Performance and reliability of five commercial enzyme-linked immunosorbent assay kits in screening for anti-human immunodeficiency virus antibody in high-risk subjects

Abstract

Anti-human immunodeficiency virus enzyme-linked immunosorbent assay kits marketed by Electro-Nucleonics Inc. (ENI), Genetic Systems Corp. (GSC), Organon Teknika Inc. (OTI), Ortho Diagnostic Systems Inc. (ODSI), and Wellcome Diagnostics (WD) were evaluated by using 289 randomly selected serum samples from a high-risk population and 53 serum samples likely to produce false-positive results. The radioimmunoprecipitation assay was used as the reference test. Sensitivities ranged from 96.51% (ODSI, WD) to 97.67% (ENI, GSC, OTI). Sera showing antibodies to viral glycoproteins only produced the false-negative results. Specificities ranged from 99.6% (ENI, GSC, ODSI, OTI) to 100% (WD). False-positive results were obtained with sera from patients with autoimmune disease or Epstein-Barr virus infection. Only results from GSC and OTI kits were distributed in two compact clusters well segregated on either side of the cutoff point. ODSI and GSC kits had the best intralot reproducibility. The GSC kit had the best interlot reproducibility. Cutoff values for ODSI and GSC kits were the least variable. Intraplate repeatability was good for all kits. Sample localization was not an important source of variability. Our results do not point out one outstanding kit among the five evaluated. However, the GSC kit showed the best overall results.