Evaluation of Three Commercial Screening Tests for AIDS Virus Antibodies

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Abstract
Three commercial enzyme-linked immunosorbent assays (ELISA) for acquired immune deficiency syndrome (AIDS) virus antibodies were evaluated using serum that had been characterized by an ELISA and western blot procedure developed at the University of California at Davis (UCD). Each of the commercial tests was more specific than the UCD ELISA, but the UCD ELISA was more sensitive in the detection of sera that lacked reactivity by western blot to the envelope glycoprotein (gp-41). The HTLV-III Bio-EnzaBead® (Litton Bionetics, Charleston, SC) was less sensitive and specific than the Abbott® HTLV-III EIA (Abbott Laboratories, North Chicago, IL) or the Virgo® HTLV-III ELISA (Electro-Nucleonics Inc., Columbia, MD). Overall, 22.9% (57 of 250) and 51.0% of sera that were repeatedly (×2) positive by commercial screening kits tested at blood donor centers and clinical laboratories, respectively, were confirmed by western blot. These results indicate that the screening assays for AIDS virus antibodies are not equal in performance and that positive screening test results must be confirmed by a more specific test like western blot before results are released.