同一厂家两种胱抑素C检测试剂盒的性能验证及其检测结果的一致性(1)
摘 要：目的 对同一厂家生产的胶体金增强免疫法(标为A)和胶乳免疫比浊法(标为B)胱抑素C测定试剂盒在日立7600全自动分析仪上的分析性能进行验证，并通过方法比对评估两试剂盒检测结果的一致性。方法 参照我国卫生行业标准WS/T420-2013对两试剂盒的精密度、正确度及线性范围进行验证，其结果与厂家声称的性能指标进行比较；并参照EP9-A2文件对两试剂盒進行方法比对，评估其检测结果的一致性。结果 两试剂盒的批内不精密度均≤3.15%，总不精密度均≤4.81%；5份室间质评样本的检测结果与靶值的偏倚≤10.07%；线性范围内其斜率(b)均在0.97～1.03范围内，截距(a)接近于0，相关系数R2均>0.995，回收率均在理论值±10%的范围内；两试剂盒的以上性能指标均满足YY/T1230-2014行业标准及试剂厂家声明的性能和质量指标的要求。两试剂盒方法比对结果显示，回归方程为Y=1.03X+0.0181，相关系数R2为0.9956，不同医学决定水平处的预期偏倚均小于我国室间质评要求的1/5。结论 某公司生产的两种Cys-C检测试剂盒的分析性能均满意，且两方法间检测结果一致，均能满足临床实验室的要求。
, 百拇医药
关键词：胱抑素C；性能验证；一致性
中图分类号：R446.6 文献标识码：A DOI：10.3969/j.issn.1006-1959.2018.15.018
文章编号：1006-1959(2018)15-0055-04
Performance Verification of Two Cystatin C Test Kits and Consistency of Test Results from the Same Manufacturer
XIONG Wu-fang，YANG Na，XIAO Guang-jun，LIU Yan-ting，CAO Dan，LI Xiang-kun
(Department of Clinical Laboratory，Suining Central Hospital，Suining 629000，Sichuan，China)
, 百拇医药
Abstract：Objective To verify the analytical performance of colloidal gold enhanced immunoassay(marked as A)and latex immunoturbidimetric assay(marked as B)cystatin C kit produced by the same manufacturer on Hitachi 7600 automatic analyzer. The consistency of the test results of the two kits was evaluated by comparing the methods.Methods The precision，accuracy and linear range of the two kits were verified by referring to the health industry standard WS/T420-2013 of China， and the results were compared with the performance indexes claimed by the manufacturers，and the two kits were compared with the EP9-A2 documents. Evaluate the consistency of the test results.Results The intraspecific inaccuracies of the two kits were≤3.15%，the total inaccuracies were≤4.81%.The bias between the measured results and the target values of 5 samples was≤10.07%.In the linear range，the slope(b) is in the range of 0.97～1.03， the intercept(a)is close to 0，the correlation coefficient R2 is>0.995，and the recoveries are within the range of theoretical value ±10%.The above performance indexes of both kits meet the requirements of YY/T1230-2014 industry standards and the performance and quality indicators declared by reagent manufacturers.Two kits method comparison result showed that the regression equation was Y=1.03X+0.0181 and the correlation coefficient R2 was 0.9956.The expected bias of different medical decision levels was less than 1/5 of the requirement of our country.Conclusion The analytical performance of the two Cys-C test kits produced by a certain company is satisfactory，and the results of the two methods are consistent，which can meet the requirements of clinical laboratory., http://www.100md.com(熊武芳 杨娜 肖光军 刘艳婷 曹丹 李祥坤)
, 百拇医药
关键词：胱抑素C；性能验证；一致性
中图分类号：R446.6 文献标识码：A DOI：10.3969/j.issn.1006-1959.2018.15.018
文章编号：1006-1959(2018)15-0055-04
Performance Verification of Two Cystatin C Test Kits and Consistency of Test Results from the Same Manufacturer
XIONG Wu-fang，YANG Na，XIAO Guang-jun，LIU Yan-ting，CAO Dan，LI Xiang-kun
(Department of Clinical Laboratory，Suining Central Hospital，Suining 629000，Sichuan，China)
, 百拇医药
Abstract：Objective To verify the analytical performance of colloidal gold enhanced immunoassay(marked as A)and latex immunoturbidimetric assay(marked as B)cystatin C kit produced by the same manufacturer on Hitachi 7600 automatic analyzer. The consistency of the test results of the two kits was evaluated by comparing the methods.Methods The precision，accuracy and linear range of the two kits were verified by referring to the health industry standard WS/T420-2013 of China， and the results were compared with the performance indexes claimed by the manufacturers，and the two kits were compared with the EP9-A2 documents. Evaluate the consistency of the test results.Results The intraspecific inaccuracies of the two kits were≤3.15%，the total inaccuracies were≤4.81%.The bias between the measured results and the target values of 5 samples was≤10.07%.In the linear range，the slope(b) is in the range of 0.97～1.03， the intercept(a)is close to 0，the correlation coefficient R2 is>0.995，and the recoveries are within the range of theoretical value ±10%.The above performance indexes of both kits meet the requirements of YY/T1230-2014 industry standards and the performance and quality indicators declared by reagent manufacturers.Two kits method comparison result showed that the regression equation was Y=1.03X+0.0181 and the correlation coefficient R2 was 0.9956.The expected bias of different medical decision levels was less than 1/5 of the requirement of our country.Conclusion The analytical performance of the two Cys-C test kits produced by a certain company is satisfactory，and the results of the two methods are consistent，which can meet the requirements of clinical laboratory., http://www.100md.com(熊武芳 杨娜 肖光军 刘艳婷 曹丹 李祥坤)