phil@wubios.wustl.edu (J. Philip Miller) (07/27/90)
in > Volume 3, Number 27 July 25, 1990 > ! Health Info-Com Network ! > ! Newsletter ! the following item from USA Today appeared: > FDA LICENSES HIV-2 TEST: > > The Food and Drug Administration has licensed the first test kit that > detects antibody to human immunodeficiency virus type 2 (HIV-2). Genetic > Systems Corp. of Seattle created Genetic Systems HIV-2 EIA to aid in the > diagnosis of potential HIV-2 infection. Some specimens that yield negative > results when tested for HIV-1 may test positive for HIV-2. does anyone know what this company has done about counseling about results. As I recall the FDA just turned down another company (University Labs ?) with one of the major objections being that there were inadequate provisions for the manner in which the results (particularly positive) were to be handled. -phil -- J. Philip Miller, Professor, Division of Biostatistics, Box 8067 Washington University Medical School, St. Louis MO 63110 phil@wubios.WUstl.edu - Internet (314) 362-3617 uunet!wuarchive!wubios!phil - UUCP (314)362-2693(FAX) C90562JM@WUVMD - bitnet