@article{PAR00028046,
  title = {{D}evelopment and field evaluation in {A}frican and {A}sian countries of an hepatitis {B} virus {PCR} on open polyvalent platforms to determine treatment eligibility : results from the "{A}gence {N}ationale de {R}echerche sur le {S}ida et les hepatites" 12327 study},
  author = {{K}ania, {D}. and {N}ouhin, {J}. and {B}ollor{\'e}, {K}. and {N}jouom, {R}. and {T}oni, {T}. {D}. and {M}aiga, {A}. {I}. and {K}ane, {C}. {T}. and {N}go-{G}iang-{H}uong, {N}icole and {D}agnra, {A}. and {L}e, {D}. {H}. {C}. and {L}unel-{F}abiani, {F}. and {C}astera-{G}uy, {J}. and {R}ubbo, {P}. {A}. and {P}isoni, {A}. and {P}lantier, {J}. {C}. and {T}uaillon, {E}.},
  editor = {},
  language = {{ENG}},
  abstract = {{O}bjectives: {W}idespread testing and treatment are essential to eliminate hepatitis {B} virus ({HBV}) infection as a public health concern. {H}owever, in resource-limited countries, access to {HBV} {PCR} is limited. {I}n 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}/m{L}, 20 000 {IU}/m{L}, and 200 000 {IU}/m{L}). {M}ethods: {W}e implemented our {HBV} {PCR} test in seven {A}frican and {A}sian countries and {F}rance, using either an in-house laboratory method or a {E}uropean conformity for in vitro diagnostic ({CE}-{IVD}) marked version of the {PCR} ({G}eneric {HBV} {C}harge {V}irale, {B}iocentric). {R}esults were compared with reference tests ({R}oche {C}obas {A}mpli{P}rep/{C}obas {T}aq{M}an and {A}bbott {R}eal{T}ime on {A}bbott m2000). {R}esults: {T}here 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}/m{L} and-0.2 +/- 0.9 log 10 {IU}/m{L} when compared with {R}oche and {A}bbott tests, respectively). {K}appa-{C}ohen agreements between the {HBV} {PCR} on open polyvalent platforms and the {R}oche/{A}bbott assays appeared almost perfect for {HBV} {DNA} levels ranged from >20 000 to 200 000 {IU}/m{L} and >200 000 {IU}/m{L}, substantial and moderate for {HBV} {DNA} levels ranged from 2000 to 20 000 {IU}/m{L} when compared with {A}bbott and {R}oche, respectively. {T}he assay's performance was consistent across genotypes {A}, {B}, {C}, {D}, and {E}. {D}iscussion: {T}his 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}/m{L}) mother-to-child prophylaxis ( >200 000 {IU}/m{L}). {D}ramane {K}ania, {C}lin {M}icrobiol {I}nfect 2024;30:1067 (c) 2024 {P}ublished by {E}lsevier {L}td on behalf of {E}uropean {S}ociety of {C}linical {M}icrobiology and {I}nfectious {D}iseases.},
  keywords = {{A}frica ; {A}sia ; {G}enotypes ; {H}epatitis {B} virus ; {PCR} ; {AFRIQUE} ; {ASIE}},
  booktitle = {},
  journal = {{C}linical {M}icrobiology and {I}nfection},
  volume = {30},
  numero = {8},
  pages = {1067--1073},
  ISSN = {1198-743{X}},
  year = {2024},
  DOI = {10.1016/j.cmi.2024.05.002},
  URL = {https://www.documentation.ird.fr/hor/{PAR}00028046},
}