Comparative analysis of three nucleic acid-based detection systems for hepatitis C virus RNA in plasma from liver transplant recipients

被引:9
作者
Chen, YP
Cooper, DL
Ehrlich, GD
机构
[1] UNIV PITTSBURGH,DEPT PATHOL,PITTSBURGH,PA 15261
[2] UNIV PITTSBURGH,SCH MED,DEPT OTOLARYNGOL,PITTSBURGH,PA 15261
[3] UNIV PITTSBURGH,GRAD SCH PUBL HLTH,DEPT INFECT DIS & MICROBIOL,PITTSBURGH,PA 15261
关键词
polymerase chain reaction; signal amplification; hepatitis C virus; molecular diagnostics; assay comparison; liver transplantation;
D O I
10.1006/mcpr.1996.0045
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
The early detection of hepatitis C viraemia (HCV) following liver transplantation is important for monitoring disease recurrence and planning antiviral chemotherapy. In the current study, the sensitivity, specificity and concordance of three HCV RNA assays were compared using a random sample of 84 plasma specimens from 23 transplant recipients. Two of the assays were prototype commercial tests: Roche Molecular Diagnostic's RT-PCR HCV Amplicor(TM) system; and Chiron's QuantiplexTM HCV-RNA assay. The third was a 'home brew' PCR-liquid hybridization/gel retardation assay developed at the University of Pittsburgh Medical Center (UPMC). On all criteria the PCR-based assays out-performed the Quantiplex assay and displayed an overall concordance of 87%. A high percentage of specimens in the Quantiplex assay gave indeterminate results (12%) or high coefficients of variance (13%). The specificities of all RNA assays were determined using HCV serostatus as the gold standard. Both of the PCR-based assays had specificities of 100%, whereas the Chiron Quantiplex HCV assay had a specificity of 88%, if indeterminates were counted as negatives, and a specificity of 64% if indeterminates were counted as positives. The calculated sensitivities of the PCR-based assays were 56% and 48% for the 'home brew' and the Roche assays, respectively. The UPMC HCV assay, however, was determined to be capable of reproducibly detecting four or fewer chimpanzee infectious doses, suggesting that HCV viraemia was not present in the PCR-negative cases. The sensitivity of the Quantiplex assay was 41% counting indeterminates as negatives and 46% counting them as positives. The high cost of the Quantiplex assay combined with the number of uninterpretable results, the lack of sensitivity, and reduced specificity may limit the usefulness of this assay for monitoring HCV recurrence. (C) 1996 Academic Press Limited
引用
收藏
页码:331 / 336
页数:6
相关论文
共 13 条
[1]   SERUM ALANINE AMINOTRANSFERASE OF DONORS IN RELATION TO THE RISK OF NON-A,NON-B HEPATITIS IN RECIPIENTS - THE TRANSFUSION-TRANSMITTED VIRUSES STUDY [J].
AACH, RD ;
SZMUNESS, W ;
MOSLEY, JW ;
HOLLINGER, FB ;
KAHN, RA ;
STEVENS, CE ;
EDWARDS, VM ;
WERCH, J .
NEW ENGLAND JOURNAL OF MEDICINE, 1981, 304 (17) :989-994
[2]   ISOLATION OF A CDNA CLONE DERIVED FROM A BLOOD-BORNE NON-A, NON-B VIRAL-HEPATITIS GENOME [J].
CHOO, QL ;
KUO, G ;
WEINER, AJ ;
OVERBY, LR ;
BRADLEY, DW ;
HOUGHTON, M .
SCIENCE, 1989, 244 (4902) :359-362
[3]  
EHRLICH GD, 1990, PCR PROTOCOLS GUIDE, P325
[4]   PREVALENCE OF HEPATITIS-C VIRUS-ANTIBODY IN A LIVER-TRANSPLANTATION POPULATION [J].
ELASHMAWY, L ;
HASSANEIN, T ;
GAVALER, JS ;
VANTHIEL, DH .
DIGESTIVE DISEASES AND SCIENCES, 1992, 37 (07) :1110-1115
[5]   PRIMARY HEPATOCELLULAR-CARCINOMA AFTER CHRONIC NON-A, NON-B POST-TRANSFUSION HEPATITIS [J].
GILLIAM, JH ;
GEISINGER, KR ;
RICHTER, JE .
ANNALS OF INTERNAL MEDICINE, 1984, 101 (06) :794-795
[6]   DETECTION OF HEPATITIS-C VIRUS-RIBONUCLEIC-ACID IN THE SERUM BY AMPLIFICATION WITH POLYMERASE CHAIN-REACTION [J].
KATO, N ;
YOKOSUKA, O ;
OMATA, M ;
HOSODA, K ;
OHTO, M .
JOURNAL OF CLINICAL INVESTIGATION, 1990, 86 (05) :1764-1767
[7]   AN ASSAY FOR CIRCULATING ANTIBODIES TO A MAJOR ETIOLOGIC VIRUS OF HUMAN NON-A, NON-B-HEPATITIS [J].
KUO, G ;
CHOO, QL ;
ALTER, HJ ;
GITNICK, GL ;
REDEKER, AG ;
PURCELL, RH ;
MIYAMURA, T ;
DIENSTAG, JL ;
ALTER, MJ ;
STEVENS, CE ;
TEGTMEIER, GE ;
BONINO, F ;
COLOMBO, M ;
LEE, WS ;
KUO, C ;
BERGER, K ;
SHUSTER, JR ;
OVERBY, LR ;
BRADLEY, DW ;
HOUGHTON, M .
SCIENCE, 1989, 244 (4902) :362-364
[8]  
MATEO R, 1994, PCR BASED DIAGNOSTIC, P375
[10]   DETECTION OF ANTIBODY AGAINST ANTIGEN EXPRESSED BY MOLECULARLY CLONED HEPATITIS-C VIRUS CDNA - APPLICATION TO DIAGNOSIS AND BLOOD SCREENING FOR POSTTRANSFUSION HEPATITIS [J].
MIYAMURA, T ;
SAITO, I ;
KATAYAMA, T ;
KIKUCHI, S ;
TATEDA, A ;
HOUGHTON, M ;
CHOO, QL ;
KUO, G .
PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, 1990, 87 (03) :983-987