Mahler Michael, Malyavantham Kishore, Seaman Andrea, Bentow Chelsea, Anunciacion-Llunell Ariadna, Sanz-Martínez María Teresa, Viñas-Gimenez Laura, Selva-O'Callaghan Albert
Research and Development, Inova Diagnostics, San Diego, CA 92131, USA.
Autoimmune Systemic Diseases Unit, Department of Internal Medicine, Hospital Vall d'Hebron, Universitat Autònoma de Barcelona, 08035 Barcelona, Spain.
Diagnostics (Basel). 2021 Nov 30;11(12):2246. doi: 10.3390/diagnostics11122246.
(1) Background: Myositis specific antibodies (MSA) represent important diagnostic and stratification tools in idiopathic inflammatory myositis (IIM) patients. Here we aimed to evaluate the clinical performance of MSA profiled by a novel particle based multi-analyte technology (PMAT) in IIM and subsets thereof. (2) Methods: 264 IIM patients and 200 controls were tested for MSA using PMAT (Inova Diagnostics, research use only). Diagnostic performance was analyzed and composite scores were generated. (3) Results: The sensitivity/specificity of the individual MSA were: 19.7%/100% (Jo-1), 7.2%/100.0% (Mi-2), 3.0%/99.0% (NXP2), 3.8%/100.0% (SAE), 2.7%/100.0% (PL-7), 1.9%/99.5 (PL-12), 1.1%/100.0% (EJ), 15.5%/99.5% (TIF1γ), 8.3%/98.5% (MDA5), 6.1%/99.0% (HMGCR) and 1.9%/98.5% (SRP). Of all IIM patients, 180/264 tested positive for at least one of the MSAs. In the individual control group, 12/200 (6.0%) tested positive for at least one MSA, most of which had levels close to the cut-off (except one SRP and one PL-12). Only 6/264 (2.3%) IIM patients were positive for more than one antibody (MDA5/HMGCR, EJ/PL-7, 2 x MDA5/TIF1γ, EJ/SAE, SAE/TIF1γ). The overall sensitivity was 68.2% paired with a specificity of 94.0%, leading to an odds ratio of 33.8. The composite scores showed good discrimination between subgroups (e.g., anti-synthetase syndrome). (4) Conclusion: MSA, especially when combined in composite scores (here measured by PMAT), provide value in stratification of patients with IIM.
(1) 背景：肌炎特异性抗体（MSA）是特发性炎性肌病（IIM）患者重要的诊断和分层工具。在此，我们旨在评估一种基于新型颗粒的多分析物技术（PMAT）检测的MSA在IIM及其亚组中的临床性能。(2) 方法：使用PMAT（Inova诊断公司，仅用于研究）对264例IIM患者和200例对照进行MSA检测。分析诊断性能并生成综合评分。(3) 结果：各MSA的敏感性/特异性分别为：19.7%/100%（Jo-1）、7.2%/100.0%（Mi-2）、3.0%/99.0%（NXP2）、3.8%/100.0%（SAE）、2.7%/100.0%（PL-7）、1.9%/99.5（PL-12）、1.1%/100.0%（EJ）、15.5%/99.5%（TIF1γ）、8.3%/98.5%（MDA5）、6.1%/99.0%（HMGCR）和1.9%/98.5%（SRP）。在所有IIM患者中，180/264至少有一种MSA检测呈阳性。在个体对照组中，12/200（6.0%）至少有一种MSA检测呈阳性，其中大多数水平接近临界值（除一例SRP和一例PL-12）。仅6/264（2.3%）IIM患者的一种以上抗体呈阳性（MDA5/HMGCR、EJ/PL-7、2例MDA5/TIF1γ、EJ/SAE、SAE/TIF1γ）。总体敏感性为68.2%，特异性为94.0%，优势比为33.8。综合评分显示各亚组之间有良好的区分度（如抗合成酶综合征）。(4) 结论：MSA，尤其是以综合评分形式（此处通过PMAT测量），在IIM患者分层中具有价值。
