评价VAPRO 5520渗透压分析仪性能  

Evaluation of analytical performance characteristics of VAPRO 5520 pressure osmometer

作　　者：李贵星[1] 高宝秀[1] 宋昊岚[1] 周君[1] 黄俊[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：《四川医学》2006年第10期993-995,共3页Sichuan Medical Journal

基　　金：美国中华医学会临床实验室认可资助项目(CMB00-737)

摘　　要：目的对VAPRO 5520渗透压分析仪性能进行评价，判断其分析性能是否满足临床要求。方法按照国家实验室认可及CAP认可要求，依照NCCLS EP5-A文件，分析VAPRO 5520日内和日间精密度；用能力对比（PT）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；并对说明书的参考范围进行验证。结果VAPRO 5520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％。分析方法的能力比对结果合格；分析方法的线性范围为50．0～1000．0mmol/kg，符合临床要求；分析方法提供的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VAPRO 5520渗透压分析仪性能符合实验室性能标准。Objective To analyze the analytical performance characteristics of VAPRO 5520 pressure osmometer and to identify whether the performance is acceptable for medical use of the test results. Methods According to the requirement of accreditation of national laboratory and CAP, following the NCCLS EP5-A document, We analyze the with-day and between-day precision; Using the results of proficiency testing identify the accuracy of the test methods; According to NCCLS EP6-P document, We analyze the linear range of the test methods; Evaluating the low limited detection and validating the reference range of the reagent instruction. Results the high/low with-day precision are 0.78 % and 0.54 % and high/low between-day precision are 1.23 % and 1.25 %; the results of proficiency testing of the test methods are qualification;the linear range of the test methods is 50.0～1000.0mmol/kg and satisfy the medical requirement; the reference range of instrument satisfy the laboratory requirement; another performances satisfy the definition of quality goal. Conclusion The analytical performance characteristics of enzyme analytic system of VAORI 5520 pressure osmomete satisfy the laboratory performance goals.

关 键 词：VAPRO 5520渗透压分析仪 渗透压 性能 评价 

分 类 号：TH774[机械工程—仪器科学与技术]