WHO was informed that at least 8,240 falsified rapid diagnostic tests to detect HIV-1/2 have been distributed in Guyana at end-user level. The product is Uni-Gold™ HIV and claims to be manufactured by
Trinity Biotech plc. Subsequent reports revealed that the same falsified product is also circulating in Kenya.
Uni-Gold™ HIV is a single-use rapid diagnostic test – an immunoassay for the qualitative detection of antibodies to HIV-1 and HIV-2 in serum, plasma and whole blood. Uni-Gold™ HIV is intended for use in point of care settings as an aid in diagnosis of HIV-1 and HIV-2 infection.
The WHO testing strategy recommends three HIV reactive test results to confirm an HIV-positive status in a patient. The use of this falsified Uni-Gold™ HIV, subject of WHO medical product alert n°2 of 2020, is likely to lead to delayed diagnosis of HIV status.
Consumers are advised not to use these falsified test kits with lot number HIV7120026.
Details of the falsified product Uni-Gold™ HIV:
The packaging of this falsified HIV test kit is in English.
The genuine manufacturer (Trinity Biotech plc) has confirmed that:
- They did not manufacture the falsified product.
- Genuine lot HIV7120026 was made by Trinity Biotech plc and expired in 2019.
- The expiry date is incorrect and does not correspond with their batch manufacturing records.
Falsified HIV test kit with incorrect indication and expiry date:
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