HIV Test Produces Results in 10 Minutes

The test has been cleared by the U.S. Food and Drug Administration (FDA).

Conventional laboratory tests for HIV may not produce results for hours or even days. The FDA approval was based on the results of a clinical trial involving more than 9,000 patient specimens, where the test demonstrated a sensitivity of 100% and a specificity of more than 99.7%. Called Uni-Gold Recombigen, the test was developed by Trinity Biotech plc (Dublin, Ireland).

There is a huge market for such a test. As Trinity Biotech notes, about 800,000 needle-stick injuries occur in hospitals in the United States alone every year, requiring an immediate serum/plasma HIV test. Moreover, at least 200,000 at-risk pregnant women present at U.S. hospitals each year and require a rapid HIV test. No other rapid test with a serum or plasma claim has been approved, according to Trinity Biotech.

"Experience in CDC (Centers for Disease Control, Atlanta, GA, USA) programs has shown that up to 40% of those tested for HIV using conventional lab-based tests will not return for their results. The rapid test allows for on-the-spot results that can increase the diagnosis of infected people,” said Brendan Farrell, president of Trinity Biotech.




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