Annals of laboratory medicine · 2026
Performance of the Line Blot Immunoassay for Detecting Myositis Autoantibodies in Real-Life Laboratory Settings: An Italian Multicenter Study.
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Ghirardello Anna, Infantino Maria, Gallo Nicoletta, Buzzulini Francesca, Zanatta Elisabetta, Franco Chiara, Bizzaro Nicola, Villalta Danilo, Migliorini Paola, Ramonda Roberta, Iaccarino Luca, Forum Interdisciplinare per la Ricerca nelle Malattie Autoimmuni (FIRMA) Collaborators, on behalf of the FIRMA Group
Аннотация
BACKGROUND: Commercial line immunoassays (LIAs) are used to detect myositis-specific and myositis-associated autoantibodies (MSAs/MAAs) in patients with suspected idiopathic inflammatory myopathy (IIM). However, performance consistency with LIAs remains challenging. We evaluated the appropriateness, clinical consistency, and diagnostic performance of MSA/MAA LIA testing in real-life clinical practice.
METHODS: Between January and December 2024, eight Italian laboratories performed 1,127 MSA/MAA LIA determinations (Euroline Myopathies 16 Ags plus cN-1A). LIA appropriateness was defined as concordance between the clinical information provided and the MSA/MAA request; clinical consistency was defined as agreement between the IIM diagnosis and LIA results; and diagnostic performance was defined as the reliability of LIA in confirming an IIM diagnosis.
RESULTS: MSA/MAA positivity was observed with 564/1,127 (50.1%) LIA requests. LIA appropriateness and consistency were 31.6% and 51.3%, respectively. Of the 1,127 LIA requests, 666 (59.1%) included a clinical diagnosis. The appropriateness and consistency of the 666 LIA reports were 53.4% and 86.8%, respectively. Among the 666 patients, 337 (50.6%) were diagnosed as having IIM, and 329 (49.4%) were diagnosed as having a non-IIM disease. In patients with IIM, 288/337 (85.4%) received true-positive MSA/MAA LIA results, whereas 105/329 (31.9%) of patients with non-IIM disease received false-positive results (P<0.001). Significant positive odds ratios were observed for anti-Jo-1, anti-MDA5, anti-PM-Scl-75/100, and MSA-associated anti-Ro52 antibodies (P<0.001).
CONCLUSIONS: With increasing MSA/MAA requests for suspected IIM, LIA testing can help identify certain antibodies in real-life scenarios. The appropriateness of the request and the clinical information provided mainly influence the LIA diagnostic performance.
METHODS: Between January and December 2024, eight Italian laboratories performed 1,127 MSA/MAA LIA determinations (Euroline Myopathies 16 Ags plus cN-1A). LIA appropriateness was defined as concordance between the clinical information provided and the MSA/MAA request; clinical consistency was defined as agreement between the IIM diagnosis and LIA results; and diagnostic performance was defined as the reliability of LIA in confirming an IIM diagnosis.
RESULTS: MSA/MAA positivity was observed with 564/1,127 (50.1%) LIA requests. LIA appropriateness and consistency were 31.6% and 51.3%, respectively. Of the 1,127 LIA requests, 666 (59.1%) included a clinical diagnosis. The appropriateness and consistency of the 666 LIA reports were 53.4% and 86.8%, respectively. Among the 666 patients, 337 (50.6%) were diagnosed as having IIM, and 329 (49.4%) were diagnosed as having a non-IIM disease. In patients with IIM, 288/337 (85.4%) received true-positive MSA/MAA LIA results, whereas 105/329 (31.9%) of patients with non-IIM disease received false-positive results (P<0.001). Significant positive odds ratios were observed for anti-Jo-1, anti-MDA5, anti-PM-Scl-75/100, and MSA-associated anti-Ro52 antibodies (P<0.001).
CONCLUSIONS: With increasing MSA/MAA requests for suspected IIM, LIA testing can help identify certain antibodies in real-life scenarios. The appropriateness of the request and the clinical information provided mainly influence the LIA diagnostic performance.