NAFDAC Issues Alert on Faulty HIV Test Kits: Abbott’s m-PIMA HIV-1/2 VL

In a recent public advisory, the National Agency for Food and Drug Administration and Control (NAFDAC) has raised concerns about the performance of Abbott’s m-PIMA HIV-1/2 VL test kits. These kits, designed for HIV detection, have reportedly failed to meet performance claims for specific HIV-1 groups, posing potential risks to patient health.

The revelation came to light through Abbott’s internal stability monitoring programme, prompting NAFDAC to issue a cautionary statement to healthcare providers. According to NAFDAC, the affected test kits failed to meet performance standards for HIV-1 groups O and HIV-1 group M and N throughout their claimed shelf life. It’s worth noting that the performance for HIV-2 remains unaffected.

Abbott has initiated an investigation to identify the root cause of this issue and will implement corrective actions to prevent similar incidents in the future. Rigorous statistical analysis was employed to pinpoint the impacted lots, ensuring a targeted response.

The m-PIMA HIV-1/2 VL cartridge, categorized as a point-of-care nucleic acid test (NAT), utilizes Polymerase Chain Reaction (PCR) technology to directly quantify HIV type 1 groups M/N and O, along with HIV type 2 RNA in human plasma samples. NAFDAC has underscored the potential consequences of inaccurate results for patients belonging to the affected HIV-1 groups, including delayed follow-up, improper treatment adjustments, progression of infection, and deterioration of patient health.

Details of Affected Product:

• Product Name: m-PIMA HIV-1/2 VL
• Manufacturer: Abbott Rapid Diagnostics Jena GmbH
• FSCA-Identifier: FCA-00000264
• SRN (Single Registration Number): DE-MF-000025986
• Impacted Reference Numbers (Catalogue Numbers): 270150050, 27015W50
• Impacted Lot Numbers: 08634, 08638, 08653, 08675, 08676, 08681, 08685, 08705, 08766, 08767, 08778, 08799, 08901, 08925, 08931
• Basic-UDI-DI (BUDI): 4051892HIV0002JH

NAFDAC has called upon healthcare professionals and consumers to remain vigilant, urging them to report any suspicions of adverse reactions, substandard or falsified medicines, diagnostic devices, and other regulated products to the nearest NAFDAC office. The agency’s proactive stance aims to ensure public safety and prompt intervention in the face of potential health risks associated with faulty medical products.