Trinity Biotech has approached US drug regulators seeking clearance for an over the counter (OTC) sale of the company's UniGold HIV test.
Trinity will attend a meeting of the Blood Products Advisory Committee (BPAC) of the Federal Drug Administration in Washington tomorrow and will present its position on home testing for HIV.
Trinity Biotech's president, Brendan Farrell, said: "We believe the time is now right for the home use of rapid HIV tests. Approximately 1.3 million Americans are infected with HIV, and it is estimated that 300,000 of these people are unaware of their status."
He said 40,000 new infections are occurring annually in the United States and traditional test methods have not slowed the rate of new infections.
Trinity's existing UniGold HIV test is already approved for hospitals, reference laboratories, physicians' offices and STD clinics.
The approval for OTC uses would allow individuals to purchase the UniGold test in a chemist and test their own blood samples for HIV in of their own homes. Within ten minutes the result can be read.
In clinical trials on 9,000 patient samples, Trinity's UniGold device had a sensitivity (ability to detect a true positive) of 100 per cent and a specificity (ability to detect a true negative) of 99.7 per cent.