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两种用于测定髓过氧化物酶(MPO)和蛋白酶3(PR3)自身抗体的免疫分析方法之间的差异。

Discrepancies between two immunoassays for the determination of MPO and PR3 autoantibodies.

作者信息

Sun Qian, Calderon Boris, Zhao Zhen

机构信息

NIH Clinical Center, Department of Laboratory Medicine, Bethesda, MD, USA.

Eli Lilly and Company, Indianapolis, IN, USA.

出版信息

Clin Chim Acta. 2017 Jul;470:93-96. doi: 10.1016/j.cca.2017.05.008. Epub 2017 May 8.

Abstract

BACKGROUND

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.

METHODS

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).

RESULTS

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%).

CONCLUSION

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.

摘要

背景

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。

方法

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)。

结果

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%)。

结论

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。

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