Profile of Roche’s cobas® HCV tests

References

• Gower E, Estes C, Blach S, et al. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014;61(Suppl 1):S45–S57. ​
   PubMed Web of Science ®Google Scholar
• Webster DP, Klenerman P, Dusheiko GM. Hepatitis C. Lancet. 2015;385:1124–1135.
   PubMed Web of Science ®Google Scholar
• Lanini S, Easterbrook PJ, Zumla A, et al. Hepatitis C: global epidemiology and strategies for control. Clin Microbiol Infect. 2016;22:833–838.
   PubMed Web of Science ®Google Scholar
• European Association for the Study of the Liver: EASL Recommendations on Treatment of Hepatitis C 2016 [Internet; cited Dec. 05, 2016]. Available from: [email protected].
   Google Scholar
• Micallef JM, Kaldor JM, Dore GJ. Spontaneous viral clearance following acute hepatitis C infection: a systematic review of longitudinal studies. J Viral Hepat. 2006 Jan;13(1):34–41.
   PubMed Web of Science ®Google Scholar
• Chevaliez S, Rodriguez C, Pawlotsky JM. New virologic tools for management of chronic hepatitis B and C. Gastroenterology. 2012;142:1303–1313.
   PubMed Web of Science ®Google Scholar
• Kwo P, Gitlin N, Nahass R, et al. Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study. Hepatology. 2016;64:370–380.
   PubMed Web of Science ®Google Scholar
• O’Brien TR, Feld JJ, Kottilil S, et al. No scientific basis to restrict 8 weeks of treatment with ledipasvir/sofosbuvir to patients with hepatitis C virus RNA <6,000,000 IU/mL. Hepatology. 2016;63:28–30.
   PubMed Web of Science ®Google Scholar
• Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1879–1888.
   PubMed Web of Science ®Google Scholar
• Curry M, Modi A, Pungpapong S, et al. Real world effectiveness of ledipasvir/sofosbuvir (LDV/SOF) in treatment-experienced cirrhotic genotype 1 patients with chronic hepatitis C: A comparative analysis of Gilead sponsored trials with 4 real-world cohorts. J Hepatol. 2016;64:S797.
   Google Scholar
• Vermehren J, Maasoumy B, Maan R, et al. Applicability of hepatitis C virus RNA viral load thresholds for 8-week treatments in patients with chronic hepatitis C virus genotype 1 infection. Clin Infect Dis. 2016;62:1228–1234.
   PubMed Web of Science ®Google Scholar
• Orlando C, Pinzani P, Pazzagli M. Developments in quantitative PCR. Clin Chem Lab Med. 1998;36:255–269.
   PubMed Web of Science ®Google Scholar
• Hill CS. Molecular diagnostic testing for infectious diseases using TMA technology. Expert Rev Mol Diagn. 2001;1:445–455.
   PubMedGoogle Scholar
• Directive 98/79/EC of the European Parliament and of the Council of the European Union. Off J Eur Communities. 1998;L331:1–37. ​
   Google Scholar
• 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 Sang. 1999;76:149–158.
   PubMed Web of Science ®Google Scholar
• Saldanha J, Heath A, Aberham C, et al. World Health Organization collaborative study to establish a replacement WHO international standard for hepatitis C virus RNA nucleic acid amplification technology assays. Vox Sang. 2005;88:202–204.
   PubMed Web of Science ®Google Scholar
• WHO International Standard: 5th WHO International Standard for HCV NAT: NIBSC code: 14/150: Instructions for use (Version 2.00, Dated 08/07/2016) [Internet; cited Dec. 05, 2016]. Available from: https://www.nibsc.org/documents/ifu/14-150.pdf.
   Google Scholar
• Caliendo AM, Valsamakis A, Zhou Y, et al. Multilaboratory comparison of hepatitis C virus viral load assays. J Clin Microbiol. 2006;44:1726–1732.
   PubMed Web of Science ®Google Scholar
• Maasoumy B, Hunyady B, Calvaruso V, et al. Performance of two HCV RNA assays during protease inhibitor-based triple therapy in patients with advanced liver fibrosis and cirrhosis. Plos One. 2014;9:e110857.
   Google Scholar
• Vermehren J, Kau A, Gartner BC, et al. 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. 2008;46:3880–3891.
   PubMed Web of Science ®Google Scholar
• Chevaliez S, Bouvier-Alias M, Brillet R, et al. Overestimation and underestimation of hepatitis C virus RNA levels in a widely used real-time polymerase chain reaction-based method. Hepatology. 2007;46:22–31.
   PubMed Web of Science ®Google Scholar
• Elkady A, Tanaka Y, Kurbanov F, et al. Performance of two Real-Time RT-PCR assays for quantitation of hepatitis C virus RNA: evaluation on HCV genotypes 1-4. J Med Virol. 2010;82:1878–1888.
   PubMed Web of Science ®Google Scholar
• Bossler A, Gunsolly C, Pyne MT, et al. Performance of the COBAS® AmpliPrep/COBAS® TaqMan automated system for hepatitis C virus (HCV) quantification in a multi-center comparison. J Clin Virol. 2011;50:100–103.
   PubMed Web of Science ®Google Scholar
• Vermehren J, Colucci G, Gohl P, et al. Development of a second version of the Cobas® AmpliPrep/Cobas® TaqMan hepatitis C virus quantitative test with improved genotype inclusivity. J Clin Microbiol. 2011;49:3309–3315.
   PubMed Web of Science ®Google Scholar
• Chevaliez S, Bouvier-Alias M, Rodriguez C, et al. The Cobas® AmpliPrep/Cobas® TaqMan HCV test, version 2.0, real-time PCR assay accurately quantifies hepatitis C virus genotype 4 RNA. J Clin Microbiol. 2013;51:1078–1082.
   PubMed Web of Science ®Google Scholar
• Zitzer H, Heilek G, Truchon K, et al. Second-generation Cobas® AmpliPrep/Cobas® TaqMan HCV quantitative test for viral load monitoring: a novel dual-probe assay design. J Clin Microbiol. 2013;51:571–577.
   PubMed Web of Science ®Google Scholar
• Kessler HH, Cobb BR, Wedemeyer H, et al. Evaluation of the COBAS® AmpliPrep/COBAS® TaqMan HCV Test, v2.0 and comparison to assays used in routine clinical practice in an international multicenter clinical trial: the ExPECT study. J Clin Virol. 2015;67:67–72.
   PubMed Web of Science ®Google Scholar
• Kessler HH, Hübner M, Konrad PM, et al. Genotype impact on HCV RNA levels determined with the VERSANT HCV RNA 1.0 assay (kPCR). J Clin Virol. 2013;58:522–527.
   PubMed Web of Science ®Google Scholar
• Gruner N, Viazov S, Korn K, et al. Performance characteristics of the VERSANT hepatitis C virus RNA 1.0 (kPCR) assay. Int J Med Microbiol. 2015;305:627–635.
   PubMed Web of Science ®Google Scholar
• Saune K, Abravanel F, Hasle C, et al. Analytical performance of the VERIS MDx system HCV assay for detecting and quantifying HCV RNA. J Clin Virol. 2016;84:7–11.
   PubMed Web of Science ®Google Scholar
• Cobb B, Simon CO, Stramer SL, et al. The cobas® 6800/8800 System: a new era of automation in molecular diagnostics. Expert Rev Mol Diagn. 2017 Feb;17(2):167–180.
   PubMed Web of Science ®Google Scholar
• Longo MC, Berninger MS, Hartley JL. Use of uracil DNA glycosylase to control carry-over contamination in polymerase chain reactions. Gene. 1990;93:125–128.
   PubMed Web of Science ®Google Scholar
• Heid CA, Stevens J, Livak KJ, et al. Real time quantitative PCR. Genome Res. 1996;6:986–994.
   PubMed Web of Science ®Google Scholar
• Templer S, Seiverth S, Heilek G, et al. Next-Generation of HCV viral load monitoring: assessment of a new technology. Poster session, presented at: 25th European Congress of Clinical Microbiology and Infectious Diseases; 2015;Apr 25-28; Copenhagen, Denmark.
   Google Scholar
• Valsamakis A, Marino E, Young S The COBAS® HCV Test for use on the cobas® 6800/8800 system: diagnosis and viral load monitoring of patients with chronic hepatitis C. Poster session, presented at: 32nd Clinical Virology Symposium; 2016;May 19-22; Daytona Beach, FL, USA.
   Google Scholar
• Vermehren J, Stelzl E, Massoumy B, et al. International multi-center comparison study of both analytical and clinical performance across four Roche HCV RNA assays utilizing different platforms. J Clin Microbiol. Forthcoming 2017. ​
   PubMedGoogle Scholar
• Raggam RB, Saldanha J, Kessler HH. Quality assurance and quality control. In: Kessler HH, editor. Molecular diagnostics of infectious diseases. 3rd ed. Berlin/Boston: De Gruyter; 2014. p. 41–55. ​
   Google Scholar
• Stelzl E, Appel HM, Mehta R, et al. Evaluation of the new cobas® HCV genotyping test based on real-time PCRs of three different HCV genome regions. Clin Chem Lab Med. 2017. DOI:10.1515/cclm-2016-0620 . [Epub ahead of print].
   PubMedGoogle Scholar
• Nieto-Aponte L, Quer J, Ruiz-Ripa A, et al. Assessment of a novel automatic real-time PCR assay on the cobas 4800 analyzer as a screening platform for hepatitis C virus genotyping in clinical practice: comparison with massive sequencing. J Clin Microbiol. 2017 Feb;55(2):504–509.
   PubMed Web of Science ®Google Scholar
• Herman S, Perez E, Marins E, et al. COBAS® HCV GT for use on the COBAS® 4800 system: a highly accurate HCV genotyping test. J Hepatol. 2016;64:S612.
   Google Scholar
• Stelzl E, Haas B, Bauer B, et al. First identification of an intergenotypic (2/1) recombinant form of hepatitis C virus in Austria. J Virol Methods. 2016. submitted. ​
   Google Scholar
• Fevery B, Susser S, Lenz O, et al. HCV RNA quantification with different assays: implications for protease-inhibitor-based response-guided therapy. Antivir Ther. 2014;19:559–567.
   PubMed Web of Science ®Google Scholar
• Fevery B, Susser S, Lenz O, et al. Comparison of three quantitative HCV RNA assays in samples from HCV genotype 1- or 4-infected patients treated with the NS3/4A protease inhibitor simeprevir. J Clin Virol. 2015;72:133–140.
   PubMed Web of Science ®Google Scholar
• Greig SL. Sofosbuvir/Velpatasvir: A review in chronic hepatitis C. Drugs. 2016;76:1567–1578.
   PubMed Web of Science ®Google Scholar
• Gane E, Poordad F, Wang S, et al. High efficacy of ABT-493 and ABT-530 treatment in patients with HCV genotype 1 or 3 infection and compensated cirrhosis. Gastroenterology. 2016;151:651,659.e1.
   Web of Science ®Google Scholar
• Dahari H, Canini L, Graw F, et al. HCV kinetic and modeling analyses indicate similar time to cure among sofosbuvir combination regimens with daclatasvir, simeprevir or ledipasvir. J Hepatol. 2016;64:1232–1239.
   PubMed Web of Science ®Google Scholar
• Lau G, Benhamou Y, Chen G, et al. Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study. Lancet Gasrotenterol Hepatol. 2016;1:97–104.
   PubMedGoogle Scholar