Evaluation and Comparison of Three Different Anti-hepatitis C Virus Antibody Tests based on Chemiluminescence and Enzyme-linked Immunosorbent Assay Methods used in the Diagnosis of Hepatitis C Infections in Turkey

被引:26
作者
Kesli, R. [1 ]
Ozdemir, M. [2 ]
Kurtoglu, M. G. [1 ]
Baykan, M. [2 ]
Baysal, B. [2 ]
机构
[1] Konya Educ & Res Hosp, Dept Microbiol, TR-42090 Meram, Konya, Turkey
[2] Selcuk Univ, Meram Fac Med, Dept Microbiol, Konya, Turkey
关键词
HEPATITIS C VIRUS (HCV) INFECTIONS; ANTI-HCV TESTS; HCV-RNA ASSAY; RECOMBINANT IMMUNOBLOT ASSAY (RIBA); FALSE-POSITIVE RESULTS; 2ND-GENERATION ASSAYS; RNA; 2ND;
D O I
10.1177/147323000903700516
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
The routine diagnosis of hepatitis C virus (HCV) infection is based on the detection of anti-HCV antibodies by two main methods (enzyme immunoassay [EIA] and chemiluminescence immunoassay [CIA]) but false-positives are a problem. We investigated three anti-HCV tests: two CIAs (Cobas (R) e 601 and Architects i2000SR); and one EIA (Ortho (R) HCV 3.0). Two other anti-HCV tests were also performed as supplementary and confirmatory tests, respectively: a recombinant strip immunoblot assay (RIBA HCV 3.0 SIA) and a reverse transcriptase polymerase chain reaction-based assay for HCV-RNA. After discriminating the false-positive results, the true anti-HCV seropositivity rate in 7156 serum samples was 0.91%. The seropositivity and false-positive rates for the Cobas (R) e 601, Architects i2000SR and Ortho (R) HCV 3.0 anti-HCV tests were 1.9% and 0.99%, 1.2% and 0.29%, and 0.87% and 0.01%, respectively. The mean level of HCV-RNA was 3399 x 10(3) IU/ml. Critical levels for false-positivity for HCV-RNA were a cut-off index of 200 for Cobas (R) e 601, a signal/cut-off (S/CO) of 5 for Architects i2000SR and an S/CO of 1.2 for Ortho (R) HCV 3.0. Positive and negative results for the RIBA HCV 3.0 SIA assay all accorded with the HCV-RNA assay, except for 23 (17%) 'indeterminate' results, all of which were negative with the HCV-RNA assay. In conclusion, to eliminate doubts related to false-positive findings in the initial HCV screening tests, additional confirmatory HCV-RNA assay should be performed.
引用
收藏
页码:1420 / 1429
页数:10
相关论文
共 31 条
  • [11] Sensitivity and specificity of third-generation hepatitis C virus antibody detection assays: an analysis of the literature
    Colin, C
    Lanoir, D
    Touzet, S
    Meyaud-Kraemer, L
    Bailly, F
    Trepo, C
    [J]. JOURNAL OF VIRAL HEPATITIS, 2001, 8 (02) : 87 - 95
  • [12] Delialioglu N, 2001, VIRAL HEPAT DERG, V7, P416
  • [13] Low-positive anti-hepatitis C virus enzyme immunoassay results: An important predictor of low likelihood of hepatitis C infection
    Dufour, DR
    Talastas, M
    Fernandez, MDA
    Harris, B
    Strader, DB
    Seeff, LB
    [J]. CLINICAL CHEMISTRY, 2003, 49 (03) : 479 - 486
  • [14] TRANSFUSION-ASSOCIATED HEPATITIS NOT DUE TO VIRAL-HEPATITIS TYPE-A OR TYPE-B
    FEINSTONE, SM
    KAPIKIAN, AZ
    PURCELL, RH
    ALTER, HJ
    HOLLAND, PV
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 1975, 292 (15) : 767 - 770
  • [15] STUDY ON RELIABILITY OF COMMERCIALLY AVAILABLE HEPATITIS-C VIRUS-ANTIBODY TESTS
    FEUCHT, HH
    ZOLLNER, B
    POLYWKA, S
    LAUFS, R
    [J]. JOURNAL OF CLINICAL MICROBIOLOGY, 1995, 33 (03) : 620 - 624
  • [16] Goncales Neiva S. L., 2000, Revista do Instituto de Medicina Tropical de Sao Paulo, V42, P263, DOI 10.1590/S0036-46652000000500005
  • [17] KARSLIGIL T, 2001, VIRAL HEPAT DERG, V7, P393
  • [18] Kasifoglu N, 2007, MIKROBIYOL BUL, V41, P557
  • [19] Kolgeliler S, 2003, VIRAL HEPATIT DERGIS, V8, P166
  • [20] AN ASSAY FOR CIRCULATING ANTIBODIES TO A MAJOR ETIOLOGIC VIRUS OF HUMAN NON-A, NON-B-HEPATITIS
    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
    [J]. SCIENCE, 1989, 244 (4902) : 362 - 364