Gentier96全自动医用PCR分析系统检测HBV-DNA及HCV-RNA的性能验证

A Performance Verification of a Gentier96 Automatic Medical PCR Analytic System via Quantitative Tests on HBV-DNA and HCV-RNA

目的 对实验室新购入设备Gentier96全自动医用PCR分析系统使用HBV-DNA及HCV-RNA定量检测项目进行性能验证。方法 通过检测HBV-DNA及HCV-RNA定量检测项目,对精密度、正确度、线性范围及抗干扰能力进行验证和评价。结果 该系统检测低水平和高水平HBV-DNA的实验室变异系数(CV)分别为4.12%、1.27%。低水平和高水平HCV-RNA的实验室变异系数(CV)分别为4.75%、1.46%。HBV-DNA国家标准物质GBW(E)090137(浓度编号S5)靶值的对数值3.15、GBW(E)090139(浓度编号S2)靶值的对数值6.66。HCV-RNA国家标准物质GBW(E)090140(浓度编号S5)靶值的对数值3.34、GBW(E)090142(浓度编号S3)靶值的对数值5.64,实测值与靶值的差异均在±0.4对数值范围内。该分析系统HBV-DNA定量检测在4.69×10~2.04×109范围内呈线性,线性回归方程为Y=0.9884X+0.1452,R2=0.9994。HCV-RNA定量检测在3.47×10~2.33×107范围内呈线性,线性回归方程为Y=0.9548X+0.3302,R2=0.9997。干扰物质血红蛋白(Hb)样本与对照组样本偏倚<±7.5%,表明常见抗干扰物质血红蛋白(Hb)浓度≤2g/dL时对HBV-DNA和HCV-RNA定量检测结果无影响。结论 Gentier96全自动医用PCR分析系统检测HBV-DNA及HCV-RNA已达到相关标准要求,可用于样本检测。

Objective The current research aimed to verify the performance of newly purchased laboratory equipment,namely,a gentier96 automatic medical PCR analytic system,through quantitative tests on HBV-DNA and HCV-RNA.Methods The precision,accuracy,linear range,and anti-jamming capability of the system were verified and evaluated through quantitative tests on HBV-DNA and HCV-RNA.Results The within-laboratory coefficients of variation(CV s)for low and high levels of the system were 4.12%and 1.27%,respectively,when testing HBV-DNA.The within-laboratory CV s for low and high levels of the system when testing HCV-DNA were 4.75%and 1.46%,respectively.The logarithmic values of target values for national standard reference materials GBW(E)090137(concentration no.S5)and GBW(E)090139(concentration no.S2)of HBV-DNA were 3.15 and 6.66,respectively.The logarithmic values of target values for national standard reference materials GBW(E)090140(concentration no.S5)and GBW(E)090142(concentration no.S3)of HCV-RNA were 3.34 and 5.64,respectively.The differences between the measured values and the target values were all within the logarithmic value of±0.4.The quantitative test results of the analytic system on HBV-DNA were linear within 4.69×10-2.04×109,and the linear regression equation was Y=0.9884 X+0.1452(R 2=0.9994).The results on HCV-RNA were linear within 3.47×10-2.33×107,and the linear regression equation was Y=0.9548 X+0.3302(R 2=0.9997).Samples of the interferent hemoglobin(Hb)showed a bias smaller than±7.5%with samples in the control group,which indicated that Hb at concentrations not larger than 2 g/dL did not influence the quantitative test results on HBV-DNA and HCV-RNA.Conclusion The current research verifies that the Gentier96 automatic medical PCR analytic system can reach the relevant standards and requirements for testing HBV-DNA and HCV-RNA,and therefore it can be used to test samples.