胶乳增强免疫透射比浊法测定Cys C的性能评价  

Evaluation of the analytical performance characteristics of latex particle intensified immunity transmission turbidity for systatin C

作　　者：余霆[1] 胥劲[1] 黄丽[1] 李贵星[1] 贺勇[1] 宋昊岚[1] 高宝秀[1] 唐书强[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：《中国输血杂志》2010年第3期191-194,共4页Chinese Journal of Blood Transfusion

基　　金：美国中华医学基金会资助项目(CMB00-737)

摘　　要：目的建立满足临床要求的测定半胱氨酸蛋白酶抑制剂C(cystatin C,CysC)的方法。方法在全自动生化分析仪上建立胶乳增强免疫透射比浊法测定血清CysC的方法,按照国家实验室认可及美国病理学家协会(CAP)认可要求,依据NCCLS EP5-A文件分析该方法的日内和日间精密度;采用回收试验反映该方法的准确度;依据NCCLSEP6-P文件评价该方法的线性范围;评价该分析方法的最低检测限;并对该方法的参考范围做验证。同时对该方法的灵敏度、携带污染率、稀释方案等给予评价。结果该方法日内精密度高、低值分别为0.78%和0.54%,日间精密度高、低值分别为1.23%和1.25,均低于CLIA,88要求的1/4TEA(<5.0%)和1/3TEA(<7.5%);高、低值的回收率为92.7%和96.9%(标准为95.0%—105.0%);线性范围在(0.13—6.92)mg/L,满足试剂所提供的线性范围;参考范围验证结果符合临床要求。结论胶乳增强免疫透射比浊测定CysC,其精密度、回收率、线性范围、参考范围及其他指标均符合临床实验室要求。Objective To establish a method for systatin C to meet the clinical requirements.Methods Using latex particle intensified immunity transmission turbidity to detect Cys C with Olympus AU400 automatic biochemical analyzer,according to the requirement of accreditation of national laboratory and College of America Pathologists（CAP）,following the NCCLS EP5-A document,We analyzed the with-day and between-day precision;recovery test methods were used to reflect the accuracy.According to NCCLS EP6-P document,we analyzed the linear range of the test methods;evaluating the low limited detection and validating the reference range of the reagent instruction.Results The with-day precision were lower than the quarter of allowable total error （TEA,1/4TEA5.0%） and the between-day precision were lower than one-third of TEA （1/3TEA7.5%）.The accuracy of the high and low concentration were 92.7% and 96.9%（standard is 95.0%—105.0%）.The linear range of the test method was（0.13—6.92）mg/L,which satisfied the medical requirement.The reference range of manufacturer satisfied the laboratory requirement;another performances satisfied the definition of quality goal.Conclusions The analytical performance characteristics of latex particle intensified immunity transmission turbidity for systatin C satisfy the laboratory performance goals.

关 键 词：半胱氨酸蛋白酶抑制剂C(Cys C) 胶乳增强的免疫透射比浊法 肾功能 性能评价 精密度 回收率 线性范围 参考范围 

分 类 号：R466.112[医药卫生—临床医学] R692