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Evaluation of sequencing of HCV core/E1, NS5A and NS5B as a genotype predictive tool in comparison with commercial assays targeting 5'UTR.
J Clin Virol. 2015 May; 66:56-9.JC

Abstract

BACKGROUND

Hepatitis C virus (HCV) genotyping is required for tailoring the dose and duration of antiviral therapy, predicting virological response rates, and selecting future treatment options.

OBJECTIVE

To establish whether baseline genotypes, performed by INNO-LiPA Version 1.0 (v1.0), before 2008, were valid for making treatment decisions now or whether genotypic determination should be repeated. Furthermore, to evaluate concordance between Abbott RealTime genotype II assay (RT) and genotyping by sequencing HCV C/E1, NS5A, NS5B.

STUDY DESIGN

Genotyping by RT and sequencing was performed on paired historic and current specimens from 50 patients previously baseline genotyped using INNO-LiPA.

RESULTS

Of 100 samples from 50 patients, ≥ 2 of HCV genomic target regions yielded a sequence that was suitable for genotyping, with 100% concordance, providing no evidence of recombination events. Genotype and subtype prediction based on RT and sequencing agreed in 62.8% historic and 72.7% current specimens, with a kappa coefficient score of 0.48 and 0.76, respectively. LiPA could not subtype 46% of HCV gt1 infections, and LiPA subgenotype was only in agreement with RT and sequencing in 28.6% cases, where matched baseline and historic specimens were available. Three patients were indeterminate by RT, and five patients with HCV gt1 infections could not be subtyped by RT. However, RT revealed mixed infections in five patients where sequencing detected only single HCV infection at 20% threshold.

CONCLUSION

Genotyping by sequencing, exhibited excellent concordance, with moderate to good agreement with RT, and could resolve RT indeterminates and subtype HCV-gt1 infections not possible by LiPA.

Authors+Show Affiliations

Department of Virology, Royal Free London NHS Foundation Trust, London, UK. Electronic address: a.mccormick@westminster.ac.uk.Department of Virology, Royal Free London NHS Foundation Trust, London, UK.Department of Virology, Royal Free London NHS Foundation Trust, London, UK.Department of Virology, Royal Free London NHS Foundation Trust, London, UK.Department of Infection and Population Health, University College London, UK.Department of Virology, Royal Free London NHS Foundation Trust, London, UK.Department of Virology, Royal Free London NHS Foundation Trust, London, UK.Department of Virology, Royal Free London NHS Foundation Trust, London, UK.

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

25866338

Citation

McCormick, Adele L., et al. "Evaluation of Sequencing of HCV core/E1, NS5A and NS5B as a Genotype Predictive Tool in Comparison With Commercial Assays Targeting 5'UTR." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 66, 2015, pp. 56-9.
McCormick AL, Macartney MJ, Abdi-Abshir I, et al. Evaluation of sequencing of HCV core/E1, NS5A and NS5B as a genotype predictive tool in comparison with commercial assays targeting 5'UTR. J Clin Virol. 2015;66:56-9.
McCormick, A. L., Macartney, M. J., Abdi-Abshir, I., Labbett, W., Smith, C., Irish, D., Webster, D. P., & Haque, T. (2015). Evaluation of sequencing of HCV core/E1, NS5A and NS5B as a genotype predictive tool in comparison with commercial assays targeting 5'UTR. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 66, 56-9. https://doi.org/10.1016/j.jcv.2015.03.006
McCormick AL, et al. Evaluation of Sequencing of HCV core/E1, NS5A and NS5B as a Genotype Predictive Tool in Comparison With Commercial Assays Targeting 5'UTR. J Clin Virol. 2015;66:56-9. PubMed PMID: 25866338.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of sequencing of HCV core/E1, NS5A and NS5B as a genotype predictive tool in comparison with commercial assays targeting 5'UTR. AU - McCormick,Adele L, AU - Macartney,Malcolm J, AU - Abdi-Abshir,Ikran, AU - Labbett,Wendy, AU - Smith,Colette, AU - Irish,Dianne, AU - Webster,Daniel P, AU - Haque,Tanzina, Y1 - 2015/03/10/ PY - 2014/12/15/received PY - 2015/02/24/revised PY - 2015/03/06/accepted PY - 2015/4/14/entrez PY - 2015/4/14/pubmed PY - 2015/12/23/medline KW - DNA sequencing KW - Genotyping KW - Hepatitis C virus KW - LiPA KW - RealTime PCR KW - Subtyping SP - 56 EP - 9 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 66 N2 - BACKGROUND: Hepatitis C virus (HCV) genotyping is required for tailoring the dose and duration of antiviral therapy, predicting virological response rates, and selecting future treatment options. OBJECTIVE: To establish whether baseline genotypes, performed by INNO-LiPA Version 1.0 (v1.0), before 2008, were valid for making treatment decisions now or whether genotypic determination should be repeated. Furthermore, to evaluate concordance between Abbott RealTime genotype II assay (RT) and genotyping by sequencing HCV C/E1, NS5A, NS5B. STUDY DESIGN: Genotyping by RT and sequencing was performed on paired historic and current specimens from 50 patients previously baseline genotyped using INNO-LiPA. RESULTS: Of 100 samples from 50 patients, ≥ 2 of HCV genomic target regions yielded a sequence that was suitable for genotyping, with 100% concordance, providing no evidence of recombination events. Genotype and subtype prediction based on RT and sequencing agreed in 62.8% historic and 72.7% current specimens, with a kappa coefficient score of 0.48 and 0.76, respectively. LiPA could not subtype 46% of HCV gt1 infections, and LiPA subgenotype was only in agreement with RT and sequencing in 28.6% cases, where matched baseline and historic specimens were available. Three patients were indeterminate by RT, and five patients with HCV gt1 infections could not be subtyped by RT. However, RT revealed mixed infections in five patients where sequencing detected only single HCV infection at 20% threshold. CONCLUSION: Genotyping by sequencing, exhibited excellent concordance, with moderate to good agreement with RT, and could resolve RT indeterminates and subtype HCV-gt1 infections not possible by LiPA. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/25866338/Evaluation_of_sequencing_of_HCV_core/E1_NS5A_and_NS5B_as_a_genotype_predictive_tool_in_comparison_with_commercial_assays_targeting_5'UTR_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(15)00083-9 DB - PRIME DP - Unbound Medicine ER -