US FDA approves 10-minute HIV test

Main Category: HIV / AIDS
Article Date: 31 Dec 2003 - 0:00 PDT


A 10-minute HIV test will soon be available in the US following regulatory approval.

Dublin, Ireland-based Trinity Biotech says that the US Food and Drug Administration has approved its Uni-Gold Recombigen HIV test, which company president Brendan Farrell says addresses a significant need.

The test is currently available in Africa and Asia.

Trinity expects to sell up to 500,000 units in the US in 2004.

Near perfect accuracy

The test requires just one drop of whole blood, serum or plasma.

In more than 9,000 trials, it detected 100% of HIV-positive samples and was accurate for 99.7% of HIV-negative samples.

Trinity plans to sell the test to doctors and hospitals to rapidly check health workers who prick their fingers with needles that may be infected with HIV-positive blood.

Quick administration of anti-HIV drugs can reduce chances of infection, but traditional lab tests can take days or weeks to return a diagnosis.

A competing product made by Bethlehem, Pennsylvania-based OraSure Technologies uses whole blood and takes 20 minutes to return a result.

Trinity plans to sell its test for US$10

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