World Health Organisation warns on faulty HIV test kit

A majority of HIV self-testing kits introduced recently are faulty, World Health Organisation (WHO) has said.

According to the agency, the rapid test kits have a seven out of eight chance of giving wrong diagnosis.

The problem is further compounded by a row between two State agencies over the mandate of ensuring only genuine kits are available in the local market.

The kits that have been retailing in selected pharmacies for Sh800 apiece are popular with first-time users and individuals seeking absolute privacy.

“In this first systematic head-to-head evaluation of the most widely used Rapid Diagnostic Tests, individual tests performed more poorly than in the WHO evaluations and only one test met the recommended threshold for Rapid Diagnostic Tests near 100 per cent sensitivity and specificity,” reads part of a World Health Organisation (WHO) report.

The report titled, Towards more accurate HIV testing in sub-Saharan Africa, which was published on March 24, 2017 cast a shadow on the efficacy of the kits.

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The findings published in the Journal of the International Aids Society showed that the kits gave 438 false positives from 2,785 samples.

But Director of Medical Services (DMS) Jackson Kioko has defended the kits, saying that due process was followed in their acquisition.

“Let me clearly state that all health products in this country are duly evaluated and registered before they are adopted in the national diagnostic and treatment protocols,” he said.

At the same time the push and pull between Kenya Medical Laboratory Technicians and Technologists Board (KMLTTB) and the Pharmacy and Poisons Board (PPB) has now created a lacuna for some businesses to easily sell the test kits.

KMLTTB, which is mandated through an Act of Parliament to regulate all in-vitro diagnostics to be used in the country, maintains that PPB is overstepping its mandate.

“Let me make this clear, Legal Notice No. 113 of 2011 gives this board the mandate to regulate all diagnostics to be used in the country,” said the KMLTTB Chairman Abel Onyango.

Despite the mandate, Cabinet Secretary Cleopa Mailu has sent an executive order charging the PPB with the duty to evaluate all diagnostics in the country.

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In a memo to Kenya Bureau of Standards Managing Director, Dr Mailu said the order was meant to streamline the importation challenges of Government agencies. 

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