Presence of antibodies to human immunodeficiency virus-1 in reference reagents of human origin in diagnostic kits.

We tested 54 reagents of human origin that were included in a number of diagnostic kits to be used as positive or negative control material, and for quality assurance, for the presence of antibodies to human immunodeficiency virus-1 (HIV-1). Of these, 12 (22%) reagents were found to give positive results for antibodies to HIV-1 by enzyme-linked immunosorbent assay and/or supplementary tests. These results suggest that some diagnostic reagents of human origin may be contaminated with HIV-1 and potentially may be infectious.