Abbott RealTime HBV assay 与 Roche Cobas AmpliPrep/Cobas TaqMan HBV assay 用于 HBV DNA 检测和定量的比较。
Comparison of the Abbott RealTime HBV assay with the Roche Cobas AmpliPrep/Cobas TaqMan HBV assay for HBV DNA detection and quantification.
机构信息
Division of Hepatobiliary, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Hepatitis Center, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Division of Hepatobiliary, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Occupational Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
出版信息
J Clin Virol. 2014 Jul;60(3):206-14. doi: 10.1016/j.jcv.2014.04.008. Epub 2014 Apr 13.
BACKGROUND
Measurement of hepatitis B virus (HBV) DNA levels is essential in the clinical management of patients with chronic HBV infection. Performance and accuracy of quantitation for HBV DNA are therefore critical in clinical practice.
OBJECTIVES
We aimed to compare and evaluate the performance characteristics of two HBV DNA quantitative assays: Abbott RealTime HBV (RealTime assay) and Cobas AmpliPrep/Cobas TaqMan HBV assays 2.0 (TaqMan assay).
STUDY DESIGN
Serum samples from 220 HBV-infected patients were collected. Performance characteristics of the HBV DNA quantitative assays, including sensitivity, linearity, and reproducibility were measured. The assays were compared based on the viral status, including HBeAg, genotype, core promoter and pre-core region mutations.
RESULTS
The RealTime assay had a sensitivity and specificity of 98.2% and 100%, respectively. The intra-assay coefficients of variation of serum samples ranged from 0.00% to 11.25% for the RealTime assay and 1.22% to 8.22% for TaqMan assay. Paired quantitative results showed excellent correlation by linear regression analysis (R(2)=0.961), good level of agreement with a mean difference of 0.31log10IU/mL, and limits of agreement of -0.62 to 1.24log10IU/mL, irrespective of HBeAg, genotype, core promoter and pre-core region mutation-specific differences. In this study, a difference of ≥1log10IU/mL between the two assays was observed in 8.6% of the samples. Genotype B and average HBV DNA levels of <3log10IU/mL were significant associated factors of this discordance.
CONCLUSIONS
The Abbott assay delivered high performance for HBV DNA quantification and correlated extremely well with the TaqMan assay, irrespective of viral status.
背景
乙型肝炎病毒 (HBV) DNA 水平的测量在慢性 HBV 感染患者的临床管理中至关重要。因此，HBV DNA 定量检测的性能和准确性在临床实践中至关重要。
目的
我们旨在比较和评估两种 HBV DNA 定量检测方法的性能特征：雅培实时 HBV（实时检测）和 Cobas AmpliPrep/Cobas TaqMan HBV 检测 2.0（TaqMan 检测）。
研究设计
收集了 220 例 HBV 感染患者的血清样本。测量了 HBV DNA 定量检测方法的性能特征，包括灵敏度、线性度和重现性。根据 HBeAg、基因型、核心启动子和前核心区突变等病毒状态对检测方法进行了比较。
结果
实时检测的灵敏度和特异性分别为 98.2%和 100%。实时检测血清样本的批内变异系数范围为 0.00%至 11.25%，而 TaqMan 检测为 1.22%至 8.22%。通过线性回归分析，配对定量结果显示出极好的相关性（R²=0.961），平均差异为 0.31log10IU/mL，一致性良好，一致性界限为-0.62 至 1.24log10IU/mL，与 HBeAg、基因型、核心启动子和前核心区突变特异性差异无关。在本研究中，两种检测方法之间差异≥1log10IU/mL 的样本占 8.6%。基因型 B 和平均 HBV DNA 水平<3log10IU/mL 是这种不一致的显著相关因素。
结论
雅培检测法在 HBV DNA 定量方面表现出优异的性能，与 TaqMan 检测法相关性极好，与病毒状态无关。
Zotero 插件