Health ministry, firm battle over HIV testing kits

Health CS Aden Duale at Afya House on 26th May 2025. [Wilberforce Okwiri, Standard]

The Ministry of Health clashed with a HIV and AIDs kits manufacturer on effectiveness of kits procured by the government following a rollout of a three-process testing.

On one hand, the Chinese manufacturer accused the ministry of categorising expensive but less effective kits, putting Kenyans at risk of the disease spread.

On Tuesday, during the final submissions before High Court Judge Chacha Mwita, Guangzhou Wondfo Biotech, Company Limited and Kathambi Ruchami’s lawyer Elias Mutuma argued that the process of developing the three-test algorithm was vague, and that ministry officials selected the most expensive test kits, which could easily mislead an individual’s status.

“Priority is paid to the individuals testing positive but little or no attention to the individuals testing negative. There are no chances of confirmatory tests as a follow-up on individuals misdiagnosed as being HIV negative based on a test done using an inaccurate kit since only people who test positive in the first instance proceed for confirmatory steps two and three,” argued Mutuma.

On the other hand, the Health Cabinet Secretary and Attorney General argued that the kits’ effectiveness was determined in a rigorous process, which had been conducted in accordance with WHO Guidelines, and Generic Verification Protocols, HIV Prevention and Treatment Guidelines 2022.

According to the two, categorisation of the test kits into three test assay algorithms was a noble policy decision, done openly and factored in taxpayers' money.

“The categorisation as conducted by the taskforce was done in accordance with the law, guidelines and policies as applied in the medical field. The categorization was done in good faith and transparency hence ought not to be overturned,” replied Deputy Cjief State Counsel Rodgers Sekwe.

For the last 16 years, Kenya had been implementing a two-test strategy in HIV testing. However, the strategy had been generating problems owing to some tests giving contradicting results. 

Following WHO recommendations, Kenya in 2022 started adopting three testing algorithm. The ministry shortlisted eight kits for consideration. Those shortlisted were One Step HIV ½ whole Blood/Serum/Plasma manufactured by Guangzhou, Trinscreen HIV by Trinity Biotech Manufacturing, Determine HIV-1/2 (Abbott Diagnostics Medical Co.Ltd), Insti HIV-1/HIV-2 Antibody Test that is manufactured by BioLytical Laboratories Inc.

Others are Standard Q HIV ½ Ab 3-Line Test made by SD Biosensor Inc, First Response HIV 1-2.0 Card Test (version 2.0) that is made by Premier Medical Corporation

Private Limited, Bioline HIV-1/2 3.0 (Abbott Diagnostics Korea Inc) and HIV ½ STAT-PAK that is made by Chembio diagnostic Systems Inc.

In the case, Mutuma argued that the ministry illegally dropped One Step HIV ½ whole Blood/Serum/Plasma from the list without following the WHO guidelines.

He argued that the kits were piloted in different parts of the country in which he donated Sh 3 million to the ministry as per its request in a bid to scale up the process.

“The probability of false negatives cannot be downplayed as the kits are prone to err, making it even more dangerous for the community and the public in general, as the falsely tested negative individual will go about spreading the HIV disease unaware. This instance defeats the goal and vision by WHO to eradicate HIV as a global pandemic by 2030 as well as the Government’s goal and vision to do away with the mother-to-child HIV transmission by 2027,” said Mutuma.