Dejaco Christian, Klotz Werner, Larcher Heike, Duftner Christina, Schirmer Michael, Herold Manfred
Clinical Department of Internal Medicine, Division of General Internal Medicine, Innsbruck Medical University, Anichstrasse 35, 6020 Innsbruck, Austria.
Arthritis Res Ther. 2006;8(4):R119. doi: 10.1186/ar2008.
Antibodies directed against citrullinated vimentin are members of the family of autoantibodies reactive with citrullinated proteins and are among the most specific serological markers for the diagnosis of rheumatoid arthritis (RA). This study was performed to test the diagnostic value of a newly developed enzyme-linked immunosorbent assay (ELISA) for the detection of antibodies against a genetically modified citrullinated vimentin (anti-MCV) in comparison with a second-generation anti-cyclic citrullinated peptides (anti-CCP2) ELISA test system. Blinded sera from 631 patients (409 consecutive out-patients and 222 randomly selected stored sera) with RA (n = 164) and non-RA (osteoarthritis [n = 120], polymyalgia rheumatica/giant cell arteritis [n = 80], spondyloarthritis [n = 36], and other inflammatory rheumatic or non-inflammatory disease [n = 67]) were tested for the presence of anti-MCV and anti-CCP2 antibodies according to the manufacturers' instructions. The diagnostic performance of the anti-MCV was comparable with the anti-CCP2 assay for the diagnosis of RA according to the calculated area under the curve (0.824; 95% confidence interval (CI) 0.778-0.870 versus 0.818; 95% CI 0.767-0.869) as analysed by receiving operating characteristic curve. When categorised with a cutoff value of 20.0 U/ml (as recommended by the manufacturer), sensitivity and specificity of the anti-MCV ELISA were 69.5% (95% CI 61.9%-76.5%) and 90.8% (86.9%-93.8%), respectively, compared with 70.1% (62.5%-77.0%) and 98.7% (96.7%-99.6%) of the anti-CCP2 assay. Using the cutoff values of 19.0 U/ml and 81.5 U/ml for the anti-MCV test to obtain a sensitivity and specificity identical to the anti-CCP2 assay, showed a reduced specificity (89.8%; 85.8%-92.9%) and sensitivity (53.7%; 45.7%-61.5%), respectively, of the anti-MCV ELISA compared with the anti-CCP2 test. In conclusion, the serum ELISA testing for anti-MCV antibodies as well as the anti-CCP-2 assay perform comparably well in the diagnosis of RA. In the high-specificity range, however, the anti-CCP2 assay appears to be superior to the anti-MCV test.
抗瓜氨酸波形蛋白抗体是与瓜氨酸化蛋白发生反应的自身抗体家族成员，也是类风湿关节炎（RA）诊断中最具特异性的血清学标志物之一。本研究旨在测试一种新开发的酶联免疫吸附测定（ELISA）检测抗基因改造瓜氨酸波形蛋白抗体（抗MCV）的诊断价值，并与第二代抗环瓜氨酸肽（抗CCP2）ELISA检测系统进行比较。根据制造商的说明，对631例患者（409例连续门诊患者和222例随机选择的储存血清）的盲法血清进行检测，这些患者患有RA（n = 164）和非RA（骨关节炎[n = 120]、风湿性多肌痛/巨细胞动脉炎[n = 80]、脊柱关节炎[n = 36]以及其他炎性风湿性或非炎性疾病[n = 67]），以检测抗MCV和抗CCP2抗体的存在。根据计算的曲线下面积分析，抗MCV在RA诊断中的诊断性能与抗CCP2检测相当（0.824；95%置信区间[CI] 0.778 - 0.870，而抗CCP2为0.818；95% CI 0.767 - 0.869），通过接受操作特征曲线进行分析。当以20.0 U/ml的临界值分类时（如制造商推荐），抗MCV ELISA的敏感性和特异性分别为69.5%（95% CI 61.9% - 76.5%）和90.8%（86.9% - 93.8%），相比之下抗CCP2检测分别为70.1%（62.5% - 77.0%）和98.7%（96.7% - 99.6%）。使用抗MCV检测的19.0 U/ml和81.5 U/ml临界值以获得与抗CCP2检测相同的敏感性和特异性，结果显示抗MCV ELISA的特异性（89.8%；85.8% - 92.9%）和敏感性（53.7%；45.7% - 61.5%）分别低于抗CCP2检测。总之，血清ELISA检测抗MCV抗体以及抗CCP - 2检测在RA诊断中表现相当。然而，在高特异性范围内，抗CCP2检测似乎优于抗MCV检测。
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