In response to the many questions being asked of us as to when we would be able to offer antibody testing; this is a brief note of explanation as to the processes we have to follow before we may offer the tests.
For suppliers of invitro diagnostic tests to sell test kits to us, approval and registration with SAHPRA (South African Health Products Regulatory Authority) is necessary.
This requirement is also applicable to rapid testing for SARS-CoV-2 antibody kits, none of which to date have been approved for South Africa. A number of lesser known laboratories (and not ISO accredited) are making claims of being able to provide these – they are not approved by SAHPRA yet and consequently their use in South Africa would not be legal at this stage.
COVID-19 Antibody test