New Covid-19 test kits approved for South Africa

The South African Health Products Regulatory Authority (SAHPRA) has approved new Covid-19 antibody tests for South Africa.

The regulatory body explained that new ‘rapid-test’ kits are different from the Polymerase chain reaction (PCR) test currently used in the country.

“The difference between the molecular PCR test and the serology tests is that the PCR tests are able to detect and diagnose whether one has been infected with Covid-19 and thus give a clinical diagnosis.

“Whilst the latter, i.e. serology tests, can detect if one has developed antibodies for Covid-19 or not. This means that the serology tests cannot be used for clinical diagnosis,” the authority said.

While this may be seen as a negative Dr Boitumelo Semete-Makokotlela, chief executive of SAHPRA, said that the new tests can be used in a number of important ways.

“Rapid test kits cannot be used to clinically diagnose Covid-19 cases, but they may play a role in research, epidemiological as well as sero-surveillance studies. Rapid test kits are not recommended by WHO for clinical diagnosis of SARS-Cov-2 infection,” she said.

News24 reports that the announcement around the new kits follows a week of confusion after the tests were advertised by private laboratories and then later withdrawn.

However, Health minister Zweli Mkhize confirmed that the tests are now available in a statement on Monday evening (24 August).

“Today I am pleased to announce that the director-general for health has issued guidelines for the use of SARS-CoV-2 antibody tests and that Sahpra announced its approval of several test kits, both lab based and point of care or bedside rapid tests,” he said.

“I am sure this is a very welcome development and I would like to especially thank the Ministerial Advisory Committee on Covid-19 and the various members of the strategic management bodies in the Department of Health for all the hard work that has gone into ensuring that antibody tests are used appropriately and effectively as we continue to battle Covid-19.

“It will be important to understand the limitations of antibody testing.”

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New Covid-19 test kits approved for South Africa