Ministry to roll out new HIV testing strategy next month

 Blood sample positive with HIV. [iStockphoto]

The debate on the quality and state of HIV/AIDS testing kits procured by the government is getting even more wriggly.

The Ministry of Health now says it has not received an advisory from the World Health Organisation (WHO) on the HIV kits to be adopted for use in Kenya.

AIDS and STI Control Programme (NASCOP) Chief Executive Officer Rose Wafula has reassured Kenyans that the kits are WHO pre-qualified.

This is despite Kitutu Chache South MP Antony Kibagendi raising an alarm over the failure by the ministry to apply WHO standards while conducting suitability tests regarding the transition of the HIV testing algorithm (method).

Kibagendi, who is a member of the National Assembly Health Committee, also accused the ministry of failing to conduct proper background checks on one of the companies expected to supply the kits, adding that the company previously reported falsified diagnostic test results in some countries.

In a circular dated August 22, 2023, Kenya was set to implement a new testing algorithm.

The algorithm mandated by the ministry requires specific three-test algorithms for both general and pregnant women (antenatal population), with a target for site-level implementation, overseen by NASCOP.

Kenya has been using a two-test algorithm for over 15 years.

The strategy had, however, been generating problems with some kits producing contradicting results.

Following WHO recommendations, Kenya started a process of adopting three testing algorithms in 2022.

In an interview, Dr Wafula told The Standard that when Kenya was embracing the new strategy, a task force, consisting of WHO representatives through the ministry, reported to WHO.

The global health institution did not raise any issue with the kits.

“When we were developing the algorithm, we filed five reports to WHO and organisation 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," Wafula said.

If there was indeed any serious issue with the testing kits, she opined, WHO would have recalled the product from the market.

Wafula said the product could have been flagged by the Pharmaceutical and Poisons Board (PPB), which vets all medical supplies in the country if there were any issues.

“I can say today the product is still on. When there is a serious issue of public health in Kenya, it causes deregistration. We withdraw the product from the market. This is a global practice because public health is important. As we speak, I have no advisory on the kits," she added.

The NASCOP CEO said a lot of global and regional collaboration and alignment in public health takes place during the introduction of a new health product, akin to what went into malaria, TB and HIV programmes.

The ministry, with support from the US President’s Emergency Plan for AIDS Relief (PEPFAR) and Global Fund, is in the process of acquiring the kits.

The Kenyan government is also co-funding the procurement of the kits, expected to be fully rolled out in July.

 “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. The process of transitioning from a two-test to a three-test algorithm takes time and evidence review,””, Wafula said.

Adoption of the testing method, she said, is the best practice in the fight against HIV/AIDS.

Kenya is among ten countries in Africa that are ready for the three-test strategy for HIV/AIDS.

Public Health Principal Secretary Harry Kimtai said the supply of the kits was through a direct tender, as opposed to an open tendering process.

“Procurement of the HIV testing kits tender was not like any other tender. It was a thorough exercise that involved WHO-set protocols,” Kimtai said.

Eight companies applied for the tender, including BioLytical Laboratories, Inc, Abbott Diagnostics Medical Company, Trinity Biotech Manufacturing, Abbott Diagnostic Korea, SD Biosensor Inc, Chembio Diagnostic Systems Inc, Premier Medical Corporation Private Limited and Guangzhou Wondfo Biotech Co, Ltd.

Out of the eight, only three -Trinity Biotech Manufacturing Ltd, SD Biosensor Inc and Guangzhou Wondfo Biotech Co, qualified.