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