A ten-minute HIV test was approved by the FDA yesterday, the fastest diagnostic tool for HIV ever to be approved for the United States market. The announcement was made by Trinity Biotech, the Irish firm that will market the test under the name Uni-Gold Recombige HIV.
Unfortunately, it won't change much for the adult industry - the test works by detecting antibodies to HIV in human serum, plasma or whole blood.
Antibodies for HIV can take six week to six months to develop, not nearly fast enough to be considered an effective tool for monitoring adult industry talent.
The benefits to the general population are potentially enormous. 40 percent of those tested for HIV using conventional lab based tests will not return for their results – results that could have stopped them from spreading HIV further.
The rapid test allows for on-the-spot results that can increase the diagnosis of infected people – the doctor doesn’t need to send the test to a lab, he can check the results himself.
The company pointed to the no-shows for test results, needle injuries by hospital workers, and women giving birth a people who would need a fast test result.
"Rapid HIV testing in doctor's offices throughout the US is a new market which, while difficult to quantify, will clearly be significant. Trinity is distributing Uni-Gold HIV to this market through a range of distributors," Ronan O'Caoimh, CEO of Trinity Biotech said.
The Trinity product will compete directly with OraSure Technologies Inc.'s OraQuick Rapid HIV-1 test that was approved in November 2002. That test takes twenty minutes and can only be used on whole blood.
The product was approved on the basis of clinical trial results on over 9,000 patient specimens where the product demonstrated a test sensitivity of 100 percent and a specificity of over 99.7 percent; meaning the test always accurately identified HIV in samples known the carry the virus and almost always identified negative results accurately in samples known not to carry the virus.
According to Trinity Biotech, the test has been used extensively in Africa for the last year.
Trinity Biotech’s stock rose 57 percent yesterday on the strength of the announcement.
