A health worker analyses blood samples collected from people living with HIV/Aids. PHOTO/FILE
Nearly five months after the Ministry of Health announced a shift to a new three-test HIV testing algorithm, implementation remains stalled, raising concerns among health workers, suppliers, and other stakeholders. The algorithm outlines a specific sequence of rapid diagnostic tests (RDTs) used to confirm HIV infection with greater accuracy.
In a circular issued in November 2024, the ministry endorsed the new system in line with the World Health Organisation’s 2019 guidance, which recommends three consecutive RDTs to minimise misdiagnosis, improve accuracy, and cut testing costs for sustainable HIV response. This decision followed a 2023 evaluation of available HIV test kits by the Uganda Virus Research Institute (UVRI), supported by the Global Fund. Based on the findings, the ministry selected Wondfo One Step HIV 1/2 as the first test (A1), followed by One Step Anti-HIV (A2), and MeriScreen HIV 1/2 (A3). All three had shown strong performance in UVRI’s assessment.
Shift in manufacturers
The revised algorithm also marks a departure from previously used test kits, which were predominantly American-made—Determine and SD Bioline (by Abbott Diagnostics), and Statpak (by Chembio Diagnostic Systems). The new selections come from Chinese and Indian firms: Guangzhou Wondfo Biotech Co. (China), InTec PRODUCTS, INC. (China), and Meril Diagnostics Pvt. Ltd. (India).
This change comes at a time when the United States, a major funder of Uganda’s HIV response, is undergoing a strategic realignment. While the US Embassy has pledged continued support, key implementing agencies such as USAID are being phased out. According to sources at the US Embassy in Kampala, essential USAID programmes will now fall under the State Department as per President Trump’s executive orders issued in January 2025.
Delays and frustrations
Despite high-level endorsement, the rollout of the new algorithm has stalled. In a letter addressed to the Minister of Health and seen by Daily Monitor, Guangzhou Wondfo Biotech expressed frustration over the lack of follow-through. “Nearly five months have passed without any formal follow-up guidance,” wrote Leon Lin, Wondfo’s General Manager.
“The procurement process has been put on hold without any clear explanation,” The letter, verified by the company’s Uganda office, stated that although the ministry approved the new algorithm, no orders for test kits have been placed. The firm offered logistical support and donations for training, similar to its past support for Uganda’s HIV self-testing programme, but cited poor communication and weak stakeholder engagement as persistent barriers.
Allegations of Conflict of Interest
Some insiders within the medical supply sector allege conflicts of interest among procurement officials, claiming that internal disputes are contributing to the delays. Ministry of Health officials, however, deny these claims.
Dr Robert Mutumba, the head of the Aids Control Programme, dismissed the allegations and attributed the delays to procedural requirements.
“The discussions with stakeholders are still ongoing. Government processes take time. When you are shifting to a new product, there is the old one already in the pipeline,” he said. Health Minister Dr Jane Ruth Aceng also emphasised Uganda’s autonomy in making decisions. “As you know, the government of Uganda is sovereign, and it is free to take its decision as to when and what it wants, so nobody should force us into doing anything,” she told Daily Monitor.
Lack of Timelines and Updates
The November circular from Dr Henry Mwebesa, the Director General of Health Services, instructed hospital administrators and district health officers to oversee implementation, but it did not provide timelines or procurement updates. The WHO’s three-test algorithm is considered critical in Uganda, where accurate diagnosis is key to early treatment and prevention.
Misdiagnosis risks both public trust and effective intervention. With the country aiming to control HIV by 2030, stakeholders are calling for urgency. Prof Pontiano Kaleebu, the UVRI director, highlighted the need for the shift in his April 2024 report: “This evaluation was necessary because the current national algorithm was recommended in 2016—more than seven years ago. Several new HIV RDTs have since been developed that may offer better performance, lower cost, and easier use,” the report states. He noted that modern RDTs exceed 99 percent in sensitivity and specificity, are simpler to administer, and require no specialised equipment or technical expertise.
Competing interests
Complicating matters further, the ministry has also proposed a second national HIV testing algorithm in line with the “Buy Uganda, Build Uganda” (BUBU) policy, aimed at promoting local manufacturing.
The November circular directed UVRI to fast-track development of this locally oriented algorithm, though no details or deadlines have been communicated—leaving health workers uncertain about what to implement. How the kits were evaluated According to UVRI, the evaluation process began with a public call for suppliers to submit a minimum of 2,500 kits for laboratory testing. Fifteen RDTs were assessed during the first phase. Tests were evaluated for use in both professional settings and self-testing contexts, and suppliers were asked to provide unit prices. Field technicians and lab staff received two days of training on the kits using materials based on the manufacturer’s instructions.
In line with WHO guidelines, UVRI used a two-phase evaluation. Kits achieving 100 percent sensitivity and specificity in the laboratory phase were categorised as A1. Those with specificity ≥99.5 percent were classified as A2 or A3. Stakeholders later recommended Wondfo, Colloidal, and Trinscreen for A1. Abbott Bioline, Meriscreen, One Step, and StandardQ were categorized as A2/A3. While Wondfo was favored for its performance and cost, Trinscreen showed lower sensitivity during field testing (97.9%).
“In case of supply disruptions, the HIV (1+2) Antibody (Colloidal Gold) V2 may serve as a backup for A1, followed by Trinscreen,” UVRI recommended. “For A2 and A3, One Step Anti-HIV (1&2) and Meriscreen are recommended, with Abbott Bioline as a backup.”
While Uganda’s shift to a more accurate and cost-effective HIV testing approach holds promise, the continued delay in implementation, amid allegations of procurement conflicts, unclear timelines, and competing policy priorities, puts this progress at risk.
Background
Uganda continues to face a significant HIV burden, with
approximately 730 new infections recorded every week, amounting to over 37,000 new infections annually. As of 2024, an estimated 1.5 million people are living with HIV, based on figures from the Uganda Aids Commission (UAC). However, the country has made notable progress in reducing HIV prevalence, which stood at 7.2% in 2010 and has since declined to 5.1 percent in 2024. This downward trend reflects the impact of sustained prevention, treatment and awareness efforts supported by the Ugandan government, civil society, and development partners.
Testing remains the entry point to HIV care. Without knowing one’s status, individuals cannot access life-saving treatment or take steps to prevent transmission.
Therefore, improving accuracy, availability, and uptake of testing is crucial—especially among key populations such as sex workers, men who have sex with men, and adolescents, where prevalence rates and barriers to care remain high.
