Hepatitis C Virus Genotype 2 May Not Be Detected by the Cobas AmpliPrep/Cobas TaqMan HCV Test, Version 1.0.
Hepatitis C Virus Genotype 2 May Not Be Detected by the Cobas AmpliPrep/Cobas TaqMan HCV Test, Version 1.0.
复制标题
Cobas AmpliPrep/Cobas TaqMan HCV 检测 1.0 版可能无法检测到丙型肝炎病毒基因型 2。
DOI：
10.1128/jcm.02102-13
复制
发表时间：
2013
期刊：
影响因子：
--
通讯作者：
Tanaka Y.
中科院分区：
文献类型：
--
作者：
Watanabe T;Inoue T;Tanoue Y;Maekawa H;Hamada-Tsutsumi S;Yoshiba S;Tanaka Y.
准确的丙型肝炎病毒（HCV）RNA定量对慢性丙型肝炎的管理和疗效至关重要。使用基于实时PCR的测定评估HCV RNA水平。两种用于HCV RNA定量的高灵敏度商业测定在许多国家是可用的：Roche Cobas AmpliPrep/Cobas TaqMan HCV测定（CAP/CTM HCV）（Roche Molecular Systems，Inc.，普莱森顿，CA）和Abbott RealTime HCV测定（ART HCV）（Abbott Molecular，Inc.，Des Plaines，IL）。尽管其对大多数HCV毒株的良好性能，CAP/CTM HCV检测版本1.0（v1. 0)未能检测到在5=非翻译区（5= UTR）第145和165位具有单核苷酸多态性的基因型4菌株（1）。HCV基因型4仅限于特定的地理区域，包括日本在内的许多国家继续使用CAP/CTM HCV v1。0监测HCV RNA定量。我们报告了2例日本患者的HCV基因型2a，其中HCV RNA是无法检测到的CAP/CTM HCV V1。0，尽管通过ART HCV检测（4.0和5.0 log 10 IU的HCV RNA/ml）和Architect HCV核心抗原测定（Abbott Diagnostics，Lake Forest，IL）（95和107 fmol/L）证实了丙型肝炎病毒血症。这种失败可能与TaqMan探针的推定结合位点中的两个或三个取代有关（图1）。如对HCV基因型4（1）所述，在位置145处，以及位置158和169处，其先前未报道。0之前已报道过（2），但未能检测到HCV基因型2a RNA是至关重要的，因为该基因型是第二常见的HCV基因型。最近，第二个版本的检测，CAP/CTM HCV v2。0（3），重新设计的引物和一个addi-
Accurate hepatitis C virus (HCV) RNA quantification is essen-tial for the management and efficacy of treatment of chronic hepatitis C. The HCV RNA level is assessed using real-time PCR-based assays. Two highly sensitive commercial assays for HCV RNA quantification are available in many countries: the Roche Cobas AmpliPrep/Cobas TaqMan HCV assay (CAP/CTM HCV)(Roche Molecular Systems, Inc., Pleasanton, CA) and the Abbott RealTime HCV assay (ART HCV)(Abbott Molecular, Inc., Des Plaines, IL). Despite its good performance with most HCV strains, the CAP/CTM HCV test version 1.0 (v1. 0) fails to detect genotype 4 strains with single nucleotide polymorphisms at positions 145 and 165 in the 5= untranslated region (5= UTR)(1). HCV genotype 4 is restricted to particular geographical areas, and many countries, including Japan, continue to use CAP/CTM HCV v1. 0 to monitor HCV RNA quantification. We report two Japanese patients with HCV genotype 2a in whom HCV RNA was undetectable by CAP/CTM HCV v1. 0, although hepatitis C viremia was confirmed by the ART HCV test (4.0 and 5.0 log10 IU of HCV RNA/ml) and the Architect HCV core antigen assay (Abbott Diagnostics, Lake Forest, IL)(95 and 107 fmol/liter). This failure could be related to two or three substitutions in the putative binding site for the TaqMan probe (Fig. 1). The substitutions are at position 145, as described for HCV genotype 4 (1), and positions 158 and 169, which have not been reported previously.Underestimation of HCV genotype 2 RNA by CAP/CTM HCV v1. 0 has been reported previously (2), but failure to detect HCV genotype 2a RNA is critical as this genotype is the second most common HCV genotype. Recently, a second version of the assay, CAP/CTM HCV v2. 0 (3), with redesigned primers and an addi-