血清胰淀粉酶试剂盒方法性能评价  

Evaluation of Analytic Performance of Pancreatic Amylase Reagent

作　　者：杨滨[1] 李贵星[1] 李萍[1] 彭志英[1] 周君[1] 唐书强[1] 朱义芳[1] 

机构地区：[1]四川大学华西医院实验医学科,四川成都610041

出　　处：《华西医学》2008年第4期832-833,共2页West China Medical Journal

基　　金：美国中华医学基金会临床实验室认可项目(CMB00-737)

摘　　要：目的:对商品化血清胰淀粉酶试剂盒进行性能评价,判断其分析性能是否满足临床要求。方法:按照国家医学实验室认可及CAP认可要求,依照NCCLS EP5-A文件,分析P-胰蛋白酶试剂盒日内和日间精密度;用能力对比评价分析方法的准确度;按照NCCLS EP6-P文件评价分析方法的线性范围;评价分析方法的最低检测限和携带污染率;并对说明书的参考范围进行验证。结果:胰蛋白酶试剂盒的日内精密度小于1/4总分析误差,日间精密度小于1/3总分析误差;分析方法的能力比对结果合格;分析方法的线性范围符合临床要求;说明书提供的分析方法参考范围符合实验室需要;其它指标符合性能评价要求。结论:该商品化胰淀粉酶试剂盒符合实验室性能标准。Objective：To analyzed a novel commercial pancreatic amylase reagent and to identify whether its performance is acceptable for medical use of the test results.Methods：According to the requirement of accreditation of national laboratory and CAP,the within-day and between-day precision of pancreatic amylase reagent were analyzed following the NCCLS EP5-A document.Accuracy of the method was analyzed by results of proficiency testing of CAP.Linear range of the test methods were analyzed according to NCCLS EP6-P document.The low limited detection and carryover of the method were evaluated,and the reference range of the reagent instruction was validated.Results：The with-day precision of pancreatic amylase reagent was lower than quarter of total allowed error and the between-day precision was lower than one-third of total allowed error.Results of proficiency testing of the test methods were qualified.The linear range of the test method satisfied the medical requirement.The reference range of reagent instruction satisfied the laboratory requirement.And other performances satisfied the definition of quality goal.Conclusion：The analytical performance characteristics of pancreatic amylase reagent satisfied the laboratory performance goals.

关 键 词：胰淀粉酶 性能 评价 

分 类 号：R446.1[医药卫生—诊断学]