The Ministry of Health (MoH) has dismissed allegations that poor-quality HIV testing kits are being used in Kenya. On Monday, Principal Secretary for Medical Services Harry Kimtai issued a statement refuting these claims, emphasizing that the progress made in HIV response efforts remains intact.
Kimtai highlighted the importance of routine quality assurance proficiency tests, which are crucial in monitoring and safeguarding the quality of HIV testing across the country. “The Ministry of Health assures Kenyans of its unwavering commitment to ensuring access to the highest-quality health services and urges all citizens to continue seeking HIV testing services across the country,” the statement read.
The Ministry has aligned with the latest World Health Organization (WHO) advisory, transitioning from a two-test to a three-test algorithm for HIV diagnosis. This new protocol involves using three different test kits sequentially to enhance diagnostic accuracy.
“The three-test algorithm marks a pivotal advancement in diagnostic accuracy, which is critical in Kenya’s fight against HIV and AIDS, underscoring the MOH’s dedication to the health and well-being of all citizens,” said Kimtai.
The statement follows a legal dispute involving Guangzhou Wondfo Biotech Co Ltd, a Chinese company that allegedly sued the Kenyan government for classifying its HIV testing kits as substandard. The company claimed that this reclassification unfairly affected its bid to supply new testing materials. They also alleged that the winning supplier’s kits were substandard and could lead to inaccurate results.
Director General of Health Dr. Patrick Amoth, in response to the case filed in the High Court, argued that the company was aware that its kits were classified at the second level, Assay 2 (A2). The classification levels—A1, A2, and A3—are based on the specificity and sensitivity of the kits, with specificity detecting HIV-negative status and sensitivity detecting HIV-positive status.
The Ministry of Health reported that Kenya has the 7th largest HIV epidemic globally, with approximately 1.4 million people living with HIV (PLHIV). By the end of December 2023, 1,336,234 PLHIV were receiving treatment at 3,752 facilities nationwide.
“Annually, over 8 million HIV tests are conducted in a standardized manner across different populations in over 8,851 public, private, and faith-based HIV testing sites across the country,” the Ministry noted.
