Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has issued a nationwide warning over the circulation of counterfeit HIV diagnostic test kits in the country, cautioning healthcare providers, laboratories, distributors, and the general public about the potential health risks associated with the falsified products.
The alert, issued as Public Alert No. 011/2026, specifically concerns counterfeit and parallel-imported versions of the VISITECT HIV Advanced Disease Test Kits that have been identified within Nigeria’s medical supply chain.
According to the regulatory agency, these unregistered products are being distributed through unauthorized channels and may already be present in some health facilities or medical stores.
Nairametrics The VISITECT CD4 Advanced Disease assay is a rapid diagnostic device designed to detect advanced HIV infection by measuring low CD4 cell levels in blood samples.
The test is widely used in resource-limited healthcare settings because it does not require laboratory equipment and can deliver results in about 40 minutes, helping clinicians quickly identify patients who require urgent treatment and advanced care.
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NAFDAC explained that the presence of falsified or unregistered medical devices poses significant risks to public health because such products have not undergone regulatory evaluation for safety, quality, or effectiveness.
The agency warned that inaccurate diagnostic kits could lead to false results, either falsely indicating infection or missing actual cases of HIV, which may delay treatment, expose patients to unnecessary medication, or create a false sense of security.
The regulatory authority also highlighted key differences between the genuine product and the counterfeit versions discovered in circulation.
The authentic VISITECT HIV Advanced Disease test kit is manufactured by AccuBio Ltd in Scotland and marketed in Nigeria by Euro Specs International Nigeria Limited, carrying the NAFDAC registration number A3-100-153.
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In contrast, the counterfeit version lists Omega Diagnostics Ltd in Scotland as the manufacturer, carries no NAFDAC registration number, and indicates a shelf life of three years, which differs from the 18-month shelf life approved for the registered product.
Following the discovery, NAFDAC directed its zonal directors and state coordinators across the country to intensify surveillance and immediately remove any counterfeit or unregistered versions of the test kits from circulation.
Healthcare providers and medical laboratory operators were instructed to check their inventory and discontinue the use or distribution of any suspicious products.
The agency further urged distributors, retailers, and healthcare professionals to procure medical devices only from authorized suppliers and to verify the registration status of diagnostic products before use.
Members of the public and medical practitioners were also encouraged to report suspected falsified medical products to the nearest NAFDAC office to support regulatory enforcement and protect the integrity of Nigeria’s healthcare system.
Health authorities emphasize that accurate HIV diagnosis remains a critical component of Nigeria’s public health strategy, as early detection enables timely treatment and reduces the risk of further transmission.
The circulation of counterfeit diagnostic kits therefore threatens ongoing efforts to control HIV and ensure reliable medical testing across the country.
Source: Nairametrics
