Analytical performance of commercial myositis-specific autoantibody tests evaluated against immunoprecipitation assays as a reference standard: A systematic review and meta-analysis.
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Gono Takahisa, Gil-Vila Albert, Selva-O'Callaghan Albert, van Royen-Kerkhof Annet, Vincze Anett, Mecoli Christopher, Gómez-Martín Diana, Hamann Dörte, Conticini Edoardo, Griger Zoltán, Torres-Ruiz Jose Jiram, Pauling John D, Chinoy Hector, Gupta Latika, Bodoki Levente, Nasir Noreen, Chavan Pallavi Pimpale, Khubchandani Raju, Ernesto Trallero-Araguás, Hamaguchi Yasuhito, Rider Lisa G, Aggarwal Rohit, Tansley Sarah, Rönnelid Johan, Kuwana Masataka, McHugh Neil J, International Myositis Assessment and Clinical Studies Group (IMACS) Myositis Autoantibody Scientific Interest Group (SIG) Study
Аннотация
METHODS: A systematic literature search was conducted in PubMed, Web of Science, and Scopus through July 2024. Data were extracted on study design, participant characteristics, index tests, and 2 × 2 contingency tables for diagnostic performance. Study quality was assessed using the QUADAS-2 tool. Sensitivity and specificity were calculated for each dataset and presented as paired forest plots and summary receiver operating characteristic (SROC) curves. A hierarchical SROC model was used to estimate pooled sensitivity and specificity for meta-analysis.
RESULTS: Of 3156 articles, 23 met inclusion criteria and were judged to have low risk of bias across all QUADAS-2 domains. The most frequently evaluated commercial assay was the line blot assay (LBA; 16 studies), followed by enzyme immunoassay (EIA; 9 studies). In the meta-analyses, the highest pooled sensitivity was observed for anti-MDA5 with EIA (95.7 %), followed by anti-SAE with LBA (88.3 %), anti-PL-12 with LBA (87.2 %), and anti-Jo-1 and anti-MDA5 with LBA (82.8 %). Lower sensitivities were observed for anti-Mi-2 (67.4 %), anti-NXP2 (69.7 %), and anti-TIF1-γ (63.8 %) with LBA. Pooled specificity ranged from 94.7 % to 99.3 % across MSA assays, but a false-positive result was a common concern for LBA, except for anti-EJ.
CONCLUSION: False-positive and false-negative results remain a significant challenge in the use of commercial MSA assays.