Abstract
(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.
Highlights
Myositis specific (MSA) and myositis associated antibodies (MAA) have been used as an aid in the diagnosis of idiopathic inflammatory myopathies (IIM) for decades [1]
Besides immunoprecipitation (IP), mostly line immunoassays (LIA) and dot blot (DB) assays are routinely used for the detection of Myositis specific antibodies (MSA) [6], which are convenient tools for the simultaneous detection of various antibodies, but are accompanied by some limitations [7] including the lack of true quality controls [8], lack of sensitivity [9,10] and specificity (10) for some analytes and subjectivity in interpretation [10,11,12]
Since publication of updated new classification criteria for IIM [13,14], a debate has been triggered about the omission of MSA, which was eventually explained by the lack of standardization of autoantibody assays and missing data derived from large multicentric studies [15,16]
Summary
Myositis specific (MSA) and myositis associated antibodies (MAA) have been used as an aid in the diagnosis of idiopathic inflammatory myopathies (IIM) for decades [1]. Besides immunoprecipitation (IP), mostly line immunoassays (LIA) and dot blot (DB) assays are routinely used for the detection of MSA [6], which are convenient tools for the simultaneous detection of various antibodies, but are accompanied by some limitations [7] including the lack of true quality controls [8], lack of sensitivity [9,10] and specificity (10) for some analytes and subjectivity in interpretation [10,11,12]. Since publication of updated new classification criteria for IIM [13,14], a debate has been triggered about the omission of MSA (except anti-Jo-1 antibodies), which was eventually explained by the lack of standardization of autoantibody assays and missing data derived from large multicentric studies [15,16]. The aim of the present study was to evaluate the diagnostic performance of MSA for IIM and in particular for IIM subsets as well as using composite scores derived from a novel particle-based multi-analyte technology (PMAT)
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