Biohit's SARS-CoV-2 IgM/IgG Antibody Test Kit Granted FDA Emergency Use Authorization

Biohit Healthcare’s (Helsinki, Finland) SARS-CoV-2 IgM/IgG antibody test kit has been authorized by the FDA under a EUA (Emergency Use Authorization) for use in laboratories certified by CLIA (Clinical Laboratory Improvement Amendments of 1988).

EUA authorization is given only to products that have met FDA's rigid criteria showing these tests may be effective in detecting recent or prior infection by identifying individuals with an adaptive immune response to the virus that causes COVID-19 disease. In an independent study by a FDA-designated agency using frozen positive and negative antibody serum samples, Biohit’s SARS-CoV-2 IgM/IgG Antibody Test Kit was estimated to show a very high IgM and IgG sensitivity as well as a very high specificity. It is also a rapid test, giving results within minutes.

For critically ill COVID-19 patients, the FDA has authorized the transfusion of convalescent plasma (CP) to improve the patient's outcome. CP obtained from former COVID-19 patients who have been free of symptoms for more than 14 days, has shown to be extremely effective in helping the seriously ill recover.

"The utilization of the Biohit SARS-CoV-2 IgM/IgG antibody test kit can play an integral role in the selection of CP donors," said Frederick M. Schaffer M.D., Board certified Immunologist, formerly an Associate Professor at the Medical University of South Carolina. "CP is thought to diminish the morbidity and mortality associated with COVID-19 infections."

Additionally, a Yale University study in respect to Biohit concluded, "Overall, this LFA (lateral flow immunoassay) shows promise for use as a mobile diagnostic tool, and underscores the potential utility of such a simple and cost-effective assay for cataloging epidemiological data like prevalence and past infection status."