The Emergency use approval has been granted to Roche from the U.S. Food and Drug Administration (FDA) for an antibody test in determining if people have ever been infected with the covid-19, according to the Swiss drugmaker.
Roche had previously pledged to make its antibody test available by early May and to boost production by June to “high double-digit millions” per month.
The Basel-based company, which also makes separate molecular tests to identify people with active COVID-19 infections, said its antibody test, Elecsys Anti-SARS-CoV-2, has a specificity rate of about 99.8% and sensitivity rate of 100%.
These rates will help in determining if a patient has been exposed to novel coronavirus, the respiratory disease caused by the coronavirus, and if the patient has ever developed antibodies against it. Various other companies including U.S. based Abbott Laboratories, Becton Dickinson and Co, Italy’s DiaSorin have also developed tests to identify antibodies that develop after somebody has come into contact with the virus.