Sun Qian, Calderon Boris, Zhao Zhen
NIH Clinical Center, Department of Laboratory Medicine, Bethesda, MD, USA.
Eli Lilly and Company, Indianapolis, IN, USA.
Clin Chim Acta. 2017 Jul;470:93-96. doi: 10.1016/j.cca.2017.05.008. Epub 2017 May 8.
Testing for autoantibodies to myeloperoxidase (MPO) and proteinase 3 (PR3) is part of anti-neutrophil cytoplasmic antibodies (ANCA) test that aids the diagnosis of a number of autoimmune diseases including small-vessel vasculitis. We characterized the differences between two automated immunoassays at three facilities for measuring MPO- and PR3-ANCA autoantibodies.
117 serum samples were analyzed for MPO and PR3 autoantibodies. The INOVA QUANTA Lite® IgG assay (INOVA Diagnostics) were performed at two facilities and the Bio-Plex® 2200 Vasculitis Panel (Bio-Rad) were performed at a third reference lab. The results were compared both qualitatively (between INOVA QUANTA Lite® and Bio-Plex® methods) and quantitatively (between two sites performing INOVA QUANTA Lite® assays).
Comparison of the INOVA QUNATA Lite® assays at two different facilities (n=36) demonstrated high concordance (97.2% for MPO and 94.4% for PR3) and quantitative correlation (R=0.973 for MPO and R=0.935 for PR3). Conversely, INOVA QUNATA Lite® and Bio-Plex® methods showed poor concordance at 70.4% for MPO (n=81; 95% CI: 59.7% to 79.2%) and at 76.5% for PR3 (n=81; 95% CI: 66.2% to 84.4%).
This study demonstrated low concordance between two methods for MPO-ANCA and PR3-ANCA measurements. Given the discrepancies, the performance of different autoantibody immunoassay methods should be taken into consideration when evaluating MPO-ANCA and PR3-ANCA results.
检测髓过氧化物酶(MPO)和蛋白酶3(PR3)自身抗体是抗中性粒细胞胞浆抗体(ANCA)检测的一部分,有助于诊断包括小血管血管炎在内的多种自身免疫性疾病。我们对三个机构用于检测MPO-和PR3-ANCA自身抗体的两种自动化免疫测定方法之间的差异进行了表征。
对117份血清样本进行MPO和PR3自身抗体分析。两种机构采用INOVA QUANTA Lite® IgG测定法(INOVA诊断公司),第三个参考实验室采用Bio-Plex® 2200血管炎检测板(伯乐公司)。对结果进行了定性比较(INOVA QUANTA Lite®法与Bio-Plex®法之间)和定量比较(进行INOVA QUANTA Lite®测定的两个机构之间)。
两个不同机构(n = 36)的INOVA QUNATA Lite®测定结果显示高度一致性(MPO为97.2%,PR3为94.4%)和定量相关性(MPO的R = 0.973,PR3的R = 0.935)。相反,INOVA QUNATA Lite®法与Bio-Plex®法显示出较差的一致性,MPO为70.4%(n = 81;95%置信区间:59.7%至79.2%),PR3为76.5%(n = 81;95%置信区间:66.2%至84.4%)。
本研究表明,两种检测MPO-ANCA和PR3-ANCA的方法一致性较低。鉴于存在差异,在评估MPO-ANCA和PR3-ANCA结果时应考虑不同自身抗体免疫测定方法的性能。