HIV testing kits recalled over accuracy fears

More than one million HIV testing kits have been recalled following a global alert by the World Health Organisation over their accuracy.

The Public Health and Sanitation ministry has said the Standard Diagnostic Bioline, one of the three kits used for HIV testing in the country, had diagnosed patients as HIV negative when they were positive.

“Following the World Health Organisation (WHO) global alert, the Government of Kenya has instituted an immediate recall of all Bioline rapid test kits supplies from all health facilities and VCTs in the country,” said the National Aids and STI Control Programme (Nascop).

The Public Health ministry directed provincial directors and Aids and sexually transmitted diseases sector co-ordinators to remove the kits from health facilities. The Director of Public Health and Sanitation, Shanaz Sharif, said Bioline rapid test kits constituted about a tenth of the tools in circulation which he estimated at 10 million units.

WHO issued the directive following increased cases of discrepancies in results from the testing kits. The kit is manufactured by Standard Diagnostic Inc, a South Korean medical equipment maker. The recall suggests failure on the part of government laboratories which conduct quality tests on equipment and approve use. Medical practitioners use three test kits to check the presence of the HIV virus in a patient. The first test, called screening test, is performed using the Determine kit, which detects if someone is HIV positive.

Bioline is used to detect HIV negative blood samples. In cases where the two don’t give consistent results, the Unigold test is used as a tie breaker.

Following the anomaly, the government has replaced the Bioline kit with Unigold for confirmatory tests.

The Long Elisa method will be used as a tie breaker in cases of discrepancies, with Determine being used for screening. “Unigold will replace Bioline as the confirmatory HIV test kit,” said Dr Sharif.

In cases of discrepancies, HIV testing and counselling service providers will now have to send dried blood samples to the National HIV Reference Laboratory by courier service for determination of final test results.

Officials at Kenya Medical Research Institute (Kemri), however, said that Bioline was not widely used. “About seven per cent of Kenyans coming for HIV tests are positive. Given that Bioline is used to detect negative status, there are less of the Bioline kits out there,” said Dr Matilu Mwau, a paediatrician with Kemri.

rotini@ke.nationmedia.com