Policy & Regulation
Virality Rapid SARS-CoV-2 Diagnostics Antibody Test Cleared by FDA, EUA
26 June 2020 - - The Food and Drug Administration has issued an Emergency Use Authorization for a rapid COVID-19 antibody test distributed by Virality Diagnostics LLC, manufactured by Biohit (Hefei), the company said.

This test, authorized on June 18th, 2020, is a rapid SARS-CoV-2 lateral flow immunoassay which detects both IgG and IgM antibodies with 98.5% accuracy.
Virality's diagnostic 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.

The antibody test measures the body's immune response to determine whether an individual has produced certain antibodies in response to a SARS-CoV-2 infection, indicating past exposure to and infection by the novel coronavirus.

Recent studies involving over 1,500 patients were conducted at multiple sites, including Yale University and the National Cancer Institute.

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.

Although research is still ongoing, evidence suggests that antibodies to SARS-CoV-2 confer immunity to COVID-19. 


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