化学发光法定量检测抗ENA抗体和抗dsDNA抗体临床性能评价

Clinical performance evaluation to chemiluminescence immunoassay for the detection of anti-ENA and anti-dsDNA

目的分析SMART-6500化学发光检测平台针对抗可提取物核抗原抗体(抗ENA抗体)及抗双链DNA抗体(抗dsDNA抗体)的定量检测性能。方法参照美国临床和实验室标准化协会(CLSI)EP系列文件的要求,分析SMART-6500化学发光检测平台检测抗ENA抗体和抗dsDNA抗体的精密度、线性范围、生物参考区间和方法学对比等性能指标。应用世界卫生组织(WHO)标准物质(NIBCS代码:15/174)对抗dsDNA抗体检测项目开展量值溯源研究。结果抗ENA抗体和抗dsDNA抗体的批内精密度变异系数(CV)和批间精密度CV分别处于2.16%~6.67%和4.70%~12.71%;线性范围R值处于0.9926~0.9980;方法学对比显示所有检测项目的总符合率均大于90%。抗dsDNA抗体国际标准物质经SMART-6500检测结果为24.67U/mL。结论SMART-6500化学发光检测平台在检测抗ENA抗体和抗dsDNA抗体时,表现出良好的精密度和线性范围,与酶联免疫吸附试验的检测结果具有较高的符合率,因此可满足免疫临床对于抗ENA抗体和抗dsDNA抗体定量检测的需要。

Objective To evaluate the feature of quantitative measurement to anti-ENA antibody and anti-dsDNA with SMART-6500 chemiluminescence immunoassay. Methods According to the requirements of Clinical and Laboratory Standards Institute (CLSI) EP series documents,the performance indicators of SMART-6500 Chemiluminescence Detection Platform for detecting anti-ENA and anti-dsDNA,such as precision,linear range,biological reference range and methodological comparison,were analyzed.The quantitative traceability of anti dsDNA detection project was studied by using World Health Organization (WHO) reference material (NIBCS code:15/174). Results The coefficient variation (CV) for each assay from the precision study ranged from 2.16% to 6.67%(within-run) and from 4.70% to 12.71%(intra-day),respectively.The linearity analysis showed linearity regression value within 0.992 6-0.998 0 for each assay.Methodological comparison showed that the total coincidence rate of all test items was more than 90%.Anti-dsDNA international standard substance was detected by SMART-6500 was 24.67 U/mL. Conclusion SMART-6500 Chemiluminescence Detection Platform shows good precision and linearity in detecting anti-ENA and anti-dsDNA,and has a high coincidence rate with enzyme linked immunosorbent assay detection results,so it can meet the needs of immunology clinic for quantitative detection of anti-ENA and anti-dsDNA.