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PQDx 0149-052-00 WHO PQ Public Report December 2018, version 8.0
WHO Prequalification of In Vitro Diagnostics Programme
Product: Uni-Gold HIV
Number: PQDx 0149-052-00
Uni-Gold HIV with product codes 1206502, 1206502N, 1206502E, 1206502N-100
manufactured by Trinity Biotech Manufacturing Ltd., rest of the world regulatory version, was
accepted for the WHO list of prequalified diagnostics and was listed on 20 December 2012. This
public report was updated on 28 February 2017, 26 July 2017, 06 November 2017, and 20
December 2018 to reflect recent changes.
Summary of WHO prequalification assessment for Uni-Gold HIV
PQ public report amended
20 December 2018
03 November 2017
26 July 2017
28 February 2017
12 August 2016
20 December 2012
03 December 2012
Site inspection(s) of quality
18-20 July 2016 (Supplier)
11-14 September 2012 (Supplier)
29-31 August 2012 (Ireland)
Laboratory evaluation of performance
and operational characteristics
17 December 2012
MR: Meets Requirements
Uni-Gold HIV is a single use rapid immunoassay, for the qualitative detection of antibodies to
HIV-1 and HIV-2 in serum, plasma and whole blood (venous and fingerstick). Uni-Gold HIV is
intended for use in point of care settings as an aid in diagnosis of HIV-1 and HIV-2 infection.
Uni-Gold HIV is a rapid immunoassay based on the immunochromatographic sandwich
principle. Recombinant proteins representing the immunodominant regions of the envelope
proteins of HIV-1 and HIV-2, glycoprotein gp41, gp120 (HIV-1) and glycoprotein gp36 (HIV-2)
respectively, are immobilized at the test region of the nitrocellulose strip. These proteins are
also linked to colloidal gold and impregnated below the test region of the device. A narrow band
of the nitrocellulose membrane is also sensitized as a control region.