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罗氏COBas TAQMAN 48 HCV实时检测法与拜耳Versant HCV 3.0分支DNA检测法的比较评估

A comparative evaluation between real time Roche COBas TAQMAN 48 HCV and bDNA Bayer Versant HCV 3.0.

作者信息

Giraldi Cristina, Noto Alessandra, Tenuta Robert, Greco Francesca, Perugini Daniela, Spadafora Mario, Bianco Anna Maria Lo, Savino Olga, Natale Alfonso

机构信息

UOC Microbiologia e Virologia, PO Annunziata AO Cosenza.

出版信息

New Microbiol. 2006 Oct;29(4):243-50.

PMID:17201090
Abstract

The HCV virus is a common human pathogen made of a single stranded RNA genome with 9600nt. This work compared two different commercial methods used for HCV viral load, the bDNA Bayer Versant HCV 3.0 and the RealTime Roche COBAS TaqMan 48 HCV. We compared the reproducibility and linearity of the two methods. Seventy-five plasma samples with genotypes 1 to 4, which represent the population (45% genotype 1; 24% genotype 2; 13% genotype 3; 18% genotype 4) were directly processed with the Versanto method based upon signal amplification; the same samples were first extracted (COBAS Ampliprep - TNAI) and then amplified using RealTime PCR (COBAS TaqMan 48). The results obtained indicate the same performance for both methods if they have genotype 1, but in samples with genotypes 2, 3 and 4 the RealTime PCR Roche method gave an underestimation in respect to the Bayer bDNA assay.

摘要

丙型肝炎病毒(HCV)是一种常见的人类病原体,由一个含有9600个核苷酸的单链RNA基因组构成。这项研究比较了两种用于检测HCV病毒载量的不同商业方法,即拜耳Versant HCV 3.0分支DNA分析法和罗氏COBAS TaqMan 48实时荧光定量PCR法。我们比较了这两种方法的重复性和线性。选取了75份1至4型基因型的血浆样本,这些样本代表了总体人群(45%为1型基因型;24%为2型基因型;13%为3型基因型;18%为4型基因型),采用基于信号放大的Versanto方法直接处理;同样的样本先进行提取(COBAS Ampliprep - TNAI),然后使用实时荧光定量PCR(COBAS TaqMan 48)进行扩增。所得结果表明,如果样本为1型基因型,两种方法表现相同,但对于2、3和4型基因型的样本,罗氏实时荧光定量PCR法相对于拜耳分支DNA分析法会出现低估情况。

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