FA info icon.svg Angle down icon.svg Medical equipment data
Health topic HIV/AIDS
Health classification Diagnosis
FA info icon.svg Angle down icon.svg Project data
Location Wicklow, Ireland
Status Commercialized
OKH Manifest Download

Problem being addressed[edit | edit source]

HIV/AIDS is an extreme health threat in much of the developing world. To diagnose HIV, blood samples are often required to be sent to a central laboratory to be processed, which is time-consuming and costly.

Detailed description of the solution[edit | edit source]

The Uni-Gold HIV rapid HIV test is a rapid diagnostic test that enables HIV to be diagnosed at the point of care. During testing, plasma or whole blood is applied to the sample port, and antibodies specific to the recombinant HIV-1 or HIV-2 proteins will react with the colloidal gold-linked antigens. A positive reaction is visualized by a pink/red band in the test region of the device. A negative reaction occurs in the absence of human immunoglobulin antibodies and results in no visually detectable band develops in the test region of the device.

Designed by[edit | edit source]

  • Designed by: TRINITY BIOTECH PLC, IDA Business Park, Bray, Co Wicklow, Ireland. The company's website is found here.
  • Manufacturer location: Ireland and the United States

Externally generated reports[edit | edit source]

A PDF of instructions on how to use the device is found here.

Approval by regulatory bodies or standards boards[edit | edit source]

This device was approved by the FDA in 2003. The CDC Report can be found here.

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Part of Global Health Medical Device Compendium
SDG SDG03 Good health and well-being, SDG09 Industry innovation and infrastructure
Authors Eva Shiu
License CC-BY-SA-3.0
Language English (en)
Translations Spanish
Related 1 subpages, 3 pages link here
Impact 775 page views
Created January 26, 2012 by Eva Shiu
Modified November 28, 2022 by Irene Delgado
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