Diagnostic Evaluation of ELISA and Chemiluminescent Assays as Alternative Screening Tests to Indirect Immunofluorescence for the Detection of Antibodies to Cellular Antigens

Abstract

Some ELISA kits have comparable or superior diagnostic sensitivity to ANA HEp-2 and could be used as an alternative method for ANA screening, therefore allowing the immediate report of the results with fewer false negatives than ANA HEp-2. Owing to the lower specificity, ELISA-positive samples should be submitted to ANA HEp-2 for confirmation of results.

A hierarchical bivariate meta-analysis of diagnostic test accuracy to provide direct comparisons of immunoassays vs. indirect immunofluorescence for initial screening of connective tissue diseases

“…The HSROC plot of the study estimates for ELISA sensitivity vs. specificity is similar to IIF: variance in the test results across the studies lead to a high level of uncertainty in the estimates of diagnostic test accuracy (a large prediction region). Figure 1, top right panel, shows 10 ELISA test results (from six studies [43,[45][46][47][48]54]) with a similar association between increased sensitivity and decreased specificity as IIF. A HSROC plot of ELISA test data for ELISAs with and without a HEp-2 component is shown in Supplementary Material, Figure S-2.…”

“…The literature review (up to March 2018) identified 17 studies (from 18 citations [40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57]) that met the inclusion criteria for this review (set out in the section Inclusion criteria) (see PRISMA diagram in Supplementary Material, Figure S-1). A summary of the studies is provided in Table S…”

“…Of the 17 fully paired studies included in this review, four studies [42,44,45,56] reported diagnostic test accuracy data for CLIA ( Figure 1, middle right panel). There is a high level of uncertainty in the estimates of diagnostic test accuracy for CLIA given the large confidence and prediction region, and that the 95% prediction region crosses the line of 'no effect' (DOR = 1).…”

“…Five studies incorporating 2321 patients reported diagnostic test accuracy data for both IIF at a 1:80 dilution and an ELISA [43,[45][46][47]54]. Results from the mixed-effect bivariate model (Table 2) showed no significant difference in sensitivity and specificity between IIF and ELISA.…”

Anything You Can Do, I Can Do Better: Can Aptamers Replace Antibodies in Clinical Diagnostic Applications?

“…As such, these tests require a high sensitivity and specificity to prevent false positives and false negatives. The enzyme-linked immunosorbent assay (ELISA) provides a familiar example, as it represents the mainstay of analytical biochemistry and may also replace indirect immunofluorescence for the detection of autoantibodies [43]. ELISAs are used as both a diagnostic tool and an assay for the purpose of discerning the concentration of analytes, particularly proteins within a solution of proteins [44].…”