The Ministry of Health (MoH) has refuted claims regarding the presence of inferior HIV testing kits in Kenya.
Principal Secretary for Medical Services, Harry Kimtai, stated that these allegations are false and emphasized that the progress achieved in combating HIV will not be compromised.
Kimtai highlighted the importance of regular quality assurance proficiency tests in monitoring and upholding the standard of HIV testing in Kenya. He reassured Kenyans of the Ministry’s steadfast dedication to providing top-tier health services and encouraged citizens to continue accessing HIV testing services nationwide.
Furthermore, Kimtai mentioned the Ministry’s alignment with the latest advisory from the World Health Organization (WHO), which entails transitioning from a two-test algorithm to a three-test algorithm.
This approach involves employing three distinct test kits in a specific sequence to ensure accurate HIV diagnosis, signifying a significant stride in enhancing diagnostic precision crucial to Kenya’s HIV/AIDS response efforts.
The decision to adopt the three-test algorithm follows a legal dispute involving a Chinese company, Guangzhou Wondfo Biotech Co Ltd, which alleged that the Kenyan government unfairly classified its HIV testing kits as substandard.
The company asserted that this classification disadvantaged them, resulting in the loss of a bid to supply the country with new testing materials.

Additionally, the company accused the winning bidder of producing inferior kits, raising concerns about potential inaccuracies due to inefficiencies.
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Responding to the lawsuit, Director General of Health, Dr. Patrick Amoth, clarified that the company was aware of its kits being categorized under Assay 2 (A2), denoting their specificity and sensitivity levels for detecting HIV status.
Kenya faces a substantial HIV epidemic, ranking seventh globally, with approximately 1.4 million people living with HIV (PLHIV) as of December 2023. Over 1.3 million PLHIV were undergoing treatment at various facilities nationwide.
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The Ministry highlighted that more than 8 million HIV tests are conducted annually across diverse populations and settings, underscoring the standardized approach maintained across over 8,800 testing sites operated by public, private, and faith-based organizations throughout Kenya.
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