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Comparison of Abbott RealTime genotype II, GeneMatrix restriction fragment mass polymorphism and Sysmex HISCL HCV Gr assays for hepatitis C virus genotyping

  • Mi-Soon Han , Yongjung Park and Hyon-Suk Kim EMAIL logo
Published/Copyright: January 11, 2017
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 55 Issue 8

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.

Keywords: Abbott RealTime; HCV genotype; nucleic acid amplification test (NAAT); restriction fragment mass polymorphism (RFMP); serology; Sysmex HISCL Gr
Corresponding author: Hyon-Suk Kim, MD, Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea, Phone: +82-2-2228-2443, Fax: +82-2-364-1583

Acknowledgments

We thank the Academic and Research Department of GeneMatrix for expert technical assistance.

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. 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.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. 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.

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Received: 2016-2-18
Accepted: 2016-11-29
Published Online: 2017-1-11
Published in Print: 2017-7-26

©2017 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Biomarkers of acute kidney injury: a step forward
  4. Reviews
  5. Biomarkers of acute kidney injury: the pathway from discovery to clinical adoption
  6. Prognostic value of glycated hemoglobin among patients with ST-segment elevation myocardial infarction: a systematic review and meta-analysis
  7. Opinion Paper
  8. Traceability in laboratory medicine: a global driver for accurate results for patient care
  9. Point
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  11. Counterpoint
  12. Reporting altered test results in hemolyzed samples: is the cure worse than the disease?
  13. Genetics and Molecular Diagnostics
  14. Early mixed hematopoietic chimerism detection by digital droplet PCR in patients undergoing gender-mismatched hematopoietic stem cell transplantation
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  29. A new strategy for calculating the risk of ovarian malignancy algorithm (ROMA)
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  33. Hb variants in Korea: effect on HbA1c using five routine methods
  34. Letters to the Editor
  35. Pseudohyperkalemia in capillary whole-blood samples – an occasional error or a significant problem in a pediatric hospital?
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https://doi.org/10.1515/cclm-2016-0130
Keywords for this article
Abbott RealTime; HCV genotype; nucleic acid amplification test (NAAT); restriction fragment mass polymorphism (RFMP); serology; Sysmex HISCL Gr

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Biomarkers of acute kidney injury: a step forward
  4. Reviews
  5. Biomarkers of acute kidney injury: the pathway from discovery to clinical adoption
  6. Prognostic value of glycated hemoglobin among patients with ST-segment elevation myocardial infarction: a systematic review and meta-analysis
  7. Opinion Paper
  8. Traceability in laboratory medicine: a global driver for accurate results for patient care
  9. Point
  10. To report or not to report: a proposal on how to deal with altered test results in hemolytic samples
  11. Counterpoint
  12. Reporting altered test results in hemolyzed samples: is the cure worse than the disease?
  13. Genetics and Molecular Diagnostics
  14. Early mixed hematopoietic chimerism detection by digital droplet PCR in patients undergoing gender-mismatched hematopoietic stem cell transplantation
  15. Comparison of Abbott RealTime genotype II, GeneMatrix restriction fragment mass polymorphism and Sysmex HISCL HCV Gr assays for hepatitis C virus genotyping
  16. General Clinical Chemistry and Laboratory Medicine
  17. The relationship between vacuum and hemolysis during catheter blood collection: a retrospective analysis of six large cohorts
  18. Evaluation of the Greiner Bio-One serum separator BCA Fast Clot tube
  19. Implementation and application of moving average as continuous analytical quality control instrument demonstrated for 24 routine chemistry assays
  20. Parathormone stability in hemodialyzed patients and healthy subjects: comparison on non-centrifuged EDTA and serum samples with second- and third-generation assays
  21. Association between plasma proANP and hyperuricemia in Chinese Han women: a cross-sectional study
  22. Activity of the liver enzyme ornithine carbamoyltransferase (OTC) in blood: LC-MS/MS assay for non-invasive diagnosis of ornithine carbamoyltransferase deficiency
  23. Detecting paraprotein interference on a direct bilirubin assay by reviewing the photometric reaction data
  24. Prediction of human iron bioavailability using rapid c-ELISAs for human plasma hepcidin
  25. Reference Values and Biological Variations
  26. Determination of glucose-6-phosphate dehydrogenase cut-off values in a Tunisian population
  27. Plasma levels of endothelin-1 and renal function among young and healthy adults
  28. Cancer Diagnostics
  29. A new strategy for calculating the risk of ovarian malignancy algorithm (ROMA)
  30. Laboratory characterization of leukemic cell procoagulants
  31. Diabetes
  32. Preparation, calibration and evaluation of the First International Standard for human C-peptide
  33. Hb variants in Korea: effect on HbA1c using five routine methods
  34. Letters to the Editor
  35. Pseudohyperkalemia in capillary whole-blood samples – an occasional error or a significant problem in a pediatric hospital?
  36. Elevation of creatine kinase is linked to disease severity and predicts fatal outcomes in H7N9 infection
  37. Analytical evaluation of point-of-care procalcitonin (PCT) and clinical performances in an unselected population as compared with central lab PCT assay
  38. Evaluation of an automated commercial ELISA method for calprotectin determination in pleural fluid
  39. The unfinished story of interference in thyroid hormones with Roche immunoassays: when prewashing procedures matter
  40. Effects of apixaban on prothrombin time, activated partial thromboplastin time and anti-Xa assays: a European survey
  41. Evaluation of a chemiluminescent immunoassay for urinary aldosterone on the DiaSorin LIAISON automated platform against RIA and LC-MS/MS
  42. Complex considerations when tendering for HbA1c analysers
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