Doctors warn State against plan to acquire 'inferior' HIV test kits

Blood sample positive with HIV. [iStockphoto]

Medical experts have raised concern over the government's intention to procure contested three-test algorithm HIV test kits.

This comes as a court heard yesterday that there is a likelihood of the Ministry of Health officials rushing to conclude the procurement process despite concerns about the effectiveness and the cost of the kits.

University of Nairobi lecturers - Dr. Perminas Okemwa, Dr. Mohammed Oyaro, and Dr. Ephantus Njagi - in their joint report filed before High Court Judge Chacha Mwita said the Health Ministry falsified the criteria of the three-test algorithm kits.

Okwemwa, Oyaro and Njagi also work in Kenyatta National Hospital.

They said the government intends to buy expensive kits that do not conform with the World Health Organization (WHO) standards.

The kits project is partly donor-funded. Global Fund and the U.S. President's Emergency Plans for AIDS Relief (PEPFAR) plan to pump USD 322 million (Sh41 billion) into the fight against HIV.

But the three experts claimed the kits being procured have an error margin of 0.3 per cent, meaning at least three people who test for HIV are likely to be given false results.

The court heard that although WHO does pre-qualification of kits, it does not categorize them as the Ministry did. The experts observed that the team that had been tasked to do the exercise had admitted challenges in categorizing the kits into A1, A2 and A3. According to the Ministry of Health, A1 ought to be the most effective kits.

In court yesterday, the experts said it was strange that the Ministry officials moved kits with 100 per cent accuracy to other categories without any scientific explanation.

"For instance, the A1 kit picked by the taskforce has an error of 0.3 per cent while the One Step HIV kit has an error of 0.0 per cent and yet the One Step HIV kit was not selected into A1 as would have been expected leaving alone the implication of 0.3 per cent rate associated with A1 assigned kit and also unfair testing for HIV infections that might compromise the test results for millions of Kenyans," the three lecturers report read in part.

Former chair of Kenya Medical Laboratory Technicians Board (KMLTB) Micheal Wanga, who is listed in the case, told the court that despite the Ministry insisting the kits were approved by the Pharmacy and Poisons Board, it does not have powers to conduct tests. He said the Health Ministry has no evidence that the tests were either subjected to laboratory tests approved by the KMTLB as required by the law.

"The taskforce report indicates the products were shortlisted from WHO prequalified products and approved for use in Kenya by the Pharmacy and Poisons Board, which lacks the mandate for testing. This responsibility should have been undertaken by KMLTB. The methodology used to shortlist candidates in phases 1 and 2 was subjective and did not involve competent laboratories," said Wanga.

He said the taskforce report on the adoption of the three-test HIV testing algorithm demonstrated significant irregularities and a failure to adhere to legal and scientific standards.

Yesterday, the ministry told the court that it needs time to rebut the expert witnesses' evidence.

There is an ongoing court battle between two women and the government over the two-test strategy after the kits indicated they were positive while they are negative.