Horizon 1 1 17 ACL : Articles dans des revues avec comité de lecture répertoriées par l'AERES Clinical Microbiology and Infection 1067-1073 Africa Asia Genotypes Hepatitis B virus PCR AFRIQUE ASIE 2024 PAR00028046 ENG Clinical Microbiology and Infection 1198-743X ISI:001272702600001 8 10.1016/j.cmi.2024.05.002 https://www.documentation.ird.fr/hor/PAR00028046 30 Horizon (IRD) 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. 052 ; 050 UR224 Burkina Faso / Côte d'ivoire / Cameroun / Cambodge / Mali / Sénégal / Togo / Thaïlande / Vietnam