COBAS® AmpliPrep/COBAS TaqMan® 自动化系统在多中心比较中用于丙型肝炎病毒（HCV）定量的性能。

Performance of the COBAS® AmpliPrep/COBAS TaqMan® automated system for hepatitis C virus (HCV) quantification in a multi-center comparison.

机构信息

University of Iowa, Roy J and Lucille A. Carver College of Medicine, Department of Pathology, 200 Hawkins Drive, Iowa City, IA 52242, USA.

出版信息

J Clin Virol. 2011 Feb;50(2):100-3. doi: 10.1016/j.jcv.2010.10.020. Epub 2010 Dec 9.

DOI:10.1016/j.jcv.2010.10.020

PMID:21145783

Abstract

BACKGROUND

Quantitative HCV RNA testing is considered standard of care for monitoring during treatment of patients infected with HCV. The COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HCV Test fully automates specimen processing and reaction assembly for HCV viral load testing using reverse transcription and real-time PCR amplification.

OBJECTIVES

The performance of the COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HCV Test was evaluated in a multi-center study.

STUDY DESIGN

Typical plasma based specimens were tested for accuracy, analytic range of measurement, reproducibility and genotype specific quantitation.

RESULTS

Linear regression analysis of the quantitative results demonstrated a linear range of detection from 50 to 5 million (1.7-6.7 log(10))IU/mL and a coefficient of determination (R(2)) of 0.9948. The precision of the assay was highly reproducible within and between runs and among laboratories with coefficients of variance (CV) ranging from 6.7% to 40.0% across the seven laboratories. A representative sample for each of the six major HCV genotypes demonstrated reproducible quantitation between the seven laboratories.

CONCLUSIONS

The COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HCV Test is a reliable and sensitive assay for HCV RNA quantitation.

摘要

背景

定量 HCV RNA 检测被认为是监测 HCV 感染患者治疗过程中的标准护理。COBAS(®)AmpliPrep/COBAS(®)TaqMan(®)HCV 测试完全自动化了使用逆转录和实时 PCR 扩增进行 HCV 病毒载量测试的标本处理和反应组装。

目的

在一项多中心研究中评估了 COBAS(®)AmpliPrep/COBAS(®)TaqMan(®)HCV 测试的性能。

研究设计

典型的基于血浆的标本用于评估准确性、测量分析范围、重现性和基因型特异性定量。

结果

定量结果的线性回归分析表明，检测的线性范围为 50 至 500 万（1.7-6.7 log(10))IU/mL，决定系数（R(2))为 0.9948。该测定方法在实验室内部和之间以及在七个实验室之间的精密度高度重现，变异系数（CV）范围从 6.7%到 40.0%。在七个实验室中，每个 HCV 六个主要基因型的代表性样本都表现出可重复的定量。