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Comparative Study
. 2021 Mar 22:38:294.
doi: 10.11604/pamj.2021.38.294.24819. eCollection 2021.

Comparison of Amplix® hepatitis B virus and Roche COBAS AmpliPrep/COBAS Taqman hepatitis B virus assay in quantifying HBV DNA in plasma of chronic hepatitis B in Senegal

Gora Lô  1   2 , Anna Julienne Selbé Ndiaye  2 , Amina Sow  2 , Amina Fall  1 , Aissatou Sow  2 , Oumar Barry  1 , Ndèye Marième Diop  1 , Halimatou Diop Ndiaye  2   3 , Ndèye Coumba Touré Kâne  2   4 , Souleymane Mboup  2
Affiliations
Comparative Study

Comparison of Amplix® hepatitis B virus and Roche COBAS AmpliPrep/COBAS Taqman hepatitis B virus assay in quantifying HBV DNA in plasma of chronic hepatitis B in Senegal

Gora Lô et al. Pan Afr Med J. .

Abstract

Introduction: quantification of hepatitis B virus DNA, a key element in the management of chronic hepatitis B, allows a more direct and reliable measurement of viral replication and monitoring of the virological response to therapy. Polymerase chain reaction (PCR) platforms performing this quantification and adaptable to intermediate laboratories have been developed. Thus, this study was conducted to evaluate the on-site performance of the AMPLIX® hepatitis B virus (HBV) real-time PCR technique in comparison with the COBAS AmpliPrep™ technique.

Methods: performance of the AMPLIX® HBV real-time PCR technique was evaluated with repeatability and intermediate precision (reproducibility) determined. The comparison with COBAS Taqman was performed by testing, in parallel, 42 plasma samples. The statistical analysis using Meth Val® software was focused on correlation and concordance determination.

Results: AMPLIX® real-time PCR assay showed good reproducibility for the low (CV=6.65%) and high (CV=3.15%) control levels but also good repeatability for both the low (CV=2.12%) and high (CV=1.60%) concentration levels. Accuracy obtained in our study were less than acceptability limit fixed to 5%. Viral load measurements between Amplix and COBAS Taqman correlated strongly with a correlation coefficient of 0.97%. Concordance analysis gave an average of the differences of 0.54 log IU/L between the viral load measurements of the 2 techniques.

Conclusion: based on these results, the Amplix real-time PCR platform for the quantification of HBV DNA can be considered as a reliable system for the monitoring of chronic hepatitis B and also a system adapted to intermediate laboratories.

Keywords: Amplix®; Roche COBAS AmpliPrep/COBAS Taqman; deoxyribonucleic acid; hepatitis B virus.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
the Passing-Bablok equation
Figure 2
Figure 2
the mean difference (Amplix - CAP/CTM) in Bland-Altman plot
Figure 3
Figure 3
diagram of levey-jennings of concentration level 4 log10 IU/ml
Figure 4
Figure 4
diagram of levey-jennings of concentration level 7 log10 IU/ml
See this image and copyright information in PMC

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