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Differences between quantification of genotype 3 hepatitis C virus RNA by Versions 1.0 and 2.0 of the COBAS AmpliPrep/COBAS TaqMan HCV Test

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Published/Copyright: December 19, 2016
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 55 Issue 7

Abstract

Background:

Differences between the designs of hepatitis C virus (HCV) viral load assays can result in genotype-related variability in RNA quantification. We tested paired aliquots of plasma specimens from HCV-infected individuals using two versions (v1.0 and v2.0) of the Roche COBAS AmpliPrep/COBAS TaqMan HCV Test (CAP/CTM HCV) and noted variability between results for a subset of specimens; we then sought to determine whether discrepant results were more prevalent among specific HCV genotypes.

Methods:

Archived and prospectively-collected plasma samples from 114 unique patients were tested using CAP/CTM HCV v1.0 and v2.0. The HCV genotype result for each patient was determined by retrospectively reviewing laboratory records.

Results:

All (46/46) specimens with quantifiable viral loads from patients with genotype 1 or 2 infection had CAP/CTM HCV v1.0 and v2.0 results that were within 0.5 log10 IU/mL; in contrast, only 3/11 (27.3%) from patients with HCV genotype 3 (mean difference, 0.56 log10 IU/mL higher with v2.0) and 0/3 (0%) from patients with HCV genotype 4 (mean difference, 0.91 log10 IU/mL higher with v2.0) had results within 0.5 log10 IU/mL. Among specimens with detectable HCV RNA below the lower limit of quantification with v1.0, greater proportions of genotype 3 (4/7, 57.1%) and genotype 4 (3/4, 75.0%) specimens than genotype 1 or 2 specimens (6/30, 20.0%) had v2.0 results within the quantifiable range.

Conclusions:

In patients infected with HCV genotype 3, sequential CAP/CTM HCV viral load results should be compared with caution and interpreted in the context of the specific assay version used.

Keywords: genotype; hepatitis C; quantitative real-time polymerase chain reaction; viral load
Corresponding author: Eric S. Rosenberg, MD, Massachusetts General Hospital, Gray-Bigelow 526, 55 Fruit Street, Boston, MA 02114, USA, Phone: +617-724-7519, Fax: +617-726-5957

Acknowledgments

The authors thank Bryan Cobb, PhD and Gabrielle Heilek, PhD at Roche Molecular Systems, Inc. for performing viral nucleic acid sequence analysis. The authors also gratefully acknowledge Kent B. Lewandrowski, MD for his thoughtful critical review of an earlier draft of the manuscript.

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

  2. Research funding: None declared.

  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: 2016-9-6
Accepted: 2016-11-1
Published Online: 2016-12-19
Published in Print: 2017-6-27

©2017 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Opportunities and drawbacks of nonstandard body fluid analysis
  4. How I first met Dr. Morton K. Schwartz
  5. Reviews
  6. Measurement of thyroglobulin, calcitonin, and PTH in FNA washout fluids
  7. Quality control materials for pharmacogenomic testing in the clinic
  8. Modulating thrombotic diathesis in hereditary thrombophilia and antiphospholipid antibody syndrome: a role for circulating microparticles?
  9. Opinion Papers
  10. Advances in laboratory diagnosis of hereditary spherocytosis
  11. Analytical performance specifications for external quality assessment – definitions and descriptions
  12. Genetics and Molecular Diagnostics
  13. Differences between quantification of genotype 3 hepatitis C virus RNA by Versions 1.0 and 2.0 of the COBAS AmpliPrep/COBAS TaqMan HCV Test
  14. General Clinical Chemistry and Laboratory Medicine
  15. Estimating the intra- and inter-individual imprecision of manual pipetting
  16. Effect of multiple freeze-thaw cycles on selected biochemical serum components
  17. The effect of storage temperature fluctuations on the stability of biochemical analytes in blood serum
  18. Comparison of ex vivo stability of copeptin and vasopressin
  19. Physiologic changes of urinary proteome by caffeine and excessive water intake
  20. Assessment of autoantibodies to interferon-ω in patients with autoimmune polyendocrine syndrome type 1: using a new immunoprecipitation assay
  21. Reference Values and Biological Variations
  22. Within-day biological variation and hour-to-hour reference change values for hematological parameters
  23. Relationship between anti-Müllerian hormone and antral follicle count across the menstrual cycle using the Beckman Coulter Access assay in comparison with Gen II manual assay
  24. Cardiovascular Diseases
  25. Low-grade inflammation and tryptophan-kynurenine pathway activation are associated with adverse cardiac remodeling in primary hyperparathyroidism: the EPATH trial
  26. Infectious Diseases
  27. Comparison between procalcitonin and C-reactive protein in predicting bacteremias and confounding factors: a case-control study
  28. Monitoring of procalcitonin but not interleukin-6 is useful for the early prediction of anastomotic leakage after colorectal surgery
  29. Activation of the tryptophan/serotonin pathway is associated with severity and predicts outcomes in pneumonia: results of a long-term cohort study
  30. Letters to the Editor
  31. Incidental findings of monoclonal proteins from carbohydrate-deficient transferrin analysis using capillary electrophoresis
  32. IgD-λ myeloma with extensive free light-chain excretion: a diagnostic pitfall in the identification of monoclonal gammopathies
  33. 25-Hydroxyvitamin D threshold values should be age-specific
  34. Effect of dabigatran treatment at therapeutic levels on point-of-care international normalized ratio (INR)
  35. Alkaline phosphatase activity – pH impact on the measurement result
  36. Cyst hydatid and cancer: the myth continues
  37. Role of activated platelets in severe acne scarring and adaptive immunity activation
  38. Towards a random-access LC-MS/MS model for busulfan analysis
https://doi.org/10.1515/cclm-2016-0799
Keywords for this article
genotype; hepatitis C; quantitative real-time polymerase chain reaction; viral load

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Opportunities and drawbacks of nonstandard body fluid analysis
  4. How I first met Dr. Morton K. Schwartz
  5. Reviews
  6. Measurement of thyroglobulin, calcitonin, and PTH in FNA washout fluids
  7. Quality control materials for pharmacogenomic testing in the clinic
  8. Modulating thrombotic diathesis in hereditary thrombophilia and antiphospholipid antibody syndrome: a role for circulating microparticles?
  9. Opinion Papers
  10. Advances in laboratory diagnosis of hereditary spherocytosis
  11. Analytical performance specifications for external quality assessment – definitions and descriptions
  12. Genetics and Molecular Diagnostics
  13. Differences between quantification of genotype 3 hepatitis C virus RNA by Versions 1.0 and 2.0 of the COBAS AmpliPrep/COBAS TaqMan HCV Test
  14. General Clinical Chemistry and Laboratory Medicine
  15. Estimating the intra- and inter-individual imprecision of manual pipetting
  16. Effect of multiple freeze-thaw cycles on selected biochemical serum components
  17. The effect of storage temperature fluctuations on the stability of biochemical analytes in blood serum
  18. Comparison of ex vivo stability of copeptin and vasopressin
  19. Physiologic changes of urinary proteome by caffeine and excessive water intake
  20. Assessment of autoantibodies to interferon-ω in patients with autoimmune polyendocrine syndrome type 1: using a new immunoprecipitation assay
  21. Reference Values and Biological Variations
  22. Within-day biological variation and hour-to-hour reference change values for hematological parameters
  23. Relationship between anti-Müllerian hormone and antral follicle count across the menstrual cycle using the Beckman Coulter Access assay in comparison with Gen II manual assay
  24. Cardiovascular Diseases
  25. Low-grade inflammation and tryptophan-kynurenine pathway activation are associated with adverse cardiac remodeling in primary hyperparathyroidism: the EPATH trial
  26. Infectious Diseases
  27. Comparison between procalcitonin and C-reactive protein in predicting bacteremias and confounding factors: a case-control study
  28. Monitoring of procalcitonin but not interleukin-6 is useful for the early prediction of anastomotic leakage after colorectal surgery
  29. Activation of the tryptophan/serotonin pathway is associated with severity and predicts outcomes in pneumonia: results of a long-term cohort study
  30. Letters to the Editor
  31. Incidental findings of monoclonal proteins from carbohydrate-deficient transferrin analysis using capillary electrophoresis
  32. IgD-λ myeloma with extensive free light-chain excretion: a diagnostic pitfall in the identification of monoclonal gammopathies
  33. 25-Hydroxyvitamin D threshold values should be age-specific
  34. Effect of dabigatran treatment at therapeutic levels on point-of-care international normalized ratio (INR)
  35. Alkaline phosphatase activity – pH impact on the measurement result
  36. Cyst hydatid and cancer: the myth continues
  37. Role of activated platelets in severe acne scarring and adaptive immunity activation
  38. Towards a random-access LC-MS/MS model for busulfan analysis
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