Motsoaledi explains SD Bioline HIV test kits

Monday, July 16, 2012

This following reports that the ministry has distributed these testing kits to public health facilities despite the World Health Organisation delisting the use of these kits from their procumbent list.

WHO blacklisted the SD Bioline kits last year after it found that there was unacceptably high rate of invalid tests on two separate slots.

But a R22 million transversal tender was issued by Treasury this year to a local company to provide these kits to state facilities in the country's nine provinces.

Briefing the media on the issue, Motsoaledi was at pains to explain that the SD Bioline HIV testing was safe to use in South Africa - a view that was also emphasised by the WHO.

Motsoaledi said the SD kits results in South Africa were never invalid because the company had sent a different batch to the country.

The minister added that the test kits where also sent to the National Institute for Communicable Diseases (NICD) where they passed the quality control mechanism.

"The fault of this kit will not lie to anyone, it will just give no result."

The minister further explained that when HIV testing is done at local public health facilities two test kits from two different companies are used with one as a control measure.

"We use two different test kits from two different manufactures. The first kit is called the screening and the second the confirmatory test. If onscreen the person tests positive, the results are not released but a confirmatory test will be done first using the second kit which must always be from a different manufacture.

"If both show a positive result then the results can be released to the individual. However, if one is negative and the other is positive, we still don't release such results but we send the blood to the National Health Laboratory Services to perform a test using laboratory equipment."

WHO representative Dr de Joncheere also explained that the test kits had been delisted from their procurement list until the company has made necessary improvements to its quality of test kits.

De Joncheere said the test kits with the fault showed a substantial red background colour in the test window where the results are read.

This, he said, blurs the visibility of the test lines and therefore no results could be read - making the test invalid - which meant no results can be recorded.

"Given the HIV testing guidelines in SA, any invalid results would have led to a retesting. This means nobody's life has been put at risk by the use of these specific SD bioline HIV tests in South Africa."

Both the WHO and the Ministry were of the view that the same company was sending different batches to different counties, hence why the WHO had issued the communique to warn countries about this particular company.

Although Motsoaledi would not confirm how many kits had already been used, he said they had recalled them and were discontinuing the use of them as cautionary measure.

About 500 000 of the test kits were in circulation in Northern, Western and Eastern Cape and in KwaZulu-Natal.

A team has been set up by both Health and Treasury to investigate the tender process of the kits. The outcomes of the investigation is expected to be released in four weeks

"Both of us are investigating what went wrong," said the minister, who was under the view that junior officials were involved in the tender process should have elevated the matter to the level of Minister or DG.

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