Performance Evaluation of the New Roche cobas AmpliPrep/cobas TaqMan HCV Test, Version 2.0, for Detection and Quantification of Hepatitis C Virus RNA

S. Pas; R. Molenkamp; J. Schinkel; S. Rebers; C. Copra; S. Seven-Deniz

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Performance Evaluation of the New Roche cobas AmpliPrep/cobas TaqMan HCV Test, Version 2.0, for Detection and Quantification of Hepatitis C Virus RNA

机译：新罗氏COBAS AMPLIPREP / COBAS TAQMAN HCV测试的性能评估，2.0版，用于丙型肝炎病毒RNA的检测和定量

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To evaluate the analytical performance and explore the clinical applicability of the new Roche cobas AmpliPrep/cobas TaqMan HCV test, v2.0 (CAP/CTM v2.0), a platform comparison was performed on panels and diagnostic samples with the Roche cobas AmpliPrep/cobas TaqMan HCV test (CAP/CTM v1.0), the Siemens Versant HCV RNA 3.0 branched DNA (bDNA) test, the Abbott m2000 RealTime HCV assay (Realtime assay), and the Siemens Versant HCV transcription-mediated amplification (TMA) test (TMA assay). The analytical performance of the CAP/CTM v2.0 on WHO and Acrometrix panels and clinical specimens of patients infected with HCV genotype 1, 2, 3, 4, 5, or 6 relative to that of the CAP/CTM v1.0 was significantly improved. In a qualitative comparison of the CAP/CTM v2.0 relative to the TMA assay on genotype 1 to 4 samples, the two tests proved to be almost equally sensitive. Response-guided therapy in one of five HCV genotype 4-infected patients previously tested with the CAP/CTM v1.0 would have significantly changed if tested with the CAP/CTM v2.0. In conclusion, the Roche CAP/CTM v2.0 has significantly better performance characteristics than the former CAP/CTM HCV v1.0 and the bDNA assay and performance characteristics comparable to those of the Realtime assay.

机译：为了评估分析性能并探索新的罗氏COBAS SAMPRIPREP / COBAS Taqman HCV测试的临床适用性，V2.0（CAP / CTM V2.0），对罗氏COBAS AMPLIPREP的诊断样品进行平台比较/ COBAS Taqman HCV测试（CAP / CTM V1.0），西门子Versant HCV RNA 3.0分支DNA（BDNA）测试，Abbott M 2000 RealTi M E HCV测定（真正的时间测定），以及西门子Versant HCV转录介导的扩增（TMA）试验（TMA测定）。 CAP / CTM V2.0对WHO和ACROMETRIX面板的分析性能以及相对于CAP / CTM V1.0的HCV基因型1,2,3,4,5或6感染的患者的临床标本显着显着改善。在帽/ ctm v2.0相对于基因型1至4样品的TMA测定的定性比较中，两种测试证明几乎同样敏感。如果用CAP / CTM V2.0测试，则用帽/ CTM V1.0测试的五种HCV基因型4感染患者中的五个感染患者中的一种响应引导的疗法将显着改变。总之，罗氏帽/ CTM v2.0具有比前帽/ CTM HCV V1.0的性能特性明显更好，并且BDNA测定和与真实时间测定相当的性能特征。 展开▼

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《Journal of Clinical Microbiology》 |2013年第1期|共5页

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S. Pas; R. Molenkamp; J. Schinkel; S. Rebers; C. Copra; S. Seven-Deniz;
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中图分类医学微生物学（病原细菌学、病原微生物学）;

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专利

1. Performance evaluation of the DAAN HCV assay for quantification of hepatitis C virus RNA and its comparison with COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0 [J] . Yuting He, Yichong Wang, Xuefang Chen, Journal of clinical laboratory analysis. . 2020,第7期

机译：DaaN HCV测定对甲型肝炎病毒RNA定量的性能评估及其与COBAS AMPLIPREP / COBAS Taqman HCV定量测试的比较，V2.0

2. Performance Evaluation of the New Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 Test Version 2.0 for Quantification of Human Immunodeficiency Virus Type 1 RNA [J] . Suzan Pas, John W. A. Rossen, Daniel Schoener, Journal of Clinical Microbiology . 2010,第4期

机译：新的罗氏Cobas AmpliPrep / Cobas TaqMan HIV-1测试版本2.0对人类免疫缺陷病毒1型RNA定量的性能评估

3. Performance of the cobas Hepatitis B virus (HBV) test using the cobas 4800 system and comparison of HBV DNA quantification ability between the COBAS AmpliPrep/COBAS TaqMan HBV test version 2.0 and cobas HBV test [J] . Shin Kyung-Hwa, Lee Hyun-Ji, Chang Chulhun L., Journal of clinical virology: The official publication of the Pan American Society for Clinical Virology . 2018,第期

机译：COBAS乙型肝炎病毒（HBV）的性能使用COBAS 4800系统和COBAS AMPLIPREP / COBAS HBV测试版本2.0和COBAS HBV测试之间的HBV DNA定量能力的比较

4. Simultaneous extraction of human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) RNA with the M1000 apparatus does not impair the measurement of the viral load of both viruses when tested by using the LCx PCR system [C] . T. Bourlet, S. Thamm, S. Pillet, European Congress of Virology . 2004

机译：通过使用LCX PCR系统测试，同时提取人免疫缺陷病毒类型1（HIV-1）和丙型肝炎病毒（HCV）RNA，不会损害两种病毒的病毒载量的测量

5. Protein-ligand and protein-protein interactions involved in de novo initiation of RNA synthesis by the hepatitis C virus (HCV) RNA-dependent RNA polymerase (RdRp). [D] . Kim, Young-Chan. 2006

机译：丙肝病毒（HCV）RNA依赖性RNA聚合酶（RdRp）参与RNA合成从头开始的蛋白质-配体和蛋白质-蛋白质相互作用。

6. Performance Evaluation of the New Roche cobas AmpliPrep/cobas TaqMan HCV Test Version 2.0 for Detection and Quantification of Hepatitis C Virus RNA [O] . S. Pas, R. Molenkamp, J. Schinkel, 2013

机译：新罗氏cobas AmpliPrep / cobas TaqMan HCV测试（2.0版）对丙型肝炎病毒RNA的检测和定量的性能评估

7. Performance evaluation of the new Roche cobas AmpliPrep/cobas TaqMan HCV test, version 2.0, for detection and quantification of hepatitis C virus RNA [O] . Pas, S.D. (Suzan), Molenkamp, R. (Richard), Schinkel, J. (Janke), 2013

机译：新的罗氏cobas AmpliPrep / cobas TaqMan HCV测试（2.0版）的性能评估，用于检测和定量丙型肝炎病毒RNA

1. 罗氏COBAS HCV RNA定量一代和二代检测试剂对556例丙型肝炎患者HCV RNA定量检测结果的比较 [J] . 孙梅 ,谈国蕾 ,王建芳 . 临床肝胆病杂志 . 2014,第012期

2. 加拿大批准罗氏HPV检测试剂盒coba HPV Test用于宫颈癌一线初级筛查 [J] . 无 . 中国医药技术经济与管理 . 2014,第003期

3. 探讨丙型肝炎病毒抗体（抗-HCV）和丙型肝炎病毒核酸（HCV-RNA）荧光定量检测在丙型肝炎诊断中的临床应用价值 [J] . 陈俊平 . 中外健康文摘 . 2013,第027期

4. 定量竞争核糖核酸(RNA)多聚酶反应法检测丙型肝炎病毒RNA水平:高滴度病毒血症与疾病进展期相关 [J] . 叶晓光 . 中华生物医学工程杂志 . 1997,第001期

5. 丙型肝炎病毒抗体、丙型肝炎病毒RNA联合丙氨酸氨基转移酶检测用于丙型肝炎诊断的临床分析 [J] . 刘涛 . 医药 . 2015,第005期

6. 某国产HIV-1核酸定量检测试剂盒的临床应用性能评估 [C] . 李梅 ,王静 . 第一次全国中西医结合检验医学学术会议 . 2014

7. 慢性丙型肝炎患者尿液中丙型肝炎病毒RNA的定量检测及其片段分布的研究 [A] . 鲁添 . 2018

1. 一种特异性定量PCR反应混合液、miRNA定量检测试剂盒以及检测方法 [P] . 中国专利： CN109957611B . 2020.06.26

2. 一种特异性定量PCR反应混合液、miRNA定量检测试剂盒以及检测方法 [P] . 中国专利： CN109957611A . 2019-07-02

3. Genetically engineered hepatitis c virus (hcv) nucleic acid clone, plasmid clone that houses a life-size hcv cdna, dna or rna transcribed from the full-length hcv cdna, transfected and in vitro infected host cell line with hcv, non-human animal infected with hcv, hcv viral particle, in vitro test system, hcv cell free, hcv vaccine and hcv test set and processes for identifying a cell line that is permissive and an animal that is permissive for hcv infection, to select hcv with adaptive mutations that allow higher levels of hcv replication in a permissive cell line, to infect an animal with hcv, to spread hcv in vitro, to transduce an animal susceptible to hcv infection with a heterologous gene, to produce hcv viral particles, hcv particle proteins and hcv antibodies, to separate agents capable of to modulate hcv replication, to prepare a hcv nucleic acid and to detect hcv antibodies in a biological sample from a patient. [P] . 外国专利： BR9808147A . 2000-03-28

机译：基因工程丙型肝炎病毒（hcv）核酸克隆，质粒克隆，其中包含从全长hcv cdna转录而来的真人大小的hcv cdna，dna或rna，并通过非人类动物的hcv转染和体外感染宿主细胞系被hcv感染，hcv病毒颗粒，体外测试系统，无hcv细胞，hcv疫苗和hcv测试仪的感染以及鉴定允许的细胞系和允许感染hvv的动物的过程，以选择具有以下适应性突变的hcv：允许在允许的细胞系中进行更高水平的hvv复制，以hvv感染动物，在体外传播hvv，用异源基因转导易感染hvv的动物，产生hvv病毒颗粒，hvv颗粒蛋白和hvv抗体分离能够调节hcv复制的试剂，制备hcv核酸并检测患者生物样品中的hcv抗体。

4. Methods for detecting peptides derived from the hepatitis C virus (HCV) 33 (C) region, antibodies thereto, and hepatitis C virus (PEPTIDES FROM THE C33 REGION OF HCV, ANTIBODIES THERETO AND METHODS FOR THE DETECTION OF HCV) [P] . 外国专利： KR950704354A . 1995-11-20

机译：检测源自丙型肝炎病毒（HCV）33（C）区的肽，其抗体和丙型肝炎病毒的方法（来自HCV C33区域的肽，其抗体和检测HCV的方法）

5. A reaction mixture for the detection and quantification of RNA of three cereal viruses (WDV, WSMV, BYDV) using TaqMan Real-time RT-PCR [P] . 外国专利： CZ31435U1 . 2018-02-14

机译：使用TaqMan实时RT-PCR检测和定量三种谷类病毒（WDV，WSMV，BYDV）RNA的反应混合物

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Performance Evaluation of the New Roche cobas AmpliPrep/cobas TaqMan HCV Test, Version 2.0, for Detection and Quantification of Hepatitis C Virus RNA

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