Hirose Orie, Itabashi Mitsuyo, Takei Takashi, Nitta Kosaku
Department of Medicine, Kidney Center, Tokyo Women's Medical University , Tokyo , Japan.
Mod Rheumatol. 2015 Mar;25(2):230-4. doi: 10.3109/14397595.2014.951113. Epub 2014 Nov 12.
Myeloperoxidase (MPO) anti-neutrophil cytoplasmic antibody (ANCA) represents the serological hallmark of ANCA-associated vasculitis (AAV). We evaluated the analytical and diagnostic accuracy of chemiluminescence enzyme immunoassay (CLEIA) versus enzyme-linked immunosorbent assay (ELISA) for the detection of MPO-ANCA.
A total of 242 sera obtained from 51 patients with AAV and 103 patients without AAV were tested for MPO-ANCA by ELISA (NephroScholor MPOANC II) and CLEIA (the STACIA MEBLux test). Disease activity in the patients with AAV was determined based on the Birmingham Vasculitis Activity Score. We analyzed the correlations between the MPO-ANCA titers determined by the CLEIA and those determined by the ELISA, and also between the MPO-ANCA titers and the disease activity.
The MPO-ANCA titers determined by the CLEIA (x) were strongly correlated with those determined by the ELISA (y). The correlation could be expressed by the following equation in this study: y = 1.8x + 7.7 (r = 0.96; p < 0.0001). At the cutoff value of 3.5 U/ml, the CLEIA yielded positive test results for MPO-ANCA in 73 of the 242 sera (30.2%), while at the cutoff value of 20 U/ml, ELISA yielded positive test results in 57 of the 242 sera (23.6%). The CLEIA yielded false-positive test results in 4 of the 120 sera obtained from the non-AAV patients (3.3%), whereas the ELISA yielded a false-positive result in only 1 of the 120 sera obtained from the non-AAV patients (0.8%). The sensitivity and specificity of the CLEIA for the diagnosis of AAV were 100% and 96.7%, respectively, while those of the ELISA were 94.3% and 99.2%, respectively. The sensitivity and specificity of the CLEIA for the prediction of active disease were 100% and 64.4%, respectively, while those of the ELISA were 94.3% and 73.6%, respectively.
The false positivity rate of the CLEIA for MPO-ANCA tended to be high as compared with that of the ELISA. Also, according to the correlation coefficient between the results of the CLEIA and the ELISA calculated in this study, it is necessary to pay attention to the differences in the sensitivity and specificity between CLEIA and ELISA.
髓过氧化物酶（MPO）抗中性粒细胞胞浆抗体（ANCA）是ANCA相关性血管炎（AAV）的血清学标志。我们评估了化学发光酶免疫分析（CLEIA）与酶联免疫吸附测定（ELISA）检测MPO-ANCA的分析准确性和诊断准确性。
通过ELISA（NephroScholor MPOANC II）和CLEIA（STACIA MEBLux检测）对从51例AAV患者和103例非AAV患者获得的共242份血清进行MPO-ANCA检测。根据伯明翰血管炎活动评分确定AAV患者的疾病活动度。我们分析了CLEIA测定的MPO-ANCA滴度与ELISA测定的滴度之间的相关性，以及MPO-ANCA滴度与疾病活动度之间的相关性。
CLEIA测定的MPO-ANCA滴度（x）与ELISA测定的滴度（y）高度相关。在本研究中，相关性可用以下方程表示：y = 1.8x + 7.7（r = 0.96；p < 0.0001）。在3.5 U/ml的临界值时，CLEIA在242份血清中的73份（30.2%）中检测到MPO-ANCA阳性结果，而在20 U/ml的临界值时，ELISA在242份血清中的57份（23.6%）中检测到阳性结果。在从非AAV患者获得的120份血清中，CLEIA产生了4份假阳性结果（3.3%），而ELISA在从非AAV患者获得的120份血清中仅产生了1份假阳性结果（0.8%）。CLEIA诊断AAV的敏感性和特异性分别为100%和96.7%，而ELISA的敏感性和特异性分别为94.3%和99.2%。CLEIA预测活动性疾病的敏感性和特异性分别为100%和64.4%，而ELISA的敏感性和特异性分别为94.3%和73.6%。
与ELISA相比，CLEIA检测MPO-ANCA的假阳性率往往较高。此外，根据本研究计算的CLEIA和ELISA结果之间的相关系数，有必要注意CLEIA和ELISA在敏感性和特异性方面的差异。
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