Maasoumy Benjamin, Bremer Birgit, Lehmann Patrick, Marins Ed G, Michel-Treil Véronique, Simon Christian O, Njoya Merlin, Cornberg Markus, Paxinos Ellen, Manns Michael P, Vermehren Johannes, Sarrazin Christoph, Sohn Ji Yeon, Cho Yunjung, Wedemeyer Heiner
Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany.
Hannover Medical School, Hanover, Germany.
Therap Adv Gastroenterol. 2017 Aug;10(8):609-618. doi: 10.1177/1756283X17722745. Epub 2017 Aug 7.
HBV DNA is the most important molecular marker in hepatitis B, used to determine treatment indication and monitoring. Most patients require lifelong hepatitis B virus (HBV) management, thus viral load (VL) monitoring may be performed at different laboratories, with different HBV assays, which may result in different VL results. This multicenter study compares the commutability and concordance of results from four different HBV DNA assays: CAP/CTM HBVv2, HPS/CTM HBVv2 and the new cobas 6800/8800 HBV and cobas 4800 HBV assays.
Across all four assays, HBV limit of detection (LoD) and linearity at lower concentrations were assessed using panels traceable to the World Health Organization international standard, and concordance was investigated at the important medical decision cutoffs 2000 and 20,000 IU/ml, using specimens from HBV-positive patients.
The calculated LoD a probit curve was 2.7 IU/ml for cobas 6800/8800 HBV, 2.8 IU/ml for cobas 4800 HBV, 9.6 IU/ml for CAP/CTM HBVv2, and 6.2 IU/ml for HPS/CTM HBVv2. The average accuracy was comparable between cobas 6800/8800 HBV, cobas 4800 HBV and CAP/CTM HBVv2 (0.04-0.05 log IU/ml), while a slightly lower accuracy was documented for HPS/CTM HBVv2 (-0.16 log IU/ml). A total of 211-245 clinical samples were used for a pairwise comparison. Mean paired log differences ranged from -0.17 log IU/ml to -0.01 log IU/ml. Coefficient of determination was over 98% for all pairs with high overall percent agreement at the 2000 and 20,000 IU/ml cutoffs (from 91.7% to 96.3%). In a subset of samples with VL±0.5 log to the 2000 and 20,000 IU/ml thresholds, concordance was still 72% and 82%, respectively.
The new cobas 6800/8800 HBV and 4800 HBV assays show high accuracy in samples with low-level viremia and a high concordance with the established HBV tests, CAP/CTM HBVv2 and HPS/CTM HBVv2, at 2000 and 20,000 IU/ml. Thus, all four HBV assays have high commutability and may be used interchangeably in routine clinical practice.
乙肝病毒脱氧核糖核酸（HBV DNA）是乙型肝炎最重要的分子标志物，用于确定治疗指征和监测。大多数患者需要终身进行乙肝病毒（HBV）管理，因此病毒载量（VL）监测可能在不同实验室使用不同的HBV检测方法进行，这可能导致不同的VL结果。这项多中心研究比较了四种不同HBV DNA检测方法（CAP/CTM HBVv2、HPS/CTM HBVv2以及新的cobas 6800/8800 HBV和cobas 4800 HBV检测方法）结果的互换性和一致性。
针对所有四种检测方法，使用可溯源至世界卫生组织国际标准的样本组评估HBV检测下限（LoD）和较低浓度下的线性，并使用HBV阳性患者的样本在重要医学决策临界值2000和20000 IU/ml处研究一致性。
cobas 6800/8800 HBV的计算LoD（概率曲线）为2.7 IU/ml，cobas 4800 HBV为2.8 IU/ml，CAP/CTM HBVv2为9.6 IU/ml，HPS/CTM HBVv2为6.2 IU/ml。cobas 6800/8800 HBV、cobas 4800 HBV和CAP/CTM HBVv2之间的平均准确度相当（0.04 - 0.05 log IU/ml），而HPS/CTM HBVv2的准确度略低（-0.16 log IU/ml）。总共211 - 245份临床样本用于成对比较。平均成对对数差异范围为-0.17 log IU/ml至-0.01 log IU/ml。在2000和20000 IU/ml临界值处，所有成对的决定系数均超过98%，总体一致性百分比很高（从91.7%至96.3%）。在VL与2000和20000 IU/ml阈值相差±0.5 log的样本子集中，一致性分别仍为72%和82%。
新的cobas 6800/8800 HBV和4800 HBV检测方法在低水平病毒血症样本中显示出高准确度，并且在2000和20000 IU/ml时与既定的HBV检测方法CAP/CTM HBVv2和HPS/CTM HBVv2具有高度一致性。因此，所有四种HBV检测方法都具有高互换性，可在常规临床实践中互换使用。
