policy, which has served as a regulatory roadmap for COVID-19 antibody tests. That revision came about two weeks after FDA issued a warning to healthcare providers about the limitations of such tests.