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Uni-Gold HIV

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This Global Health Medical Device is designed for or implemented within resource-limited settings - Browse the devices - Add a device

Health Topic HIV/AIDS
Classification Diagnosis
Scope Commercialized
Location Africa, Asia, South America

Problem being addressed[edit]

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]

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]

  • 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]

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

Approval by regulatory bodies or standards boards[edit]

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