Abstract
Background:
Hepatitis C virus (HCV) genotype is a predictive marker for treatment response. We sequentially evaluated the performances of two nucleic acid amplification tests (NAATs) and one serology assay for HCV genotype: Abbott RealTime genotype II (RealTime II), GeneMatrix restriction fragment mass polymorphism (RFMP), and Sysmex HISCL HCV Gr (HISCL Gr).
Methods:
We examined 281 clinical samples with three assays. The accuracy was assessed using the HCV Genotype Performance Panel PHW204 (SeraCare Life Sciences) for two NAATs. Discrepant cases were re-genotyped by the Versant HCV v.2.0 (line probe 2.0) assay.
Results:
With the RealTime II assay, clinic samples were analyzed as follows: genotypes 1b (43.1%), 2 (40.2%), 1 subtypes other than 1a and 1b (12.5%), 3 (1.8%), 4 (1.4%), 1a (0.7%), 6 (0.4%), and mixed (1.1%). The RealTime II and RFMP assays showed a type concordance rate of 97.5% (274/281) (κ=0.80) and no significant discordance (p=0.25). Both assays accurately genotyped all samples in the Performance Panel by the subtype level. The HISCL Gr assay showed concordance rates of about 91% (κ<0.40) and statistically significant discordances with two NAATs (p<0.05). In confirmation tests, the results of RFMP assay were the most consistent with those of Versant 2.0 assay.
Conclusions:
The three HCV assays provided genotyping and serotyping results with good concordance rates. The two NAATs (RealTime II and RFMP) showed comparable performance and good agreement. However, the results of the HISCL Gr assay showed statistically significant differences with those of the NAATs.
Acknowledgments
We thank the Academic and Research Department of GeneMatrix for expert technical assistance.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: The reagents and consumables for HISCL Gr Assays were provided by Sysmex Korea. Sysmex did not influence the study design, study implementation, or manuscript writing.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
1. World Health Organization (WHO). WHO fact sheet 164-hepatitis C. Geneva, Switzerland: WHO, 2014.Search in Google Scholar
2. Gower E, Estes C, Blach S, Razavi-Shearer K, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol 2014;61:S45–57.10.1016/j.jhep.2014.07.027Search in Google Scholar
3. Seong MH, Kil H, Kim YS, Bae SH, Lee YJ, Lee HC, et al. Clinical and epidemiological features of hepatitis C virus infection in South Korea: a prospective, multicenter cohort study. J Med Virol 2013;85:1724–33.10.1002/jmv.23661Search in Google Scholar
4. Kuiken C, Hraber P, Thurmond J, Yusim K. The hepatitis C sequence database in Los Alamos. Nucleic Acids Res 2008;36:D512–6.10.1093/nar/gkm962Search in Google Scholar
5. Smith DB, Bukh J, Kuiken C, Muerhoff AS, Rice CM, Stapleton JT, et al. Expanded classification of hepatitis C virus into 7 genotypes and 67 subtypes: updated criteria and genotype assignment web resource. Hepatology 2014;59:318–27.10.1002/hep.26744Search in Google Scholar
6. Di Bisceglie AM, Hoofnagle JH. Optimal therapy of hepatitis C. Hepatology 2002;36:S121–7.10.1053/jhep.2002.36228Search in Google Scholar
7. Legrand-Abravanel F, Colson P, Leguillou-Guillemette H, Alric L, Ravaux I, Lunel-Fabiani F, et al. Influence of the HCV subtype on the virological response to pegylated interferon and ribavirin therapy. J Med Virol 2009;81:2029–35.10.1002/jmv.21583Search in Google Scholar
8. Raimondi S, Bruno S, Mondelli MU, Maisonneuve P. Hepatitis C virus genotype 1b as a risk factor for hepatocellular carcinoma development: A meta-analysis. J Hepatol 2009;50:1142–54.10.1016/j.jhep.2009.01.019Search in Google Scholar
9. Sood A, Midha V, Goyal O. Treatment of chronic hepatitis C genotype 1 early responders with 36 week pegylated interferon and ribavirin therapy. Ann Hepatol 2014;13:503–9.10.1016/S1665-2681(19)31249-9Search in Google Scholar
10. Young KK, Resnick RM, Myers TW. Detection of hepatitis C virus RNA by a combined reverse transcription-polymerase chain reaction assay. J Clin Microbiol 1993;31:882–6.10.1128/jcm.31.4.882-886.1993Search in Google Scholar PubMed PubMed Central
11. Kim YJ, Kim SO, Chung HJ, Jee MS, Kim BG, Kim KM, et al. Population genotyping of hepatitis C virus by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry analysis of short DNA fragments. Clin Chem 2005;51: 1123–31.10.1373/clinchem.2004.047506Search in Google Scholar PubMed
12. Kuiken C, Mizokami M, Deleage G, Yusim K, Penin F, Shin IT, et al. Hepatitis C databases, principles and utility to researchers. Hepatology 2006;43:1157–65.10.1002/hep.21162Search in Google Scholar PubMed
13. Oh HB, Kim SO, Cha CH, Hong SP, Folk WR, Kim KM, et al. Identification of hepatitis C virus genotype 6 in Korean patients by analysis of 5' untranslated region using a matrix assisted laser desorption/ionization time of flight-based assay, restriction fragment mass polymorphism. J Med Virol 2008;80:1712–9.10.1002/jmv.21162Search in Google Scholar PubMed
14. Cai Q, Zhao Z, Liu Y, Shao X, Gao Z. Comparison of three different HCV genotyping methods: core, NS5B sequence analysis and line probe assay. Int J Mol Med 2013;31:347–52.10.3892/ijmm.2012.1209Search in Google Scholar PubMed
15. Backx M, Lewszuk A, White JR, Cole J, Sreedharan A, van Sanden S, et al. The cost of treatment failure: resource use and costs incurred by hepatitis C virus genotype 1-infected patients who do or do not achieve sustained virological response to therapy. J Viral Hepat 2014;21:208–15.10.1111/jvh.12132Search in Google Scholar PubMed
16. Chakravarti A, Dogra G, Verma V, Srivastava AP. Distribution pattern of HCV genotypes & its association with viral load. Indian J Med Res 2011;133:326–31.Search in Google Scholar
17. Jensen D, Sherman KE, Hezode C, Pol S, Zeuzem S, Ledinghen V, et al. Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders. J Hepatol 2015;63:30–7.10.1016/j.jhep.2015.02.018Search in Google Scholar PubMed
18. Erhardt A, Deterding K, Benhamou Y, Reiser M, Forns X, Pol S, et al. Safety, pharmacokinetics and antiviral effect of BILB 1941, a novel hepatitis C virus RNA polymerase inhibitor, after 5 days oral treatment. Antivir Ther 2009;14:23–32.10.1177/135965350901400104Search in Google Scholar
19. Chayama K, Notsumata K, Kurosaki M, Sato K, Rodrigues L Jr, Setze C, et al. Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced HCV-infected patients. Hepatology 2015;61:1523–32.10.1002/hep.27705Search in Google Scholar PubMed PubMed Central
20. CADTH Rapid Response Reports. Hepatitis C polymorphism testing: A review of the clinical evidence. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health, 2014.Search in Google Scholar
21. Sohn YH, Ko SY, Kim MH, Oh HB. Performance evaluation of the Abbott RealTime HCV Genotype II for hepatitis C virus genotyping. Clin Chem Lab Med 2010;48:469–74.10.1515/CCLM.2010.093Search in Google Scholar PubMed
22. Chevaliez S, Bouvier-Alias M, Brillet R, Pawlotsky JM. Hepatitis C virus (HCV) genotype 1 subtype identification in new HCV drug development and future clinical practice. PLoS One 2009;4:e8209.10.1371/journal.pone.0008209Search in Google Scholar PubMed PubMed Central
23. Bouchardeau F, Cantaloube JF, Chevaliez S, Portal C, Razer A, Lefrere JJ, et al. Improvement of hepatitis C virus (HCV) genotype determination with the new version of the INNO-LiPA HCV assay. J Clin Microbiol 2007;45:1140–5.10.1128/JCM.01982-06Search in Google Scholar PubMed PubMed Central
24. Zhang HQ, Li SB, Wang GH, Chen K, Song XG, Feng XY. Detection of hepatitis C virus core antigen for early diagnosis of hepatitis C virus infection in plasma donor in China. World J Gastroenterol 2007;13:2738–42.10.3748/wjg.v13.i19.2738Search in Google Scholar PubMed PubMed Central
25. Fabrizi F, Lunghi G, Aucella F, Mangano S, Barbisoni F, Bisegna S, et al. Novel assay using total hepatitis C virus (HCV) core antigen quantification for diagnosis of HCV infection in dialysis patients. J Clin Microbiol 2005;43:414–20.10.1128/JCM.43.1.414-420.2005Search in Google Scholar PubMed PubMed Central
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