SA’s DoH recalls defective HIV tests

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Defective HIV tests – showing incorrect positive results – a have been recalled countrywide. The Cape Times quotes national Department of Health spokesperson Joe Maila as saying that the defective tests have come from two batches of HIV rapid-test kits and show weak positive results on negative samples. These batches were found faulty and then quarantined. Maila confirmed that the Western Cape, North West, Limpopo, KwaZulu-Natal and Northern Cape had been affected.

“All the test kits in these batches have been quarantined for collection and replacement by the supplier. The test kits are being replaced with new batches,” Maila said. “These tests were utilised for screening purposes and all positive results were subjected to a confirmatory test. In this case, the final results were found to be discordant and sent for ELISA (Enzyme-Linked Immunosorbent Assays) – an extremely sensitive test used to detect antibodies.”

Western Cape Health Department spokesperson Mark van der Heever said in the report that the department had received a few reports of defective screening tests last month and immediately asked for an investigation. Batch checks were performed, and the faulty batches found and recalled.

He said while there was no need for retesting, as only the initial test was defective and secondary and third confirmatory tests would clarify results, in some areas, due to people moving around, health co-ordinators also contacted clients who had had the test to ensure they visited their health facility again for their results and, if needed, for retesting.

Marcus Louw, of the Treatment Action Campaign, said the vast majority of HIV tests provided in the public sector were very reliable. “In the light of recent findings showing that HIV-positive people benefit from starting antiretroviral treatment earlier, it has become even more important that all people in South Africa have easy access to reliable HIV counselling and testing services so that they can start treatment if they are HIV-positive.”


Reports indicate that the rapid-test kits were showing positive results on negative samples. But, says an eNCA report, the department has denied the claims.

“Nobody got the wrong results. Let me explain how the testing is done. So when a person goes to one of our facilities to get tested, we use two tests. The first is a screening test and the next test is a confirmative test,” said Dr Yogan Pillay, the Department of Health’s deputy director-general. “If both tests come out with the same result then that result is communicated to the patent. If one test says positive and the other says negative, we call that a discordant result, that means it’s not the same. The blood of that patient is sent to a laboratory to do a third test and only when we get that result is the patient informed of their status.”

Full Cape Times report
Full eNCA report

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