Trials of 7-Minute AIDS Test to Begin

Disease Detection International Inc. of Irvine said Tuesday that it will begin clinical trials of a seven-minute AIDS test under U.S. Food and Drug Administration regulations.

Schiff & Co.--a consultant in West Caldwell, N.J., that specializes in pharmaceutical and diagnostic regulations--will conduct the clinical studies and FDA submissions of the device, called SeroCard(R) HIV-1. Testing will require three to five months.

SeroCard(R) HIV-1 can allegedly detect the presence of antibodies to the AIDS virus and has received scientific and regulatory approval in Thailand, Mexico and Sweden. DDI said that studies in those countries indicated that the device has a sensitivity of 99.7% and a specificity of 99.8%.

Morris said the patented device has been licensed exclusively to Trinity Biotech PLC in Ireland.