Unhealthy Choice: Susan Nakhumicha’s HIV Testing Kits Put Lives At Risk

Guangzhou Wondfo Biotech Co Ltd has sued Health Cabinet Secretary Susan Nakhumicha for allegedly wrongfully reclassifying their HIV testing kit to its disadvantage.

In court papers, the company said that it lost a bid to supply a new set of testing materials which the country is adopting.

The firm also alleges that the company which won the tender to supply the kits made substandard ones, and this could lead to inaccuracies because “the kits are inefficient”.

The government, however, denies the accusations, saying the country is moving from a two-test algorithm to a three-test algorithm as advised by the World Health Organization (WHO).

The State says the recommendation is critical to ensure accurate diagnosis of the virus so as to prevent transmission by correctly identifying those who have it and those who do not have it for appropriate interventions.

Screening test

The higher the reactive tests to diagnose HIV, which is scientifically referred to as algorithm, the higher the accuracy of the result.

The Ministry of Health says that this evolution is important considering that the prevalence of HIV adjusted to treatment functions and the positivity of the screening test at national level continues to diminish with time.

The aim is to ensure the screening strategy has a positive predictive value of positive of 99 percent (less than one false negative for every 100 true positive and less than two false positives for every 100 true negatives).

Based on their specificity and sensitivity, the Chinese firm says, testing kits are categorised as either Assay1 (A1), Assay2 (A2) or Assay3 (A3) in that order.

“It is thus recommended that kits categorised as A1 ought to have the highest rates of specificity, while under category A1 and A2 sensitivity of the testing kit is given priority,” the firm says.

The biotech company told the court that the Health ministry, after downgrading its product, opted to go for much expensive but low quality testing kit compared to theirs which is the cheapest and of higher quality.

The court heard that some of the kits procured by the ministry are of inferior performance and they give both false positive and negative results.

HIV negative status

According to the Chinese firm, their expert view is based on specificity and sensitivity, arguing that the Health ministry is likely to jeopardise the lives of many Kenyans seeking HIV testing and diagnosis.

While specificity of a kit is useful to detect a HIV negative status, its sensitivity, the manufacturer explains, is useful to detect a HIV positive status.

The manufacturer, therefore, wants the court to intervene and stop the entire process.

Guangzhou Wondfo Biotech Co Ltd’s woes started in February this year when the Health ministry tasked the National AIDS and STI Control Programme (Nascop) to oversee the roll out and implementation of the transitioning to the new HIV testing kits.

The Technical Taskforce For the Adoption of the Three-Test HIV Testing Algorithm made the recommendation for the changes in its report.

“The procurement of the testing kits, now categorised as A1 under the new algorithm, which are less accurate as a result of their lower rates of specificity and sensitivity, will lead to cases of false negatives in the testing process being high thus exposing the public to increased infections based on wrong negative HIV diagnosis,” the Chinese firm says.

“The probability of false negatives cannot be downplayed as the kits are prone to err, making it even more dangerous for the community and the public in general as the falsely tested negative individual will go about spreading the HIV disease unaware,” added the firm.

Further, the China-based company told the High Court that the procurement of “lower quality yet much more expensive” HIV testing kits by the Health ministry began in mid-March and the government has been in contact with various manufacturers.

The Attorney-General, the firm says, contacted manufacturers with instructions to confirm their readiness to supply the kits in the various categories within specific timelines beginning from March 15.

Guangzhou Wondfo Biotech Co Ltd

An email to Guangzhou Wondfo Biotech Co Ltd from the Kenya Medical Supplies Authority (Kemsa), acting on CS Nakhumicha’s instructions, confirmed the intention to roll out the procurement process as part of the implementation of the large roll out plan of the scale up process.

The High Court was told that Ms Nakhumicha and the ministry executed a pilot study rollout of the kits in four counties namely; Mombasa, Garissa, Kiambu and Kisumu that was completed in February 2023.

But before the pilot study, the biotech company revealed that the CS, in an official letter, told the firm “as one of the manufacturers whose kits had been approved and recommended as first kit in the three-assay algorithm (A1), to offer monetary support in form of donations to the ministry to facilitate the pilot study at a budget estimated at Sh9 million”.

Towards the support of the intended piloting exercise, Guangzhou Wondfo Biotech Co Ltd said that it wired $25,000 (Sh3 million) to CS Nakhumicha as per the ministry’s request.

Acting Director-General of Health Dr Patrick Amoth told the High Court that when the ministry was communicating with the biotech company, it realised there was an error in the classification of the kits as A1 instead of A1/A3 but was corrected.

He told Justice Chacha Mwita that the approved research protocol does not require countries to invite manufacturers to defend their product as this would amount to solicitation.

Dr Amoth wants the case dismissed, claiming that it is driven by commercial interests rather than public good.