A panel of experts recommended the Food and Drug Administration reject an application to market the nation's first home blood-collection kit for AIDS antibody testing. Such recommendations usually prevail.
The FDA's Blood Products Advisory Committee on Wednesday voted 3-1 against approval of the proposal by University Hospital Laboratories Corp. of Bethesda.
With the company's test kit, an individual would draw a drop of blood, blot it on filter paper, and send the sample anonymously to a laboratory where it would be tested. The individual would telephone and give a code number to get the results.
Panel members said they were concerned about the safety of people drawing their own blood and the validity of tests obtained through this system, said Jay S. Epstein of the FDA's Center for Biologics Evaluation and Research.
The experts also were concerned about the adequacy of phone counseling for those who test positive.
The FDA began accepting applications for AIDS home test kits last spring after officials said they would reconsider opposition to them.
University Hospital Laboratories' application was the first received, Epstein said, but he could not say how many others, if any, have been received since then.
At the time, Paul Parkman, director of the Center for Biologics Evaluation and Research, said officials were persuaded to rethink their opposition because there were now drugs that could slow progression of the disease and many who insisted on anonymous testing otherwise might not learn they have the disease.