Research & Development
Virality Diagnostics wins FDA's EUA for rapid COVID-19 antibody test with 98.5% accuracy
26 June 2020 -

Diagnostic information company Virality Diagnostics LLC reported on Thursday the receipt of the Food and Drug Administration's (FDA) Emergency Use Authorization (EUA) for a rapid COVID-19 antibody test manufactured by Biohit (Hefei) and distributed by Virality Diagnostics.

This test is a rapid SARS-CoV-2 lateral flow immunoassay (LFA) which detects both IgG and IgM antibodies with 98.5% accuracy.

It requires a simple finger-prick and only one drop of blood and delivers easily interpreted results within 15 minutes.

Recent trials involving over 1,500 patients at multiple sites, including Yale University and the National Cancer Institute (NCI), 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 two weeks from symptom onset.