Durban - A world-renowned KwaZulu-Natal Aids researcher and Centre for the Aids Programme of Research in South Africa director Professor Salim Abdool Karim, said the recall of batches of HIV rapid test kits - because their results were checked in a laboratory - need not spark panic.
The national Department of Health confirmed the kits would be taken back from five provinces - including KwaZulu-Natal - because they had been yielding “weak positive results on negative samples”.
Health spokesman, Joe Maila, said the test kits were not clearly showing the results as they were supposed to and “appeared pale”. “The batches are quarantined and counting is still being confirmed”.
Maila said the test kits would be replaced by the supplier in the affected regions of KZN, Western Cape, North West, Limpopo and the Northern Cape.
Maila said no patients were misdiagnosed by the faulty test kits.
“These tests were used 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 assay).”
Karim said the rapid tests administered by health professionals in clinics worked by testing for antibodies against HIV, which produced a colour change on the indicator strip.
Echoing Maila, he said the results were then checked at a laboratory. “The tests are developed to be robust, meaning that they can be accurate in conditions different to a temperature-controlled lab, where it might be warmer or cooler or humid. They are usually pretty accurate,” he said.
But, every now and then, he said, the tests were found to have “processing problems” and were re-called. “This is by no means a South African problem. It happens everywhere; there’s no need for panic. Companies try hard to guard against it because of the damage to their reputations.”
Karim said that problems were not always picked up at the factory.
Dr Imran Keeka, provincial DA spokesman on health, welcomed the decision to recall the tests.
“It is well known that rapid HIV testing can produce either a false positive or false negative result.
“There is also the problem of whole batches being faulty. It is for this very reason that, in the case of a positive finding, further testing is done.
“Particularly worrying, though, are the cases of false negative results, where people have gone home from a hospital or clinic in the belief that they do not have HIV.
“It is now critical that the KZN Health department ensures that all people who were tested are traced and re-tested with more formal tests, particularly those who were found to be negative,” he said.
The KZN Health Department referred questions to the national department.