化学发光法定量检测抗MPO和PR3抗体的性能评价

Performance evaluation to chemiluminescence immunoassay for the quantitative measurement to anti-MPO and anti-PR3

目的分析化学发光法(CLIA)对抗髓过氧化物酶抗体(anti-MPO)和抗蛋白酶3抗体(anti-PR3)定量检测的相关性能。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,应用临床标本对CLIA方法检测anti-MPO和anti-PR3的精密度、线性和方法学对比等重点性能指标开展分析,同时应用美国疾病控制中心(CDC)标准物质对基于CLIA建立的anti-MPO和anti-PR3检测项目开展量值溯源检测。结果应用CLIA检测anti-MPO和anti-PR3的批内精密度和批间精密度CV均<10%;anti-MPO和anti-PR3线性范围r值分别为0.998和0.992;CLIA与ELISA的检测结果对比显示anti-MPO和anti-PR3的总符合率均>95%,而量值相关系数rho分别为0.67和0.64。anti-MPO和anti-PR3国际标准物质经CLIA检测,结果分别为1214 RU/mL和5714 RU/mL。结论CLIA检测anti-MPO和anti-PR3时,表现出良好的精密度和线性范围,与ELISA方法具有较高的符合率且量值具有相关性,可满足临床对于anti-MPO和anti-PR3定量检测的需要。

Objective To evaluate the feature of quantitative measurement to anti myeloperoxidase antibody(anti-MPO)and Anti protease 3 antibody(anti-PR3)with chemiluminescence immunoassay(CLIA).Methods According to the requirements of EP series documents of American Society for clinical and laboratory standardization(CLSI),clinical samples were used to analyze the precision,linearity and methodological comparison of CLIA method in detecting anti-MPO and anti-PR3.At the same time,CDC reference materials were used to carry out quantitative traceability detection for anti-MPO and anti-PR3 detection projects based on CLIA.Results The coefficient variation(CV)within run and intra-day for both anti-MPO and anti-PR3 from the precision study were all below 10%.The linearity analysis showed linearity regression value for anti-MPO and anti-PR3 were 0.998 and 0.992,respectively.The total agreement from method comparison between CLIA and ELISA for each assays were all higher than 95%,together with good correlation coefficient as 0.67(anti-MPO)and 0.64(anti-PR3).The international standard for anti-MPO and anti-PR3 yielded result of 1214 RU/mL and 5714 RU/mL in CLIA.Conclusion CLIA showed good precision and linear range in the detection of anti-MPO and anti-PR3.It had high coincidence rate with ELISA method and had correlation with the quantity value.It could meet the clinical needs for quantitative detection of anti-MPO and anti-PR3.