罗氏电化学发光免疫分析仪残留试剂的检测结果分析

Analysis of test results using residual reagents in electrochemiluminescence immunoassay analyzer

目的：探讨电化学发光免疫分析仪残留试剂的检测性能。方法合并残留试剂检测癌胚抗原（CEA ）、甲胎蛋白（AFP）、总前列腺特异性抗原（TPSA），评价其精密度和回收率；同时依据美国国家临床实验室标准委员会EP9-A2文件要求，每天选取8例，连续5个工作日，共分析40个样本，以新试剂为比较方法，合并试剂为试验方法，对检测结果进行对比和偏倚评估。结果回收的残余试剂检测低、高浓度质控品批内和批间变异系数均符合相关标准；回收率在90％～110％间；两种试剂检测结果相关性较好（r2＞0．95）；CEA、AFP、TPSA在两个医学决定水平上的 SE％均在允许偏差的范围内。结论电化学发光免疫分析仪残留试剂检测CEA、AFP、TPSA的性能符合临床要求，能够保证检测质量，同时降低检测成本。

Objective To evaluate the detection efficiency of residual reagent used in electrochemiluminescence immunoassay an-alyzer .Methods Alpha fetoprotein （AFP） ,carcino-embryonic antigen（CEA） and total prostate specific antigen（TPSA） were de-tected by using remaining reagents .The precision and recovery rate of remaining reagents were analyzed .Referring to the document of NCCLS EP9-A2 ,8 clinic samples were detected everyday by residual reagent and new reagent respectively .The test results of to-tal 40 samples were recorded within 5 days .The test results derived from 2 kinds of reagents were analyzed comparatively and their bias was evaluated by using new reagent as a control method and residual reagent as experimental methods .Results The within-run and between-run coefficients of variation（CV） of the 3 items measured by residual reagents in low and high levels of quality control products met the related standard .The recovery rate was variable from 90% to 110% .The test rewults of the 2 kinds of reagents were positively correlated（r2 〉0 .95） .Their anticipated biases were within allowed biases on the medical decision level of CEA ,AFP and T PSA .Conclusion Residual reagent of electrochemiluminescence immunoassay analyzer can meet the clinical practice needs , which also can ensure the quality of measurement and the reduction of the cost .