E-DRUG: Falsified HIV rapid diagnostic test circulating in the WHO regions of the Americas and Africa
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https://www.who.int/news-room/detail/27-03-2020-medical-product-alert-n-2-2020
Medical Product Alert N°2/2020Falsified HIV rapid diagnostic test
circulating in the WHO regions of the Americas and Africa
27 March 2020 News release Geneva
french
<https://www.who.int/news-room/detail/27-03-2020-medical-product-alert-n-2-2020>
-
Spanish
<https://www.who.int/news-room/detail/27-03-2020-medical-product-alert-n-2-2020>
This Medical Product Alert relates to a confirmed falsified human
immunodeficiency virus (HIV) in vitro diagnostic medical device (IVD) that
has been identified circulating in Guyana and Kenya.
Through its Global Surveillance and Monitoring System (GSMS)
<https://www.who.int/medicines/regulation/ssffc/surveillance/en/>
for substandard/falsified medical products, 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-Goldâ„- HIV and claims to be manufactured by
Trinity Biotech plc. Subsequent reports revealed that the same falsified
product is also circulating in Kenya.
Uni-Goldâ„- 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-Goldâ - 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
<https://apps.who.int/iris/rest/bitstreams/1261990/retrieve>
recommends three HIV reactive test results to confirm an HIV-positive status in a
patient. The use of this falsified Uni-Goldâ„¢ HIV, subject of WHO medical
product alert n°2 of 2020, is likely to lead to delayed diagnosis of HIV
status.
Table 1: Specific details of the falsified product Uni-Goldâ„¢ HIV, subject
of WHO Medical Product Alert n°2 of 2020
Product Name Uni-Goldâ„¢ HIV
Lot Number HIV7120026
Expiry Date 5 DEC 2020
Stated manufacturer Trinity Biotech
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 in Table 1.
- 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.
Photographs and advice to the public are available.
*Figure 1 [image: Falsified UniGold HIV Images 1 and 2 Alert]
*Figure 2 [image: Falsified UniGold HIV Image 3 Alert]
Advice on action to be taken by end-users
- Please check to see if any Uni-Goldâ„¢ HIV test kits in your facility
have lot number HIV7120026.
- If you are in possession of these falsified test kits with lot number
HIV7120026:
1. Please do not use.
2. Please immediately contact the organization that supplied you with
the product (either your HIV testing programme, nongovernmental
organization or local distributor).
3. Please contact Trinity Biotech plc
Phone : +353 1 276 9800
E-mail : hiv@trinitybiotech.com
1. Please contact your national health authorities
All medical products must be obtained from authentic and reliable sources.
Their authenticity and condition should be carefully checked.
Advice on action to be taken by national health authorities:
WHO requests increased scrutiny within the supply chains of all countries,
particularly at testing sites (health facilities, community-based),
clinical laboratories, medical stores/warehouses, and at the facilities of
relevant economic operators (agents, authorized representatives,
distributors, wholesalers, etc.).
If these falsified test kits with lot number HIV7120026 are discovered,
please do not use.
National health authorities are asked to immediately inform WHO, if these
falsified products are discovered in their country using the WHO IVD
complaint form.
<https://www.who.int/diagnostics_laboratory/postmarket/150804_pms_guidance_annex3.docx>
If you have any information concerning the manufacture, distribution, or
supply of this product, please contact rapidalert@who.int
WHO Global Surveillance and Monitoring System for Substandard and
Falsified Medical Products
For further information, please visit our website:
https://www.who.int/medicines/regulation/ssffc/en/
Bruneton Carinne E-Med
<carinne.bruneton@gmail.com>