Analytical performance of commercial myositis-specific autoantibody tests evaluated against immunoprecipitation assays as a reference standard: A systematic review and meta-analysis

Takahisa Gono; Albert Gil-Vila; Albert Selva-O'Callaghan; Annet van Royen-Kerkhof; Anett Vincze; Christopher Mecoli; Diana Gómez-Martín; Dörte Hamann; Edoardo Conticini; Zoltán Griger; Jose Jiram Torres-Ruiz; John D Pauling; Hector Chinoy; Latika Gupta; Levente Bodoki; Noreen Nasir; Pallavi Pimpale Chavan; Raju Khubchandani; Trallero-Araguás Ernesto; Yasuhito Hamaguchi; Lisa G Rider; Rohit Aggarwal; Sarah Tansley; Johan Rönnelid; Masataka Kuwana; Neil J McHugh

doi:10.1016/j.semarthrit.2025.152858

Analytical performance of commercial myositis-specific autoantibody tests evaluated against immunoprecipitation assays as a reference standard: A systematic review and meta-analysis

Takahisa Gono
, Albert Gil-Vila
, Albert Selva-O'Callaghan
, Annet van Royen-Kerkhof
, Anett Vincze
, Christopher Mecoli
, Diana Gómez-Martín
, Dörte Hamann
, Edoardo Conticini
, Zoltán Griger
, Jose Jiram Torres-Ruiz
, John D Pauling
, Hector Chinoy
, Latika Gupta
, Levente Bodoki
, Noreen Nasir
, Pallavi Pimpale Chavan
, Raju Khubchandani
, Trallero-Araguás Ernesto
, Yasuhito Hamaguchi

Lisa G Rider, Rohit Aggarwal, Sarah Tansley, Johan Rönnelid, Masataka Kuwana, Neil J McHugh^*,

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

OBJECTIVE: To evaluate the analytical performance of commercial myositis-specific autoantibody (MSA) assays against immunoprecipitation (IP) assays.

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.

Original language	English
Article number	152858
Number of pages	11
Journal	Seminars in Arthritis and Rheumatism
Volume	75
Early online date	27 Oct 2025
DOIs	https://doi.org/10.1016/j.semarthrit.2025.152858
Publication status	Published - Dec 2025

Keywords

Autoantibody
Diagnostic accuracy test
Meta-analysis
Myositis
Systematic review

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10.1016/j.semarthrit.2025.152858

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Gono, T., Gil-Vila, A., Selva-O'Callaghan, A., van Royen-Kerkhof, A., Vincze, A., Mecoli, C., Gómez-Martín, D., Hamann, D., Conticini, E., Griger, Z., Torres-Ruiz, J. J., Pauling, J. D., Chinoy, H., Gupta, L., Bodoki, L., Nasir, N., Chavan, P. P., Khubchandani, R., Ernesto, T.-A. (2025). Analytical performance of commercial myositis-specific autoantibody tests evaluated against immunoprecipitation assays as a reference standard: A systematic review and meta-analysis. Seminars in Arthritis and Rheumatism, 75, Article 152858. https://doi.org/10.1016/j.semarthrit.2025.152858

@article{17d1ceb1940041da85009aaba407c411,

title = "Analytical performance of commercial myositis-specific autoantibody tests evaluated against immunoprecipitation assays as a reference standard: A systematic review and meta-analysis",

abstract = "OBJECTIVE: To evaluate the analytical performance of commercial myositis-specific autoantibody (MSA) assays against immunoprecipitation (IP) assays.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.",

keywords = "Autoantibody, Diagnostic accuracy test, Meta-analysis, Myositis, Systematic review",

author = "Takahisa Gono and Albert Gil-Vila and Albert Selva-O'Callaghan and \{van Royen-Kerkhof\}, Annet and Anett Vincze and Christopher Mecoli and Diana G{\'o}mez-Mart{\'i}n and D{\"o}rte Hamann and Edoardo Conticini and Zolt{\'a}n Griger and Torres-Ruiz, \{Jose Jiram\} and Pauling, \{John D\} and Hector Chinoy and Latika Gupta and Levente Bodoki and Noreen Nasir and Chavan, \{Pallavi Pimpale\} and Raju Khubchandani and Trallero-Aragu{\'a}s Ernesto and Yasuhito Hamaguchi and Rider, \{Lisa G\} and Rohit Aggarwal and Sarah Tansley and Johan R{\"o}nnelid and Masataka Kuwana and McHugh, \{Neil J\}",

note = "Publisher Copyright: {\textcopyright} 2025 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.",

year = "2025",

month = dec,

doi = "10.1016/j.semarthrit.2025.152858",

language = "English",

volume = "75",

journal = "Seminars in Arthritis and Rheumatism",

issn = "0049-0172",

publisher = "W.B. Saunders",

}

Gono, T, Gil-Vila, A, Selva-O'Callaghan, A, van Royen-Kerkhof, A, Vincze, A, Mecoli, C, Gómez-Martín, D, Hamann, D, Conticini, E, Griger, Z, Torres-Ruiz, JJ, Pauling, JD, Chinoy, H, Gupta, L, Bodoki, L, Nasir, N, Chavan, PP, Khubchandani, R, Ernesto, T-A, Hamaguchi, Y, Rider, LG, Aggarwal, R, Tansley, S, Rönnelid, J, Kuwana, M, McHugh, NJ 2025, 'Analytical performance of commercial myositis-specific autoantibody tests evaluated against immunoprecipitation assays as a reference standard: A systematic review and meta-analysis', Seminars in Arthritis and Rheumatism, vol. 75, 152858. https://doi.org/10.1016/j.semarthrit.2025.152858

Analytical performance of commercial myositis-specific autoantibody tests evaluated against immunoprecipitation assays as a reference standard: A systematic review and meta-analysis. / Gono, Takahisa; Gil-Vila, Albert; Selva-O'Callaghan, Albert et al.
In: Seminars in Arthritis and Rheumatism, Vol. 75, 152858, 12.2025.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Analytical performance of commercial myositis-specific autoantibody tests evaluated against immunoprecipitation assays as a reference standard

T2 - A systematic review and meta-analysis

AU - Gono, Takahisa

AU - Gil-Vila, Albert

AU - Selva-O'Callaghan, Albert

AU - van Royen-Kerkhof, Annet

AU - Vincze, Anett

AU - Mecoli, Christopher

AU - Gómez-Martín, Diana

AU - Hamann, Dörte

AU - Conticini, Edoardo

AU - Griger, Zoltán

AU - Torres-Ruiz, Jose Jiram

AU - Pauling, John D

AU - Chinoy, Hector

AU - Gupta, Latika

AU - Bodoki, Levente

AU - Nasir, Noreen

AU - Chavan, Pallavi Pimpale

AU - Khubchandani, Raju

AU - Ernesto, Trallero-Araguás

AU - Hamaguchi, Yasuhito

AU - Rider, Lisa G

AU - Aggarwal, Rohit

AU - Tansley, Sarah

AU - Rönnelid, Johan

AU - Kuwana, Masataka

AU - McHugh, Neil J

PY - 2025/12

Y1 - 2025/12

N2 - OBJECTIVE: To evaluate the analytical performance of commercial myositis-specific autoantibody (MSA) assays against immunoprecipitation (IP) assays.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.

AB - OBJECTIVE: To evaluate the analytical performance of commercial myositis-specific autoantibody (MSA) assays against immunoprecipitation (IP) assays.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.

KW - Autoantibody

KW - Diagnostic accuracy test

KW - Meta-analysis

KW - Myositis

KW - Systematic review

UR - https://www.scopus.com/pages/publications/105024915482

U2 - 10.1016/j.semarthrit.2025.152858

DO - 10.1016/j.semarthrit.2025.152858

M3 - Article

C2 - 41176843

SN - 0049-0172

VL - 75

JO - Seminars in Arthritis and Rheumatism

JF - Seminars in Arthritis and Rheumatism

M1 - 152858

ER -

Gono T, Gil-Vila A, Selva-O'Callaghan A, van Royen-Kerkhof A, Vincze A, Mecoli C et al. Analytical performance of commercial myositis-specific autoantibody tests evaluated against immunoprecipitation assays as a reference standard: A systematic review and meta-analysis. Seminars in Arthritis and Rheumatism. 2025 Dec;75:152858. Epub 2025 Oct 27. doi: 10.1016/j.semarthrit.2025.152858

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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