The Ministry of Health (MoH) has dispelled reports of poor-quality HIV testing kits in the country. 

In a statement released on Monday May 27, the Principal Secretary for Medical Services Harry Kimtai noted that these claims are untrue and that the gains made in the nation’s HIV response will not be rolled back due to misinformation. 

“The Ministry of Health is deeply concerned about claims of poor quality of HIV testing services in the country. It is important that the gains made in the response to HIV are not rolled back due to misinformation,” read the statement in part.

Kimtai emphasized that the routine quality assurance proficiency tests carried out by the ministry play a major role in monitoring and safeguarding the quality of HIV testing services across Kenya. 

“The MOH’s routine capacity-building efforts, the independent pharmacovigilance system under the Pharmacy and Poisons Board (PPB), and the robust quality assurance proficiency testing routinely monitor and safeguard the quality of HIV testing in Kenya,” stated the Health PS.

“The WHO also supports member countries in global pharmacovigilance. There is no advisory on poor quality of HIV testing services in Kenya.”

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Additionally, he assured Kenyans of the Ministry’s unwavering commitment to ensuring access to the highest-quality health services and urged all citizens to continue seeking HIV testing at facilities nationwide. 

Adherence with WHO Standards

The PS noted that in 2019, the World Health Organization (WHO) recommended using a three-test algorithm in HIV diagnosis for all countries, which Kenya has adopted.

He also revealed that Kenya was among the first 10 countries transitioning from a two-test algorithm to a three-test algorithm for accurate HIV diagnosis. 

“Following a stringent process for adopting the WHO protocol to the country by a multi-stakeholder Task Force, Kenya is among the first ten countries transitioning to the three-test algorithm for HIV diagnosis.”

“The three-test algorithm marks a pivotal advancement in diagnostic accuracy, which is critical in Kenya, fight against HIV and AIDS, underscoring the MOH’s dedication to the health and well-being of all citizens,” said Kimtai.

Chinese Firm Sues the Government Over Testing Kits

This response from the MOH comes after a Chinese company, Guangzhou Wondfo Biotech Co Ltd, allegedly sued the government for classifying its HIV testing kits as substandard. 

The company claimed that it was wrongfully reclassified, something they say cost them a bid to supply a new set of testing materials the country is adopting. 

The firm also alleged that the company that won the tender to supply the kits made substandard ones, potentially leading to testing inaccuracies. 

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Kenya’s HIV Statistics

According to the MoH, Kenya has the 7th largest HIV epidemic in the world, with an estimated 1.4 million people living with HIV (PLHIV). 

As of the end of December 2023, 1,336,234 PLHIV were receiving treatment at 3,752 facilities across the country. 

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.

The PS attributed this progress to consistent policy guidance by the ministry which aims to support and ensure accurate and safe HIV testing, comprehensive care and prevention services for all Kenyans.

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