NAFDAC RAISES ALARM OVER FAKE VISITECT HIV TEST KITS IN NIGERIA

By Prince Uwalaka Chimaroke
5- MAR- 2026

Nigeria’s foremost drug regulatory body, the National Agency for Food and Drug Administration and Control (NAFDAC), has issued a public safety warning concerning the circulation of counterfeit and illegally imported versions of the VISITECT HIV Advanced Disease Test Kits within the country.

In a Public Alert tagged No. 011/2026, the agency cautioned healthcare professionals, patients, and the general public to remain vigilant following reports that fake and unregistered variants of the diagnostic kits are being distributed through unauthorised channels. According to the regulatory authority, the Marketing Authorisation Holder for the product, EURO SPECS International Nigeria Limited, confirmed the presence of these counterfeit or parallel-imported versions currently making their way into the Nigerian market.

The VISITECT CD4 Advanced Disease assay is a rapid diagnostic device designed to detect severe HIV infection by identifying patients with critically low CD4 levels—below 200 cells per microlitre of blood. The test is particularly valuable in low-resource medical environments because it delivers results within approximately 40 minutes without the need for complex laboratory instruments, thereby enabling healthcare workers to quickly identify patients who require urgent advanced medical care.

However, NAFDAC revealed that the fake products currently in circulation bear misleading labeling information. Notably, the counterfeit kits reportedly display a shelf-life of three years, marked from August 2024 to January 2027, whereas the officially approved shelf-life by the agency is only eighteen months. This discrepancy has raised serious concerns regarding the authenticity, safety, and reliability of the falsified products.

In light of the development, NAFDAC has urged hospitals, clinics, pharmacies, and other healthcare facilities across the country to immediately audit their medical inventories and verify the authenticity of any VISITECT HIV Advanced Disease Test Kits in their possession.

The agency further encouraged healthcare providers and members of the public to promptly report any suspected counterfeit or compromised medicines and medical devices to the nearest NAFDAC office. Reports can also be made through the agency’s dedicated hotline or via email to ensure swift regulatory action against those responsible for distributing the fake products.

NAFDAC reiterated its commitment to safeguarding public health and warned that strict enforcement measures will continue against individuals and organisations found culpable in the manufacture, importation, or distribution of counterfeit medical products in Nigeria.