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.

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.