NAFDAC warns of fake, unapproved HIV test kits in Nigeria

Business, Health

Abuja, Nigeria (NPA) — March 6, 2026 — The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert regarding counterfeit and unapproved versions of the VISITECT HIV Advanced Disease Test Kits circulating in Nigeria.

In Public Alert No. 011/2026, the agency cautioned healthcare providers, patients, and the general public about reports of falsified and parallel-imported, unregistered versions of the kits being sold through unauthorized channels.

According to NAFDAC, the Marketing Authorisation Holder (MAH), EURO SPECS International Nigeria Limited, confirmed the existence of these counterfeit products.

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The VISITECT CD4 Advanced Disease assay is a rapid, instrument-free lateral flow test designed to identify patients with severe HIV (CD4 count < 200 cells/µL) within 40 minutes using blood samples. It is considered a vital diagnostic tool in resource-limited settings, enabling timely triage for patients requiring advanced care.

NAFDAC noted a key discrepancy in the counterfeit kits: the fake product labels display a three-year shelf life (2024-08 to 2027-01), whereas the agency has only approved an 18-month shelf life for the genuine product.

Healthcare professionals are urged to:

• Review stocks in hospitals, clinics, and pharmacies.
• Report suspected falsified or compromised products to the nearest NAFDAC office.
• Call 0800-162-3322 or email sf.alert@nafdac.gov.ng for immediate reporting.