CAJ | 학술논문

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。
목적：대미국라씨공사LightCycler Nano 32공형광정량취합매련반응（PCR）의적주요성능지표진행평개。방법안조미국림상실험실표준화협회（CLSI）제정적평개표준，평개의기정밀도、준학도、령민도、가보고범위、의기간비대등지표。결과 LightCycler Nano 정밀도비내변이계수（CV ）위2．63％、1．51％，비간 CV 위6．2％、4．15％；준학도여실간질공물비교，5개표본균재파치구간내；령민도검측 CV≤10％；가보고범위위최대희석비례1∶100；여비대의기적비대결과편차결과균소우15％。결론라씨LightCycler Nano형광정량PCR의5항성능경험증후여엄가제공적성능삼수상부，가이용우림상검측。
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 .