%0 Journal Article
%9 ACL : Articles dans des revues avec comité de lecture répertoriées par l'AERES
%A Kania, D.
%A Nouhin, J.
%A Bolloré, K.
%A Njouom, R.
%A Toni, T. D.
%A Maiga, A. I.
%A Kane, C. T.
%A Ngo-Giang-Huong, Nicole
%A Dagnra, A.
%A Le, D. H. C.
%A Lunel-Fabiani, F.
%A Castera-Guy, J.
%A Rubbo, P. A.
%A Pisoni, A.
%A Plantier, J. C.
%A Tuaillon, E.
%T 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
%D 2024
%L PAR00028046
%G ENG
%J Clinical Microbiology and Infection
%@ 1198-743X
%K Africa ; Asia ; Genotypes ; Hepatitis B virus ; PCR
%K AFRIQUE ; ASIE
%M ISI:001272702600001
%N 8
%P 1067-1073
%R 10.1016/j.cmi.2024.05.002
%U https://www.documentation.ird.fr/hor/PAR00028046
%V 30
%W Horizon (IRD)
%X 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.
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