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

Abstract

(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.

Performance and reliability of the Enzygnost measles enzyme-linked immuno-sorbent assay for detection of measles virus-specific immunoglobulin M antibody during a large measles epidemic

“…Intrasite reproducibility for measles-IgM-positive sera (>99%) was similar to the reproducibilities of other ELISA kits tested in our laboratory (9). Results that were interpreted as equivocal were highly variable on repeat testing.…”

“…This study was a field evaluation of the Enzygnost Measles ELISA kit during an epidemic. It was not a formal evaluation with a selected panel that included, among other things, true-negative sera and tricky sera, such as panels that we have used in other evaluations (9). Thus, the specificity could not be formally evaluated.…”

Comparison of five commercial enzyme-linked immunosorbent assays and Western immunoblotting for human immunodeficiency virus antibody detection in serum samples from Central Africa

“…Several commercial enzyme-linked immunosorbent assays (ELISAs) for detection of antibody to human immunodeficiency virus (HIV) infection have been evaluated, mainly in the United States and Europe, with various reported sensitivities and specificities (1,2,5,6,8,11,(12)(13)(14). Only a few studies, evaluating a limited number of ELISAs, using Central African sera have been conducted (15,16).…”

Sensitivity and specificity of pooled versus individual sera in a human immunodeficiency virus antibody prevalence study

“…Additional studies have found HIV antibodies in samples of pooled control sera (2,12) and pooled immunoglobulin tested for safety concerns (5,8). Numerous other studies attest to the extreme sensitivity and specificity of the commercially available HIV ELISAs (1, 7,10,11,14), which approach 100% when these results are combined with results from supplemental assays such as the immunofluorescence assay (IFA) and/or Western blotting (WB) (1). In the present study, we evaluated the reliability and cost efficiency of testing pooled versus individual sera for the detection of HIV antibodies.…”