Prof Gisela Enders and Kollegen, MVZ GbR Rosenbergstr. 85, 70193 Stuttgart, Germany, Phone: +0711 6357 140, Fax: +0711 6357 148.
Prof Gisela Enders and Kollegen, MVZ GbR, Stuttgart, Germany.
Clin Chem Lab Med. 2018 Mar 28;56(4):634-641. doi: 10.1515/cclm-2017-0701.
Proper management of patients with chronic hepatitis B virus (HBV) infection requires monitoring of plasma or serum HBV DNA levels using a highly sensitive nucleic acid amplification test. Because commercially available assays differ in performance, we compared herein the performance of the Hologic Aptima HBV Quant assay (Aptima) to that of the Roche Cobas TaqMan HBV test for use with the high pure system (HPS/CTM).
Assay performance was assessed using HBV reference panels as well as plasma and serum samples from chronically HBV-infected patients. Method correlation, analytical sensitivity, precision/reproducibility, linearity, bias and influence of genotype were evaluated. Data analysis was performed using linear regression, Deming correlation analysis and Bland-Altman analysis.
Agreement between the assays for the two reference panels was good, with a difference in assay values vs. target <0.5 log. Qualitative assay results for 159 clinical samples showed good concordance (88.1%; κ=0.75; 95% confidence interval: 0.651-0.845). For the 106 samples quantitated by both assays, viral load results were highly correlated (R=0.92) and differed on average by 0.09 log, with 95.3% of the samples being within the 95% limit of agreement of the assays. Linearity for viral loads 1-7 log was excellent for both assays (R2>0.98). The two assays had similar bias and precision across the different genotypes tested at low viral loads (25-1000 IU/mL).
Aptima has a performance comparable with that of HPS/CTM, making it suitable for use for HBV infection monitoring. Aptima runs on a fully automated platform (the Panther system) and therefore offers a significantly improved workflow compared with HPS/CTM.
慢性乙型肝炎病毒 (HBV) 感染患者的合理管理需要使用高度敏感的核酸扩增试验监测血浆或血清 HBV DNA 水平。由于市售检测方法的性能不同，我们在此比较了 Hologic Aptima HBV Quant 检测（Aptima）与高灵敏度系统（HPS/CTM）下罗氏 Cobas TaqMan HBV 检测的性能。
使用 HBV 参考品以及慢性 HBV 感染者的血浆和血清样本评估检测方法的性能。评估了方法相关性、分析灵敏度、精密度/重复性、线性、偏差和基因型的影响。数据分析采用线性回归、Deming 相关分析和 Bland-Altman 分析。
两个参考品的两种检测方法之间的一致性良好，检测值与目标值的差异<0.5 log。159 份临床样本的定性检测结果一致性良好（88.1%；κ=0.75；95%置信区间：0.651-0.845）。两种方法定量检测的 106 份样本中，病毒载量结果高度相关（R=0.92），平均差异为 0.09 log，95.3%的样本在两种方法的 95%一致性界限内。两种检测方法的线性范围均为 1-7 log，病毒载量均为极好（R2>0.98）。两种检测方法在低病毒载量（25-1000 IU/mL）时，不同基因型的偏差和精密度相似。
Aptima 的性能与 HPS/CTM 相当，适用于 HBV 感染监测。Aptima 在全自动平台（Panther 系统）上运行，因此与 HPS/CTM 相比，工作流程有显著改善。
