Enzyme-linked immunosorbent assay for detection of anti-RNA polymerase III antibody - Analytical accuracy and clinical associations in systemic sclerosis
Enzyme-linked immunosorbent assay for detection of anti-RNA polymerase III antibody - Analytical accuracy and clinical associations in systemic sclerosis
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DOI：
10.1002/art.21232
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发表时间：
2005-08-01
影响因子：
--
通讯作者：
Medsger, TA
中科院分区：
文献类型：
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作者：
Kuwana, M;Okano, Y;Medsger, TA
Objective.我们最近开发了一种酶联免疫吸附试验（ELISA）用于检测抗RNA聚合酶III（抗RNAP 111）抗体，使用含有免疫显性表位的重组片段作为抗原源。本研究旨在评估抗RNAP III ELISA在系统性硬化症（SSc）患者中的分析准确性和临床相关性。评价分析灵敏度。为探讨ELISA的特异性和特异性，我们分别用免疫沉淀法和ELISA法检测了来自3个医学中心的534份SSc患者血清中的抗RNAP Ⅲ抗体。来自522例SSc患者和516例对照（包括其他结缔组织疾病患者和血库供体）的血清也进行了评价，以评估ELISA的临床敏感性和特异性。抗RNAP III抗体阳性的SSc患者的临床结果进行了比较，根据ELISA测定的抗RNAP III抗体水平分层的患者组。在SSc患者中，我们的ELISA与免疫沉淀法（检测抗RNAP III抗体的金标准）相比，分析灵敏度为91%，分析特异性为99%。使用大量SSc和对照血清的额外分析表明，ELISA诊断SSc的临床灵敏度和特异性分别为17%和98%。高水平的抗RNAP III抗体与弥漫性皮肤SSc、较高的最大皮肤总评分和肌腱摩擦频率增加相关。抗RNAP III ELISA在分析上准确且具有临床特异性。通过这种检测，可以常规地进行抗RNAP III抗体的检测。
Objective. We have recently developed an enzyme-linked immunosorbent assay (ELISA) for detection of anti-RNA polymerase III (anti-RNAP 111) antibody, using a recombinant fragment containing the immunodominant epitope as the antigen source. This study was conducted to assess the analytical accuracy and clinical associations of the anti-RNAP III ELISA in patients with systemic sclerosis (SSc).Methods. To evaluate analytical sensitivity. and specificity of the ELISA, both immunoprecipitation tests and ELISA were used to detect anti-RNAP III antibody in 534 SSc sera from patients at 3 medical centers. Sera from 522 SSc patients and 516 controls, including patients with other connective tissue diseases and blood bank donors, were also evaluated to assess the clinical sensitivity and specificity of the ELISA. Clinical findings in anti-RNAP III antibody-positive SSc patients were compared between patient groups stratified according to anti-RNAP III antibody levels determined by the ELISA.Results. In SSc patients, our ELISA showed analytical sensitivity of 91% and analytical specificity of 99% compared with the immunoprecipitation assay (a gold standard for detection of anti-RNAP III antibody). The additional analysis using a large series of SSc and control sera showed that clinical sensitivity and specificity of the ELISA with respect to the diagnosis of SSc were 17% and 98%, respectively. A high level of anti-RNAP III antibody was associated with diffuse cutaneous SSc, higher maximum total skin score, and increased frequency of tendon friction rubs.Conclusion. The anti-RNAP III ELISA is analytically accurate and clinically specific. With this assay, testing for anti-RNAP III antibody can be made routinely available.