Current and future hepatitis C virus diagnostic testing: Problems and advancements

Microbes and Infection

Volumn 4, Issue 12, 2002, Pages 1227-1236

  Majid, Ayaz M ^a   Gretch, David R ^a,b  

^a UNIVERSITY OF WASHINGTON MEDICAL CENTER   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Diagnostics; Hepatitis C virus; Serology; Viremia

Indexed keywords

ANTIVIRUS AGENT; MONOCLONAL ANTIBODY; PROTEINASE; RECOMBINANT PROTEIN; VIRUS ANTIGEN;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIBODY DETECTION; ANTIBODY SCREENING; B LYMPHOCYTE; CARBOXY TERMINAL SEQUENCE; DIAGNOSIS; DIAGNOSTIC ACCURACY; DIAGNOSTIC PROCEDURE; DIAGNOSTIC TEST; DNA DETERMINATION; ELECTROIMMUNOASSAY; GENE AMPLIFICATION; GENOTYPE; HEPATITIS C; HEPATITIS C VIRUS; HISTOLOGY; HUMORAL IMMUNITY; IMMUNOBLOTTING; INCUBATION TIME; LIVER BIOPSY; NONHUMAN; NUCLEIC ACID SEQUENCE BASED AMPLIFICATION; POLYMERASE CHAIN REACTION; POSTTRANSFUSION HEPATITIS; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REVIEW; SCREENING TEST; SERODIAGNOSIS; VIREMIA; VIRUS DETECTION;

HEPATITIS C VIRUS;

EID: 0036815985     PISSN: 12864579     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1286-4579(02)01650-7     Document Type: Article

References (46)

1. Hoofnagle J.H. Hepatitis C: the clinical spectrum of disease. Hepatology. 26:(3 Suppl):1997;15S-20S.
2. Hallam N.F., Fletcher M.L., Read S.J., Majid A.M., Kurtz J.B., Rizza C.R. Low risk of sexual transmission of hepatitis C virus. J. Med. Virol. 40:1993;251-253.
3. Lin H.J., Lau J.Y., Lauder I.J., Shi N., Lai C.L., Hollinger F.B. The hepatitis C virus genome: a guide to its conserved sequences and candidate epitopes. Virus Res. 30:1993;27-41.
4. Aach R., Stevens C., Hollinger F., Mosley J., Peterson D., Taylor P., Johnson R., Barbosa L., Nemo G. Hepatitis C virus infection in post-transfusion hepatitis. An analysis with first- and second-generation assays. New Engl. J. M. 325:1991;1325-1329.
5. Morishima C.G.D. Clinical use of hepatitis C virus tests for diagnosis and monitoring during therapy. Clin. Liver Dis. 3:1999;717-740.
6. Clemens J.M., Taskar S., Chau K., Vallari D., Shih J.W., Alter H.J., chleicher J.B., Mimms L.T. IgM antibody response in acute hepatitis C viral infection. Blood. 79:(1):1992;169-172.
7. Gretch D.R. Use and interpretation of HCV diagnostic tests in the clinical setting. Clin. Liver Dis. 1:1997;543-557.
8. Mondelli M.U., Cividini A., Cerino A. Role of humoral responses in hepatitis B and C virus infections. Eur. J. Clin. Invest. 25:1995;543-547.
9. Wang Y.F., Brotman B., Andrus L., Prince A.M. Immune response to epitopes of hepatitis C virus (HCV) structural proteins in HCV-infected humans and chimpanzees. J. Infect. Dis. 173:1996;808-821.
10. Sallberg M., Zhang Z.X., Chen M., Jin L., Birkett A., Peterson D.L., Milich D.R. Immunogenicity and antigenicity of the ATPase/helicase domain of the hepatitis C virus non-structural 3 protein. J. Gen. Virol. 77:(Pt. 11):1996;2721-2728.
11. Hitzler W.E., Runkel S., Routine H.C.V. PCR screening of blood donations to identify early HCV infection in blood donors lacking antibodies to HCV. Transfusion. 41:2000;333-338.
12. Lee S.R., Peterson J., Niven P., Bahl C., Page E., DeLeys R., Giordani-Schmidt D., Baggett D., Green G. Efficacy of a hepatitis C virus core antigen enzyme-linked immunosorbent assay for the identification of 'window-phase' blood donations. Vox. Sang. 80:2001;19-23.
13. Gretch D.R., de la Rosa C., Carithers R.L., Willson R.A., Williams B., Corey L. Assessment of hepatitis C viremia using molecular amplification technologies: correlations and clinical implications. Ann. Intern. M. (123):1995;321-329.
14. Read S.J. Recovery efficiencies of nucleic acid extraction kits as measured by quantitative LightCycler™ PCR. J. Clin. Pathol. 54:2001;86-90.
15. O'Meara D., Yun Z., Sonnerborg A., Lundeberg J. Cooperative oligonucleotides mediating direct capture of hepatitis C virus RNA from serum. J. Clin. Microbiol. 36:1998;2454-2459.
16. Sarrazin C., Teuber G., Kokka R., Rabenau H., Zeuzem S. Detection of residual hepatitis C virus RNA by transcription-mediated amplification in patients with complete virologic response according to polymerase chain reaction-based assays. Hepatology. 32:(4 Pt. 1):2000;818-823.
17. Polyak S.J., Gretch D.R. Molecular diagnostic testing for viral hepatitis: methods and applications. Willson R.A. Viral Hepatitis: Diagnosis, Treatment, and Prevention. vol. 4:1997;1-33 Marcel Dekker, Inc, New York.
18. Saldanha J., Heath A., Lelie N., Pisani G., Nubling M., Yu M. Calibration of HCV working reagents for NAT assays against the HCV international standard. The Collaborative Study Group. Vox. Sang. 78:2000;217-224.
19. Pawlotsky J.M., Bouvier-Alias M., Hezode C., Darthuy F., Remire J., Dhumeaux D. Standardization of hepatitis C virus RNA quantification. Hepatology. 32:2000;654-659.
20. Mahmood S., Nakata K., Sho M., Kimura T., Manabe Y., Kinoyama S., Ito T., Yamada G. Clinical usefulness of the branched DNA assay version 2 in predicting the efficacy of interferon treatment in a group of chronic HCV patients based on serotype. Hepatol. Res. 20:2001;9-17.
21. Mellor J., Hawkins A., Simmonds P. Genotype dependence of hepatitis C virus load measurement in commercially available quantitative assays. J. Clin. Microbiol. 37:1999;2525-2532.
22. Pawlotsky J.M. Measuring hepatitis C viremia in clinical samples: can we trust the assays? Hepatology. 26:1997;1-4.
23. Lunel F., Cresta P., Vitour D., Payan C., Dumont B., Frangeul L., Reboul D., Brault C., Piette J.C., Huraux J.M. Comparative evaluation of hepatitis C virus RNA quantitation by branched DNA, NASBA, and monitor assays. Hepatology. 29:1999;528-535.
24. Martinot-Peignoux M., Boyer N., Le Breton V., LeGuludec G., Castelnau C., Akremi R., Marcellin P. A new step toward standardization of serum hepatitis C virus-RNA quantification in patients with chronic hepatitis C. Hepatology. 31:2000;726-729.
25. Gerken G., Rothaar T., Rumi M.G., Soffredini R., Trippler M., Blunk M.J., Butcher A., Soviero S., Colucci G. Performance of the COBAS Amplicor HCV Monitor test, version 2.0, an automated reverse transcription-PCR quantitative system for hepatitis C virus load determination. J. Clin. Microbiol. 38:2000;2210-2214.
26. Martell M., Gomez J., Esteban J.I., Sauleda S., Quer J., Cabot B., Esteban R., Guardia J. High-throughput real-time reverse transcription-PCR quantitation of hepatitis C virus RNA. J. Clin. Microbiol. 37:1999;327-332.
27. Takeuchi T., Katsume A., Tanaka T., Abe A., Inoue K., Kohara K., Kawaguchi R., Tanaka S., Kohara M. Real-time detection system for quantification of hepatitis C virus genome. Gastroenterology. 166:1999;636-643.
28. Komurian-Pradel F., Paranhos-Baccala G., Sodoyer M., Chevallier P., Mandrand B., Lotteau V., André P. Quantitation of HCV RNA using real-time PCR and fluorimetry. J. Virol. Methods. 95:2001;111-119.
29. Schroter M., Zollner B., Schafer P., Laufs R., Feucht H.H. Quantitative detection of hepatitis C virus RNA by light cycler PCR and comparison with two different PCR assays. J. Clin. Microbiol. 39:2001;765-768.
30. Damen M., Sillekens P., Cuypers H.T., Frantzen I., Melsert R. Characterization of the quantitative HCV NASBA assay. J. Virol. Methods. 82:1999;45-54.
31. Zein N.N. Clinical significance of hepatitis C virus genotypes. Clin. Microbiol. Rev. 13:2000;223-235.
32. Halfon P., Trimoulet P., Bourliere M., Khiri H., de Ledinghen V., Couzigou P., Feryn J.M., Alcaraz P., Renou C., Fleury H.J., Ouzan D. Hepatitis c virus genotyping based on 5′ noncoding sequence analysis (trugene). J. Clin. Microbiol. 39:2001;1771-1773.
33. Alberti A., Morsica G., Chemello L., Cavalletto D., Noventa F., Pontisso P., Ruol A. Hepatitis C viraemia and liver disease in symptom-free individuals with anti-HCV. Lancet. 340:1992;697-698.
34. Gretch D., Corey L., Wilson J., dela Rosa C., Willson R., Carithers Jr R., Busch M., Hart J., Sayers M., Han J. Assessment of hepatitis C virus RNA levels by quantitative competitive RNA polymerase chain reaction: high-titer viremia correlates with advanced stage of disease. J. Infect. Dis. 169:1994;1219-1225.
35. Lindsay K.L. Therapy of hepatitis C: overview. Hepatology. 26:1997;71S-77S.
36. Reichard O., Norkrans G., Fryden A., Braconier J.H., Sonnerborg A., Weiland O. Comparison of three quantitative HCV RNA assays - accuracy of baseline viral load to predict treatment outcome in chronic hepatitis C. Scand. J. Infect. Dis. 30:1998;441-446.
37. Shiratori Y., Kato N., Yoshida H., Nakata R., Ihori M., Imazeki F., Yokosuka O., Kawase T., Katamoto T., Unuma T., Nakamura A., Ikegami F., Hirota K., Omata M. Sustained viral response is rarely achieved in patients with high viral load of HCV RNA by excessive interferon therapy. Dig. Dis. Sci. 45:2000;565-574.
38. Webster G., Barnes E., Brown D., Dusheiko G. HCV genotypes - role in pathogenesis of disease and response to therapy. Baillieres Best Pract. Res. Clin. Gastroenterol. 14:2000;229-240.
39. Statement NIoHSCP: Management of Hepatitis C. Hepatology. 26:1997;2S-10S.
40. Lau D.T.Y.K.D., Ghany M.G., et al. Ten-year follow-up after interferon-alpha therapy for chronic hepatitis C. Hepatology. 28:1998;1121-1127.
41. Civeira M.P., Prieto J. Early predictors of response to treatment in patients with chronic hepatitis C. J. Hepatol. 31:1999;237-243.
42. Zeuzem S. Clinical implications of hepatitis C viral kinetics. J. Hepatol. 31:1999;61-64.
43. Neuman A., Lam N., Dahari H., Gretch D., Wiley T., Layden T., et al. Hepatitis C viral dynamics in vivo and the antiviral efficacy of interferon-aplha therapy. Science. 282:1998;103-107.
44. Kato N., Yokosuka O., Hosoda K., Ito Y., Ohto M., Omata M. Quantification of hepatitis C virus by competitive reverse transcription-polymerase chain reaction: increase of the virus in advanced liver disease. Hepatology. 18:1993;16-20.
45. Lau J.Y., Davis G.L., Kniffen J., Qian K.P., Urdea M.S., Chan C.S., Mizokami M., Neuwald P.D., Wilber J.C. Significance of serum hepatitis C virus RNA levels in chronic hepatitis C. Lancet. 341:1993;1501-1504.
46. Pontisso P., Bellati G., Brunetto M., Chemello L., Colloredo G., Di Stefano R., Nicoletti M., Rumi M.G., Ruvoletto M.G., Soffredini R., Valenza L.M., Colucci G. Hepatitis C virus RNA profiles in chronically infected individuals: do they relate to disease activity. Hepatology. 29:1999;585-589.