COVID-19 antibody test not ‘immunity passport’, warns SAHPRA
The authority has approved one COVID-19 antibody test, the Orient Gene Biotech, that will be used going forward.
CAPE TOWN – The South African Health Products Regulatory Authority (SAHPRA) says a positive COVID-19 antibody test should not be used as an “immunity passport”.
The authority has approved one COVID-19 antibody test, the Orient Gene Biotech, that will be used going forward.
Three companies won distribution rights for the serological test.
The COVID-19 Ministerial Advisory Committee has made recommendations on how antibody tests will be used.
A national testing algorithm of how the serological tests will be applied in the fight against the pandemic, will be made available by the national health department.
Doctor Andrea Julsing-Keyter, senior manager for medical devices and radiation control at the regulatory authority, said the test indicates whether or not someone has developed antibodies against COVID-19.
“So it’s very important to recognise what information you’re getting from this test, it can only tell you at that point of time do you have antibodies, yes or no. That’s all it can tell you, it is not to be used as an immunity passport to say, ‘I’ve got antibodies therefore I’m immune,’ this is really not the appropriate use or the intended purpose or intended use of these test kits.”
Julsing-Keyter said the approved test kits meet the necessary sensitivity and specificity requirements.
The antibody test will not be available as a self-test and will require a healthcare professional to administer it.
