Kania D. auteur aut IRD Nouhin J. auteur aut IRD Bolloré K. auteur aut IRD Njouom R. auteur aut IRD Toni T. D. auteur aut IRD Maiga A. I. auteur aut IRD Kane C. T. auteur aut IRD Ngo-Giang-Huong Nicole auteur aut IRD Dagnra A. auteur aut IRD Le D. H. C. auteur aut IRD Lunel-Fabiani F. auteur aut IRD Castera-Guy J. auteur aut IRD Rubbo P. A. auteur aut IRD Pisoni A. auteur aut IRD Plantier J. C. auteur aut IRD Tuaillon E. auteur aut IRD text journalArticle eng Objectives: Widespread testing and treatment are essential to eliminate hepatitis B virus (HBV) infection as a public health concern. However, in resource-limited countries, access to HBV PCR is limited. In this study, we developed a quantitative HBV PCR assay on open molecular platforms and evaluate its performance in diagnosing clinically signi ficant HBV DNA thresholds as de fined by the WHO (2000 IU/mL, 20 000 IU/mL, and 200 000 IU/mL). Methods: We implemented our HBV PCR test in seven African and Asian countries and France, using either an in-house laboratory method or a European conformity for in vitro diagnostic (CE-IVD) marked version of the PCR (Generic HBV Charge Virale, Biocentric). Results were compared with reference tests (Roche Cobas AmpliPrep/Cobas TaqMan and Abbott RealTime on Abbott m2000). Results: There was a good agreement between the HBV DNA results of 1015 samples tested by the PCR open polyvalent platforms and the results from reference tests (mean difference (bias +/- standard deviation [SD]):-0.3 +/- 0.7 log 10 IU/mL and-0.2 +/- 0.9 log 10 IU/mL when compared with Roche and Abbott tests, respectively). Kappa-Cohen agreements between the HBV PCR on open polyvalent platforms and the Roche/Abbott assays appeared almost perfect for HBV DNA levels ranged from >20 000 to 200 000 IU/mL and >200 000 IU/mL, substantial and moderate for HBV DNA levels ranged from 2000 to 20 000 IU/mL when compared with Abbott and Roche, respectively. The assay's performance was consistent across genotypes A, B, C, D, and E. Discussion: This field evaluation showed that our HBV PCR test is a valuable alternative to proprietary PCR systems. PCR assays on open platforms contribute to expanding clinical laboratory solutions diagnosing individuals who meet the viral load criteria for antiviral therapy ( >20 000 IU/mL) mother-to-child prophylaxis ( >200 000 IU/mL). Dramane Kania, Clin Microbiol Infect 2024;30:1067 (c) 2024 Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases. specialized Africa Asia Genotypes Hepatitis B virus PCR AFRIQUE ASIE 052 050 30 8 1067-1073 2024 1198-743X https://www.documentation.ird.fr/hor/PAR00028046 10.1016/j.cmi.2024.05.002 1198-743X https://www.documentation.ird.fr/hor/PAR00028046 IRD - Base Horizon / Pleins textes 2024-09-27 2025-11-06 PAR00028046 fre