Cape Town – Defective HIV tests – showing incorrect positive results – have been recalled countrywide.
The defective tests have come from two batches of HIV rapid-test kits and show weak positive results on negative samples, national Health department spokesperson Joe Maila said.
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.
“This happened in the Western Cape. In the other provinces, this challenge of weak positive results on negative samples was picked up at IQC level (quality control process for HIV rapid testing) and contained at that level.”
At the time of publishing, Cape Times was unclear how many tests had been recalled.
Western Cape health department spokesperson Mark van der Heever said 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.
Mayco member for safety and security JP Smith said City health had removed the stock in question from circulation.
SA HIV Clinicians Society chief executive Lauren Jankelowitz said: “Getting a positive HIV test result is a life-changing medical experience for most people, similar to being told you have cancer. The psychological implications are therefore huge.
“While it will likely come as a relief to be told tests are defective, ‘so come back and retest’, this could build up false hope for people who are indeed HIV-positive. The system in place with a screening test, confirmatory and lab blood test should be sufficient to protect most patients from this.”
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.”