Associated Regional and University Pathologists (ARUP) Institute for Clinical and Experimental Pathology, University of Utah School of Medicine, Salt Lake City, UT 84108-1221, United States.
Clin Chim Acta. 2011 May 12;412(11-12):1100-5. doi: 10.1016/j.cca.2011.02.031. Epub 2011 Mar 1.
The aim of this study was to compare the correlation between new diagnostic methodologies for detecting anti-polymyositis/scleroderma (anti-PM/Scl) IgG antibodies associated with myositis and/or systemic scleroderma assays with existing platforms.
Sera from 164 samples previously tested for anti-PM/Scl IgG antibody by immunodiffusion, ID; 171 sera screened for anti-PM/Scl IgG by immunoprecipitation, IP; an additional group of 215 sera tested by ID and 46 healthy blood donor sera were retrospectively evaluated. Anti-PM/Scl IgG antibodies were measured using three PM/Scl-100 specific enzyme immunoassays (EIAs), PM1-alpha (PM1-α) EIA and a line immunoblot assay (LIA) for anti-PM/Scl-75 and -100 IgG antibodies. Selected samples were tested for the presence of antinuclear antibody (ANA) by indirect fluorescent antibody (IFA) assay.
The overall agreement between ID and all anti-PM/Scl IgG EIAs as determined by Crohnbach's alpha was unacceptable (α<0.50). The concordance between the IP and either LIA or PM1-α EIA was greater than 90% however, the best agreement was seen between the IP and LIA PM/Scl-100 assays (98.3%). Compared to the LIA PM/Scl-75 and PM1-α tests, the LIA PM/Scl-100 IgG assay showed the best specificity in the healthy control group.
Our results demonstrate considerable differences between assays for detecting anti-PM/Scl IgG antibodies which cannot be attributable to heterogeneity in antibody response alone. Further characterization and standardization of these assays are needed.
本研究旨在比较检测与肌炎和/或系统性硬皮病相关的抗多肌炎/硬皮病（抗 PM/Scl） IgG 抗体的新诊断方法与现有平台之间的相关性。
对先前通过免疫扩散（ID）检测抗 PM/Scl IgG 抗体的 164 份血清、通过免疫沉淀（IP）筛选抗 PM/Scl IgG 的 171 份血清、另外一组通过 ID 检测的 215 份血清和 46 份健康献血者血清进行回顾性评估。使用三种 PM/Scl-100 特异性酶免疫分析（EIA）、PM1-alpha（PM1-α）EIA 和用于检测抗 PM/Scl-75 和 -100 IgG 抗体的线免疫印迹分析（LIA）来测量抗 PM/Scl IgG 抗体。选择的样本通过间接荧光抗体（IFA）检测抗核抗体（ANA）的存在。
通过 Crohnbach's alpha 确定的 ID 与所有抗 PM/Scl IgG EIA 之间的总体一致性不可接受（α<0.50）。然而，IP 与 LIA 或 PM1-α EIA 之间的一致性大于 90%，但 IP 与 LIA PM/Scl-100 检测之间的一致性最好（98.3%）。与 LIA PM/Scl-75 和 PM1-α 检测相比，LIA PM/Scl-100 IgG 检测在健康对照组中显示出最佳的特异性。
我们的结果表明，用于检测抗 PM/Scl IgG 抗体的检测方法之间存在相当大的差异，这不能仅归因于抗体反应的异质性。需要进一步对这些检测方法进行特征描述和标准化。
