Commutability and concordance of four hepatitis B virus DNA assays in an international multicenter study

Benjamin Maasoumy, Birgit Bremer, Patrick Lehmann, Ed G. Marins, Véronique Michel-Treil, Christian O. Simon, Merlin Njoya, Markus Cornberg, Ellen Paxinos, Michael P. Manns, Johannes Vermehren, Christoph Sarrazin, Ji Yeon Sohn, Yunjung Cho, Heiner Wedemeyer

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Background HBV DNA is the most important molecular marker in hepatitis B, used to determine treatment indication and monitoring. Most patients require lifelong hepatitis B virus (HBV) management, thus viral load (VL) monitoring may be performed at different laboratories, with different HBV assays, which may result in different VL results. This multicenter study compares the commutability and concordance of results from four different HBV DNA assays: CAP/CTM HBVv2, HPS/CTM HBVv2 and the new cobas 6800/8800 HBV and cobas 4800 HBV assays. Methods Across all four assays, HBV limit of detection (LoD) and linearity at lower concentrations were assessed using panels traceable to the World Health Organization international standard, and concordance was investigated at the important medical decision cutoffs 2000 and 20,000 IU/ml, using specimens from HBV-positive patients. Results The calculated LoD via a probit curve was 2.7 IU/ml for cobas 6800/8800 HBV, 2.8 IU/ml for cobas 4800 HBV, 9.6 IU/ml for CAP/CTM HBVv2, and 6.2 IU/ml for HPS/CTM HBVv2. The average accuracy was comparable between cobas 6800/8800 HBV, cobas 4800 HBV and CAP/CTM HBVv2 (0.04-0.05 log10 IU/ml), while a slightly lower accuracy was documented for HPS/CTM HBVv2 (-0.16 log10 IU/ml). A total of 211-245 clinical samples were used for a pairwise comparison. Mean paired log differences ranged from -0.17 log10 IU/ml to -0.01 log10 IU/ml. Coefficient of determination was over 98% for all pairs with high overall percent agreement at the 2000 and 20,000 IU/ml cutoffs (from 91.7% to 96.3%). In a subset of samples with VL±0.5 log10 to the 2000 and 20,000 IU/ml thresholds, concordance was still 72% and 82%, respectively. Conclusions The new cobas 6800/8800 HBV and 4800 HBV assays show high accuracy in samples with low-level viremia and a high concordance with the established HBV tests, CAP/CTM HBVv2 and HPS/CTM HBVv2, at 2000 and 20,000 IU/ml. Thus, all four HBV assays have high commutability and may be used interchangeably in routine clinical practice.

Original languageEnglish
Pages (from-to)609-618
Number of pages10
JournalTherapeutic Advances in Gastroenterology
Volume10
Issue number8
DOIs
Publication statusPublished - 2017 Aug 1

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Hepatitis B virus
Multicenter Studies
DNA
Viral Load
Limit of Detection
Viremia
Hepatitis B

Keywords

  • cobas
  • HBV diagnostics
  • HBV DNA assay
  • HBV treatment
  • hepatitis B virus

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Maasoumy, B., Bremer, B., Lehmann, P., Marins, E. G., Michel-Treil, V., Simon, C. O., ... Wedemeyer, H. (2017). Commutability and concordance of four hepatitis B virus DNA assays in an international multicenter study. Therapeutic Advances in Gastroenterology, 10(8), 609-618. https://doi.org/10.1177/1756283X17722745

Commutability and concordance of four hepatitis B virus DNA assays in an international multicenter study. / Maasoumy, Benjamin; Bremer, Birgit; Lehmann, Patrick; Marins, Ed G.; Michel-Treil, Véronique; Simon, Christian O.; Njoya, Merlin; Cornberg, Markus; Paxinos, Ellen; Manns, Michael P.; Vermehren, Johannes; Sarrazin, Christoph; Sohn, Ji Yeon; Cho, Yunjung; Wedemeyer, Heiner.

In: Therapeutic Advances in Gastroenterology, Vol. 10, No. 8, 01.08.2017, p. 609-618.

Research output: Contribution to journalArticle

Maasoumy, B, Bremer, B, Lehmann, P, Marins, EG, Michel-Treil, V, Simon, CO, Njoya, M, Cornberg, M, Paxinos, E, Manns, MP, Vermehren, J, Sarrazin, C, Sohn, JY, Cho, Y & Wedemeyer, H 2017, 'Commutability and concordance of four hepatitis B virus DNA assays in an international multicenter study', Therapeutic Advances in Gastroenterology, vol. 10, no. 8, pp. 609-618. https://doi.org/10.1177/1756283X17722745
Maasoumy, Benjamin ; Bremer, Birgit ; Lehmann, Patrick ; Marins, Ed G. ; Michel-Treil, Véronique ; Simon, Christian O. ; Njoya, Merlin ; Cornberg, Markus ; Paxinos, Ellen ; Manns, Michael P. ; Vermehren, Johannes ; Sarrazin, Christoph ; Sohn, Ji Yeon ; Cho, Yunjung ; Wedemeyer, Heiner. / Commutability and concordance of four hepatitis B virus DNA assays in an international multicenter study. In: Therapeutic Advances in Gastroenterology. 2017 ; Vol. 10, No. 8. pp. 609-618.
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abstract = "Background HBV DNA is the most important molecular marker in hepatitis B, used to determine treatment indication and monitoring. Most patients require lifelong hepatitis B virus (HBV) management, thus viral load (VL) monitoring may be performed at different laboratories, with different HBV assays, which may result in different VL results. This multicenter study compares the commutability and concordance of results from four different HBV DNA assays: CAP/CTM HBVv2, HPS/CTM HBVv2 and the new cobas 6800/8800 HBV and cobas 4800 HBV assays. Methods Across all four assays, HBV limit of detection (LoD) and linearity at lower concentrations were assessed using panels traceable to the World Health Organization international standard, and concordance was investigated at the important medical decision cutoffs 2000 and 20,000 IU/ml, using specimens from HBV-positive patients. Results The calculated LoD via a probit curve was 2.7 IU/ml for cobas 6800/8800 HBV, 2.8 IU/ml for cobas 4800 HBV, 9.6 IU/ml for CAP/CTM HBVv2, and 6.2 IU/ml for HPS/CTM HBVv2. The average accuracy was comparable between cobas 6800/8800 HBV, cobas 4800 HBV and CAP/CTM HBVv2 (0.04-0.05 log10 IU/ml), while a slightly lower accuracy was documented for HPS/CTM HBVv2 (-0.16 log10 IU/ml). A total of 211-245 clinical samples were used for a pairwise comparison. Mean paired log differences ranged from -0.17 log10 IU/ml to -0.01 log10 IU/ml. Coefficient of determination was over 98{\%} for all pairs with high overall percent agreement at the 2000 and 20,000 IU/ml cutoffs (from 91.7{\%} to 96.3{\%}). In a subset of samples with VL±0.5 log10 to the 2000 and 20,000 IU/ml thresholds, concordance was still 72{\%} and 82{\%}, respectively. Conclusions The new cobas 6800/8800 HBV and 4800 HBV assays show high accuracy in samples with low-level viremia and a high concordance with the established HBV tests, CAP/CTM HBVv2 and HPS/CTM HBVv2, at 2000 and 20,000 IU/ml. Thus, all four HBV assays have high commutability and may be used interchangeably in routine clinical practice.",
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T1 - Commutability and concordance of four hepatitis B virus DNA assays in an international multicenter study

AU - Maasoumy, Benjamin

AU - Bremer, Birgit

AU - Lehmann, Patrick

AU - Marins, Ed G.

AU - Michel-Treil, Véronique

AU - Simon, Christian O.

AU - Njoya, Merlin

AU - Cornberg, Markus

AU - Paxinos, Ellen

AU - Manns, Michael P.

AU - Vermehren, Johannes

AU - Sarrazin, Christoph

AU - Sohn, Ji Yeon

AU - Cho, Yunjung

AU - Wedemeyer, Heiner

PY - 2017/8/1

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N2 - Background HBV DNA is the most important molecular marker in hepatitis B, used to determine treatment indication and monitoring. Most patients require lifelong hepatitis B virus (HBV) management, thus viral load (VL) monitoring may be performed at different laboratories, with different HBV assays, which may result in different VL results. This multicenter study compares the commutability and concordance of results from four different HBV DNA assays: CAP/CTM HBVv2, HPS/CTM HBVv2 and the new cobas 6800/8800 HBV and cobas 4800 HBV assays. Methods Across all four assays, HBV limit of detection (LoD) and linearity at lower concentrations were assessed using panels traceable to the World Health Organization international standard, and concordance was investigated at the important medical decision cutoffs 2000 and 20,000 IU/ml, using specimens from HBV-positive patients. Results The calculated LoD via a probit curve was 2.7 IU/ml for cobas 6800/8800 HBV, 2.8 IU/ml for cobas 4800 HBV, 9.6 IU/ml for CAP/CTM HBVv2, and 6.2 IU/ml for HPS/CTM HBVv2. The average accuracy was comparable between cobas 6800/8800 HBV, cobas 4800 HBV and CAP/CTM HBVv2 (0.04-0.05 log10 IU/ml), while a slightly lower accuracy was documented for HPS/CTM HBVv2 (-0.16 log10 IU/ml). A total of 211-245 clinical samples were used for a pairwise comparison. Mean paired log differences ranged from -0.17 log10 IU/ml to -0.01 log10 IU/ml. Coefficient of determination was over 98% for all pairs with high overall percent agreement at the 2000 and 20,000 IU/ml cutoffs (from 91.7% to 96.3%). In a subset of samples with VL±0.5 log10 to the 2000 and 20,000 IU/ml thresholds, concordance was still 72% and 82%, respectively. Conclusions The new cobas 6800/8800 HBV and 4800 HBV assays show high accuracy in samples with low-level viremia and a high concordance with the established HBV tests, CAP/CTM HBVv2 and HPS/CTM HBVv2, at 2000 and 20,000 IU/ml. Thus, all four HBV assays have high commutability and may be used interchangeably in routine clinical practice.

AB - Background HBV DNA is the most important molecular marker in hepatitis B, used to determine treatment indication and monitoring. Most patients require lifelong hepatitis B virus (HBV) management, thus viral load (VL) monitoring may be performed at different laboratories, with different HBV assays, which may result in different VL results. This multicenter study compares the commutability and concordance of results from four different HBV DNA assays: CAP/CTM HBVv2, HPS/CTM HBVv2 and the new cobas 6800/8800 HBV and cobas 4800 HBV assays. Methods Across all four assays, HBV limit of detection (LoD) and linearity at lower concentrations were assessed using panels traceable to the World Health Organization international standard, and concordance was investigated at the important medical decision cutoffs 2000 and 20,000 IU/ml, using specimens from HBV-positive patients. Results The calculated LoD via a probit curve was 2.7 IU/ml for cobas 6800/8800 HBV, 2.8 IU/ml for cobas 4800 HBV, 9.6 IU/ml for CAP/CTM HBVv2, and 6.2 IU/ml for HPS/CTM HBVv2. The average accuracy was comparable between cobas 6800/8800 HBV, cobas 4800 HBV and CAP/CTM HBVv2 (0.04-0.05 log10 IU/ml), while a slightly lower accuracy was documented for HPS/CTM HBVv2 (-0.16 log10 IU/ml). A total of 211-245 clinical samples were used for a pairwise comparison. Mean paired log differences ranged from -0.17 log10 IU/ml to -0.01 log10 IU/ml. Coefficient of determination was over 98% for all pairs with high overall percent agreement at the 2000 and 20,000 IU/ml cutoffs (from 91.7% to 96.3%). In a subset of samples with VL±0.5 log10 to the 2000 and 20,000 IU/ml thresholds, concordance was still 72% and 82%, respectively. Conclusions The new cobas 6800/8800 HBV and 4800 HBV assays show high accuracy in samples with low-level viremia and a high concordance with the established HBV tests, CAP/CTM HBVv2 and HPS/CTM HBVv2, at 2000 and 20,000 IU/ml. Thus, all four HBV assays have high commutability and may be used interchangeably in routine clinical practice.

KW - cobas

KW - HBV diagnostics

KW - HBV DNA assay

KW - HBV treatment

KW - hepatitis B virus

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