Human immunodeficiency virus type 1 reference materials.

Since licensure of the first human immunodeficiency virus type 1 screening assay in March 1985, there has been a need for well-characterized human immunodeficiency virus type 1 reference sera. These sera would be used in an effort to ensure uniformity of human immunodeficiency virus type 1 test results worldwide. Three major organizations--the World Health Organization, the Pan American Health Organization, and the National Committee for Clinical Laboratory Standards working with the College of American Pathologists--have ongoing programs aimed at the preparation of these reference sera. All three organizations are preparing both negative and human immunodeficiency virus type 1 seropositive sera. In addition, one organization is preparing early sero-converter and late acquired immunodeficiency syndrome samples. The status of these efforts and the serologic characteristics of the sera were reviewed.