HIV Testing Kits Are Standard, Says Kenyan Government



By Modupe Adeniyi. Freelance Health Reporter.




WEDNESDAY JUNE 5, 2024. The debate surrounding the quality and state of HIV/AIDS testing kits procured by the Kenyan government is intensifying. The Ministry of Health has reassured Kenyans that the kits are WHO pre-qualified despite concerns raised by Kitutu Chache South MP Antony Kibagendi over the failure to apply WHO standards while conducting suitability tests during the transition of the HIV testing algorithm.


Kibagendi, a member of the National Assembly Health Committee, had accused the ministry of inadequate background checks on one of the companies expected to supply the kits. He alleged that the company had previously reported falsified diagnostic test results in some countries.


Kenya has been using a two-test algorithm for over 15 years but the strategy has been generating problems, with some kits producing contradictory results. Following WHO recommendations, Kenya started the process of adopting three testing algorithms in 2022.


In response, Rose Wafula, the Chief Executive Officer of the AIDS and STI Control Programme (NASCOP) commented, "When we were developing the algorithm, we filed five reports to WHO and the organization gave us feedback. If this product and any manufacturer that is linked to it had an integrity issue, WHO had an opportunity to give an advisory."


"The process of transitioning from a two-test to a three-test algorithm takes time and evidence review," Wafula explained. "The programme is currently at capacity building, and we believe in July, services will be offered with the three algorithms, phasing out the two-test algorithms."


While addressing concerns, Wafula said the product would have been flagged by the Pharmaceutical and Poisons Board (PPB), which vets all medical supplies in the country if there were any issues. "If there was indeed any serious issue with the testing kits, WHO would have recalled the product from the market," she added.


Ongoing collaboration among the Kenyan government, the US President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, has enabled Kenya to acquire the kits through a direct tender process as opposed to an open tendering process.


Speaking about the integrity of the exercise, Public Health Principal Secretary Harry Kimtai commented, "Procurement of the HIV testing kits tender was not like any other tender. It was a thorough exercise that involved WHO protocols."


Eight companies applied for the tender, however after rigorous screening processes, only three qualified – Trinity Biotech Manufacturing Ltd, SD Biosensor Inc and Guangzhou Wondfo Biotech Co.


Kenya is ranked among the ten countries in Africa that are ready to implement the three-test strategy, signifying willingness and proactiveness as they aim to win the fight against HIV/AIDS.





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Published: JUNE 5, 2024

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