文章摘要

全自动核酸提取及荧光定量多聚酶链式反应分析系统对HBV-DNA试剂盒检测性能的验证及评价

作者: 1,2史露宾, 1毛逸琪, 1,2李世宝, 2马萍
1 徐州医科大学医学技术学院,江苏 徐州 221000
2 徐州医科大学附属医院检验科,江苏 徐州 221000
通讯: 马萍 Email: pingm62@aliyun.com
DOI: 10.3978/j.issn.2095-6959.2022.02.001
基金: 青苗人才 (2019128014)。

摘要

目的:评估全自动核酸提取仪及荧光定量多聚酶链式反应(polymerase chain reaction,PCR)分析系统Anadas9850检测乙型肝炎病毒核酸(HBV-DNA)的性能。方法:根据美国临床实验室标准化协会(Clinical and Laboratory Standards Institution,CLSI)批准指南,对全自动核酸提取及荧光PCR分析系统Anadas9850检测HBV-DNA试剂盒进行性能评估实验,包括精密度、正确度、线性实验、最低检测限、抗干扰能力。结果:在精密度方面,批内精密度高值、低值CV分别是1.71%和2.64%,批间精密度高值、低值CV分别是2.40%和2.61%;在正确度方面,标本检测结果对数值与给定的质控品靶值的对数值差值在±0.4个log值;线性检测范围,在50~5.0×108 U/mL的梯度范围具有良好的线性,线性回归方程为Y=0.9385X+0.2552,R2=0.9986;在最低检出限方面,实验结果的检出率为100%,符合检出要求;在抗干扰能力方面,溶血、高血脂、高胆红素对检测结果无影响。结论:全自动核酸提取及荧光PCR分析系统Anadas9850检测HBV-DNA的各项性能参数均符合临床检测的要求,可以在临床检测中使用。
关键词: 乙型肝炎病毒;乙型肝炎病毒核酸;精密度;实时荧光定量多聚酶链式反应;性能验证

Verification and evaluation of detection performance of HBV-DNA kit by automatic nucleic acid extractor and fluorescence quantitative polymerase chain reaction analysis system

Authors: 1,2SHI Lubin, 1MAO Yiqi, 1,2LI Shibao, 2MA Ping
1 Medical Technology Institute, Xuzhou Medical University, Xuzhou Jiangsu 221000, China
2 Department of Laboratory Medicine, Affiliated Hospital of Xuzhou Medical University, Xuzhou Jiangsu 221000, China

CorrespondingAuthor: MA Ping Email: pingm62@aliyun.com

DOI: 10.3978/j.issn.2095-6959.2022.02.001

Foundation: This work was supported by the Young Talent, China (2019128014).

Abstract

Objective: To evaluate the performance of automatic nucleic acid extractor and fluorescence quantitative polymerase chain reaction (PCR) analysis system Anadas9850 for detection of hepatitis B virus nucleic acid (HBV-DNA). Methods: According to the guidelines approved by the Clinical and Laboratory Standards Institution (CLSI), the performance verification of the automatic nucleic acid extractor and fluorescence PCR analysis system Anadas9850 for detection of HBV-DNA kit was carried out, including precision, accuracy, linear test, minimum detection range and anti-interference ability. Results: In terms of precision, the coefficient of variations (CVs) of high and low intra-batch precision were 1.71% and 2.64% respectively. The high and low CVs of inter-batch precision were 2.40% and 2.61%, respectively. In terms of accuracy, the difference between the logarithmic value of the test result of the sample and the quality control target value was ±0.4 in log value. It had good linearity in the gradient range of 50 to 5.0×108 U/mL. The linear regression equation was Y = 0.9385X ± 0.2552, R2=0.9986. The minimum detection rate of the experimental results was 100%, which met the detection requirements. In terms of anti-interference ability, hemolysis, hyperlipidemia, and high bilirubin had no effect on the test results. Conclusion: The performance of automatic nucleic acid extractor and fluorescence PCR analysis system Anadas9850 for detection of hHBV-DNA meets the requirements of clinical detection and can be used in clinical detection.
Keywords: hepatitis B virus; HBV-DNA; precision; real-time fluorescence quantitative polymerase chain reaction; performance verification

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