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Expert Review of Molecular Diagnostics Volume 3, 2003 - Issue 6
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Miscellaneous

Hepatitis C virus RNA tests: performance attributes and their impact on clinical utility

Lorraine Comanor 1801 Waverley Street, Palo Alto, CA 94301, USA. [email protected]
&
David Hendricks Medical and Scientific Affairs Bayer Corporation, Diagnostics Division, PO Box 2466, Berkeley, CA 94702-0466, USA. [email protected]
Pages 689-702 | Published online: 09 Jan 2014

References

  • Lavanchy D, McMahon B. Worldwide prevalence and prevention of hepatitis C. In: Hepatitis C Biomedical Research Reports. Liang TJ, Hoofnagle JH (Eds), Academic Press, CA, USA (2000).
  • Germer JJ, Zein NN. Advances in the molecular diagnosis of hepatitis C and their clinical implications. Mayo Clin. Proc.76(9), 911–920 (2001).
  • ••Review of molecular biology of hepatitis Cvirus (HCV) and assays with algorithms for treatment and monitoring.
  • Lauer GM, Walker BD. Hepatitis C virus infection. N Engl. I Merl 345(1), 41–52 (2001).
  • •Review of epidemiology, pathogenesis, diagnosis and treatment of HCV infection.
  • Seeff LB. Natural history of chronic hepatitis C. Hepatology36(5 Suppl. 1), S35—S46 (2002).
  • Podzorski RP. Molecular testing in the diagnosis and management of hepatitis C virus infection. Arch. Pallid Lab. Merl 126(3), 285–290 (2002).
  • ••Reviews HCV tests and their appropriate use and comments on standardization and proper specimen handling.
  • Flamm SL. Chronic hepatitis C virus infection. JAIVIA 289 (18), 2413–2417 (2003).
  • •National Institutes of Health guidelines for diagnosis, monitoring and treatment of HCV infection.
  • Baker DE. Pegylated interferon plus ribavirin for the treatment of chronic hepatitis C. Rev. Castroenterol Disarl. 3(2), 93–109 (2003).
  • Erensoy S. Diagnosis of hepatitis C virus (HCV) infection and laboratory monitoring of its therapy. J. Gun. Virol. 21(3), 271–281 (2001).
  • Richter SS. Laboratory assays for diagnosis and management of hepatitis C virusinfection. J. Gun. Microbial. 40(12), 4407–4412 (2002).
  • ••Minireview of assays used for diagnosisand management of HCV infection.
  • Krajden M. Hepatitis C virus diagnosis and testing. Can. J. Public Health 91 (Suppl. 1), S34—S42 (2000).
  • Pawlotsky JM. Use and interpretation of virological tests for hepatitis C. Hepatology 36(5 Suppl. 1), S65—S73 (2002).
  • ••Review of kinetics of HCV markers and current assays and their practical use.
  • Almroth G, Ekermo B, Mansson AS, Svensson G, Widell A. Detection and prevention of hepatitis C in dialysis patients and renal transplant recipients. A long-term follow-up (1989—January 1997). J. Intern. Merl 251(2), 119–128 (2002).
  • Hanuka N, Sikuler E, Tovbin D etal. Hepatitis C virus infection in renal failure patients in the absence of anti-hepatitis C virus antibodies. J. Vital Hepat. 9(2), 141–145 (2002).
  • Zanetti AR, Romano L, Brunetto M, Colombo M, Bellati G, Tackney C. Total HCV core antigen assay: a new marker of hepatitis C viremia for monitoring the progress of therapy. J. Merl Viral. 70(1), 27–30 (2003).
  • Bouvier-Alias M, Patel K, Dahari H etal Clinical utility of total HCV core antigen quantification: a new indirect marker of HCV replication. Hepatology36(1), 211–218 (2002).
  • Cividini A, Cerino A, Muzzi A et al Kinetics and significance of serum hepatitis C virus core antigen in patients with acute hepatitis C. J. Clin. Microbial. 41(5), 2144–2146 (2003).
  • Centers for Disease Control and Prevention. Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. Morb. Mortal. Wkly Rep. 52,1–24 (2003).
  • Pawlotsky JM. Diagnostic tests for hepatitis C.Hepatol 31 (Suppl. 1), 71–79 (1999).
  • ••Overview of HCV testing.
  • Castro FJ, Esteban JI, Juarez A eta]. Early detection of nonresponse to interferon plus ribavirin combination treatment of chronic hepatitis C. J. Viral Hepat. 9(3), 202–207 (2002).
  • Fried MW Shiffman ML, Reddy KR eta Peginterferon a2a plus ribavirin for chronic hepatitis C virus infection. N Eng/. I Med. 347(13), 975–982 (2002).
  • ••Comparison of peginterferon-a2aand a2b and development of 12-week stopping rule.
  • Rosen HR, Ribeiro RR, Weinberger L etal Early hepatitis C viral kinetics correlate with long-term outcome in patients receiving high-dose induction followed by combination interferon and ribavirin therapy. I Hepatol 37(1), 124–130 (2002).
  • Berg T, Sarrazin C, Herrmann E et al Prediction of treatment outcome in patients with chronic hepatitis C: significance of baseline parameters and viral dynamics during therapy. Hepatology37 (3), 600–609 (2003).
  • Zeuzem S, Schmidt JM, Lee JH, Ruster B, Roth WK. Effect of interferon a on the dynamics of hepatitis C virus turnover in viva Hepatology23(2), 366–371 (1996).
  • Terrault NA, Dailey PJ, Ferrell L eta]. Hepatitis C virus: quantitation and distribution in liver. I Med. Viral. 51(3), 217–224 (1997).
  • Neumann AU, Lam NP, Dahari H etal Hepatitis C viral dynamics in vivo and the antiviral efficacy of interferon-a therapy. Science 282 (5386), 103–107 (1998) .
  • Pawlotsky J-M. HCV markers and quasispecies. In: Hepatitis C Biomedical Research Reports. Liang TJ, Hoofnagle JH (Eds), Academic Press, CA, USA (2000).
  • Poynard T, McHutchison J, Davis GL etal Impact of interferon-a2b and ribavirin on progression of liver fibrosis in patients with chronic hepatitis C. Hepatology 32 (5), 1131–1137 (2000).
  • Kojima H, Hongo Y, Harada H etal Long-term histological prognosis and serum fibrosis markers in chronic hepatitis C patients treated with interferon. Gastroenterol Hepatol 16(9), 1015–1021 (2001).
  • Manns MP, McHutchison JG, Gordon SC etal Peginterferon a2b plus ribavirin compared with interferon a2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 358(9286), 958–965 (2001).
  • •Comparison of the sustained virologic response rate among HCV-infected patients treated with interferon a2b plus ribavirin versus peginterferon a2b plus ribavirin.
  • Davis GL. Monitoring of viral levels during therapy of hepatitis C. Hepatology36 Suppl. 1), S145-5151 (2002).
  • ••Comprehensive review of establishment ofstopping rules in HCV treatment.
  • Nolte FS, Fried MW, Shiffman ML etal Prospective multicenter clinical evaluation of AMPLICOR and COBAS AMPLICOR hepatitis C virus tests. I Gun. Microbial. 39(11), 4005–4012 (2001).
  • Comanor L, Elkin C, Leung K eta]. Successful HCV genotyping of previously failed and low viral load specimens using an HCV RNA Qualitative Assay based on transcription-mediated amplification in conjunction with the line probe assay. I Gun. Viral 28(1), 14–26 (2003).
  • Zein NN. Clinical significance of hepatitis C virus genotypes. Gun. Microbial. Rev 13(2), 223–235 (2000).
  • Pawlotsky JM. Molecular diagnosis of viral hepatitis. Gastroenterology 122 (6), 1554–1568 (2002).
  • ••Review of molecular basis of HCV andhepatitis B virus tests and their applications.
  • Schrijver I, Baron EJ. Labor and cost requirements of two commercial assays for qualitative molecular detection of hepatitis C virus. I Gun. Microbial. 40(9), 3476–3477 (2002).
  • Krajden M, Ziermann R, Khan A etal 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. Clin. Microbial. 40(8), 2903–2907 (2002).
  • ••Determination of the limit of detection ofthe VERSANT HCV Qualitative Assay (TMA) and the AMPLICOR HCV v2.0 Test. Describes the difference in the assays' ability to detect HCV RNA in enzyme immunoassay-positive and -indeterminate specimens and comparison of workflow.
  • Elbeik T, Delassandro R, Chen YA, Souctchkov SV, Loftus RA, Beringer S. Global cost modeling analysis of HIV-1 and HCV viral load assays: Expert Rev Pharmacoeconomics Outcomes Res. 3(4), 383–407 (2003).
  • ••In-depth evaluation of the costs associated with the Bayer VERSANT and Roche AMPLICOR MONITOR assays in resource-poor and resource-rich countries.
  • Zeuzem S. What is (cost) effective in patients with chronic hepatitis C virusinfection? Eur. I Gastroenteml Hepatol 13(5), 473–476 (2001).
  • National Genetics Institute. Determination of analytical sensitivity of multiplexed and non-multiplexed NGI UltraQual RT PCR assays for the detection of HCV RNA in plasma pools. Product Licensure Application to National Genetics Institute (1999).
  • Saldanha J, Lelie N, Heath A. Establishment of the first international standard for nucleic acid amplification technology (NAT) assays for HCV RNA. WHO Collaborative Study Group. Vox Sang76(3), 149–158 (1999).
  • •Description of the first World Health Organization international standard for HCV RNA.
  • Bayer Corporation. VERSANT HCV RNA Qualitative Assay. US package insert. (2002).
  • Ross RS, Viazov S, Sarr S, Hoffmann S, Kramer A, Roggendorf M. Quantitation of hepatitis C virus RNA by third generation branched DNA-based signal amplification assay.I Vital Methods101(1-2), 159–168 (2002).
  • Gorrin G, Friesenhahn M, Lin P etal. Performance evaluation of the VERSANT HCV RNA Qualitative Assay by using transcription-mediated amplification. Clin. Microbial. 41(1), 310–317 (2003).
  • ••Preclinical evaluation of the sensitivity,specificity, reproducibility, effect of interfering substances and genotype detection of the VERSANT HCV Qualitative Assay (TMA).
  • Hendricks DA, Friesenhahn M, Tanimoto L, Goergen B, Dodge D, Comanor L. Multicenter evaluation of the VERSANT HCV RNA Qualitative Assay for detection of hepatitis C virus RNA. Clin. Nfirmbiol. 41(2), 651–656 (2003).
  • •Initial performance evaluation of the VERSANT HCV Qualitative Assay (TMA) at 15 different clinical sites.
  • Khan N, Aswad S, Shidban H etal Improved detection of HCV infection in hemodialysis patients using a new HCV RNA qualitative test: experience of a transplant center. I an. Vital (2003) (In Press).
  • 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), 818–823 (2000).
  • Comanor L, Anderson F, Ghany M etal Transcription-mediated amplification is more sensitive than conventional PCR-based assays for detecting residual serum HCV RNA at end of treatment. Am. Gastroenterol 96(10), 2968–2972 (2001).
  • •Examines the ability of the VERSANT HCV Qualitative Assay (TMA) to detect HCV RNA in end-of-treatment samples that were HCV RNA-negative by PCR from patients who experienced virologic relapse.
  • Sarrazin C. Highly sensitive hepatitis C virus RNA detection methods: molecular backgrounds and clinical significance. Clin. Viral 25\(Suppl. 3), S23—S29 (2002).
  • Weegink CJ, Sentjens RE, Beld MG, Dijkgraaf MG, Reesink HW. Chronic hepatitis C patients with a post-treatment virological relapse re-treated with an induction dose of 18 MU interferon-CL in combination with ribavirin and amantadine: a two-arm randomized pilot study. J. Vital Hepat. 10(3), 174–182 (2003).
  • Buti M, Valdes A, Sanchez-Avila F, Esteban R, Lurie Y. Extending combination therapy with peginterferon a2b plus ribavirin for genotype 1 chronic hepatitis C late responders: a report of 9 cases. Hepatology 37 (5), 1226–1227 (2003) .
  • Bayer Corporation. VERSANT HCV RNA 3.0 Assay (bDNA). Package insert. (2003).
  • Lee SC, Antony A, Lee N et al Improved version 2.0 qualitative and quantitative AMPLICOR reverse transcription-PCR tests for hepatitis C virus RNA: calibration to international units, enhanced genotype reactivity and performance characteristics. Clin. Microbial. 38(11), 4171–4179 (2000).
  • Beld M, Sentjens R, Rebers S etal Performance of the new Bayer VERSANT HCV RNA 3.0 assay for quantitation of hepatitis C virus RNA in plasma and serum: conversion to international units and comparison with the Roche COBAS AMPLICOR HCV MONITOR, Version 2.0 assay. j Clin. IVlicmbiol. 40(3), 788–793 (2002).
  • ••Evaluation of specificity, reproducibilityand linearity of the VERSANT HCV RNA 3.0 Assay (bDNA) and comparison of its quantification values with the AMPLICOR HCV MONITOR v2.0 Test.
  • Irving WL. The role of the virology laboratory in the management of hepatitis C virus infection. Clin. Viral 25(1), 3–13 (2002).
  • ••Examines three roles of the clinicalvirologist: interpretation of diagnostic results, guiding treatment and interpretation of prognosis and pathogenesis.
  • Trimoulet P, Halfon P, Pohier E, Khiri H, Chene G, Fleury H. Evaluation of the VERSANT HCV RNA 3.0 assay for quantification of hepatitis C virus RNA in serum. j Clin. IVlicmbiol. 40(6), 2031–2036 (2002).
  • •Evaluates specificity, linearity and reproducibility of the VERSANT HCV RNA 3.0 Assay (bDNA) and examines the correlation between versions 2.0 and 3.0.
  • Konnick EQ, Erali M, Ashwood ER, Hillyard DR. Performance characteristics of the COBAS AMPLICOR Hepatitis C Virus (HCV) MONITOR, Version 2.0, International Unit assay and the National Genetics Institute HCV Superquant assay. Clin. Microbial. 40(3), 768–773 (2002).
  • Jorgensen PA, Neuwald PD. Standardized hepatitis C virus RNA panels for nucleic acid testing assays. j Clin. Vim. 20(1-2), 35–40 (2001).
  • Brouwer JT, Hansen BE, Niesters HG, Schalm SW Early prediction of response in interferon monotherapy and in interferon—ribavirin combination therapy for chronic hepatitis C: HCV RNA at 4 weeks versus ALT I Hepatol 30(2), 192–198 (1999).
  • Ferenci P, Shiffman ML, Fried M etal Early prediction of response to 40 KD (pegasys) plus ribavirin in patients with chronic hepatitis C. Hepatology30, 192–198 (2001).
  • Lee SS, Heathcote EJ, Reddy KR etal Prognostic factors and early predictability of sustained viral response with peginterferon a2a (40KD). I Hepatol 37(4), 500–506 (2002).
  • Martinot-Peignoux M, Comanor L, Ripault MP etal Early virologic response at weeks 2 or 4 is more predictive of sustained response to pegylated combination therapy than at week 12. Hepatology36(4), 206A (2002).
  • Terrault N, Friesenhahn M, Anderson F etal Decline in HCV viral load in chronically infected subjects during the first eight weeks of therapy with standard interferon/ribavirin is highly predictive of virologic outcome. Hepatology 36 (4), 294A (2002).
  • Pawlotsky JM, Bouvier-Alias M, Hezode C, Darthuy F, Remire J, Dhumeaux D. Standardization of hepatitis C virus RNA quantification. Hepatology 32 (3), 654–659 (2000).
  • 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(4), 217–224 (2000).
  • Pisani G, Cristiano K, Wirz M, Bisso GM, Gentili G. Overestimation of the hepatitis C virus RNA content of reference preparations by the AMPLICOR HCV MONITOR test, version 2.0.1 Clin. Nlicrobiol 40(12), 4765–4767 (2002).
  • Sherman KE, Rouster SD, Horn PS. Comparison of methodologies for quantification of hepatitis C virus (HCV) RNA in patients coinfected with HCV and human immunodeficiency virus. Clin. Infect. Dir. 35(4), 482–487 (2002).
  • Germer JJ, Heimgartner PJ, Ilstrup DM, Harmsen WS, Jenkins GD, Patel R. Comparative evaluation of the VERSANT HCV RNA 3.0, Quantiplex HCV RNA 2.0 and COBAS AMPLICOR HCV MONITOR version 2.0 Assays for quantification of hepatitis C virus RNA in serum. Clin. Microbial 40(2), 495–500 (2002).
  • ••Direct comparison in international unitsof results from the VERSANT HCV RNA 3.0 Assay (bDNA) and COBAS AMPLICOR HCV MONITOR v2.0 Test.
  • Hadziyannis E, Hadziyannis A, Yen-Lieberman B etal Hepatitis C virus RNA assays: a comparison of SuperQuant and MONITOR. Clin. Gastmenterol 33(1), 45–48 (2001).
  • •Shows correlation of 0.681 and agreement of 0.470 between the AMPLICOR HCV MONITOR v2.0 Test and the SuperQuant assay.
  • European Association for the Study of the Liver. International consensus conference on hepatitis C: Paris, 26–28 February 1999.1 Hepatol 30(5), 956–961 (1999).
  • •European Association for the Study of the Liver guidelines for diagnosis, monitoring and treatment of HCV infection.
  • Agence Nationale d'Accreditation et d'Evaluation en Sante. Consensus conference: treatment of hepatitis C. Gastmenterol Clin. Biol. 26, B303—B320 (2002).
  • Simmonds P, Holmes EC, Cha TA et al Classification of hepatitis C virus into six major genotypes and a series of subtypes by phylogenetic analysis of the NS-5 region. Gen. Viral. 74\(Pt 11), 2391–2399 (1993).
  • Halfon P, Trimoulet P, Bourliere M eta]. Hepatitis C virus genotyping based on 5 noncoding sequence analysis (Trugene). Gun. Microbial. 39(5), 1771–1773 (2001).
  • Dev AT, McCaw R, Sundararajan V, Bowden S, Sievert W Southeast Asian patients with chronic hepatitis C: the impact of novel genotypes and race on treatment outcome. Hepatology 36 (5), 1259–1265 (2002).
  • Chinchai T, Labout J, Noppornpanth S etal Comparative study of different methods to genotype hepatitis C virus Type 6 variants. .1. Vim. Methods 109(2), 195–201 (2003).
  • Hui CK, Yuen MF, Sablon E, Chan AO, Wong BC, Lai CL. Interferon and ribavirin therapy for chronic hepatitis C virus genotype 6: a comparison with genotype 1. .1. Infect. Dis. 187(7), 1071–1074 (2003).
  • Abdel-Hamid M. Mid-core sequencing of hepatitis C virus from Egyptian isolates representing different clinical status and geographical distribution. International Symposium for Viral Hepatitis and Liver Disease, Sydney, Australia (2003).
  • Jungkind D. Molecular testing for infectious disease. Science 294(5546), 1553–1555 (2001).
  • Urdea MS, Wuestehube LJ, Laurenson PM, Wilber JC. Hepatitis C diagnosis and monitoring. Gun. Chem. 43(8 Pt 2),1507–1511 (1997).
  • Reichard 0, Yun ZB, Sonnerborg A, Weiland 0. Hepatitis C viral RNA titers in serum prior to, during and after oral treatment with ribavirin for chronic hepatitis C. j Med. Viral. 41(2), 99–102 (1993).
  • Orito E, Mizokami M, Nakano T et al Serum hepatitis C virus RNA level as a predictor of subsequent response to interferon-CL therapy in Japanese patients with chronic hepatitis C. j Med. Viral. 44(4), 410–414 (1994).
  • Mackay IM, Arden KE, Nitsche A. Real-time PCR in virology. Nucleic Acids Res. 30(6), 1292–1305 (2002).
  • Hill CS. Molecular diagnostic testing for infectious diseases using TMA technology. Expert Rev Mol. Diagn. 1(4), 445–455 (2001).
  • Stuyver L, Wyseur A, van Arnhem W, Hernandez F, Maertens G. Second-generation line probe assay for hepatitis C virus genotyping. j Gun. Microbial. 34(9), 2259–2266 (1996).
  • Jungkind D. Automation of laboratory testing for infectious diseases using the polymerase chain reaction: our past, our present, our future. j Clin. Vim. 20(1-2), 1–6 (2001).
  • Abbott Laboratories. LCx HCV RNA Quantitative. Package insert. (2003).
  • Roque-Afonso AM, Ferey MP, Poveda JD, Marchadier E, Dussaix E. Performance of Trugene hepatitis C virus 5 noncoding genotyping kit, a new CLIP sequencing-based assay for hepatitis C virus genotype determination. I Vital Hepat. 9 (5), 385–389 (2002).

Websites

  • Joint United Nations Programme on HIV/AIDS (LTNAIDS) and World Health Organization (WHO). AIDS epidemic up' date December 2002.. www.unaids.org(Viewed October 2003)
  • National Institutes of Health Consensus Development Conference Statement. Management of Hepatitis C: 2002. http://consensus.nih.gov/cons/ 116/116cdc_intro.htm(Viewed October 2003)
  • Roche Molecular Systems. AMPLICOR Hepatitis C Virus (HCV) Test, version 2.0. www.fda.gov/cdrh/pdf/p000010.html (Viewed October 2003)
  • Hill CS. Gen-Probe transcription-mediated amplification: system principles. www.gen-probe.com/pdfs/tmawhiteppr.pdf (Viewed October 2003)

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