HIV kits donation saga brews as ministry, manufacturer differ

Testing kits are categorized as either A1, A2 or A3. [iStockphoto]

A donation saga is brewing in the Ministry of Health with conflicting accounts of what transpired during the HIV and Aids pilot test.

On the one hand, acting Director General of Health Dr Patrick Amoth stated that a Chinese company challenging the classification of donated kits, partly funded the pilot test.

In his reply to a case filed before the High Court, Amoth says the company knew that the kits had been placed in the second level of classification, Assay 2 (A2).

Nevertheless, Guangzhou Wondfo Biotech Co. Ltd Vice President Wenjie Xu in the case before Justice Chacha Mwita, claimed that the Susan Nakhumicha-led ministry informed it that the kits had been approved and recommended as the first kits, Assay 1 (A1).

In addition, Xu said that the ministry asked for monetary support to facilitate a pilot study budgeted at Sh9.7 million.

“The second petitioner or applicant, elated for the consideration, approval and recommendation of its kit in the programme as the first kit (A1), noted in its response to the Ministry of Health that it was willing and ready to partner with the ministry of health in the implementation plan and scale up the process and therefore offered its donation as requested.”

“Towards the support of the intended piloting exercise, the 2nd petitioner or applicant donated USD 25,000 (Sh3 million) to the 1st respondent as per the Ministry’s request,” said Xu.

The specificity of a kit is used to detect an HIV-negative status while the sensitivity of a kit detects an HIV-positive status. Based on their specificity and sensitivity, testing kits are categorized as either A1, A2 or A3.

At the heart of the court battle between Wondfo Biotech, health ambassador Kathambi Ruchiami and the Ministry of Health is the classification of test kits adopted by the ministry.

Kenya is moving from a two-test algorithm to a three-test algorithm.

Wondfo Biotech and Kathambi claimed that the ministry classified kits as A1 while they were more expensive by 0.35 dollars and had a less specificity and sensitivity rating than the company’s kits.

According to the two, the World Health Organization (WHO) recommended that each kit should have a 98 per cent sensitivity and specificity as the minimum prequalification standard.

They claimed that their kits dubbed “One Step HIV 1/2 Whole Blood/Serum/Plasma Test” have 100 percent sensitivity and specificity, have a 24-month shelf life and ought to cost as low as 0.68 US dollars per test.

Wondfo Biotech and Kathambi’s lawyer Elias Mutuma alleged that after the ministry received the money, and did pilot tests in Kisumu, Garissa, Kiambu and Mombasa, it went quiet.

“ It was legitimately expected that as a key stakeholder whose testing assay had been shortlisted and prequalified for verification and also having funded the taskforce’s study, the second petitioner would not only be consulted and involved during the planned pilot study but also be afforded an opportunity to defend the quality, specifications and accuracy of its kits before an adverse determination was made on the products in accordance with Article 47 on fair administrative action,” said Mutuma.

Mutuma stated that his client challenged the categorization of its kits as A2 but was informed that a decision to move them from the first category was only based on a lack of adequate kits in the other categories.

Dr.Amoth on the other hand said at the time the ministry was communicating with Wondfo Biotech, it realised that there was an error in the classification of the kits as A1 instead of A1/A3.

He said that the letter informing the firm about the kits was corrected.

“The 2nd 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,” replied Amoth.

He said that the ministry went quiet as there was another case that had been filed over the rollout of three test algorithms in the country.

Dr Amoth claimed that the approved research protocol does not require countries to invite manufacturers to defend their products.

He stated that it would amount to solicitation.

He asserted that Kenya has to move from two test algorithms to three as a report for HIV indicated that between 2023 and 2023 at least 220, 666 children were at risk of misdiagnosis.

At the same time, he said that 2.6 million women attending antenatal care, 4.1 million adult population, 2.4 million vulnerable persons, 130,000 military and uniformed persons 1.1 million key population which includes sex workers were at risk of getting the wrong diagnosis.

According to him, for the Global Fund and the U.S. President’s Emergency Plans for AIDS Relief (PEPFAR) to continue funding the fight against HIV, Kenya has to fully transition to three test algorithms.

“ The Ministry is at advanced stages of implementation of the transition to the three-test algorithm in compliance with the Funding Requirements from the Global Fund and PEPFAR with the total commodity costs for Global Fund, PEPFAR and GOK being approximately Sh 2 billion,” he said.

Amoth wants the case dismissed claiming that it was driven by commercial interests rather than public interest.