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丙型肝炎病毒基因分型比色寡核苷酸芯片的临床评估

Clinical evaluation of a colorimetric oligonucleotide chip for genotyping hepatitis C virus.

机构信息

Shanghai Institute of Microsystem and Information Technology, Chinese Academy of Sciences, 865 Changning Road, Shanghai 200050, PR China.

出版信息

Clin Biochem. 2010 Jan;43(1-2):214-9. doi: 10.1016/j.clinbiochem.2009.09.013. Epub 2009 Sep 26.

DOI:10.1016/j.clinbiochem.2009.09.013
PMID:19786007
Abstract

INTRODUCTION

Hepatitis C virus (HCV) is a major cause of chronic liver disease worldwide. It is associated with the development of end-stage liver disease and hepatocellular carcinoma. Studies have shown that determination of hepatitis C virus (HCV) genotypes is clinically important for prediction of the clinical course and the outcome of antiviral therapy. The aim of this study was to evaluate a colorimetric oligonucleotide chip, which can be used for the rapid and economical detection of the genotypes/subtypes of hepatitis C virus.

DESIGN AND METHODS

A total of 860 serum specimens were tested by an oligonucleotide chip genotyping test. Partial genotype results were compared with those obtained by sequencing method and INNOLiPA HCV II assay. The relative sensitivities of the methods were assessed by using the 5'NCR amplicon from the HCV RNA fluorescent amplicor HCV tests and Light Cycler.

RESULTS

Of 860 serum specimens tested for their genotypes/subtypes by the oligonucleotide array, 607 HCV positive serum samples could be typed by the sequencing method and 60 of 607 HCV positive serum specimens were typed by INNOLiPA HCV II method. Identification of genotype/subtypes by nucleotide sequencing and INNOLiPA HCV II assay showed respective coincidence rates of 99.8% and 96.7% with the HCV oligonucleotide chip results. And the colorimetric method exhibited 99.8% of relative sensitivity compared with the fluorescent amplicor HCV tests.

CONCLUSION

To our knowledge this oligonucleotide chip genotyping method offers a fast and convenient way to determine the genotype in large-scale settings. The tests can be easily adapted by a clinical diagnostic laboratory.

摘要

简介

丙型肝炎病毒(HCV)是全球慢性肝病的主要病因。它与终末期肝病和肝细胞癌的发展有关。研究表明,确定丙型肝炎病毒(HCV)基因型对于预测抗病毒治疗的临床过程和结果具有重要的临床意义。本研究旨在评估一种可用于快速、经济地检测丙型肝炎病毒基因型/亚型的比色寡核苷酸芯片。

设计与方法

采用寡核苷酸芯片基因分型试验检测 860 份血清标本。部分基因型结果与测序法和 INNOLiPA HCV II 检测法进行比较。采用 HCV RNA 荧光扩增 HCV 检测和 LightCycler 的 5'NCR 扩增子评估方法的相对灵敏度。

结果

860 份血清标本经寡核苷酸阵列检测其基因型/亚型,607 份 HCV 阳性血清标本可经测序法进行分型,607 份 HCV 阳性血清标本中的 60 份可经 INNOLiPA HCV II 法进行分型。核苷酸测序和 INNOLiPA HCV II 检测法鉴定基因型/亚型的符合率分别为 99.8%和 96.7%,与 HCV 寡核苷酸芯片结果一致。比色法与荧光扩增 HCV 检测相比,相对灵敏度为 99.8%。

结论

据我们所知,这种寡核苷酸芯片基因分型方法为大规模确定基因型提供了一种快速、方便的方法。该检测可由临床诊断实验室轻松采用。

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Clinical evaluation of a colorimetric oligonucleotide chip for genotyping hepatitis C virus.丙型肝炎病毒基因分型比色寡核苷酸芯片的临床评估
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