A major court battle over Kenya's certification of HIV and AIDs test kits is looming.
The Ministry of Health is accused of failing to apply World Health Organization (WHO) standards while conducting suitability tests.
For the last 15 years, Kenya has 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 a process of adopting three testing algorithm.
The ministry shortlisted eight kits for consideration to be used in the country.
Those shortlisted were One Step HIV whole Blood/Serum/Plasma manufactured by Guangzhou Wondfo Biotech, Company Limited, 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 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 STAT-PAK that is made by Chembio diagnostic Systems Inc.
The case filed by lawyer Elias Mutuma on behalf of Kathambi Ruchami and Guangzhou stems from the exercise.
Mutuma claimed that the ministry illegally dropped One Step HIV 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 Sh3 million to the ministry as per its request in a bid to scale up the process.
" The second petitioner, elated for the consideration, approval and recommendation of its kit in the program 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 process and therefore offered its donation as requested towards the support of the intended piloting exercise, the second petitioner donated USD 25,000 to the respondent as per the Ministry's request," said Mutuma.
According to the lawyer, Guangzhou knew that the kits would be passed for use after the pilot study.
He said that the ministry went quiet after the study.
The court heard that Guangzhou reached out to the ministry and it was informed that the launch of three-test algorithm would be launched in Homabay on September 3, 2023.
Guangzhou said that it learned that the ministry had moved its kits from A1 classification to the second and third category.
"Suffice to note that as of August 2023 the outcome of the said pilot exercise had not been communicated or availed to the 2nd Petitioner upon conclusion of the study in march 2023 (four months after the report had been submitted) and adopted by Ministry of Health," argued Mutuma.
It then appealed in which the ministry informed it that although the kits qualified in A1, the decision to move the kits to the other categories was made by a task-force as there were inadequate kits in A2 and A3.
Mutuma said that a cursory look at the Ministry's response dated September 11, 2023, revealed that it wrongly categorized the kits based on non-existent WHO protocol and guidelines.
"Further the said categorization is not supported by any scientific criteria. The decision to move the petitioner's kits from category A1 to A2 was done arbitrarily and based on illogical considerations hence the same is not only unjustifiable but equally, irrational, unreasonable, irrelevant, bias and illegal," argued Mutuma.
He claimed that the kits made by the Chinese firm qualified in all areas and were the most affordable as it was the cheapest of all the shortlisted kits at a cost of Sh 92 per test kit.
The firm wants the court to bar the ministry from implementing the three-test HIV testing algorithm without first scaling up its kits to the first category.
At the same time, Guangzhou urged the court to compel the ministry to classify its kits as the most affordable and exceeding WHO guidelines.
Guangzhou sued the Ministry of Health and the Attorney General.
The case will be mentioned before Justice Chacha Mwita on April 16.
