HIV kits maker, State in Sh9.7m 'grant' battle

Ministry of Health officials sought Sh9.7 million from a manufacturer as a donation to facilitate a pilot study for three algorithms HIV test kits.

A Chinese manufacturer has told the High Court that after its product was prequalified for the study in Mombasa, Garissa, Kiambu and Kisumu, the government asked that it gives the money.

“It was at this juncture that the Ministry of Health in the said letter requested the 2nd Petitioner as one of the manufacturers whose kits had been approved and recommended as the first kit in the three-assay algorithm (A1) to offer monetary support in form of donations to the Ministry to facilitate the pilot study at a budget estimated at Sh9.7 million,” says Guangzhou Wondfo Biotech.

According to the company, it gave Sh3 million in the hope that it would be involved in the pilot study and called upon to defend its product before the ranking would be done.

It claims that after the money was disbursed, the ministry went quiet. Upon follow-up, it emerged that its kits had been moved from category A1 to A2.

But Acting Director General Patrick Amoth, while admitting that the ministry received the money and the kits, says the company would have declined to participate in the study.

“The second petitioner did not raise any issue with the classification of their test kit as A2. Indeed, the 2nd petitioner donated test kits and partly funded the algorithm pilot with full knowledge of being an A2 in the Kenya HIV testing algorithm,” says Dr Amoth in his response to the case filed by Kathambi Ruchiami and Guangzhou.

In 2019, the World Health Organisation recommended that countries should shift from two-test to three-test algorithms to improve efficacy.

There is already a separate court battle between two women and the government over the two-test strategy after the kits indicated they were positive while they were negative.

The women have sued Thika Level Five Hospital, (former) Health Cabinet Secretary Mutahi Kagwe, Diani Health Centre, Msambweni County Referral Hospital, and (former) Attorney General Kihara Kariuki.

One of the women, who had gone for a routine antenatal visit, claims that she tested and found positive at the Diani Health Centre on July 20, 2016. Tests on her spouse and their one-year-old child by a different staff member were negative.

She claims that the staff who tested her was a counselor with a two-week training certificate and no known medical laboratory training background.

“The hospital relied on the HIV test result given to me to administer antiviral therapy (ARV) to my one-year-old at the time. The ARV has permanently changed the life of my entire family in all aspects,” she claims.

According to her, this led to family fights, adding that Msambweni County Referral Hospital declined to admit her when she was to give birth.

“An HIV positive tag put on me was a result of an HIV misdiagnosis, had a big toll on my entire family due to suspicion, stigma, mistrust and regular domestic quarrels that made our lives as a family appear worthless.”

She claims that when it was discovered that she did not have HIV, the hospital demanded she return all the medical records and medicine for destruction.

The other complainant claims she and her husband of 22 years were tested at the Thika Level Five Hospital on March 2, 2018. She was declared positive for HIV while the man was cleared.

She says the husband disappeared the following morning without a word.

According to her, she got a call 14 days later from the hospital requiring her to get medication. The woman claims she contemplated suicide due to trauma.

“I tried mixing rat poison with iodine and yogurt to take.”

On December 10, 2018, she went for a second test, which gave a contrary verdict. Amazed, she did another test that confirmed she was negative.

A year later, she went to the same hospital for free cervical cancer medical camp, which included testing HIV, and the result was negative. Two days later, she again did another test at the hospital and the result was the same.

Her blood sample was taken to the Kenyatta National Hospital, and doctors concluded she had been negative all along.

“I wish to state that at the time of misdiagnosis, I was working as a food vendor and as a result of the stigmatisation I lost my customers,” she says.

The country started the process of adopting three testing algorithm in 2022 as the case was going on. Eight kits, among them Guangzhou's, were identified to consideration.

In the new case, the ministry says it was in advanced stage of rolling out the three algorithm test kits.