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Performance evaluation of cobas HBV real-time PCR assay on Roche cobas 4800 System in comparison with COBAS AmpliPrep/COBAS TaqMan HBV Test

  • Hanah Kim , Mina Hur EMAIL logo , Eunsin Bae , Kyung-A Lee and Woo-In Lee
Published/Copyright: February 19, 2018
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 56 Issue 7

Abstract

Background:

Hepatitis B virus (HBV) nucleic acid amplification testing (NAAT) is important for the diagnosis and management of HBV infection. We evaluated the analytical performance of the cobas HBV NAAT (Roche Diagnostics GmbH, Mannheim, Germany) on the cobas 4800 System in comparison with COBAS AmpliPrep/COBAS TaqMan HBV Test (CAP/CTM HBV).

Methods:

Precision was evaluated using three levels of cobas HBV/HCV/HIV-1 Control Kit, and linearity was evaluated across the anticipated measuring range (10.0–1.0×109 IU/mL) at seven levels using clinical samples. Detection capability, including limit of blank (LOB), limit of detection (LOD) and limit of quantitation (LOQ), was verified using the 4th WHO International Standard for HBV DNA for NAT (NIBSC code: 10/266). Correlation between the two systems was compared using 205 clinical samples (102 sera and 103 EDTA plasma).

Results:

Repeatability and total imprecision (coefficient of variation) ranged from 0.5% to 3.8% and from 0.5% to 3.5%, respectively. Linearity (coefficient of determination, R2) was 0.999. LOB, LOD and LOQ were all acceptable within the observed proportion rate (85%). Correlation was very high between the two systems in both serum and plasma samples (correlation coefficient [r]=0.995).

Conclusions:

The new cobas HBV real-time PCR assay on the cobas 4800 System showed reliable analytical performances.

Keywords: cobas 4800; COBAS CAP/CTM; cobas HBV; comparison; hepatitis B virus; performance
Corresponding author: Mina Hur, MD, PhD, Department of Laboratory Medicine, School of Medicine, Konkuk University, Konkuk University Medical Center, 120-1, Neungdong-ro, Hwayang-dong, Gwangjin-gu, Seoul 05030, Republic of Korea, Phone: +82-2-2030-5581, Fax: +82-2-2636-6764

Acknowledgments

This study was supported by the grant and product from Roche Diagnostics.

  1. Author contributions: Kim H performed the experiment, analyzed the data and wrote the draft; Hur M designed the study and finalized the draft; Bae E, Lee KA and Lee WI participated in sample collection, reviewed the draft and commented on it. 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: 2017-12-4
Accepted: 2018-1-17
Published Online: 2018-2-19
Published in Print: 2018-6-27

©2018 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2017-1133
Keywords for this article
cobas 4800; COBAS CAP/CTM; cobas HBV; comparison; hepatitis B virus; performance

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Free light chains in the cerebrospinal fluid. Do we still need oligoclonal IgG?
  4. Reviews
  5. Obese phenotype and natriuretic peptides in patients with heart failure with preserved ejection fraction
  6. Prognostic value of HE4 in patients with ovarian cancer
  7. Opinion Paper
  8. Laboratory hemostasis: from biology to the bench
  9. Genetics and Molecular Diagnostics
  10. Multicenter validation study for the certification of a CFTR gene scanning method using next generation sequencing technology
  11. General Clinical Chemistry and Laboratory Medicine
  12. IL8 and IL16 levels indicate serum and plasma quality
  13. “Send & hold” clinical decision support rules improvement to reduce unnecessary testing of vitamins A, E, K, B1, B2, B3, B6 and C
  14. CSF free light chain identification of demyelinating disease: comparison with oligoclonal banding and other CSF indexes
  15. Search for new biomarkers of pediatric multiple sclerosis: application of immunoglobulin free light chain analysis
  16. The importance of detecting anti-DFS70 in routine clinical practice: comparison of different care settings
  17. Higher D-lactate levels are associated with higher prevalence of small dense low-density lipoprotein in obese adolescents
  18. LC-MSMS assays of urinary cortisol, a comparison between four in-house assays
  19. Optimized angiotensin-converting enzyme activity assay for the accurate diagnosis of sarcoidosis
  20. Quantitative urine test strip reading for leukocyte esterase and hemoglobin peroxidase
  21. Performance evaluation of cobas HBV real-time PCR assay on Roche cobas 4800 System in comparison with COBAS AmpliPrep/COBAS TaqMan HBV Test
  22. Systematic comparison of routine laboratory measurements with in-hospital mortality: ICU-Labome, a large cohort study of critically ill patients
  23. Reference Values and Biological Variations
  24. Establishing reference intervals for sex hormones and SHBG in apparently healthy Chinese adult men based on a multicenter study
  25. Plasma midregional proadrenomedullin (MR-proADM) concentrations and their biological determinants in a reference population
  26. Cancer Diagnostics
  27. Analytical validation of the Hevylite assays for M-protein quantification
  28. Cardiovascular Diseases
  29. Assessing matrix, interferences and comparability between the Abbott Diagnostics and the Beckman Coulter high-sensitivity cardiac troponin I assays
  30. Infectious Diseases
  31. Evaluation of a novel prognostic score based on thrombosis and inflammation in patients with sepsis: a retrospective cohort study
  32. Letters to the Editor
  33. Independent evaluation using fresh patient samples under real clinical conditions is vital for confirming the suitability and marketability of any new HbA1c assay. An example
  34. Anti-streptavidin antibodies mimicking heterophilic antibodies in thyroid function tests
  35. Site-specific DNA methylation detection based on enzyme-linked immunosorbent assay using recombinant methyl-CpG binding protein
  36. 3q29 microduplication in a small family with complex metabolic phenotype from Southern Italy
  37. A D1424N mutation in the MYH9 gene results in macrothrombocytopenia and granulocytic inclusion bodies in a Chinese inherited macrothrombocytopenia pedigree
  38. Evaluation of analytical performance of a chemiluminescence enzyme immunoassay (CLEIA) for cTnI using the automated AIA-CL2400 platform
  39. Cellular markers of eryptosis are altered in type 2 diabetes
  40. Platelet serotonin is not elevated in patients with benign head and neck paragangliomas
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