Subscribe to RSS
Please copy the URL and add it into your RSS Feed Reader.
https://www.thieme-connect.de/rss/thieme/en/10.1055-s-00000069.xml
Semin Liver Dis 2000; 20(2): 159-172
DOI: 10.1055/s-2000-9939
DOI: 10.1055/s-2000-9939
Diagnostic Testing for Hepatitis C
Robert L. Carithers, Jr., Anthony Marquardt, David R. Gretch- University of Washington, Seattle, Washington
Further Information
Publication History
Publication Date:
31 December 2000 (online)
ABSTRACT
Diagnostic tests for hepatitis C virus have improved dramatically over the past decade. Highly accurate tests are now available for screening patients for possible hepatitis C infections and confirming the presence of active viral infection. HCV RNA levels and genotype are very useful in assessing the likelihood of response to antiviral therapy and in guiding the optimum duration of treatment. Absence of detectable HCV RNA using PCR methodology has become the gold standard of successful treatment of patients with chronic hepatitis C. The various tests for hepatitis C are expensive and have their limitations. However, selective use of these assays has greatly improved the care of patients with chronic hepatitis C.
KEYWORD
hepatitis C virus - diagnostic tests - HCV genotypes - HCV RNA - anti-viral therapy
REFERENCES
- 1 McHutchison J G, Gordon S C, Schiff E R. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. N Engl J Med . 1998; 339 1485-1492
- 2 Poynard T, Marcellin P, Lee S S. Randomised trial of interferon alpha2b plus ribavirin for 48 weeks or for 24 weeks versus interferon alpha2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus. International Hepatitis Interventional Therapy Group (IHIT). Lancet . 1998; 352 1426-1432
- 3 Gretch D R. Diagnostic tests for hepatitis C. Hepatology . 1997; 26(Suppl 1) 43S-47S
- 4 Gretch D R, Bacchi C E, Corey L. Persistent hepatitis C virus infection after liver transplantation: Clinical and virological features. Hepatology . 1995; 22 1-9
- 5 Kao J-H, Lai M-Y, Hwang Y-T. Chronic hepatitis C without anti-hepatitis C antibodies by second-generation assay. A clinicopathologic study and demonstration of the usefulness of a third-generation assay. Dig Dis Sci . 1996; 41 161-165
- 6 Uyttendaele S, Claeys H, Mertens W, Verhaert H, Vermylen C. Evaluation of third-generation screening and confirmatory assays for HCV antibodies. Vox Sang . 1994; 66 122-129
- 7 Barrera J, Prancis B, Ercilla G. Improved detection of anti-HCV in post-transfusion hepatitis by a third-generation ELISA. Vox Sang . 1995; 68 15-18
- 8 Pawlotsky J M, Lonjon I, Hezode C. What strategy should be used for diagnosis of hepatitis C virus infection in clinical laboratories?. Hepatology . 1998; 27 1700-1702
- 9 Morishima C, Gretch D R. Clinical use of hepatitis C virus tests for diagnosis and monitoring during therapy. In: Keefe EB, ed. Treatment of Chronic Hepatitis C Philadelphia: W.B. Saunders 1999: 717-740
- 10 Atrah H I, Hutchinson F, Gough D, Ala F A. Hepatitis C seroconversion rate in established blood donors. J Med Virol . 1995; 46 329-333
- 11 Pawlotsky J M, Bastie A, Pellet C. Significance of indeterminate third-generation hepatitis C virus recombinant immunoblot assay. J Clin Microbiol . 1996; 34 80-83
- 12 Damen M, Zaaijer H L, Cuypers H T. Reliability of the third-generation recombinant immunoblot assay for hepatitis C virus. Transfusion . 1995; 35 745-749
- 13 Younossi Z M, McHutchison J G. Serological tests for HCV infection. Viral Hepatol Rev . 1996; 2 161-173
- 14 Pawlotsky J M, Bastie A, Lonjon I. What technique should be used for routine detection and quantification of HBV DNA in clinical samples?. J Virol Methods . 1997; 65 245-253
- 15 Fried M W. Clinical application of hepatitis C virus genotyping and quantitation. In: Davis GL, ed. Clinics in Liver Disease Philadelphia: W.B. Saunders 1997: 631-645
- 16 Busch M P, Wilber J C, Johnson P, Tobler L, Evans C S. Impact of speciman handling and storage on detection of hepatitis C virus RNA. Transfusion . 1992; 32 420-425
- 17 Davis G L, Lau J Y, Urdea M S. Quantitative detection of hepatitis C virus RNA with a solid-phase signal amplification method: Definition of optimal conditions for specimen collection and clinical application in interferon-treated patients. Hepatology. 1994; 19 1337-1341
- 18 Polyak S J, Gretch D R. Molecular diagnostic testing for viral hepatitis: Methods and applications. In: Willson RA, ed. Viral Hepatitis New York: Marcel Dekker 1997: 1-33
- 19 Gretch D R, Wilson J J, Carithers Jr L R, dela Rosa C, Han J H, Corey L. Detection of hepatitis C virus RNA: Comparison of one-stage polymerase chain reaction (PCR) with nested-set PCR. J Clin Microbiol. 1993; 31 289-291
- 20 Kwok S, Higuchi R. Avoid false positives with PCR. Nature . 1989; 339 237-238
- 21 Zaaijer H L, Cuypers H T, Reesink H W, Winkel I N, Gerken G, Lelie P N. Reliability of polymerase chain reaction for detection of hepatitis C virus. Lancet . 1993; 341 722-724
- 22 Damen M, Cuypers H T, Zaaijer H L. International collaborative study on the second Eurohep HCV RNA reference panel. J Virol Methods . 1996; 58 175-185
- 23 Saldanha J. Standardization, quantification and quality control of assays for HCV RNA. Viral Hepatol Rev . 1999; 5 1-11
- 24 Nolte F S, Thurmond C, Fried M W. Preclinical evaluation of AMPLICOR hepatitis C virus test for detection of hepatitis C virus RNA. J Clin Microbiol . 1995; 33 1775-1778
- 25 Young K K, Archer J J, Yokosuka O, Omata M, Resnick R M. Detection of hepatitis C virus RNA by a combined reverse transcription PCR assay: Comparison with nested amplification and antibody testing. J Clin Microbiol . 1995; 33 654-657
- 26 Zeuzem S, Ruster B, Roth W K. Clinical evaluation of a new polymerase chain reaction assay (AmplicorTM HCV) for detection of hepatitis C virus. Z Gastroenterol . 1994; 32 342-347
- 27 Albadalejo J, Alonso R, Antinozzi R. Multicenter evaluation of the COBAS AMPLICOR HCV assay, an integrated PCR system for rapid detection of hepatitis C in the diagnostic laboratory. J Clin Microbiol . 1998; 36 862-865
- 28 Stapleton J T, Klinzman D, Schmidt W N. Prospective comparison of whole-blood- and plasma-based hepatitis C virus RNA detection systems: Improved detection using whole blood as the source of viral RNA. J Clin Microbiol . 1999; 37 484-489
- 29 Schmidt W N, Wu P, Brashear D. Effect of interferon therapy on hepatitis C virus RNA in whole blood, plasma, and peripheral blood mononuclear cells. Hepatology . 1999; 28 1110-1116
- 30 Lunel F, Cresta P, Vitour D. Comparative evaluation of hepatitis C virus RNA quantitation by branched DNA, NASBA, and monitor assays. Hepatology . 1999; 29 528-535
- 31 Hawkins A, Davidson F, Simmonds P. Comparison of plasma virus loads among individuals infected with hepatitis C virus (HCV) genotypes 1, 2, and 3 by quantiplex HCV RNA assay versions 1 and 2, Roche monitor assay, and an in-house limiting dilution method. J Clin Microbiol . 1997; 35 187-192
- 32 Reichard O, Norkrans G, Fryden A, Braconier J H, Sonnerborg A, Weiland O. Comparison of 3 quantitative HCV RNA assays-accuracy of baseline viral load to predict treatment outcome in chronic hepatitis C. Scand J Infect Dis . 1998; 30 441-446
- 33 Tong C Y, Hollingsworth R C, Williams H, Irving W L, Gilmore I T. Effect of genotypes on the quantification of hepatitis C virus (HCV) RNA in clinical samples using the Amplicor HCV Monitor test and the Quantiplex HCV RNA 2.0 assay (bDNA). J Med Virol . 1998; 55 191-196
- 34 Gretch D R. Use and interpretation of HCV diagnostic tests in the clinical setting. In: Davis GL, ed. Clinic in Liver Disease Philadelphia: W.B. Saunders 1997: 543-557
- 35 Gretch D R, dela Rosa C, Carithers Jr L R, Willson R A, Williams B, Corey L. Assessment of hepatitis C viremia using molecular amplification technologies: Correlations and clinical implications. Ann Intern Med . 1995; 123 321-329
- 36 Pawlotsky J M, Martinot-Peignoux M, Poveda J D. Quantification of hepatitis C virus RNA in serum by branched DNA-based signal amplification assays. J Virol Methods . 1999; 79 227-235
- 37 Trabaud M A, Bailly F, Si-Ahmed S N. Comparison of HCV RNA assays for the detection and quantification of hepatitis C virus RNA levels in serum of patients with chronic hepatitis C treated with interferon. J Med Virol . 1997; 52 105-112
- 38 Bukh J, Miller R H, Purcell R H. Genetic heterogeneity of hepatitis C virus: Quasispecies and genotypes. Semin Liver Dis . 1995; 15 41-63
- 39 Simmonds P, Holmes E C, Cha T A. Classification of hepatitis C virus into six major genotypes and a series of subtypes by phylogenetic analysis of the NS-5 region. J Gen Virol . 1993; 74 2391-2399
- 40 Bukh J, Purcell R H, Miller R H. At least 12 genotypes of hepatitis C virus predicted by sequence analysis of the putative E1 gene of isolates collected worldwide. Proc Natl Acad Sci USA . 1993; 90 8234-8238
- 41 Stuyver L, Van Arnhem W, Wyseur A, Hernandez F, Delaporte E, Maertens G. Classification of hepatitis C viruses based on phylogenetic analysis of the envelope 1 and nonstructural 5B regions and identification of 5 additional subtypes. Proc Natl Acad Sci USA . 1994; 91 10134-10138
- 42 Okamoto H, Sugiyama Y, Okada S. Typing hepatitis C virus by polymerase chain reaction with type specific primers: Application to clinical surveys and tracing infectious sources. J Gen Virol . 1992; 73 673-679
- 43 Chayama K, Tsubota A, Arase Y. Genotype subtyping of hepatitis C virus. J Gastroenterol Hepatol . 1993; 8 150-156
- 44 Nakao T, Enomoto N, Takada N, Takada A, Date T. Typing of hepatitis C virus genomes by restriction fragment length polymorphism. J Gen Virol . 1991; 72 2105-2112
- 45 Simmonds P, McOmish F, Yap P L. Sequence variability in the 5′ non-coding region of hepatitis C virus: Identification of a new virus type and restrictions on sequence diversity. J Gen Virol . 1993; 74 661-668
- 46 Davidson F, Simmonds P, Ferguson J C. Survey of major genotypes and subtypes of hepatitis C virus using RFLP of sequences amplified from the 5′-non-coding region. J Gen Virol . 1995; 76 1197-1204
- 47 Mahaney K, Tedeschi V, Maertens G. Genotypic analysis of hepatitis C virus in American patients. Hepatology . 1994; 20 1405-1411
- 48 Lau J Y, Mizokami M, Kolberg J A. Application of six hepatitis C genotyping systems to sera from chronic hepatitis C patients in the United States. J Infect Dis . 1995; 171 281-289
- 49 Lau J YN, Davis G L, Prescott L E. Distribution of hepatitis C virus genotypes determined by line probe assay in patients with chronic hepatitis C seen at tertiary referral centers in the United States. Ann Intern Med . 1996; 124 868-876
- 50 Simmonds P, Rose K A, Graham S. Mapping of serotype-specific, immunodominant epitopes in the NS-4 region of hepatitis C virus (HCV): Use of type-specific peptides to serologically differentiate infections with HCV types 1, 2, and 3. J Clin Microbiol . 1993; 31 1493-1503
- 51 Pawlotsky J M, Prescott L, Simmonds P. Serological determination of hepatitis C virus genotype: Comparison with a standardized genotyping assay. J Clin Microbiol . 1997; 35 1734-1739
- 52 Prescott L E, Berger A, Pawlotsky J M, Conjeevaram P, Pike I, Simmonds P. Sequence analysis of hepatitis C virus variants producing discrepant results with two different genotyping assays. J Med Virol . 1997; 53 237-244
- 53 Hoofnagle J H. Hepatitis C: The clinical spectrum of disease. Hepatology . 1997; 26(Suppl 1) 15S-20S
- 54 Alter M J, Margolis H S, Krawczynski K. The natural history of community-acquired hepatitis C in the United States. The Sentinel Counties Chronic Non-A, Non-B Hepatitis Study Team. N Engl J Med . 1992; 327 1899-1905
- 55 Farci P, Alter H J, Wong D. A long-term study of hepatitis C virus replication in non-A, non-B hepatitis. N Engl J Med . 1991; 325 98-104
- 56 Alter H J. Descartes before the horse: I clone, therefore I am. The hepatitis C virus in current perspective. Ann Intern Med . 1991; 115 644-649
- 57 McHutchison J G, Poynard T. Combination therapy with interferon plus ribavirin for the initial treatment of chronic hepatitis C. Semin Liver Dis . 1999; 19(Suppl 1) 57-65
- 58 Davis G L, Lau J Y. Factors predictive of a beneficial response to therapy of hepatitis C. Hepatology . 1997; 26(Suppl 1) 122S-127S
- 59 Barnes E, Webster G, Whalley S, Dusheiko G. Predictors of a favorable response to alpha interferon therapy for hepatitis C. In: Keefe EB, ed. Clinics in Liver Disease Philadelphia: W.B. Saunders 1999: 774-791
- 60 Lindsay K L. Therapy of hepatitis C: Overview. Hepatology . 1997; 26(Suppl 1) 71S-77S
- 61 Tong M J, Blatt L M, McHutchison J G, Co R L, Conrad A. Prediction of response during interferon alfa 2b therapy in chronic hepatitis C patients using viral and biochemical characteristics: A comparison. Hepatology . 1997; 26 1640-1645
- 62 Chemello L, Cavalleto L, Casarin C. Persistent hepatitis C viremia predicts late relapse after sustained response to interferon-alpha in chronic hepatitis C. Ann Intern Med . 1996; 124 1058-1060
- 63 Marcellin P, Boyer N, Gervais A. Long-term histologic improvement and loss of detectable intrahepatic HCV RNA in patients with chronic hepatitis C and sustained response to interferon-alpha therapy. Ann Intern Med . 1997; 127 875-881
- 64 Lau D-TY, Kleiner D E, Ghany M G, Park Y, Schmid P, Hoofnagle J H. 10-Year follow-up after interferon-alpha therapy for chronic hepatitis C. Hepatology . 1998; 28 1121-1127
- 65 Larghi A, Tagger A, Crosignani A. Clinical significance of hepatic HCV RNA in patients with chronic hepatitis C demonstrating long-term sustained response to interferon-alpha therapy. J Med Virol . 1998; 55 7-11
- 66 Reichard O, Glaumann H, Fryden A, Norkrans G, Wejstal R, Weiland O. Long-term follow-up of chronic hepatitis C patients with sustained virological response to alpha-interferon. J Hepatol . 1999; 30 783-787
- 67 Vento S, Concia E, Ferraro T. Lack of sustained efficacy of interferon in patients with chronic hepatitis C. N Engl J Med . 1996; 334 1479-1480
- 68 National Institutes of Health Consensus Development Conference Panel statement. Management of hepatitis C. Hepatology . 1997; 26(Suppl 1) 2S-10S
- 69 Alberti A, Chemello L, Noventa F, Cavalletto L, De S G. Therapy of hepatitis C: Retreatment with alpha interferon. Hepatology . 1997; 26(Suppl 1) 137S-142S
- 70 Chemello L, Cavalletto L, Donada C. Efficacy of a second cycle of interferon therapy in patients with chronic hepatitis C. Gastroenterology . 1997; 113 1654-1659
- 71 Camma C, Giunta M, Chemello L. Chronic hepatitis C: Interferon retreatment of relapsers. A meta- analysis of individual patient data. Hepatology . 1999; 30 801-807
- 72 Davis G L, Esteban-Mur R, Rustgi V. Interferon alfa-2b alone or in combination with ribavirin for the treatment of relapse of chronic hepatitis C. International Hepatitis Interventional Therapy Group. N Engl J Med . 1998; 339 1493-1499
- 73 Davis G L. Combination therapy with interferon alfa and ribavirin as retreatment of interferon relapse in chronic hepatitis C. Semin Liver Dis . 1999; 19(Suppl 1) 49-55
- 74 Heathcote E J, Keeffe E B, Lee S S. Retreatment of chronic hepatitis C with consensus interferon. Hepatology . 1998; 27 1136-1143
- 75 Barbaro G, Di Lorenzo G, Belloni G. Interferon alpha-2B and ribavirin in combination for patients with chronic hepatitis C who failed to respond to, or relapsed after, interferon alpha therapy: A randomized trial. Am J Med . 1999; 107 112-118
- 76 Schreiber G B, Busch M P, Kleinman S H, Korelitz J J. The risk of transfusion-transmitted viral infections. N Engl J Med . 1996; 334 1685-1690
- 77 Vrielink H, Zaaijer H L, Reesink H W, van der Poel L C, Cuypers H T, Lelie P N. Sensitivity and specificity of three third-generation anti-hepatitis C virus ELISAs. Vox Sang . 1995; 69 14-17
- 78 Terrault N A, Wright T L, Pereira B JG. Hepatitis C infection in the transplant recipient. Infect Dis Clin North Am . 1995; 9 943-964
- 79 Roth D. Hepatitis C virus: The nephrologist's view. Am J Kidney Dis . 1995; 25 3-16
- 80 Tokars J I, Alter M J, Favero M S, Moyer L A, Miller E, Bland L A. National surveillance of dialysis associated diseases in the United States, 1993. ASAIO J . 1996; 42 219-229
- 81 Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR Morb Mortal Wkly Rep . 1998; 47 1-39
- 82 Chan T M, Lok A SF, Cheng I KP, Chan R T. Prevalence of hepatitis C virus infection in hemodialysis patients: A longitudinal study comparing the results of RNA and antibody assays. Hepatology . 1993; 17 5-8
- 83 Fabrizi F, Lunghi G, Andrulli S. Influence of hepatitis C virus (HCV) viraemia upon serum aminotransferase activity in chronic dialysis patients. Nephrol Dial Transplant . 1997; 12 1394-1398
- 84 Couroucé A M, Bouchardeau F, Chauveau P. Hepatitis C virus (HCV) infection in haemodialysed patients: HCV-RNA and anti-HCV antibodies (third-generation assays). Nephrol Dial Transplant . 1995; 10 234-239
- 85 Strasser S I, Myerson D, Spurgeon C L. Hepatitis C virus infection and bone marrow transplantation: A cohort study with 10-year follow-up. Hepatology . 1999; 29 1893-1899
- 86 Strasser S I, Sullivan K M, Myerson D. Cirrhosis of the liver in long-term marrow transplant survivors. Blood . 1999; 93 3259-3266
- 87 Hsu H H, Wright T L, Tsao S C. Antibody response to hepatitis C virus after liver transplantation. Am J Gastroenterol . 1994; 89 1169-1174
- 88 Lok A S, Chien D, Choo Q L. Antibody response to core, envelope and nonstructural hepatitis C virus antigens: Comparison of immunocompetent and immunosuppressed patients. Hepatology . 1993; 18 497-502
- 89 Feray C, Gigou M, Samuel D. The course of hepatitis C virus infection after liver transplantation. Hepatology . 1994; 20 1137-1143
- 90 Wright T L, Donegan E, Hsu H H. Recurrent and acquired hepatitis C viral infection in liver transplant recipients. Gastroenterology . 1992; 102 317-322
- 91 Chamot E, Hirschel B, Wintsch J. Loss of antibodies against hepatitis C virus in HIV-seropositive intravenous drug users. AIDS . 1990; 4 1275-1277
- 92 Vogt M, Lang T, Frosner G. Prevalence and clinical outcome of hepatitis C infection in children who underwent cardiac surgery before the implementation of blood-donor screening. N Engl J Med . 1999; 341 866-870
- 93 Ohto H, Terazawa S, Sasaki N. Transmission of hepatitis C virus from mothers to infants. The Vertical Transmission of Hepatitis C Virus Collaborative Study Group. N Engl J Med . 1994; 330 744-750
- 94 Giacchino R, Tasso L, Timitilli A. Vertical transmission of hepatitis C virus infection: Usefulness of viremia detection in HIV-seronegative hepatitis C virus-seropositive mothers. J Pediatr . 1998; 132 167-169
- 95 Jonas M M. Hepatitis C infection in children. N Engl J Med . 1999; 341 912-913