Mx3000p^(TM)实时荧光定量PCR仪HBV-DNA检测系统的性能验证

Performance verification of Mx3000p^(TM) real-time fluorescent quantitative PCR HBV-DNA detection system

目的验证Mx3000p^(TM)实时荧光定量PCR仪HBV-DNA检测系统的性能,确定该系统是否稳定可靠,是否满足临床需求。方法参考美国临床实验室标准化委员会(NCCLS)颁布的EP系列文件及中国合格评定国家认可委员会(CNAS)对实验室检测系统评估的要求,对Mx3000p^(TM)实时荧光定量PCR仪进行性能评价,主要从以下几个方面进行:精密度、正确度、线性、测量和/或可报告范围及抗干扰能力等。结果 Mx3000p^(TM)实时荧光定量PCR仪HBV-DNA检测系统的批内精密度(批内CV)分别为5.21%(低浓度)、3.40%(高浓度);批间精密度(批间CV)为3.45%(中值),1.39%(高值);准确度评估以参加能力验证/室间质评的项目来判断,项目PT成绩为100%,通过;线性回归方程是Y=1.010X+0.004,R^2=0.991线性范围为5.00×10~2~2.84×10~8 U/m L;临床可报告范围为10~3~10~8 U/mL;抗干扰能力评估:检测5个样品中至少个样品测量结果与分析物预期浓度偏倚<±7.5%。结论 Mx3000p^(TM)实时荧光定量PCR仪HBV-DNA检测系统具有良好的精密度、准确度、线性范围、临床可报告范围、抗干扰能力,可用于临床标本检测。

Objective To verify the performance of Mx3000p^TM real-time fluorescent quantitative PCR HBV-DNA detection system, in order to confirm its stability, accuracy and reliability. Methods According to the EP series of document issued by the National Committee for Clinical Laboratory Standards（NCCLS） and requirements for the assessment of laboratory testing systems issued by China National Accreditation Service for Conformity Assessment（CNAS）, the precision, accuracy, linear, measurement and/or reportable range and anti-interference ability of Mx3000p^TM real-time fluorescent quantitative PCR were performed and evaluated. Results The within-batch precision CV of low value and high value of Mx3000p^TM real-time fluorescent quantitative PCR HBV-DNA testing system was 5.21% and 3.40%,respectively, and the between-batch precision CV of middle value and high value was 3.45% and 1.39% respectively.The correctness was valuated by participating in verification of room to judge the qualitative evaluation of the project and PT result was 100%. The linear regression equation was Y = 1.010 X ＋0.004, R^2= 0.991. The linearity range was 5.00×10^2-2.84×10^8 U/m L, the clinical reportable range was 10^3-10^8 U/m L; five samples was tested to assess the anti-interference capability, four sample measurement results according to the concentration of expected bias was 〈±7.5%. Conclusion The performance of Mx3000p^TM real-time fluorescent quantitative PCR HBV-DNA testing system conforms to the requirements in precision, accuracy, linear range, clinical reportable range, anti-interference ability and can be applied to the clinical detection.