Virality Diagnostics Antibody Test Wins FDA EUA

The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for a rapid COVID-19 antibody test distributed by Virality Diagnostics, manufactured by Biohit (Hefei). This test, authorized on June 18th, 2020, is a rapid SARS-CoV-2 lateral flow immunoassay (LFA) which detects both IgG and IgM antibodies with 98.5% accuracy.

Virality's diagnostic test will require only one drop of blood, 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 (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.

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

"The presence of antibodies provides some level of protection and could last a few years." As such, Virality's antibody test might be crucial for governments around the world to determine rates of infection and true mortality rates, for physicians to track patient risk, maximize preventative care, and optimize treatment; and for employers and individuals to determine whether they had contracted COVID to guide workplace and personal safety decisions,” Marc Jenkins, director of the Center for Immunology at the University of Minnesota Medical School, said.