Regulator authorises Covid-19 antibody tests
Private laboratories are likely to begin offering the tests this week
SA’s medicines regulator has authorised five new Covid-19 antibody tests, which will help doctors retrospectively diagnose patients and provide a vital research tool for local vaccine trials.
The SA Health Products Regulatory Authority (Sahpra) announced on Monday that it had issued section 21 authorisation for laboratory-based antibody tests manufactured by Abbott Laboratories SA, Roche Diagnostics and Euroimmun Medical Laboratory Diagnostics SA. It has also authorised seven licence holders of Zhejiang Orient Gene Biotech’s rapid point of care antibody test.