Sunday Times (Johannesburg) - September 28, 2008
Kim Hawkey

The government has failed to warn thousands of South Africans to retest for HIV after a recall of defective rapid HIV test kits used in Mpumalanga and Limpopo.

Despite recalling the kit for "quality" reasons two months ago, the Department of Health has yet to warn members of the public who tested in these provinces.

The Sunday Times has established that a certain rapid HIV test - or finger prick test - used at public testing sites in the two provinces in the past year was recalled in late July after 10000 were found to be defective.

Futuremed Pharmaceuticals, the company that supplied the Wondfo Rapid One Step Test, confirmed that it had withdrawn more than half a million tests by the end of last month.

Mark Heywood, director of the Aids Law Project, said the government had a duty to inform the public about the recall. "There is certainly an ethical obligation - and possibly a legal one - to tell people who have tested positive or negative that the batch of HIV tests used have been found to be unreliable," he said.

"The least they should have said was that those who tested between that period should go and have another test. Those who got negative results may have got false negative results and may then be having unsafe sex," Heywood said.

The introduction of rapid tests in South Africa eight years ago led to an increase in the numbers of people testing. But concerns about the reliability of some of the tests have been raised. A 2007 study in KwaZulu-Natal, which evaluated five different rapid tests, found their performance to be "not as good as manufacturers claim". The recalled product was not used in this study.

"In high-prevalence settings, rapid HIV tests lead to a substantial number of false negative results, leaving many people unknowingly at risk for HIV complications and further transmission, even after testing," concluded the study, which was done by a team of local and international hospitals and medical schools.

Now, less than a year later, the government has temporarily withdrawn the Wondfo test kit when some were found to be "faulty" after complaints from clinic nurses and counsellors.

Fidel Hadebe, spokesman for the Department of Health, confirmed that the product was recalled and that the company's contract had been suspended so that it could " rectify some quality issues that were identified".

The department, which has opted for finger prick tests because of their speedy results and easy use, did not say why it had not announced the recall, but said it had "communicated with the affected provinces".

Scott Billy, technical adviser at the non-profit HIV testing and counselling organisation, New Start, said he was "really surprised" that the government had not told the public about the recall. "They acted strongly and were very upfront about last year's condom recall (and) issued press releases informing people," he said.

Sherry Liu of Wondfo Biotech, the Chinese company that manufactures and supplies the test to Futuremed, said it received complaints about the test giving " indeterminate results".

But she said "nothing went wrong in the manufacturing process", adding that recent samples submitted to the National Institute for Communicable Diseases had come back "good as expected".

Futuremed's sole director, Ismet Amod, said the problem was the result strip was "faint".

"There's a line that basically is supposed to be very bold and when it's tested, the lines that appeared there were very faint. So they can't really say whether it's negative or positive, so it produces some ambiguity."

Amod confirmed the tests were recalled in July after "approximately 200 boxes" - or 10000 tests - "were found to be faulty". But all the Wondfo tests on the shelves, approximately 590000 of them, were recalled as a cautionary measure, Amod said. He added that the company's contract was suspended by the department for two months, but that this period had now expired.

Hadebe could not confirm whether Wondfo would be used by the Department of Health again, while the national treasury said Futuremed remained under investigation.

080928
ST080902

Always watch for outdated information. This article first appeared in 2008. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2008. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .