现代医药卫生2024,Vol.40Issue(4) :575-580.DOI:10.3969/j.issn.1009-5519.2024.04.007

不同核酸提取方法对HBV-DNA检测性能验证情况分析

Analysis of different nucleic acid extraction methods on the verification of HBV-DNA detection performance

周文娟 林真 徐建萍
现代医药卫生2024,Vol.40Issue(4) :575-580.DOI:10.3969/j.issn.1009-5519.2024.04.007

不同核酸提取方法对HBV-DNA检测性能验证情况分析

Analysis of different nucleic acid extraction methods on the verification of HBV-DNA detection performance

周文娟 1林真 1徐建萍2
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作者信息

  • 1. 福建医科大学附属协和医院检验科,福建福州 350001
  • 2. 福建医科大学医学技术与工程学院,福建福州 350001
  • 折叠

摘要

目的 评估2种乙型肝炎病毒(HBV)-DNA提取方法及2家检测试剂的性能,有助于选择优化提取试剂和检测试剂.方法 2023年4月采用达安全自动核酸提取仪提取法(磁珠法)和手工提取法(一步法),并用达安和圣湘2种HBV-DNA试剂检测,对其进行精密度、正确度、线性范围、检出限及抗干扰能力等性能进行验证和评价.结果 达安全自动核酸提取仪提取达安试剂检测、手工提取达安试剂检测和手工提取圣湘试剂检测在精密度、正确度、线性范围、检出限方面验证结果均达标;达安全自动核酸提取仪提取圣湘试剂检测在低值检测中变异系数大于5%,最低检测限验证不合格;抗干扰能力方面,全自动核酸提取仪提取的2.0 g/dL血红蛋白浓度的样本用达安和圣湘试剂检测结果均不受影响.手工提取甘油三酯浓度达3 000 mg/dL的样本用达安和圣湘试剂检测的结果均不受影响.结论 不同厂家的提取和检测试剂避免混用,达安和圣湘试剂对HBV-DNA定量检测的结果均符合要求.

Abstract

Objective To evaluate the performance of two hepatitis B virus(HBV)-DNA extraction methods and two detection reagents,and to help select and optimize the extraction reagents and detection rea-gents.Methods In April 2023,Da'an automatic nucleic acid extractor extraction method(magnetic bead meth-od)and manual extraction method(one-step method)were used to detect HBV-DNA with Da'an and Shengx-iang reagents.The precision,accuracy,linear range,detection limit and anti-interference ability were verified and evaluated.Results The results showed that the detection results of Da'an automatic nucleic acid extrac-tion instrument extraction of Da'an reagent detection,manual extraction of Da'an reagent detection and manu-al extraction of Shengxiang reagent detection were up to the standard in terms of precision,accuracy,linear range and detection limit.Shengxiang reagent was extracted by Da'an automatic nucleic acid extraction instru-ment,coefficient of variability>5%in the low value detection,the minimum detection limit verification was not qualified.In terms of anti-interference ability,the samples with 2.0 g/dL hemoglobin concentration ex-tracted by the automatic nucleic acid extraction instrument were not affected by the detection results of Da'an and Shengxiang reagents.Samples with triglyceride concentration up to 3 000 mg/dL were extracted manual-ly,and the detection results of both reagents were not affected.Conclusion Mixing of extraction and detection reagents from different manufacturers should be avoided.The results of quantitative detection of HBV-DNA by the integrated reagents of Da'an and Shengxiang met the requirements.

关键词

乙型肝炎病毒-DNA定量检测/全自动核酸提取仪法/手工提取法/性能验证

Key words

Hepatitis B virus-DNA quantitative detection/Automatic nucleic acid extractor method/Manual extraction method/Performance verification

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出版年

2024
现代医药卫生
重庆市卫生信息中心

现代医药卫生

影响因子:0.758
ISSN:1009-5519
参考文献量16
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