摘要
目的按《医疗机构临床实验室管理方法》和ISO15189要求评价新检测系统Vitros5,1FS自动生化分析仪的分析性能。方法分别对丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、肌酸激酶、乳酸脱氢酶、碱性磷酸酶、γ-谷酰转移酶、总蛋白、清蛋白、总胆红素、血糖、尿素氮、肌肝、钙、淀粉酶、钾、钠、氯、尿酸的准确度、精密度、线性范围进行性能评价,并验证其参考区间。结果精密度日内CV%值为0%～4%;日间CV%值为0.6%～8.2%;准确度、精密度、线性范围均达到要求;ALT、AST、LDH、Crea的参考区间与《VITROS方法学手册》提供的一致,其余符合《全国临床检验操作规程》。结论通过对Vitros5,1FS自动生化分析仪的生化检测系统各项性能进行性能评价后表明,该系统18项生化指标的精密度和准确性、线性、参考范围等能满足临床需要。
Objective To estimate the efficiency of biochemistry detection system of Vitros5, 1FS automatic biochemistry analyzer with the requirement of ISO15189. Methods The accuracy,precision and linear range of alanine aminotransferase,aspartate amino transferase, creatine kinase, lactate dehydrogenase, alkaline phosphatase, γ-glutamyltransferase, total protein, albumin, total bilirubin, glucose, urea nitrogen, Crea, calcium, magnesium, phosphonium, amylase, lypase, kalium, natrium, chlorinum, uric acid, cholinesterase were estimated, and the reference interval were authenticated. Results The results indicated that the within-day precision CV% was 0%-4% and day to day CV% was 0.6%-8.2%. The accuracy,precision and linear range all achieved request. The reference interval of alanine aminotransferase, aspartate amino transferase, lactate dehydrogenase, Crea accorded with those provided by 〈VITROS technology handhook〉, and the rest was consistented with that of 〈Nation clinic laboratory operaling manual〉. Conclusion It is indicated that the accuracy,and precision of detection results of each biochemical indicator are satisfied with the demand after efficiency evaluation on VitrosS, 1FS automatic biochemistry analyzer.
出处
《重庆医学》
CAS
CSCD
北大核心
2009年第19期2406-2408,共3页
Chongqing medicine
作者简介
通讯作者，电话：（023）89012756，Email：Liuzhangcq@yahoo．com。
