Pathologist accuses Health Ministry of exposing Kenyans to danger in HIV kits case

Ministry of Health is putting the lives of Kenyans’ health in danger by procuring less sensitive but expensive HIV testing kits, a pathologist has told the High Court.

While accusing the ministry of failing to follow a scientific path to categorize HIV& AIDS kits, Dr. Perminas Okemwa told High Court Judge Chacha Mwita that the testing algorithm evaluation process was meant to give preferential treatment to one of the kits and not to offer Kenyans an effective and cost-effective option to test the disease.

“A1 assigned kit (Trinsreen HIV) and also unfair testing or screening for HIV infections that might comprise the test results for millions of Kenyans,” said Okemwa.

The ministry gave Trinscreen the first Assay 1 (A1) test in the national testing algorithm. However, Dr. Okemwa stated that the superior performance of other kits in the pool was not considered.

According to him, placing other kits superior in performance and cheaper in categories A2 or A3 meant that the ministry wanted to prevent those kits from competing with Trinscreen.

Dr. Okemwa testified in a case filed by Kathambi Ruciami and Guangzhou Wondfo Biotech Company Limited.

Through their lawyer Elias Mutuma, the two want the court to stop the procurement process and force the ministry to categorize the kits according to World Health Organization (WHO) standards.

Okemwa was the star witness in the case. He asserted that the categorization and the cost of the kits, as had been indicated by the Ministry, would affect the public's ability to access affordable and reliable HIV testing.

The court heard that since Trinscreen’s cost is higher, the government would have to get fewer kits for the amount allocated and, in turn, have more Kenyans exposed to HIV due to lower coverage of testing services.

“This, in turn, increases the risk of undiagnosed HIV cases, which could exacerbate the spread of the virus. With fewer people able to access affordable and reliable tests, the overall fight against HIV is significantly jeopardized. Fair access to quality testing is crucial in reducing transmission rates and ensuring everyone can make informed decisions about their health,” said Okemwa.

In this case, the ministry wants the court to dismiss the claims. Its witness, the Director General of Health, Dr. Patric Amoth, was meant to appear as its star witness. However, the Attorney General said that he was at a malaria conference.

In his affidavit before the court, Amoth said that when the ministry communicated with the Chinese company, it realized that the kits had been classified 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.

The DG further said the ministry went quiet as another case 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.

The government official 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.

He said the Chinese firm knew that its kits had been placed in the second classification level, Assay 2 (A2).

In 2019, the World Health Organization (WHO) recommended that countries transition from a two-test algorithm to a three-test algorithm to improve the accuracy of HIV testing.

Kenya has been employing a two-test strategy for the past 15 years. However, the primary concern with this approach is that it often results in conflicting test results.

Two women and the government are already engaged in an ongoing separate court battle regarding the two-test strategy after they received positive results from the kits despite being negative.

WHO had also recommended the use of dual HIV/syphilis rapid diagnosis tests for pregnant women attending ante-natal care. Kenya adopted this strategy for pregnant women in 2018.

The health agency also recommended that for a positive HIV diagnosis, the three consecutive tests should maintain a 99 per cent predictive value. This means that out of every 100 individuals tested, 99 will receive accurate results.

Last year, a task force was formed to review and categorize the kits intended for use in the country. To justify why the government needed to change its approach, the task force conducted tests using the two-test and the new three-test methods for comparison.

In a review test involving 1,776 individuals (excluding pregnant women) using the old two-test algorithm, 99.5 per cent, 95.23 per cent, and 98.7 per cent were mixed results.

Regarding dual HIV/syphilis testing, the task force recommended Kenya to continue using the Standard Q test for pregnant women due to its superior clinical sensitivity for syphilis, broader range for storage temperature, and lower cost.

It also recommended that the country do away with the old testing system.

In February of this year, the ministry tasked the National AIDS & STI Control Program (NASCOP) with overseeing the rollout and implementation of the transition to using new categories.

This is where the battles began. Joseph Omwando filed the first case against the Ministry of Health, accusing it of failing to involve stakeholders and procuring kits with lower sensitivity. Then Wondfo and Kathambi filed a separate one.

The case continues on October 17, 2024.