罗氏LightCycler Nano荧光定量PCR仪性能评价  

Performance evaluation of Roche LightCycler Nano fluorogenic quantitative PCR instrument

作　　者：张宇[1] 李冬[1] 戴燕[1] 郑为超[2] 万海英[1] 

机构地区：[1]同济大学附属同济医院检验科,上海200065 [2]安徽理工大学医学院,安徽淮南232001

出　　处：《检验医学与临床》2015年第2期145-146,共2页Laboratory Medicine and Clinic

基　　金：国家自然科学基金资助项目(81273777);国家自然科学基金资助项目(81272603);上海市浦江人才计划项目(13PJ1407300);安徽省自然科学基金项目(11040606M203)

摘　　要：目的对美国罗氏公司LightCycler Nano 32孔荧光定量聚合酶链反应(PCR)仪的主要性能指标进行评价。方法按照美国临床实验室标准化协会(CLSI)制定的评价标准,评价仪器精密度、准确度、灵敏度、可报告范围、仪器间比对等指标。结果LightCycler Nano精密度批内变异系数(CV)为2.63%、1.51%,批间CV为6.2%、4.15%;准确度与室间质控物比较,5个标本均在靶值区间内;灵敏度检测CV≤10%;可报告范围为最大稀释比例1∶100;与比对仪器的比对结果偏差结果均小于15%。结论罗氏LightCycler Nano荧光定量PCR仪5项性能经验证后与厂家提供的性能参数相符,可以用于临床检测。Objective To evaluate the major performance indexes of American Roche LightCycler Nano 32 holes fluorogenic quantitative PCR instrument .Methods According to the evaluation standard formulated by the Clinical and Laboratory Standars Institute（CLSI） ,the precision ,accuracy ,sensitivity ,reportable range and compari‐son between the instruments were evaluated .Results The coefficients of variation（CV） for within‐run assays were 2 .63% and 1 .51% respectively ;CV for between‐run assays were 6 .2% and 4 .15% respectively ;comparing the accu‐racy with the between‐run quality control material ,the five samples were within the target value range;CV for sensi‐tivity was ≤ 10% ;the reportable range of the maximum dilution was 1∶100;the bias of the comparison results with the comparative instrument was less than 15% .Conclusion The verified 5 items of performance in the Roche Light‐Cycler Nano fluorogenic quantitative PCR instrument conform to the performance parameters provided by the manu‐facturer ,indicating that this instrument can be applied in clinical testing in our laboratory .

关 键 词：LIGHTCYCLER NANO PCR 性能评价 精密度 

分 类 号：R378.7[医药卫生—病原生物学]