CLINICAL-EVALUATION OF A NEW POLYMERASE CHAIN-REACTION ASSAY (AMPLICOR(TM) HCV) FOR DETECTION OF HEPATITIS-C VIRUS

被引:0
作者
ZEUZEM, S [1 ]
RUSTER, B [1 ]
ROTH, WK [1 ]
机构
[1] GEORG SPEYER HAUS,CHEMOTHERAPEUT FORSCHUNGSINST,FRANKFURT,GERMANY
来源
ZEITSCHRIFT FUR GASTROENTEROLOGIE | 1994年 / 32卷 / 06期
关键词
REVERSE TRANSCRIPTION; PCR; HCV-GENOTYPES; RNA TRANSCRIPTS;
D O I
暂无
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Direct detection of hepatitis C virus (HCV) by reverse transcription (RT) and polymerase chain reaction (PCR) has clinical impact on diagnosis and the assessment of anti-viral therapy. However, recent results of a quality control study on the detection of HCV-RNA by RT-PCR revealed inappropriate sensitivity and specificity in the majority of participating laboratories. In this study we evaluated the first standardized RT-PCR-assay (Amplicor(TM) HCV) for routine detection of hepatitis C virus in serum samples from patients with hepatitis C (n = 111 ), patients with resolved acute hepatitis C (n = 7) and controls (n = 101). The Amplicor(TM) HCV assay was convenient to handle, detected all genotypes of the hepatitis C virus commonly present in Europe (type 1, 2 and 3 according to Simmonds et al.) and had a lower detection limit of 10(2)-10(3) copies as assessed by quantifiable HCV-specific RNA templates. In the clinical evaluation the Amplicor(TM) HCV system reached a sensitivity of 100 % and a specificity of 97 %.
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页码:342 / 347
页数:6
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