Beckman Coulter Access DXI800与Cobas e411两种化学发光免疫检测系统检测血清总β―HCG结果比对分析.docVIP

Beckman Coulter Access DXI800与Cobas e411两种化学发光免疫检测系统检测血清总β―HCG结果比对分析 　　[摘要] 目的 通过比较同一实验室2台不同化学发光免疫检测系统（贝克曼DXI800直接化学发光、Cobas e411电化学发光）测定血清总β-HCG的结果，探讨2种方法检测β-HCG的是否具有可比性，为不同仪器测定实验结果互认提供依据。 方法 Beckman Coulter Access DXI800使用美国伯乐公司提供的质控品Biorad低值、中值，Cobas e411采用罗氏原装质控品低值、中值分别对两台仪器进行日常室内质控，保证结果均在控。在此基础上，选取不同浓度常规血清标本40份先在Beckman Coulter Access DXI800化学发光系统进行检测，再用Cobas e411电化学发光检测系统进行检测。选择贝克曼DXI800化学发光检测系统作为参考仪器进行数据比对。所有检测结果均在2 h内完成。 结果2种检测系统对不同浓度的质控品检测总β-HCG的结果日间CV及总CV均小于15%的日间CV允许范围。40个不同浓度的β-HCG在两个检测系统上的检验结果进行配对t检验的结果P值为0.5630.05，结果差异无统计学意义。相关性分析显示相关系数r2为0.99360.95，符合美国临床化学实验室标准化委员会EP9-A2文件的要求，满足实验要求。 结论 通过比对实验，可以看出两种检测系统对总β-HCG检测结果具有较高的准确性和一致性，避免了结果差异给临床诊断带来的困扰，可以同时发布检测结果。 　　[关键词] 化学发光；β-HCG；比对分析 　　[中图分类号] R446.6 [文献标识码] A [文章编号] 1674-0742（2016）08（b）-0033-04 　　[Abstract] Objective To Compare two different chemiluminescene assays （Beckman Coulter Access DXI800 and Cobas e411） for the detection of human serum total β-chorionic gonadotropin（β-HCG）and discuss they are comparable between the two different ECL assays， in order to provide evidence for mutual accredit between different assay systems. Methods Biorad low and median value QC were used for Beckman Coulter Access DXI800 and Roche original low and median value QC were used for Cobas e411 daily， guaranteed all the results were in control. On this basis， 40 different serum samples were compared of β-HCG by Beckman Coulter Access DXI800（candidate method） and Cobas e411 （reference method）， all data were tested in 2 hours. Results The different QC daily CV and total CV for β-HCG tested by two analyzers were less than 15% of the day CV allows the scope of . Data of 40 different concentrations of β-HCG in two test systems were paired by t test， showed no significant difference（P=0.5630.05）. Correlation analysis showed the coefficient r2 was 0.99360.975， in line with the requirements of the EP9-A2 file of the American clinical chemistry laboratory standardization committee， which met the requirements of the experimen