ABI ViiA 7 Taqman HBV-DNA 检测系统性能验证

摘要

目的：验证 ABI ViiA 7 Taqman HBV-DNA 检测系统性能，确定该系统是否稳定、准确、可靠。方法参考美国临床实验室标准化协会（CLSI）颁布的相关文件，从精密度、准确度、线性、可比性等方面对 ABI ViiA 7 Taqman HBV-DNA 检测系统进行性能评价；通过稀释标本直至低于检测下限进行定量检出限验证实验；并与质量目标要求和厂商声明的分析性能进行比较。结果ABI ViiA 7 Taqman HBV-DNA 分析系统的批内精密度（CV 批内）分别为1．485％、1．990％和0．932％；总精密度（CV 总）分别为1．876％、3．361％和1．891％；准确度最大偏移为－6．8％；r2为0．9983，回归方程为Y ＝0．9748X ＋0．0507，线性范围为1．00E2～2．00E8；定量检出限为100 IU／mL；ABIViiA7与 ABI7500两台 PCR 仪的可比性：P ＝0．115，r2＝0．994，线性比对直线回归方程为Y ＝0．9872X ＋0．0517。结论ABI ViiA 7 Taqman HBV-DNA 检测系统具有优良的精密度、准确度、灵敏度、线性，与 ABI7500检测系统有良好的相关性，可用于临床标本检测。%Objective To verify the performance of the ABI ViiA 7 Taqman HBV-DNA detecting system for confirming its sta-bility,accuracy and reliability.Methods According to the evaluation protocols of Clinical and Laboratory Standards Institute (CLSI),the performance of ABI ViiA 7 Taqman HBV-DNA detecting system was assessed in the aspects of precision,accuracy,lin-earity and comparability;the quantitative detection limit validation experiments was performed by diluting specimen until quantita-tive detection limit is lower than the lower limit of detection,and the detection results were compared with the quality target re-quirements and the analysis capability declared by manufacturers.Results The CV in within-run precision of this detection system was 1.485%,1.990% and 0.932% respectively;the total CV was 1.876%,3.361% and 1.891%,respectively;the maximum devia-tion of accuracy was -6.8%;the linear correlation coefficient was 0.998 3;the regression equation was Y =0.974 8X +0.050 7. The linear range was 1.00E2 - 2.00E8;the quantitative detection limit was 100 IU/mL;the comparability of ABIViiA7 and ABI7500:P =0.115,r2 =0.994,the linear regression equation was Y =0.987 2X +0.051 7.Conclusion The ABI ViiA 7 Taqman HBV-DNA detection system has excellent precision,accuracy,sensitivity and linearity and has a good correlation with ABI7500, which can be used for the detection of clinical specimens.