Call to ensure no room for error in HIV test kit screening process

2015-09-30 18:08
The DA's Mmusi Maimane and Wilmot James.

The DA's Mmusi Maimane and Wilmot James. (Eugene Gunning/Die Burger)

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The robustness of the screening processes for South Africa’s HIV test kits has been called into question following revelations that defective batches had passed initial tests. 

Democratic Alliance spokesperson for health, Wilmot James, raised concerns following a recent scare when batches of defective HIV tests were recalled. This followed complaints that they were showing positive results on negative samples. 

Upon retesting by the National Institute for Communicable Diseases (NICD), 64% to 69% of the kits produced false positives, “a stunning figure”, James revealed this week. 

The defective batches had met the requirements when they were initially tested by the NICD prior to distribution, Health Minister Aaron Motsoaledi confirmed in a written parliamentary reply last week. He listed nine defective batches altogether. 

“So what happened? Are the NICD tests robust enough? Do they follow international norms?” asked James. 

The 64% to 69% false-positive results are contained in recall notices of three batches of Advanced Quality HIV rapid test kits issued by the Western Cape Government in July. 

To meet World Health Organisation standards, rapid tests require a “sensitivity” of 99% – that is less than 1% false negatives – and a “specificity” of 98%, that is less than 2% false positives, said James. 

When the defective tests were detected, James called for a parliamentary-led enquiry. 

“Yet there has been no response. I am aware that Motsoaledi has had an enquiry. I call on him to make the results of the enquiry public. I also call on him to tell us what steps he has taken to ensure that this does not happen again,” said James. 

But Motsoaledi’s spokesperson Joe Maila said that an investigation was still ongoing. 

“We have reason to believe that there was a problem with the cold chain,” he said, requesting that calls for an inquiry be suspended until the results were released. 

He defended the testing process, saying they followed international norms. The department had already introduced marketing surveillance and “manufacturers and suppliers must ensure compliance with cold chain requirements during transportation and storage”. 

Maila said checks and balances were in place to ensure that defects were picked up quickly. 

The department stressed in earlier reports that no one had received a false result because of the defective tests. Two tests are conducted on a blood sample. If there is a discordant result, it is sent to the lab for a third test.

Read more on:    democartic alliance  |  wilmot james  |  hiv aids

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