CAJ | 학술논문

目的：根据ISO15189：2007（E）《医学实验室质量和能力认可准则》，对强生公司的VITROS FUSION 5.1全自动生化分析仪进行精密度和正确度验证。方法：采用美国临床实验室标准化协会（CLSI）文件EP15-A2、EP9-A2对强生VITROS FUSION 5.1常规急诊项目肌酐（CR）、尿素（BUN）、尿酸（UA）三者的精密度以及正确度进行性能验证。结果：强生VITROS FUSION 5.1三个常规急诊项目的批内精密度与实验室内精密度均小于厂家声明的批内与实验室内精密度；在与参比系统Olympus5400的比对实验中，待评系统VITROS FUSION 5.1检测系统呈明显相关，各检测项目在医学决定水平的相对偏倚均小于1/2 CLIA'88总误差（TEa），两者所测结果具有可比性。结论：强生VITROS FUSION 5.1的精密度与正确度性能较好，符合临床对检测结果的要求。
목적：근거ISO15189：2007（E）《의학실험실질량화능력인가준칙》，대강생공사적VITROS FUSION 5.1전자동생화분석의진행정밀도화정학도험증。방법：채용미국림상실험실표준화협회（CLSI）문건EP15-A2、EP9-A2대강생VITROS FUSION 5.1상규급진항목기항（CR）、뇨소（BUN）、뇨산（UA）삼자적정밀도이급정학도진행성능험증。결과：강생VITROS FUSION 5.1삼개상규급진항목적비내정밀도여실험실내정밀도균소우엄가성명적비내여실험실내정밀도；재여삼비계통Olympus5400적비대실험중，대평계통VITROS FUSION 5.1검측계통정명현상관，각검측항목재의학결정수평적상대편의균소우1/2 CLIA'88총오차（TEa），량자소측결과구유가비성。결론：강생VITROS FUSION 5.1적정밀도여정학도성능교호，부합림상대검측결과적요구。
Objective:To demonstrate automatic biochemical analyzer-- VITROS FUSION 5.1 dry biochemical analyzer performance of precision and accuracy through the requirement of ISO15189:2003(E)< Medical Laboratory-Quality and Ability of Special Requirements>.Methods:In accordance with the clinical laboratory management and the national laboratory accreditation requirements, the precision and accuracy of VITROS FUSION 5.1 routine emergency items on serum creatinine (Cr), carbamide (Urea) and Uric Acid (UA) were detected by the United States Clinical and Laboratory Standard Institute document EP-15A2 and EP-9A2.Results: VITROS FUSION 5.1 dry biochemical analyzer the within-run precision and total precision of Cr, Urea, UA were less than manufacturers claimed within-run precision and total precision; In VITROS FUSION 5.1 and Olympus 5400 experiment, detection system was related, the relative bias of each items at its medical determined levels were less than the half of CLIA’88 standard.Conclusions:The precision and accuracy of VITROS FUSION 5.1 were fine; it can meet the requirements of clinical.