MyBook is a cheap paperback edition of the original book and will be sold at uniform, low price.

Preview this :
Zoom in

, Page 1 of 2

| /docserver/preview/fulltext/10.1128/9781555816728/9781555814632_Chap89-1.gif /docserver/preview/fulltext/10.1128/9781555816728/9781555814632_Chap89-2.gif
There is no abstract provided for this chapter. We are in the process of generating a full text preview. Please bookmark and return later.
Citation: Forman M, Valsamakis A. .

Key Concept Ranking

TaqMan Real-Time PCR Assay
Restriction Fragment Length Polymorphism
Hepatitis C virus
Highlighted Text: Show | Hide
Loading full text...

Full text loading...


Image of FIGURE 1

HCV genome and protein coding scheme. E, envelope; NS, nonstructural gene; nuc, nucleotide; pos, position; aa, amino acid; gp, glycoprotein. Numbering is according to references and .

Permissions and Reprints Request Permissions
Download as Powerpoint
Image of FIGURE 2

Clinical features of acute hepatitis C following exposure to low viral inoculum such as occupational needlestick exposure or community-based exposure ( ). Characteristics following higher-dose exposure (transfusion with contaminated blood products) may be different. The intermittent viremia phase was estimated from needlestick exposure ( ). Kinetics of other characteristics were derived from seroconversion panels ( ). ALT, alanine aminotransferase. Dashed lines indicate potential viremia patterns as defined by HCV RNA levels in peripheral blood. Adapted from reference .

Permissions and Reprints Request Permissions
Download as Powerpoint
Image of FIGURE 3

Individualized chronic hepatitis C therapy algorithms based on genotype, baseline viral load, and response kinetics. Rx wk, treatment week; LVL, low baseline viral load (,400,000 IU/ml); HVL, high baseline viral load (<400,000 IU/ml); UD, undetectable; 1, detectable HCV RNA. Adapted from reference .

Permissions and Reprints Request Permissions
Download as Powerpoint
Image of FIGURE 4

Antigens in serology tests and supplemental RIBA currently available commercially in the United States. Abbott HCV EIA 2.0 is the only second-generation screening test currently available. AxSYM, Architect, Ortho 3.0 EIA, Ortho Vitros, and Advia Centaur are third-generation HCV antibody screening tests. HC34, recombinant antigen containing HCV core protein (amino acids [aa] 1 to 150); HC31, recombinant antigen containing NS3 (aa 1192 to 1457) and NS4 (aa 1676 to 1931) separated by an 8-aa linker. c100-3, recombinant antigen containing NS3-4 (aa 1569 to 1931). HCr43, fusion protein of two noncontiguous antigens, c33c and core protein (aa 1 to 150). c200, recombinant antigen containing NS3-4 (aa 1192 to 1931). NS5, recombinant antigen (aa 2054 to 2995). c22-3, recombinant antigen containing core protein (aa 2 to 120). c22p, peptide containing core protein major epitope (aa 10 to 53). 5-1-1p and c100p, NS4 peptides (aa 1694 to 1735 and aa 1920 to 1935, respectively). SOD, superoxide dismutase. First-generation RIBA contained c100-3 and 5-1-1p expressed as a recombinant antigen. Second-generation RIBA contained these two antigens plus c33c and c22-3. Compared to RIBA 2.0, RIBA 3.0 contains an additional antigen (NS5) and peptides have replaced recombinant core and NS4 antigens.

Permissions and Reprints Request Permissions
Download as Powerpoint
Image of FIGURE 5

RIBA interpretation. (A) Interpretive criteria; (B) illustrations of sample results. Lane 1, illustration of band locations for human IgG (LI, level one, low-concentration IgG control; LII, level two, high-concentration IgG control), hSOD, and HCV recombinant antigens and peptides. Lanes 2 to 9, sample results. Lanes 2 to 4, RIBA positive. Lanes 5 to 7, RIBA negative. Lanes 8 and 9, RIBA indeterminate. See Fig. 4 for location of HCV antigens/peptides.

Permissions and Reprints Request Permissions
Download as Powerpoint
Image of FIGURE 6

Algorithms for HCV antibody screening and confirmation. Interpretations and suggested follow-up are indicated by boxed, italicized text. Derived from www.cdc.gov/hepatitis/HCV/ LabTesting.htm.

Permissions and Reprints Request Permissions
Download as Powerpoint


1. Abdel-Hamid, M.,, M. El-Daly,, S. El-Kafrawy,, N. Mikhail,, G. T. Strickland,, and A. D. Fix. 2002. Comparison of secondand third-generation enzyme immunoassays for detecting antibodies to hepatitis C virus. J. Clin. Microbiol. 40:16561659.
2. Adinolfi, L. E.,, R. Utili,, A. Andreana,, M. F. Tripodi,, P. Rosario,, G. Mormone,, E. Ragone,, G. Pasquale,, and G. Ruggiero. 2000. Relationship between genotypes of hepatitis C virus and histopathological manifestations in chronic hepatitis C patients. Eur. J. Gastroenterol. Hepatol. 12:299304.
3. Alberti, A.,, S. Boccato,, A. Vario,, and L. Benvegnu. 2002. Therapy of acute hepatitis C. Hepatology 36:S195S200.
4. Alfaresi, M. S.,, and A. A. Elkoush. 2007. Determination of hepatitis C virus genotypes by melting-curve analysis of quantitative polymerase chain reaction products. Indian J. Med. Microbiol. 25:249252.
5. Alter, M. J.,, W. L. Kuhnert,, and L. Finelli. 2003. Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. MMWR Recommend. Rep. 52:113, 15.; quiz CE11-14.
6. Alzahrani, A. J. 2008. Simultaneous detection of hepatitis C virus core antigen and antibodies in Saudi drug users using a novel assay. J. Med. Virol. 80:603606.
7. Antonishyn, N. A.,, V. M. Ast,, R. R. McDonald,, R. K. Chaudhary,, L. Lin,, A. P. Andonov,, and G. B. Horsman. 2005. Rapid genotyping of hepatitis C virus by primer-specific extension analysis. J. Clin. Microbiol. 43:51585163.
8. Armstrong, G. L.,, A. Wasley,, E. P. Simard,, G. M. McQuillan,, W. L. Kuhnert,, and M. J. Alter. 2006. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann. Intern. Med. 144:705714.
9. Beuselinck, K.,, M. van Ranst,, and J. van Eldere. 2005. Automated extraction of viral-pathogen RNA and DNA for high-throughput quantitative real-time PCR. J. Clin. Microbiol. 43:55415546.
10. Bouchardeau, F.,, J. F. Cantaloube,, S. Chevaliez,, C. Portal,, A. Razer,, J. J. Lefrere,, J. M. Pawlotsky,, P. De Micco,, and S. Laperche. 2007. Improvement of hepatitis C virus (HCV) genotype determination with the new version of the INNOLiPA HCV assay. J. Clin. Microbiol. 45:11401145.
11. Busch, M. P. 2001. Insights into the epidemiology, natural history and pathogenesis of hepatitis C virus infection from studies of infected donors and blood product recipients. Transfus. Clin. Biol. 8:200206.
12. Caliendo, A. M.,, A. Valsamakis,, Y. Zhou,, B. Yen-Lieberman,, J. Andersen,, S. Young,, A. Ferreira-Gonzalez,, G. J. Tsongalis,, R. Pyles,, J. W. Bremer,, and N. S. Lurain. 2006. Multilaboratory comparison of hepatitis C virus viral load assays. J. Clin. Microbiol. 44:17261732.
13. Carlsson, T.,, A. Quist,, and O. Weiland. 2008. Rapid viral response and treatment outcome in genotype 2 and 3 chronic hepatitis C: comparison between two HCV RNA quantitation methods. J. Med. Virol. 80:803807.
14. Carrat, F.,, F. Bani-Sadr,, S. Pol,, E. Rosenthal,, F. Lunel- Fabiani,, A. Benzekri,, P. Morand,, C. Goujard,, G. Pialoux,, L. Piroth,, D. Salmon-Ceron,, C. Degott,, P. Cacoub,, and C. Perronne. 2004. Pegylated interferon alfa-2b vs standard interferon alfa-2b, plus ribavirin, for chronic hepatitis C in HIV-infected patients: a randomized controlled trial. JAMA 292:28392848.
15. Castelain, S.,, V. Descamps,, V. Thibault,, C. Francois,, D. Bonte,, V. Morel,, J. Izopet,, D. Capron,, P. Zawadzki,, and G. Duverlie. 2004. TaqMan amplification system with an internal positive control for HCV RNA quantitation. J. Clin. Virol. 31:227234.
16.Centers for Disease Control and Prevention. 1998. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR Recommend. Rep. 47:139.
17.Centers for Disease Control and Prevention. 2001. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. MMWR Recommend. Rep. 50:152.
18. Chamie, G.,, M. Bonacini,, D. R. Bangsberg,, J. T. Stapleton,, C. Hall,, E. T. Overton,, R. Scherzer,, and P. C. Tien. 2007. Factors associated with seronegative chronic hepatitis C virus infection in HIV infection. Clin. Infect. Dis. 44:577583.
19. Chevaliez, S.,, M. Bouvier-Alias,, R. Brillet,, and J. M. Pawlotsky. 2007. Overestimation and underestimation of hepatitis C virus RNA levels in a widely used real-time polymerase chain reaction-based method. Hepatology 46:2231.
20. Chevaliez, S.,, M. Bouvier-Alias,, L. Castera,, and J. M. Pawlotsky. 2009. The Cobas AmpliPrep-Cobas TaqMan realtime polymerase chain reaction assay fails to detect hepatitis C virus RNA in highly viremic genotype 4 clinical samples. Hepatology 49:13971398.
21. Choo, Q. L.,, K. H. Richman,, J. H. Han,, K. Berger,, C. Lee,, C. Dong,, C. Gallegos,, D. Coit,, R. Medina-Selby,, P. J. Barr, et al. 1991. Genetic organization and diversity of the hepatitis C virus. Proc. Natl. Acad. Sci. USA 88:24512455.
22. Clancy, A.,, B. Crowley,, H. Niesters,, and C. Herra. 2008. The development of a qualitative real-time RT-PCR assay for the detection of hepatitis C virus. Eur. J. Clin. Microbiol. Infect. Dis. 27:11771182.
23. Colin, C.,, D. Lanoir,, S. Touzet,, L. Meyaud-Kraemer,, F. Bailly,, and C. Trepo. 2001. Sensitivity and specificity of third-generation hepatitis C virus antibody detection assays: an analysis of the literature. J. Viral Hepat. 8:8795.
24. Colson, P.,, A. Motte,, and C. Tamalet. 2006. Broad differences between the COBAS Ampliprep total nucleic acid isolation- COBAS TaqMan 48 hepatitis C virus (HCV) and COBAS HCV monitor v2.0 assays for quantification of serum HCV RNA of non-1 genotypes. J. Clin. Microbiol. 44:16021603.
25. Colucci, G.,, J. Ferguson,, C. Harkleroad,, S. Lee,, D. Romo,, S. Soviero,, J. Thompson,, M. Velez,, A. Wang,, Y. Miyahara,, S. Young,, and C. Sarrazin. 2007. Improved COBAS TaqMan hepatitis C virus test (Version 2.0) for use with the High Pure system: enhanced genotype inclusivity and performance characteristics in a multisite study. J. Clin. Microbiol. 45:35953600.
26. Contreras, A. M.,, C. M. Tornero-Romo,, J. G. Toribio,, A. Celis,, A. Orozco-Hernandez,, P. K. Rivera,, C. Mendez,, M. I. Hernandez-Lugo,, L. Olivares,, and M. A. Alvarado. 2008. Very low hepatitis C antibody levels predict false-positive results and avoid supplemental testing. Transfusion 48:25402548.
27. Dalgard, O.,, K. Bjoro,, H. Ring-Larsen,, E. Bjornsson,, M. Holberg-Petersen,, E. Skovlund,, O. Reichard,, B. Myrvang,, B. Sundelof,, S. Ritland,, K. Hellum,, A. Fryden,, J. Florholmen,, and H. Verbaan. 2008. Pegylated interferon alfa and ribavirin for 14 versus 24 weeks in patients with hepatitis C virus genotype 2 or 3 and rapid virological response. Hepatology 47:3542.
28. Damen, M.,, H. L. Zaaijer,, H. T. Cuypers,, H. Vrielink,, C. L. van der Poel,, H. W. Reesink,, and P. N. Lelie. 1995. Reliability of the third-generation recombinant immunoblot assay for hepatitis C virus. Transfusion 35:745749.
29. Daniel, H. D.,, G. M. Chandy,, and P. Abraham. 2008. Quantitation of hepatitis C virus using an in-house real-time reverse transcriptase polymerase chain reaction in plasma samples. Diagn. Microbiol. Infect. Dis. 61:415420.
30. Davidson, F.,, P. Simmonds,, J. C. Ferguson,, L. M. Jarvis,, B. C. Dow,, E. A. Follett,, C. R. Seed,, T. Krusius,, C. Lin,, G. A. Medgyesi, et al. 1995. Survey of major genotypes and subtypes of hepatitis C virus using RFLP of sequences amplified from the 59 non-coding region. J. Gen. Virol. 76:11971204.
31. Davis, G. L.,, J. B. Wong,, J. G. McHutchison,, M. P. Manns,, J. Harvey,, and J. Albrecht. 2003. Early virologic response to treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C. Hepatology 38:645652.
32. Denoyel, G.,, J. van Helden,, R. Bauer,, and B. Preisel- Simmons. 2004. Performance of a new hepatitis C assay on the Bayer ADVIA Centaur Immunoassay System. Clin. Lab. 50:7582.
33. Desombere, I.,, H. Van Vlierberghe,, S. Couvent,, F. Clinckspoor,, and G. Leroux-Roels. 2005. Comparison of qualitative (COBAS AMPLICOR HCV 2.0 versus VERSANT HCV RNA) and quantitative (COBAS AMPLICOR HCV monitor 2.0 versus VERSANT HCV RNA 3.0) assays for hepatitis C virus (HCV) RNA detection and quantification: impact on diagnosis and treatment of HCV infections. J. Clin. Microbiol. 43:25902597.
34. Dore, G. J.,, F. J. Torriani,, M. Rodriguez-Torres,, N. Brau,, M. Sulkowski,, R. S. Lamoglia,, C. Tural,, N. Clumeck,, M. R. Nelson,, M. C. Mendes-Correa,, E. W. Godofsky,, D. T. Dieterich,, E. Yetzer,, E. Lissen,, and D. A. Cooper. 2007. Baseline factors prognostic of sustained virological response in patients with HIV-hepatitis C virus co-infection. AIDS 21:15551559.
35. Dow, B. C.,, I. Buchanan,, H. Munro,, E. A. Follett,, F. Davidson,, L. E. Prescott,, P. L. Yap,, and P. Simmonds. 1996. Relevance of RIBA-3 supplementary test to HCV PCR positivity and genotypes for HCV confirmation of blood donors. J. Med. Virol. 49:132136.
36. Drusano, G. L.,, and S. L. Preston. 2004. A 48-week duration of therapy with pegylated interferon alpha 2b plus ribavirin may be too short to maximize long-term response among patients infected with genotype-1 hepatitis C virus. J. Infect. Dis. 189:964970.
37. Elbeik, T.,, J. Surtihadi,, M. Destree,, J. Gorlin,, M. Holodniy,, S. A. Jortani,, K. Kuramoto,, V. Ng,, R. Valdes, Jr.,, A. Valsamakis,, and N. A. Terrault. 2004. Multicenter evaluation of the performance characteristics of the Bayer VERSANT HCV RNA 3.0 assay (bDNA). J. Clin. Microbiol. 42:563569.
38. Engle, R. E.,, R. S. Russell,, R. H. Purcell,, and J. Bukh. 2008. Development of a TaqMan assay for the six major genotypes of hepatitis C virus: comparison with commercial assays. J. Med. Virol. 80:7279.
39. Fabrizi, F.,, G. Lunghi,, F. Aucella,, S. Mangano,, F. Barbisoni,, S. Bisegna,, D. Vigilante,, A. Limido,, and P. Martin. 2005. Novel assay using total hepatitis C virus (HCV) core antigen quantification for diagnosis of HCV infection in dialysis patients. J. Clin. Microbiol. 43:414420.
40. Farci, P.,, H. J. Alter,, D. Wong,, R. H. Miller,, J. W. Shih,, B. Jett,, and R. H. Purcell. 1991. A long-term study of hepatitis C virus replication in non-A, non-B hepatitis. N. Engl. J. Med. 325:98104.
41. Ferenci, P.,, M. W. Fried,, M. L. Shiffman,, C. I. Smith,, G. Marinos,, F. L. Goncales, Jr.,, D. Haussinger,, M. Diago,, G. Carosi,, D. Dhumeaux,, A. Craxi,, M. Chaneac,, and K. R. Reddy. 2005. Predicting sustained virological responses in chronic hepatitis C patients treated with peginterferon alfa-2a (40 KD)/ribavirin. J. Hepatol. 43:425433.
42. Ferenci, P.,, H. Laferl,, T. M. Scherzer,, M. Gschwantler,, A. Maieron,, H. Brunner,, R. Stauber,, M. Bischof,, B. Bauer,, C. Datz,, K. Loschenberger,, E. Formann,, K. Staufer,, and P. Steindl-Munda. 2008. Peginterferon alfa-2a and ribavirin for 24 weeks in hepatitis C type 1 and 4 patients with rapid virological response. Gastroenterology 135:451458.
43. Ferraro, D.,, M. Giglio,, C. Bonura,, V. Di Marco,, M. U. Mondelli,, A. Craxi,, and R. Di Stefano. 2008. Assessment of hepatitis C virus-RNA clearance under combination therapy for hepatitis C virus genotype 1: performance of the transcription- mediated amplification assay. J. Viral. Hepat. 15:6670.
44. Ferreira-Gonzalez, A.,, and M. L. Shiffman. 2004. Use of diagnostic testing for managing hepatitis C virus infection. Semin. Liver Dis. 24(Suppl. 2):918.
45. Fiebelkorn, K. R.,, B. G. Lee,, C. E. Hill,, A. M. Caliendo,, and F. S. Nolte. 2002. Clinical evaluation of an automated nucleic acid isolation system. Clin. Chem. 48:16131615.
46. Forman, M. S.,, and A. Valsamakis. 2004. Verification of an assay for quantification of hepatitis C virus RNA by use of an analyte-specific reagent and two different extraction methods. J. Clin. Microbiol. 42:35813588.
47. Fried, M. W.,, M. L. Shiffman,, K. R. Reddy,, C. Smith,, G. Marinos,, F. L. Goncales, Jr.,, D. Haussinger,, M. Diago,, G. Carosi,, D. Dhumeaux,, A. Craxi,, A. Lin,, J. Hoffman,, and J. Yu. 2002. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N. Engl. J. Med. 347:975982.
48. Galel, S. A.,, D. M. Strong,, G. E. Tegtmeier,, P. V. Holland,, I. K. Kuramoto,, M. Kemper,, L. Pietrelli,, and J. Gallarda. 2002. Comparative yield of HCV RNA testing in blood donors screened by 2.0 versus 3.0 antibody assays. Transfusion 42:15071513.
49. Gaudy, C.,, C. Thevenas,, J. Tichet,, N. Mariotte,, A. Goudeau,, and F. Dubois. 2005. Usefulness of the hepatitis C virus core antigen assay for screening of a population undergoing routine medical checkup. J. Clin. Microbiol. 43:17221726.
50. Ge, D.,, J. Fellay,, A. J. Thompson,, J. S. Simon,, K. V. Shianna,, T. J. Urban,, E. L. Heinzen,, P. Qiu,, A. H. Bertelsen,, A. J. Muir,, M. Sulkowski,, J. G. McHutchison,, and D. B. Goldstein. 2009. Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance. Nature 461:399401.
51. George, S. L.,, B. R. Bacon,, E. M. Brunt,, K. L. Mihindukulasuriya,, J. Hoffmann,, and A. M. Di Bisceglie. 2009. Clinical, virologic, histologic, and biochemical outcomes after successful HCV therapy: a 5-year follow-up of 150 patients. Hepatology 49:729738.
52. Germer, J. J.,, C. E. Bommersbach,, D. M. Schmidt,, J. L. Bendel,, and J. D. Yao. 2009. Quantification of genotype 4 hepatitis C virus RNA by the COBAS AmpliPrep/COBAS TaqMan hepatitis C virus test. Hepatology 50:16791680.
53. Germer, J. J.,, D. W. Majewski,, B. Yung,, P. S. Mitchell,, and J. D. Yao. 2006. Evaluation of the invader assay for genotyping hepatitis C virus. J. Clin. Microbiol. 44:318323.
54. Gerotto, M.,, F. Dal Pero,, G. Bortoletto,, A. Ferrari,, R. Pistis,, G. Sebastiani,, S. Fagiuoli,, S. Realdon,, and A. Alberti. 2006. Hepatitis C minimal residual viremia (MRV) detected by TMA at the end of Peg-IFN plus ribavirin therapy predicts post-treatment relapse. J. Hepatol. 44:8387.
55. Ghany, M. G.,, D. B. Strader,, D. L. Thomas,, and L. B. Seeff. 2009. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 49:13351374.
56. Glynn, S. A.,, D. J. Wright,, S. H. Kleinman,, D. Hirschkorn,, Y. Tu,, C. Heldebrant,, R. Smith,, C. Giachetti,, J. Gallarda,, and M. P. Busch. 2005. Dynamics of viremia in early hepatitis C virus infection. Transfusion 45:9941002.
57. Gretch, D. R. 1997. Diagnostic tests for hepatitis C. Hepatology 26:43S47S.
58. Hadlich, E.,, M. R. Alvares-Da-Silva,, R. K. Dal Molin,, R. Zenker,, and L. Z. Goldani. 2007. Hepatitis C virus (HCV) viremia in HIV-infected patients without HCV antibodies detectable by third-generation enzyme immunoassay. J. Gastroenterol. Hepatol. 22:15061509.
59. Hadziyannis, S. J.,, H. Sette, Jr.,, T. R. Morgan,, V. Balan,, M. Diago,, P. Marcellin,, G. Ramadori,, H. Bodenheimer, Jr.,, D. Bernstein,, M. Rizzetto,, S. Zeuzem,, P. J. Pockros,, A. Lin,, and A. M. Ackrill. 2004. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann. Intern. Med. 140:346355.
60. Halfon, P.,, M. Martinot-Peignoux,, H. Khiri,, and P. Marcellin. 2010. Quantification of genotype 4 serum samples: impact of hepatitis C virus genetic variability. Hepatology 52:401.
61. Hezode, C.,, N. Forestier,, G. Dusheiko,, P. Ferenci,, S. Pol,, T. Goeser,, J. P. Bronowicki,, M. Bourliere,, S. Gharakhanian,, L. Bengtsson,, L. McNair,, S. George,, T. Kieffer,, A. Kwong,, R. S. Kauffman,, J. Alam,, J. M. Pawlotsky,, and S. Zeuzem. 2009. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N. Engl. J. Med. 360:18391850.
62. Hoofnagle, J. H.,, K. D. Mullen,, D. B. Jones,, V. Rustgi,, A. Di Bisceglie,, M. Peters,, J. G. Waggoner,, Y. Park,, and E. A. Jones. 1986. Treatment of chronic non-A, non-B hepatitis with recombinant human alpha interferon. A preliminary report. N. Engl. J. Med. 315:15751578.
63. Hu, Y. W.,, E. Balaskas,, M. Furione,, P. H. Yen,, G. Kessler,, V. Scalia,, L. Chui,, and G. Sher. 2000. Comparison and application of a novel genotyping method, semiautomated primer-specific and mispair extension analysis, and four other genotyping assays for detection of hepatitis C virus mixedgenotype infections. J. Clin. Microbiol. 38:28072813.
64. Huang, R. Y.,, H. T. Chang,, C. Y. Lan,, T. W. Pai,, C. N. Wu,, C. M. Ling,, and M. D. Chang. 2008. Development and evaluation of a sensitive enzyme-linked oligonucleotidesorbent assay for detection of polymerase chain reactionamplified hepatitis C virus of genotypes 1-6. J. Virol. Methods 151:211216.
65. Ismail, N.,, G. E. Fish,, and M. B. Smith. 2004. Laboratory evaluation of a fully automated chemiluminescence immunoassay for rapid detection of HBsAg, antibodies to HBsAg, and antibodies to hepatitis C virus. J. Clin. Microbiol. 42:610617.
66. Jones, C. T.,, C. L. Murray,, D. K. Eastman,, J. Tassello,, and C. M. Rice. 2007. Hepatitis C virus p7 and NS2 proteins are essential for production of infectious virus. J. Virol. 81:83748383.
67. Jongerius, J. M.,, M. Bovenhorst,, C. L. van der Poel,, J. A. van Hilten,, A. C. Kroes,, J. A. van der Does,, E. F. van Leeuwen,, and R. Schuurman. 2000. Evaluation of automated nucleic acid extraction devices for application in HCV NAT. Transfusion 40:871874.
68. Kamal, S. M.,, S. S. El Kamary,, M. D. Shardell,, M. Hashem,, I. N. Ahmed,, M. Muhammadi,, K. Sayed,, A. Moustafa,, S. A. Hakem,, A. Ibrahiem,, M. Moniem,, H. Mansour,, and M. Abdelaziz. 2007. Pegylated interferon alpha-2b plus ribavirin in patients with genotype 4 chronic hepatitis C: the role of rapid and early virologic response. Hepatology 46:17321740.
69. Kieffer, T. L.,, C. Sarrazin,, J. S. Miller,, M. W. Welker,, N. Forestier,, H. W. Reesink,, A. D. Kwong,, and S. Zeuzem. 2007. Telaprevir and pegylated interferon-alpha-2a inhibit wild-type and resistant genotype 1 hepatitis C virus replication in patients. Hepatology 46:631639.
70. Kim, S.,, J. H. Kim,, S. Yoon,, Y. H. Park,, and H. S. Kim. 2008. Clinical performance evaluation of four automated chemiluminescence immunoassays for hepatitis C virus antibody detection. J. Clin. Microbiol. 46:39193923.
71. Kleinman, S. H.,, S. L. Stramer,, J. P. Brodsky,, S. Caglioti,, and M. P. Busch. 2006. Integration of nucleic acid amplification test results into hepatitis C virus supplemental serologic testing algorithms: implications for donor counseling and revision of existing algorithms. Transfusion 46:695702.
72. Konnick, E. Q.,, S. M. Williams,, E. R. Ashwood,, and D. R. Hillyard. 2005. Evaluation of the COBAS Hepatitis C Virus (HCV) TaqMan analyte-specific reagent assay and comparison to the COBAS Amplicor HCV Monitor V2.0 and Versant HCV bDNA 3.0 assays. J. Clin. Microbiol. 43:21332140.
73. Krajden, M.,, R. Ziermann,, A. Khan,, A. Mak,, K. Leung,, D. Hendricks,, and L. Comanor. 2002. Qualitative detection of hepatitis C virus RNA: comparison of analytical sensitivity, clinical performance, and workflow of the Cobas Amplicor HCV test version 2.0 and the HCV RNA transcription-mediated amplification qualitative assay. J. Clin. Microbiol. 40:29032907.
74. Kuntzen, T.,, J. Timm,, A. Berical,, N. Lennon,, A. M. Berlin,, S. K. Young,, B. Lee,, D. Heckerman,, J. Carlson,, L. L. Reyor,, M. Kleyman,, C. M. McMahon,, C. Birch,, J. Schulze Zur Wiesch,, T. Ledlie,, M. Koehrsen,, C. Kodira,, A. D. Roberts,, G. M. Lauer,, H. R. Rosen,, F. Bihl,, A. Cerny,, U. Spengler,, Z. Liu,, A. Y. Kim,, Y. Xing,, A. Schneidewind,, M. A. Madey,, J. F. Fleckenstein,, V. M. Park,, J. E. Galagan,, C. Nusbaum,, B. D. Walker,, G. V. Lake-Bakaar,, E. S. Daar,, I. M. Jacobson,, E. D. Gomperts,, B. R. Edlin,, S. M. Donfield,, R. T. Chung,, A. H. Talal,, T. Marion,, B. W. Birren,, M. R. Henn,, and T. M. Allen. 2008. Naturally occurring dominant resistance mutations to hepatitis C virus protease and polymerase inhibitors in treatment-naive patients. Hepatology 48:17691778.
75. Lagging, M.,, N. Langeland,, C. Pedersen,, M. Farkkila,, M. R. Buhl,, K. Morch,, A. P. Dhillon,, A. Alsio,, K. Hellstrand,, J. Westin,, and G. Norkrans. 2008. Randomized comparison of 12 or 24 weeks of peginterferon alpha-2a and ribavirin in chronic hepatitis C virus genotype 2/3 infection. Hepatology 47:18371845.
76. Laguno, M.,, M. Larrousse,, J. Murillas,, J. L. Blanco,, A. Leon,, A. Milinkovic,, M. Lonca,, E. Martinez,, J. M. Sanchez-Tapias,, E. de Lazzari,, J. M. Gatell,, J. Costa,, and J. Mallolas. 2007. Predictive value of early virologic response in HIV/hepatitis C virus-coinfected patients treated with an interferon-based regimen plus ribavirin. J. Acquir. Immune Defic. Syndr. 44:174178.
77. Laperche, S.,, F. Bouchardeau,, V. Thibault,, B. Pozzetto,, S. Vallet,, A. R. Rosenberg,, A. M. Roque-Afonso,, M. Gassin,, F. Stoll-Keller,, P. Trimoulet,, E. Gault,, B. Chanzy,, B. Mercier,, M. Branger,, J. M. Pawlotsky,, C. Henquell,, F. Lunel,, C. Gaudy-Graffin,, S. Alain,, M. L. Chaix,, G. Duverlie,, J. Izopet,, and J. J. Lefrere. 2007. Multicenter trials need to use the same assay for hepatitis C virus viral load determination. J. Clin. Microbiol. 45:37883790.
78. Laperche, S.,, M. H. Elghouzzi,, P. Morel,, M. Asso- Bonnet,, N. Le Marrec,, A. Girault,, A. Servant-Delmas,, F. Bouchardeau,, M. Deschaseaux,, and Y. Piquet. 2005. Is an assay for simultaneous detection of hepatitis C virus core antigen and antibody a valuable alternative to nucleic acid testing? Transfusion 45:19651972.
79. Lemaire, J. M.,, A. M. Courouce,, C. Defer,, F. Bouchardeau,, J. Coste,, O. Agulles,, J. F. Cantaloube,, V. Barlet,, and F. Barin. 2000. HCV RNA in blood donors with isolated reactivities by third-generation RIBA. Transfusion 40: 867870.
80. Licata, A.,, D. Di Bona,, F. Schepis,, L. Shahied,, A. Craxi,, and C. Camma. 2003. When and how to treat acute hepatitis C? J. Hepatol. 39:10561062.
81. Lindenbach, B. D.,, M. J. Evans,, A. J. Syder,, B. Wolk,, T. L. Tellinghuisen,, C. C. Liu,, T. Maruyama,, R. O. Hynes,, D. R. Burton,, J. A. McKeating,, and C. M. Rice. 2005. Complete replication of hepatitis C virus in cell culture. Science 309:623626.
82. Lindh, M.,, and C. Hannoun. 2005. Genotyping of hepatitis C virus by Taqman real-time PCR. J. Clin. Virol. 34:108114.
83. Macedo de Oliveira, A.,, K. L. White,, B. D. Beecham,, D. P. Leschinsky,, B. P. Foley,, J. Dockter,, C. Giachetti,, and T. J. Safranek. 2006. Sensitivity of second-generation enzyme immunoassay for detection of hepatitis C virus infection among oncology patients. J. Clin. Virol. 35:2125.
84. Maheshwari, A.,, S. Ray,, and P. J. Thuluvath. 2008. Acute hepatitis C. Lancet 372:321332.
85. Major, M. E.,, and S. M. Feinstone. 1997. The molecular virology of hepatitis C. Hepatology 25:15271538.
86. Mangia, A.,, N. Minerva,, D. Bacca,, R. Cozzolongo,, G. L. Ricci,, V. Carretta,, F. Vinelli,, G. Scotto,, G. Montalto,, M. Romano,, G. Cristofaro,, L. Mottola,, F. Spirito,, and A. Andriulli. 2008. Individualized treatment duration for hepatitis C genotype 1 patients: a randomized controlled trial. Hepatology 47:4350.
87. Mangia, A.,, R. Santoro,, N. Minerva,, G. L. Ricci,, V. Carretta,, M. Persico,, F. Vinelli,, G. Scotto,, D. Bacca,, M. Annese,, M. Romano,, F. Zechini,, F. Sogari,, F. Spirito,, and A. Andriulli. 2005. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N. Engl. J. Med. 352:26092617.
88. Manns, M. P.,, J. G. McHutchison,, S. C. Gordon,, V. K. Rustgi,, M. Shiffman,, R. Reindollar,, Z. D. Goodman,, K. Koury,, M. Ling,, and J. K. Albrecht. 2001. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 358:958965.
89. Mao, H.,, Z. Lu,, H. Zhang,, K. Liu,, J. Zhao,, G. Jin,, S. Gu,, and M. Yang. 2008. Colorimetric oligonucleotide array for genotyping of hepatitis C virus based on the 59 non-coding region. Clin. Chim. Acta 388:2227.
90. Margraf, R. L.,, M. Erali,, M. Liew,, and C. T. Wittwer. 2004. Genotyping hepatitis C virus by heteroduplex mobility analysis using temperature gradient capillary electrophoresis. J. Clin. Microbiol. 42:45454551.
91. Margraf, R. L.,, S. Page,, M. Erali,, and C. T. Wittwer. 2004. Single-tube method for nucleic acid extraction, amplification, purification, and sequencing. Clin. Chem. 50:17551761.
92. Martin-Carbonero, L.,, M. Nunez,, A. Marino,, F. Alcocer,, L. Bonet,, J. Garcia-Samaniego,, P. Lopez-Serrano,, M. Cordero,, J. Portu,, and V. Soriano. 2008. Undetectable hepatitis C virus RNA at week 4 as predictor of sustained virological response in HIV patients with chronic hepatitis C. AIDS 22:1521.
93. Martinot-Peignoux, M.,, H. Khiri,, L. Leclere,, S. Maylin,, P. Marcellin,, and P. Halfon. 2009. Clinical performances of two real-time PCR assays and bDNA/TMA to early monitor treatment outcome in patients with chronic hepatitis C. J. Clin. Virol. 46:216221.
94. Martinot-Peignoux, M.,, V. Le Breton,, S. Fritsch,, G. Le Guludec,, N. Labouret,, F. Keller,, and P. Marcellin. 2000. Assessment of viral loads in patients with chronic hepatitis C with AMPLICOR HCV MONITOR version 1.0, COBAS HCV MONITOR version 2.0, and QUANTIPLEX HCV RNA version 2.0 assays. J. Clin. Microbiol. 38:27222725.
95. Martro, E.,, V. Gonzalez,, A. J. Buckton,, V. Saludes,, G. Fernandez,, L. Matas,, R. Planas,, and V. Ausina. 2008. Evaluation of a new assay in comparison with reverse hybridization and sequencing methods for hepatitis C virus genotyping targeting both 5? noncoding and nonstructural 5b genomic regions. J. Clin. Microbiol. 46:192197.
96. McHutchison, J. G.,, G. T. Everson,, S. C. Gordon,, I. M. Jacobson,, M. Sulkowski,, R. Kauffman,, L. McNair,, J. Alam,, and A. J. Muir. 2009. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N. Engl. J. Med. 360:18271838.
97. Mederacke, I.,, H. Wedemeyer,, S. Ciesek,, E. Steinmann,, R. Raupach,, K. Wursthorn,, M. P. Manns,, and H. L. Tillmann. 2009. Performance and clinical utility of a novel fully automated quantitative HCV-core antigen assay. J. Clin. Virol. 46:210215.
98. Mellor, J.,, A. Hawkins,, and P. Simmonds. 1999. Genotype dependence of hepatitis C virus load measurement in commercially available quantitative assays. J. Clin. Microbiol. 37:25252532.
99. Melve, G. K.,, H. Myrmel,, G. E. Eide,, and T. Hervig. 2009. Evaluation of the persistence and characteristics of indeterminate reactivity against hepatitis C virus in blood donors. Transfusion 49:23592365.
100. Michelin, B. D.,, Z. Muller,, E. Stelzl,, E. Marth,, and H. H. Kessler. 2007. Evaluation of the Abbott RealTime HCV assay for quantitative detection of hepatitis C virus RNA. J. Clin. Virol. 38:96100.
101. Moghaddam, A.,, N. Reinton,, and O. Dalgard. 2006. A rapid real-time PCR assay for determination of hepatitis C virus genotypes 1, 2 and 3a. J. Viral Hepat. 13:222229.
102. Moreno, C.,, P. Deltenre,, J. M. Pawlotsky,, J. Henrion,, M. Adler,, and P. Mathurin. 2010. Shortened treatment duration in treatment-naive genotype 1 HCV patients with rapid virologic response: a meta-analysis. J. Hepatol. 52:2531.
103. Morishima, C.,, T. R. Morgan,, J. E. Everhart,, E. C. Wright,, M. C. Apodaca,, D. R. Gretch,, M. L. Shiffman,, G. T. Everson,, K. L. Lindsay,, W. M. Lee,, A. S. Lok,, J. L. Dienstag,, M. G. Ghany,, and T. M. Curto. 2008. Interpretation of positive transcription-mediated amplification test results from polymerase chain reaction-negative samples obtained after treatment of chronic hepatitis C. Hepatology 48:14121419.
104. Morota, K.,, R. Fujinami,, H. Kinukawa,, T. Machida,, K. Ohno,, H. Saegusa,, and K. Takeda. 2009. A new sensitive and automated chemiluminescent microparticle immunoassay for quantitative determination of hepatitis C virus core antigen. J. Virol. Methods 157:814.
105. Mosley, J. W.,, E. A. Operskalski,, L. H. Tobler,, Z. J. Buskell,, W. W. Andrews,, B. Phelps,, J. Dockter,, C. Giachetti,, L. B. Seeff,, and M. P. Busch. 2008. The course of hepatitis C viraemia in transfusion recipients prior to availability of antiviral therapy. J. Viral Hepat. 15:120128.
106. Murphy, D. G.,, B. Willems,, M. Deschenes,, N. Hilzenrat,, R. Mousseau,, and S. Sabbah. 2007. Use of sequence analysis of the NS5B region for routine genotyping of hepatitis C virus with reference to C/E1 and 59 untranslated region sequences. J. Clin. Microbiol. 45:11021112.
107. Nakao, T.,, N. Enomoto,, N. Takada,, A. Takada,, and T. Date. 1991. Typing of hepatitis C virus genomes by restriction fragment length polymorphism. J. Gen. Virol. 72:21052112.
108. Nolte, F. S.,, A. M. Green,, K. R. Fiebelkorn,, A. M. Caliendo,, C. Sturchio,, A. Grunwald,, and M. Healy. 2003. Clinical evaluation of two methods for genotyping hepatitis C virus based on analysis of the 5' noncoding region. J. Clin. Microbiol. 41:15581564.
109. Oethinger, M.,, D. R. Mayo,, J. Falcone,, P. K. Barua,, and B. P. Griffith. 2005. Efficiency of the ortho VITROS assay for detection of hepatitis C virus-specific antibodies increased by elimination of supplemental testing of samples with very low sample-to-cutoff ratios. J. Clin. Microbiol. 43:24772480.
110. Ohba, K.,, M. Mizokami,, J. Y. Lau,, E. Orito,, K. Ikeo,, and T. Gojobori. 1996. Evolutionary relationship of hepatitis C, pesti-, flavi-, plantviruses, and newly discovered GB hepatitis agents. FEBS Lett. 378:232234.
111. Ohno, O.,, M. Mizokami,, R. R. Wu,, M. G. Saleh,, K. Ohba,, E. Orito,, M. Mukaide,, R. Williams,, and J. Y. Lau. 1997. New hepatitis C virus (HCV) genotyping system that allows for identification of HCV genotypes 1a, 1b, 2a, 2b, 3a, 3b, 4, 5a, and 6a. J. Clin. Microbiol. 35:201207.
112. Okamoto, H.,, S. Kobata,, H. Tokita,, T. Inoue,, G. D. Woodfield,, P. V. Holland,, B. A. Al-Knawy,, O. Uzunalimoglu,, Y. Miyakawa,, and M. Mayumi. 1996. A secondgeneration method of genotyping hepatitis C virus by the polymerase chain reaction with sense and antisense primers deduced from the core gene. J. Virol. Methods 57:3145.
113. O’Leary, J. G.,, R. Lepe,, and G. L. Davis. 2008. Indications for liver transplantation. Gastroenterology 134:17641776.
114. Park, J. C.,, J. M. Kim,, O. J. Kwon,, K. R. Lee,, Y. G. Chai,, and H. B. Oh. 2010. Development and clinical evaluation of a microarray for hepatitis C virus genotyping. J. Virol. Methods 163:269275.
115. Pawlotsky, J. M.,, A. Bastie,, C. Pellet,, J. Remire,, F. Darthuy,, L. Wolfe,, C. Sayada,, J. Duval,, and D. Dhumeaux. 1996. Significance of indeterminate third-generation hepatitis C virus recombinant immunoblot assay. J. Clin. Microbiol. 34:8083.
116. Pawlotsky, J. M.,, A. Fleury,, V. Choukroun,, L. Deforges,, F. Roudot-Thoraval,, P. Aumont,, J. Duval,, and D. Dhumeaux. 1994. Significance of highly positive c22-3 “indeterminate” second-generation hepatitis C virus (HCV) recombinant immunoblot assay (RIBA) and resolution by third-generation HCV RIBA. J. Clin. Microbiol. 32:13571359.
117. Payan, C.,, A. Pivert,, P. Morand,, S. Fafi-Kremer,, F. Carrat,, S. Pol,, P. Cacoub,, C. Perronne,, and F. Lunel. 2007. Rapid and early virological response to chronic hepatitis C treatment with IFN alpha2b or PEG-IFN alpha2b plus ribavirin in HIV/HCV co-infected patients. Gut 56:11111116.
118. Piro, L.,, S. Solinas,, M. Luciani,, A. Casale,, T. Bighiani,, D. Santonocito,, and G. Girelli. 2008. Prospective study of the meaning of indeterminate results of the recombinant immunoblot assay for hepatitis C virus in blood donors. Blood Transfus. 6:107111.
119. Pisani, G.,, K. Cristiano,, F. Marino,, F. Luciani,, G. M. Bisso,, C. Mele,, D. Adriani,, G. Gentili,, and M. Wirz. 2009. Quantification of hepatitis C virus (HCV) RNA in a multicenter study: implications for management of HCV genotype 1-infected patients. J. Clin. Microbiol. 47:29312936.
120. Poordad, F.,, K. R. Reddy,, and P. Martin. 2008. Rapid virologic response: a new milestone in the management of chronic hepatitis C. Clin. Infect. Dis. 46:7884.
121. Pyne, M. T.,, E. Q. Konnick,, A. Phansalkar,, and D. R. Hillyard. 2009. Evaluation of the Abbott investigational use only RealTime hepatitis C virus (HCV) assay and comparison to the Roche TaqMan HCV analyte-specific reagent assay. J. Clin. Microbiol. 47:28722878.
122. Rauch, A.,, Z. Kutalik,, P. Descombes,, T. Cai,, J. di Iulio,, T. Mueller,, M. Bochud,, M. Battegay,, E. Bernasconi,, J. Borovicka,, S. Colombo,, A. Cerny,, J. F. Dufour,, H. Furrer,, H. F. Gunthard,, M. Heim,, B. Hirschel,, R. Malinverni,, D. Moradpour,, B. Mullhaupt,, A. Witteck,, J. S. Beckmann,, T. Berg,, S. Bergmann,, F. Negro,, A. Telenti,, and P. Y. Bochud. 2010. Genetic variation in IL28B is associated with chronic hepatitis C and treatment failure—a genome-wide association study. Gastroenterology 138:13381345.
123. Rehermann, B. 2009. Hepatitis C virus versus innate and adaptive immune responses: a tale of coevolution and coexistence. J. Clin. Investig. 119:17451754.
124. Ren, F. R.,, Q. S. Lv,, H. Zhuang,, J. J. Li,, X. Y. Gong,, G. J. Gao,, C. L. Liu,, J. X. Wang,, F. Z. Yao,, Y. R. Zheng,, F. M. Zhu,, M. H. Tiemuer,, X. H. Bai,, and H. Shan. 2005. Significance of the signal-to-cutoff ratios of anti-hepatitis C virus enzyme immunoassays in screening of Chinese blood donors. Transfusion 45:18161822.
125. Rolfe, K. J.,, G. J. Alexander,, T. G. Wreghitt,, S. Parmar,, H. Jalal,, and M. D. Curran. 2005. A real-time Taqman method for hepatitis C virus genotyping. J. Clin. Virol. 34:115121.
126. Ross, R. S.,, S. Viazov,, and M. Roggendorf. 2007. Genotyping of hepatitis C virus isolates by a new line probe assay using sequence information from both the 59 untranslated and the core regions. J. Virol. Methods 143:153160.
127. Ross, R. S.,, S. Viazov,, B. Wolters,, and M. Roggendorf. 2008. Towards a better resolution of hepatitis C virus variants: CLIP sequencing of an HCV core fragment and automated assignment of genotypes and subtypes. J. Virol. Methods 148:2533.
128. Sabato, M. F.,, M. L. Shiffman,, M. R. Langley,, D. S. Wilkinson,, and A. Ferreira-Gonzalez. 2007. Comparison of performance characteristics of three real-time reverse transcription-PCR test systems for detection and quantification of hepatitis C virus. J. Clin. Microbiol. 45:25292536.
129. Saldanha, J.,, A. Heath,, C. Aberham,, J. Albrecht,, G. Gentili,, M. Gessner,, and G. Pisani. 2005. World Health Organization collaborative study to establish a replacement WHO international standard for hepatitis C virus RNA nucleic acid amplification technology assays. Vox Sang. 88:202204.
130. Saldanha, J.,, N. Lelie,, A. Heath, et al. 1999. Establishment of the first international standard for nucleic acid amplification technology (NAT) assays for HCV RNA. Vox Sang. 76:149158.
131. Sanchez-Tapias, J. M.,, M. Diago,, P. Escartin,, J. Enriquez,, M. Romero-Gomez,, R. Barcena,, J. Crespo,, R. Andrade,, E. Martinez-Bauer,, R. Perez,, M. Testillano,, R. Planas,, R. Sola,, M. Garcia-Bengoechea,, J. Garcia-Samaniego,, M. Munoz- Sanchez,, and R. Moreno-Otero. 2006. Peginterferon- alfa2a plus ribavirin for 48 versus 72 weeks in patients with detectable hepatitis C virus RNA at week 4 of treatment. Gastroenterology 131:451460.
132. Sarrazin, C.,, B. C. Gartner,, D. Sizmann,, R. Babiel,, U. Mihm,, W. P. Hofmann,, M. von Wagner,, and S. Zeuzem. 2006. Comparison of conventional PCR with real-time PCR and branched DNA-based assays for hepatitis C virus RNA quantification and clinical significance for genotypes 1 to 5. J. Clin. Microbiol. 44:729737.
133. Sarrazin, C.,, T. L. Kieffer,, D. Bartels,, B. Hanzelka,, U. Muh,, M. Welker,, D. Wincheringer,, Y. Zhou,, H. M. Chu,, C. Lin,, C. Weegink,, H. Reesink,, S. Zeuzem,, and A. D. Kwong. 2007. Dynamic hepatitis C virus genotypic and phenotypic changes in patients treated with the protease inhibitor telaprevir. Gastroenterology 132:17671777.
134. Scheiblauer, H.,, M. El-Nageh,, S. Nick,, H. Fields,, A. Prince,, and S. Diaz. 2006. Evaluation of the performance of 44 assays used in countries with limited resources for the detection of antibodies to hepatitis C virus. Transfusion 46:708718.
135. Schroter, M.,, B. Zollner,, P. Schafer,, O. Landt,, U. Lass,, R. Laufs,, and H. H. Feucht. 2002. Genotyping of hepatitis C virus types 1, 2, 3, and 4 by a one-step LightCycler method using three different pairs of hybridization probes. J. Clin. Microbiol. 40:20462050.
136. Shea, D. O.,, H. Tuite,, G. Farrell,, M. Codd,, F. Mulcahy,, S. Norris,, and C. Bergin. 2008. Role of rapid virological response in prediction of sustained virological response to Peg-IFN plus ribavirin in HCV/HIV co-infected individuals. J. Viral Hepat. 15:482489.
137. Shiffman, M. L.,, F. Suter,, B. R. Bacon,, D. Nelson,, H. Harley,, R. Sola,, S. D. Shafran,, K. Barange,, A. Lin,, A. Soman,, and S. Zeuzem. 2007. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N. Engl. J. Med. 357:124134.
138. Sizmann, D.,, C. Boeck,, J. Boelter,, D. Fischer,, M. Miethke,, S. Nicolaus,, M. Zadak,, and R. Babiel. 2007. Fully automated quantification of hepatitis C virus (HCV) RNA in human plasma and human serum by the COBAS AmpliPrep/ COBAS TaqMan system. J. Clin. Virol. 38:326333.
139. Soriano, V.,, M. G. Peters,, and S. Zeuzem. 2009. New therapies for hepatitis C virus infection. Clin. Infect. Dis. 48:313320.
140. Stelzl, E.,, C. van der Meer,, R. Gouw,, M. Beld,, M. Grahovac,, E. Marth,, and H. H. Kessler. 2007. Determination of the hepatitis C virus subtype: comparison of sequencing and reverse hybridization assays. Clin. Chem. Lab. Med. 45:167170.
141. Strader, D. B.,, T. Wright,, D. L. Thomas,, and L. B. Seeff. 2004. Diagnosis, management, and treatment of hepatitis C. Hepatology 39:11471171.
142. Stramer, S. L.,, S. A. Glynn,, S. H. Kleinman,, D. M. Strong,, S. Caglioti,, D. J. Wright,, R. Y. Dodd,, and M. P. Busch. 2004. Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acidamplification testing. N. Engl. J. Med. 351:760768.
143. Sulkowski, M. S.,, S. C. Ray,, and D. L. Thomas. 2002. Needlestick transmission of hepatitis C. JAMA 287: 24062413.
144. Suppiah, V.,, M. Moldovan,, G. Ahlenstiel,, T. Berg,, M. Weltman,, M. L. Abate,, M. Bassendine,, U. Spengler,, G. J. Dore,, E. Powell,, S. Riordan,, D. Sheridan,, A. Smedile,, V. Fragomeli,, T. Muller,, M. Bahlo,, G. J. Stewart,, D. R. Booth,, and J. George. 2009. IL28B is associated with response to chronic hepatitis C interferon-alpha and ribavirin therapy. Nat. Genet. 41:11001104.
145. Tanaka, Y.,, N. Nishida,, M. Sugiyama,, M. Kurosaki,, K. Matsuura,, N. Sakamoto,, M. Nakagawa,, M. Korenaga,, K. Hino,, S. Hige,, Y. Ito,, E. Mita,, E. Tanaka,, S. Mochida,, Y. Murawaki,, M. Honda,, A. Sakai,, Y. Hiasa,, S. Nishiguchi,, A. Koike,, I. Sakaida,, M. Imamura,, K. Ito,, K. Yano,, N. Masaki,, F. Sugauchi,, N. Izumi,, K. Tokunaga,, and M. Mizokami. 2009. Genome-wide association of IL28B with response to pegylated interferon-alpha and ribavirin therapy for chronic hepatitis C. Nat. Genet. 41:11051109.
146. Thimme, R.,, D. Oldach,, K. M. Chang,, C. Steiger,, S. C. Ray,, and F. V. Chisari. 2001. Determinants of viral clearance and persistence during acute hepatitis C virus infection. J. Exp. Med. 194:13951406.
147. Thomas, D. L. 2008. The challenge of hepatitis C in the HIV-infected person. Annu. Rev. Med. 59:473485.
148. Thomas, D. L.,, C. L. Thio,, M. P. Martin,, Y. Qi,, D. Ge,, C. O’Huigin,, J. Kidd,, K. Kidd,, S. I. Khakoo,, G. Alexander,, J. J. Goedert,, G. D. Kirk,, S. M. Donfield,, H. R. Rosen,, L. H. Tobler,, M. P. Busch,, J. G. McHutchison,, D. B. Goldstein,, and M. Carrington. 2009. Genetic variation in IL28B and spontaneous clearance of hepatitis C virus. Nature 461:798801.
149. Tillmann, H. L.,, J. Wiegand,, I. Glomb,, A. Jelineck,, G. Picchio,, H. Wedemeyer,, and M. P. Manns. 2005. Diagnostic algorithm for chronic hepatitis C virus infection: role of the new HCV-core antigen assay. Z. Gastroenterol. 43:1116.
150. Tobler, L. H.,, S. L. Stramer,, S. H. Kleinman,, J. P. Brodsky,, D. S. Todd,, and M. P. Busch. 2001. Misclassification of HCV-viremic blood donors as indeterminate by RIBA 3.0 because of human superoxide dismutase reactivity. Transfusion 41:16251626.
151. Tobler, L. H.,, S. L. Stramer,, S. R. Lee,, B. L. Masecar,, J. E. Peterson,, E. A. Davis,, W. E. Andrews,, J. P. Brodsky,, S. H. Kleinman,, B. H. Phelps,, and M. P. Busch. 2003. Impact of HCV 3.0 EIA relative to HCV 2.0 EIA on blood-donor screening. Transfusion 43:14521459.
152. Torriani, F. J.,, M. Rodriguez-Torres,, J. K. Rockstroh,, E. Lissen,, J. Gonzalez-Garcia,, A. Lazzarin,, G. Carosi,, J. Sasadeusz,, C. Katlama,, J. Montaner,, H. Sette, Jr.,, S. Passe,, J. De Pamphilis,, F. Duff,, U. M. Schrenk,, and D. T. Dieterich. 2004. Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N. Engl. J. Med. 351:438450.
153. Tuaillon, E.,, A. M. Mondain,, L. Ottomani,, L. Roudiere,, P. Perney,, M. C. Picot,, F. Seguret,, F. Blanc,, D. Larrey,, P. Van de Perre,, and J. Ducos. 2007. Impact of hepatitis C virus (HCV) genotypes on quantification of HCV RNA in serum by COBAS AmpliPrep/COBAS Taq- Man HCV test, Abbott HCV realtime assay [corrected] and VERSANT HCV RNA assay. J. Clin. Microbiol. 45:30773081.
154. Uyttendaele, S.,, H. Claeys,, W. Mertens,, H. Verhaert,, and C. Vermylen. 1994. Evaluation of third-generation screening and confirmatory assays for HCV antibodies. Vox Sang. 66:122129.
155. van Doorn, L. J.,, B. Kleter,, I. Pike,, and W. Quint. 1996. Analysis of hepatitis C virus isolates by serotyping and genotyping. J. Clin. Microbiol. 34:17841787.
156. Veillon, P.,, C. Payan,, G. Picchio,, M. Maniez-Montreuil,, P. Guntz,, and F. Lunel. 2003. Comparative evaluation of the total hepatitis C virus core antigen, branched-DNA, and Amplicor monitor assays in determining viremia for patients with chronic hepatitis C during interferon plus ribavirin combination therapy. J. Clin. Microbiol. 41:32123220.
157. Verbeeck, J.,, M. J. Stanley,, J. Shieh,, L. Celis,, E. Huyck,, E. Wollants,, J. Morimoto,, A. Farrior,, E. Sablon,, M. Jankowski-Hennig,, C. Schaper,, P. Johnson,, M. Van Ranst,, and M. Van Brussel. 2008. Evaluation of Versant hepatitis C virus genotype assay (LiPA) 2.0. J. Clin. Microbiol. 46:19011906.
158. Vermehren, J.,, A. Kau,, B. C. Gartner,, R. Gobel,, S. Zeuzem,, and C. Sarrazin. 2008. Differences between two real-time PCR-based hepatitis C virus (HCV) assays (RealTime HCV and Cobas AmpliPrep/Cobas TaqMan) and one signal amplification assay (Versant HCV RNA 3.0) for RNA detection and quantification. J. Clin. Microbiol. 46:38803891.
159. Viazov, S.,, A. Zibert,, K. Ramakrishnan,, A. Widell,, A. Cavicchini,, E. Schreier,, and M. Roggendorf. 1994. Typing of hepatitis C virus isolates by DNA enzyme immunoassay. J. Virol. Methods 48:8191.
160. Villano, S. A.,, D. Vlahov,, K. E. Nelson,, S. Cohn,, and D. L. Thomas. 1999. Persistence of viremia and the importance of long-term follow-up after acute hepatitis C infection. Hepatology 29:908914.
161. von Wagner, M.,, M. Huber,, T. Berg,, H. Hinrichsen,, J. Rasenack,, T. Heintges,, A. Bergk,, C. Bernsmeier,, D. Haussinger,, E. Herrmann,, and S. Zeuzem. 2005. Peginterferon- alpha-2a (40KD) and ribavirin for 16 or 24 weeks in patients with genotype 2 or 3 chronic hepatitis C. Gastroenterology 129:522527.
162. Wakita, T.,, T. Pietschmann,, T. Kato,, T. Date,, M. Miyamoto,, Z. Zhao,, K. Murthy,, A. Habermann,, H. G. Krausslich,, M. Mizokami,, R. Bartenschlager,, and T. J. Liang. 2005. Production of infectious hepatitis C virus in tissue culture from a cloned viral genome. Nat. Med. 11:791796.
163. Wang, C. C.,, E. Krantz,, J. Klarquist,, M. Krows,, L. McBride,, E. P. Scott,, T. Shaw-Stiffel,, S. J. Weston,, H. Thiede,, A. Wald,, and H. R. Rosen. 2007. Acute hepatitis C in a contemporary US cohort: modes of acquisition and factors influencing viral clearance. J. Infect. Dis. 196:14741482.
164. Wasley, A.,, S. Grytdal,, and K. Gallagher. 2008. Surveillance for acute viral hepatitis—United States, 2006. MMWR Surveill. Summ. 57:124.
165. Watterson, J. M.,, P. Stallcup,, D. Escamilla,, P. Chernay,, A. Reyes,, and S. C. Trevino. 2007. Evaluation of the Ortho-Clinical Diagnostics Vitros ECi Anti-HCV test: comparison with three other methods. J. Clin. Lab. Anal. 21:162166.
166. White, P. A.,, X. Zhai,, I. Carter,, Y. Zhao,, and W. D. Rawlinson. 2000. Simplified hepatitis C virus genotyping by heteroduplex mobility analysis. J. Clin. Microbiol. 38:477482.
167. Yano, M.,, H. Kumada,, M. Kage,, K. Ikeda,, K. Shimamatsu,, O. Inoue,, E. Hashimoto,, J. H. Lefkowitch,, J. Ludwig,, and K. Okuda. 1996. The long-term pathological evolution of chronic hepatitis C. Hepatology 23:13341340.
168. Yeo, A. E.,, M. Ghany,, C. Conry-Cantilena,, J. C. Melpolder,, D. E. Kleiner,, J. W. Shih,, J. H. Hoofnagle,, and H. J. Alter. 2001. Stability of HCV-RNA level and its lack of correlation with disease severity in asymptomatic chronic hepatitis C virus carriers. J. Viral Hepat. 8:256263.
169. Yu, M. L.,, C. Y. Dai,, J. F. Huang,, C. F. Chiu,, Y. H. Yang,, N. J. Hou,, L. P. Lee,, M. Y. Hsieh,, Z. Y. Lin,, S. C. Chen,, L. Y. Wang,, W. Y. Chang,, and W. L. Chuang. 2008. Rapid virological response and treatment duration for chronic hepatitis C genotype 1 patients: a randomized trial. Hepatology 47:18841893.
170. Zeuzem, S.,, M. W. Fried,, K. R. Reddy,, P. Marcellin,, M. Diago,, A. Craxi,, P. Pockros,, M. Rizzetto,, D. Berstein,, M. L. Shiffman,, A. Lin,, and S. Hadziyannis. 2006. Improving the clinical relevance of pre-treatment viral load as a predictor of sustained virologic response (SVR) in patients infected with hepatitis C genotype 1 treated with peginterferon alfa-2A (40KD) (Pegasys) plus ribavirin (Copegus). Hepatology 44S1:267A.
171. Zhong, J.,, P. Gastaminza,, G. Cheng,, S. Kapadia,, T. Kato,, D. R. Burton,, S. F. Wieland,, S. L. Uprichard,, T. Wakita,, and F. V. Chisari. 2005. Robust hepatitis C virus infection in vitro. Proc. Natl. Acad. Sci. USA 102:92949299.


Generic image for table

Response and milestone definitions in chronic hepatitis C treatment

As detected by assay with limit of detection of ≤50 IU/ml.

Generic image for table

HCV RNA qualitative tests

All tests are FDA approved and Conformité Européenne (CE) marked according to European In Vitro Diagnostic Directive 98/79/EC.

Generic image for table

Commercial HCV RNA quantification tests

Lower limit of quantification to upper limit of quantification of undiluted specimens.

1 IU/ml 5 copies/ml..

All products are Conformité Européenne (CE) marked and approved according to European In Vitro Diagnostic Directive 98/79/EC. U.S. regulatory status is shown.

LOD, 10 IU/ml.

Analytical measuring range. Expanded clinical reportable range (43–6.9 × 10 IU/ml) can be obtained by maximum dilution of 1:100. LOD, 18 IU/ml.

ND, not determined. The test was developed after universal institution of IU.

LOD reported as genotype dependent, from 6 IU/ml for Gt4 to 18 IU/ml for Gt5.

Generic image for table

Commercial HCV RNA genotyping tests

Genotypes 1 through 6 can be determined with all assays.

Available globally as RUO product.

CE marked and approved according to European In Vitro Diagnostic Directive 98/79/EC.

U.S. regulatory status, RUO.

Available for sale outside the United States only.

Generic image for table

User-defined HCV RNA genotyping tests

Abbreviations: RFLP, restriction fragment length polymorphism; PSEA, primer-specific extension analysis; PSMEA, primer-specific mispair extension analysis; FRET, fluorescent resonance energy transfer.

Generic image for table

Recommendations for chronic hepatitis C screening

Synopsized from reference .

Generic image for table

Serologic assays for the detection of anti-HCV antibodies

All assays approved for diagnostic use by U.S. Food and Drug Administration.

>95% of samples with S/CO ratios above indicated threshold predicted to be confirmed positive.

Expressed in package insert as percent positive agreement.

Expressed in package insert as percent negative agreement.

NA, not available.


This is a required field
Please enter a valid email address
Please check the format of the address you have entered.
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error