An indirect comparison of automated indirect immunofluorescence vs automated solid-phase immunoassays for antinuclear antibody detection: A meta-analysis and adjusted indirect comparison of diagnostic test accuracy.

Abstract

The primary aim of this study was to conduct a meta-analysis to compare the diagnostic accuracy of automated indirect immunofluorescence (automated-IIF) and fully automated solid-phase immunoassays (solid-phase assays), compared with gold standard conventional manual indirect immunofluorescence (manual-IIF) for antinuclear antibody (ANA) detection. Indirect meta-comparison was performed using prospective studies reporting comparative data between automated-IIF and fully automated solid-phase assays individually to conventional manual-IIF. Diagnostic tests regarding different automated solid-phase assays and automated-IIF for ANA detection were retrieved from the Cochrane Library, PubMed, Embase, Web of Science, Chinese Biological Medicine Database (CBM), China National Knowledge Infrastructure (CNKI), and WANFANG electronic databases from their inception to January 2022. Assessment of the quality of the studies was undertaken using a second version of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. The investigated diagnostic indices including pooled sensitivity, pooled specificity, pooled positive likelihood ratio (PLR), pooled negative likelihood ratio (NLR), pooled diagnostic odds ratio (DOR), area under the summary receiver operating characteristic (AUC) of automated-IIF and solid-phase assays, respectively. Relative diagnostic odds ratio (RDOR) was calculated to indirectly compare the diagnostic accuracy of automated-IIF and solid-phase assays. To visualize results, we provide forest plots showing the RDOR with 95% confidence intervals (CI) of the 2 methods against the "gold standard" manual-IIF by R software. Deeks' funnel was used to investigate the publication bias. A total of 16 studies involving 6111 subjects were included in the analysis. The pooled sensitivity, pooled specificity, pooled PLR, pooled NLR, pooled DOR and the AUC were 0.85 (95% CI: 0.84-0.86), 0.82 (95% CI 0.81-0.84), 14.22 (95% CI 8.55-23.65), 0.06 (95% CI 0.03-0.12), 287.0 (95% CI 124.30-662.68) and 0.983 for automated-IIF respectively, and as for solid-phase assays those were 0.73 (95% CI 0.70-0.75), 0.87 (95% CI 0.85-0.89), 5.66 (95% CI 3.33-9.62), 0.30 (95% CI 0.20-0.47), 19.14 (95% CI 8.00-45.79) and 0.894. The results of indirect comparison indicated that automated-IIF had statistically significant higher accuracy for the detection of ANA. This meta-analysis and indirect comparison suggest that automated-IIF should be recommended as an alternative assay for ANA screening under the condition of increased demand for ANA testing in clinical immunology laboratories.