Assessment of biological reagents for presence of human immunodeficiency virus-1 (HIV-1) antigens.

We tested 122 biological reagents including laboratory quality assurance sera and therapeutic human immune serum globulin products using an immunoenzymometric assay (IEMA) for HIV-1 antigens. Biological reagents tested were 64 HIV-1 antibody non-reactive and 44 HIV-1 antibody reactive quality assurance samples, and 14 HIV-1 antibody reactive human immune serum globulins from 21 manufacturers. Twenty-one of these biological reagents were previously reported by us as Western blot reactive. All 122 samples tested were non-reactive for HIV-1 antigens. Low incidence of HIV-1 antigen in these biological reagents should not alter laboratory safety practices in which all samples are considered infectious. Use of HIV-1 antigen measurements, either alone or with HIV-1 antibody determinations does not increase the likelihood of detecting HIV-1 reactive samples.