UNITED STATES: FDA Approves Rapid HIV Test

Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.

UNITED STATES: FDA Approves Rapid HIV Test

Wall Street Journal (12.30.03) - Tuesday, December 30, 2003
Otesa Middleton

Dublin-based Trinity Biotech PLC announced that the US Food and Drug Administration has approved its 10-minute HIV test, the Uni-Gold Recombigen HIV Test. It is the first rapid-test product approved for testing blood serum, plasma and whole blood.

Company President Brendan Farrell said the test "is every bit as accurate as lab-based tests." The test requires one drop of whole blood, serum or plasma; in trials of 9,000 patients, Trinity's test detected 100 percent of HIV-positive specimens and was 99.7 percent accurate on negative samples.

Trinity plans to market the test to hospitals, physicians and government programs for quick testing of health workers who accidentally prick themselves with used needles. The firm expects to sell 400,000-500,000 tests in the United States in 2004. The tests cost $10 each. Uni-Gold is approved for use in the World Health Organization's HIV testing program in Africa, and is also sold in Asia.

Uni-Gold will compete directly with OraSure Technologies Inc.'s OraQuick Rapid HIV-1 test, approved in Nov. 2002. That test takes 20 minutes and only works on whole blood.

Trinity plans to target the roughly 200,000 pregnant women considered at risk for mother-to-child transmission of HIV. It will also market to CDC's programs, which Farrell estimates to be a $30 million potential market.
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