Mahler Michael, Waka Aderajew, Hiepe F, Fritzler Marvin J
Development and Production, Dr Fooke Laboratorien, Neuss 41469, Germany.
Arthritis Res Ther. 2007;9(4):R68. doi: 10.1186/ar2266.
Systemic lupus erythematosus is characterized by antibodies to a variety of intracellular self-antigens, such as dsDNA and Sm, and these serve as hallmarks in the diagnosis of systemic autoimmune diseases. Several studies have shown that SmD1 and SmD3 synthetic peptides represent highly functional antigens for autoantibody detection and thus for diagnostic applications. The present study analysed the technical and clinical accuracy of an anti-SmD1 (amino acids 83-119) and an anti-SmD3 (amino acids 108-122) ELISA for the detection of anti-Sm antibodies. Depending on the cut-off value of the SmD1 ELISA, we found a high degree of concordance between the two tests. At an optimized cut-off value of 100 units for SmD1 we found the same clinical sensitivity (12.5%) and specificity (100%) in a group of systemic lupus erythematosus patients (n = 48) and in controls (n = 99). The concordance at this cut-off value was 100% (P < 0.0001; chi2 = 127.61). Using a second panel of sera (n = 65) preselected based on positive anti-Sm results, we confirmed the high degree of concordance between the two assays. Using dsDNA-coated ELISA plates and biotinylated peptides we confirmed the high dsDNA binding properties for SmD1, which were significantly higher than the SmD3-derived peptide. However, no cross-linking of anti-dsDNA antibodies to SmD1 was observed after adding increasing amounts of dsDNA to anti-dsDNA positive, anti-SmD1 negative serum. We therefore conclude that the reported difference in the sensitivity is related to the different cut-off levels and not to the detection of anti-dsDNA antibodies bridged via dsDNA to the SmD1 peptide. Moreover, we found that a subpopulation of anti-Sm antibodies cross-reacted with SmD1 and SmD3. Taken together, the data indicate that both SmD peptide ELISAs represent accurate assays and may be used as important standards for the detection of anti-Sm antibodies.
系统性红斑狼疮的特征是存在针对多种细胞内自身抗原的抗体,如双链DNA和Sm,这些是系统性自身免疫性疾病诊断的标志。多项研究表明,SmD1和SmD3合成肽是用于自身抗体检测及诊断应用的高功能抗原。本研究分析了一种抗SmD1(氨基酸83 - 119)和抗SmD3(氨基酸108 - 122)酶联免疫吸附测定(ELISA)检测抗Sm抗体的技术和临床准确性。根据SmD1 ELISA的临界值,我们发现两种检测方法之间具有高度一致性。在SmD1的优化临界值为100单位时,我们在一组系统性红斑狼疮患者(n = 48)和对照组(n = 99)中发现了相同的临床敏感性(12.5%)和特异性(100%)。此临界值下的一致性为100%(P < 0.0001;卡方 = 127.61)。使用基于抗Sm结果阳性预先选择的第二批血清样本(n = 65),我们证实了两种检测方法之间的高度一致性。使用包被双链DNA的ELISA板和生物素化肽,我们证实了SmD1具有较高的双链DNA结合特性,显著高于SmD3衍生肽。然而,在向抗双链DNA阳性、抗SmD1阴性血清中加入越来越多的双链DNA后,未观察到抗双链DNA抗体与SmD1发生交联。因此,我们得出结论,所报道的敏感性差异与不同的临界值水平有关,而非与通过双链DNA桥接至SmD1肽的抗双链DNA抗体的检测有关。此外,我们发现抗Sm抗体的一个亚群与SmD1和SmD3发生交叉反应。综上所述,数据表明两种SmD肽ELISA均为准确的检测方法,可作为检测抗Sm抗体的重要标准。