Moder Kevin G, Wener Mark H, Weisman Michael H, Ishimori Mariko L, Wallace Daniel J, Buckeridge David L, Homburger Henry A
Department of Rheumatology, Mayo College of Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA.
J Rheumatol. 2007 May;34(5):978-86. Epub 2007 Apr 1.
We conducted a prospective, multicenter evaluation of autoantibody testing by multiplex immunoassay in patients with known or suspected connective tissue diseases (CTD). We evaluated agreement between multiplex immunoassay and enzyme immunoassay (EIA) and assessed the diagnostic utility of autoantibody profiles.
Samples from 908 patients with suspected CTD seen in rheumatology clinics were collected prospectively at 3 tertiary care centers. Diagnoses were established according to recognized classification criteria. Tests for autoantibodies were obtained by multiplex immunoassay and by EIA. The results of the multiplex immunoassay were analyzed using a previously validated interpretative algorithm, MDSS (Medical Decision Support Software), that suggests possible disease associations based on the pattern of results for the autoantibodies.
The median patient age was 49.7 years; 83% were female. The most common diagnoses were rheumatoid arthritis in 352 patients and systemic lupus erythematosus (SLE) in 332 patients. Agreement between multiplex and EIA testing ranged from a high of 99% (95% CI 98% to 100%) for Jo-1 to a low of 79% (95% CI 76% to 82%) for antinuclear antibodies. The MDSS algorithm suggested an appropriate disease association in 75% to 100% of patients with SLE. The results varied depending on the disease and the autoantibodies present.
These results suggest that patterns of autoantibodies detected by multiplex immunoassay testing, when analyzed by an interpretative algorithm, are useful in the evaluation of patients with CTD in situations of high disease prevalence. Further testing is necessary to determine its utility in settings of low disease prevalence.
我们对已知或疑似结缔组织病（CTD）患者采用多重免疫分析法进行自身抗体检测进行了一项前瞻性、多中心评估。我们评估了多重免疫分析法与酶免疫分析法（EIA）之间的一致性，并评估了自身抗体谱的诊断效用。
前瞻性地在3个三级医疗中心收集了908例在风湿病诊所就诊的疑似CTD患者的样本。根据公认的分类标准进行诊断。通过多重免疫分析法和EIA获得自身抗体检测结果。使用先前验证的解释算法MDSS（医学决策支持软件）分析多重免疫分析法的结果，该算法根据自身抗体的结果模式提示可能的疾病关联。
患者年龄中位数为49.7岁；83%为女性。最常见的诊断是352例类风湿关节炎和332例系统性红斑狼疮（SLE）。多重免疫分析法与EIA检测之间的一致性范围从抗Jo-1抗体的99%（95%CI 98%至100%）到抗核抗体的79%（95%CI 76%至82%）不等。MDSS算法在75%至100%的SLE患者中提示了适当的疾病关联。结果因疾病和存在的自身抗体而异。
这些结果表明，当通过解释算法进行分析时，多重免疫分析法检测到的自身抗体模式在疾病患病率高的情况下对CTD患者的评估有用。需要进一步测试以确定其在疾病患病率低的情况下的效用。
