The approval of a tender for HIV test kits despite an international warning was put through by junior officials, Health Minister Aaron Motsoaledi said. He said these officials, who issued the R22.5 million tender for seven million HIV kits, were working by the book.
"I believe [they] should have elevated the matter to the level of the minister or director general."
Motsoaledi was briefing reporters in Johannesburg on a government decision to recall 500 000 of the kits already distributed under the tender. The World Health Organisation issued a notice in January 2012 that some of the test kits, the SD Bioline, had been found to be faulty.
South Africa approved a tender for the kits in June. Motsoaledi described this as "an unfortunate, but unacceptable event".
Explaining what happened, he said South Africa's National Institute for Communicable Diseases (NICD) had given the kits the nod after the batches it checked were found to be functional.
NICD approval is a prerequisite for approval of such tenders. In view of this, the junior officials granted the tender without referring to a higher authority.
"If they did, I would have erred on the side of caution by deciding not to award the tender to this company."
The health minister said he had now opted to "err on the side of caution" by recalling the 500 000 testing kits issued so far.
Government and WHO to work together
Motsoaledi, WHO officials and local experts, who also attended the briefing, said the tests had not issued false positives or negatives.
Due to a flaw in the manufacturing of the kits, the tests would give an "invalid" answer, meaning that the result could not be read.
SA National Aids Council deputy chairman, Mark Heywood, said the test controversy should be "seen in context" and should not dissuade people from being tested and knowing their status.
HIV Clinicians' Society president Francois Venter echoed this plea. "People should not use this as an excuse to get out of their obligation," he said.
WHO director of Essential Medicines and Health Products Kees de Joncheere said his organisation had not banned the tests. Procurement had merely been suspended for the time being.
De Joncheere said the flaws had been found in only some batches of the product, and not all of them.
Motsoaledi said that while the MCID had found the tests in South Africa to be safe, the government would work with the WHO to further investigate the quality of SD Bioline tests.
(Sapa, July 2012)
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