CAJ | 학술논문

目的：根据ISO15189实验室认可的要求对Miditron ? JuniorⅡ尿液干化学分析仪的精密度、阴／阳性符合率进行性能评价及比对。方法用新鲜尿液验证批内精密度；用配套质控品验证批间精密度与日间精密度；用室间质评结果验证阴／阳性符合率；用新鲜尿液对3台仪器进行比对。结果验证结果均符合要求。结论 M id‐itron ? JuniorⅡ尿液干化学分析仪符合本科室制定的性能验证规则的要求。
목적：근거ISO15189실험실인가적요구대Miditron ? JuniorⅡ뇨액간화학분석의적정밀도、음／양성부합솔진행성능평개급비대。방법용신선뇨액험증비내정밀도；용배투질공품험증비간정밀도여일간정밀도；용실간질평결과험증음／양성부합솔；용신선뇨액대3태의기진행비대。결과험증결과균부합요구。결론 M id‐itron ? JuniorⅡ뇨액간화학분석의부합본과실제정적성능험증규칙적요구。
Objective To evaluate the negative ,positive coincidence rate and precision of Miditron ? Junior Ⅱurine dry chemistry analyzer according to the requirement of the ISO15189 laboratory accreditation .Methods Fresh urine was used to verify within‐run precision .Precision of inter‐batch and inter‐day were verified by the quality con‐trol material .The negative and positive coincidence rate was verified with external quality assessment results .Three instruments were compared with fresh urine .Results Verification results all conformed to the requirements .Conclu‐sion Miditron ? Junior Ⅱ urine dry chemistry analyzer meets the requirement of the performance validation that our laboratory formu lated .