Development and field evaluation in African and Asian countries of an hepatitis B virus PCR on open polyvalent platforms to determine treatment eligibility : results from the "Agence Nationale de Recherche sur le Sida et les hepatites" 12327 study Kania, D. Nouhin, J. Bolloré, K. Njouom, R. Toni, T. D. Maiga, A. I. Kane, C. T. /Ngo-Giang-Huong, Nicole Dagnra, A. Le, D. H. C. Lunel-Fabiani, F. Castera-Guy, J. Rubbo, P. A. Pisoni, A. Plantier, J. C. Tuaillon, E. Africa Asia Genotypes Hepatitis B virus PCR 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. 2024 text https://www.documentation.ird.fr/hor/PAR00028046 PAR00028046 Kania D., Nouhin J., Bolloré K., Njouom R., Toni T. D., Maiga A. I., Kane C. T., Ngo-Giang-Huong Nicole, Dagnra A., Le D. H. C., Lunel-Fabiani F., Castera-Guy J., Rubbo P. A., Pisoni A., Plantier J. C., Tuaillon E.. Development and field evaluation in African and Asian countries of an hepatitis B virus PCR on open polyvalent platforms to determine treatment eligibility : results from the "Agence Nationale de Recherche sur le Sida et les hepatites" 12327 study. 2024, 30 (8), 1067-1073 EN AFRIQUE ASIE