基于不同型号荧光定量PCR仪比对HBV DNA检测结果的一致性分析

Analysis of the consistency of HBV DNA results detected with two different fluorescent quantitative PCR instruments

目的:评价ABI-7500和ABI-ViiA7 Dx两台荧光定量PCR仪检测HBV DNA结果的一致性。方法:按照美国临床实验室标准化委员会EP9-A2文件的要求,以通过卫生部室间质评的ABI-7500 PCR仪为参比仪器,以ABI-ViiA7 Dx作为实验仪器,分别在两台PCR仪上检测40份临床血浆样本的HBV DNA,并进行结果比对和偏移比较。结果:两仪器检测40份血浆标本均无离群;两仪器检测每份样本的偏倚均<±7.5%,符合ISO15189《医学实验室质量和能力认可准则》中扩增检验项目实验室内分析系统定期比对的标准。结论:ABI-7500和ABI-ViiA7 Dx检测HBV DNA结果具有良好的一致性,可同时用于临床标本的检测。

Objective:To evaluate the consistency of HBV DNA results detected with ABI-7500 and ABI-ViiA7 Dx fluorescence quantitative PCR instruments,respectively.Methods:According to the requirements of EP9-A3 document of national committee for clinical laboratory standards of the united states of America,ABI-7500 PCR instrument that passed department of health's internal quality control was served as the reference instrument,and ABI-ViiA7 Dx was used as the experimental instrument to detect HBV DNA in 40 clinical plasma samples.The detected results derived from two different PCR instruments were compared with each other and the bias was calculated.Results:There were no outliers in results of HBV DNA in 40 plasma samples detected with the aforementioned two PCR instruments.The bias of the two instruments is less than±7.5%,which conforms to the standard for regular comparison of analytical systems(the absolute value of system error is less than 7.5%)of ISO15189 accreditation criteria for quality and competence of medical laboratories.Conclusion:The results of HBV DNA detected with ABI-7500 and ABI-ViiA7 Dx fluorescence quantitative PCR instruments have good consistency,which means that all of them can be used in clinical laboratory for sample detection.