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目的评价基于全自动核酸提取工作站ANAS1000的乙型肝炎病毒DNA定量试剂的检测性能,实现乙型肝炎病毒DNA荧光定量PCR自动化检测。方法取定量值为5.0×108标准品进行梯度稀释,评估灵敏度;取中值和高值标准品验证精密度;采用中值和低值质控品验证正确度;平行检测全自动与手工2种提取核酸体系的50份血清标本,评价两者结果的线性关系。结果灵敏度方面,在5.0×102IU/ml~5.0×108IU/ml的梯度范围,呈良好的线性关系(r=0.998 6)。精密度方面,2个样本的重复性实验CV值均<5%。正确度方面,与靶值相近,结果准确可靠。2种体系具有良好的相关性(r=0.985 7),检测结果差异无统计学意义(P>0.05)。结论 ANAS1000在检测HBV DNA应用上表现良好;与圣湘生物科技有限公司的荧光定量PCR有良好的相关性;自动化程度高,生物安全性好,有一定的临床应用价值。
Objective To evaluate the detection performance of Hepatitis B virus DNA quantification reagents based on the fully automated nucleic acid extraction workstation ANAS1000 and realize the automated detection of hepatitis B virus DNA by fluorescence quantitative PCR. Methods Gradient dilution of 5.0 × 108 standard was performed to evaluate the sensitivity. The medium and high standards were used to verify the precision. The medium and low quality controls were used to verify the accuracy. Two methods of parallel and automatic tests Fifty serum samples of the nucleic acid system were extracted to evaluate the linear relationship between the two results. In terms of sensitivity, there was a good linear relationship (r = 0.998 6) in the range of 5.0 × 102IU / ml to 5.0 × 108IU / ml. In terms of precision, the CV values of the two samples were all <5%. Accuracy, similar to the target value, the results are accurate and reliable. There was a good correlation between the two systems (r = 0.985 7). There was no significant difference in the test results (P> 0.05). Conclusion ANAS1000 performs well in the detection of HBV DNA. It has good correlation with fluorescence quantitative PCR of Shengxiang Biotechnology Co., Ltd. It has high degree of automation, good biosecurity and certain clinical value.