@article{fdi:010093456,
  title = {{H}epatitis {B} core-related antigen rapid diagnostic test for point-of-care identification of women at high risk of hepatitis {B} vertical transmission : a multicountry diagnostic accuracy study},
  author = {{V}incent, {J}eanne {P}erp{\'e}tue and {S}{\'e}g{\'e}ral, {O}. and {K}ania, {D}. and {B}orand, {L}. and {A}doukara, {J}. {P}. and {P}ivert, {A}. and {K}on{\'e}, {A}. and {T}iendrebeogo, {A}. {S}. {E}. and {T}all, {H}. and {S}chaeffer, {L}. and {V}ray, {M}. and {S}anou, {A}. {M}. and {N}jouom, {R}. and {C}loherty, {G}. and {H}ashimoto, {N}. and {M}iura, {T}. and {S}ugiura, {W}. and {S}ovann, {S}. and {Y}ang, {J}. {S}. and {D}elvallez, {G}. and {L}unel-{F}abiani, {F}. and {T}anaka, {Y}. and {S}himakawa, {Y}.},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground {T}imely administration of the hepatitis {B} virus ({HBV}) birth dose vaccine, along with identifying high-risk pregnant individuals for antiviral prophylaxis, is essential for the global elimination of vertical transmission of {HBV}. {H}owever, in resource-limited settings, access to {HBV} {DNA} testing is scarce, and accurate rapid tests for {HB}e{A}g are lacking. {W}e aimed to assess the diagnostic performance of a newly developed hepatitis {B} core-related antigen ({HB}cr{A}g) rapid diagnostic test ({RDT}) to identify women who are {HB}s{A}g-positive and eligible for antiviral prophylaxis. {M}ethods {I}n this multicountry diagnostic accuracy study, we retrospectively validated the {HB}cr{A}g-{RDT} using stored plasma from pregnant women who were {HB}s{A}g-positive in cohort studies from {C}ambodia and {C}ameroon and prospectively using finger-prick capillary blood from postpartum mothers at rural health centres in {B}urkina {F}aso. {W}e estimated the sensitivity and specificity of the {HB}cr{A}g-{RDT} for diagnosing high {HBV} {DNA} concentrations (>= 200 000 {IU}/m{L}) using real-time {PCR} (rt{PCR}) as the reference. {W}e compared the diagnostic performance of the {HB}cr{A}g-{RDT} with that of conventional {HB}e{A}g assays based on the area under the receiver operating characteristic curve ({AUROC}). {F}indings {I}n total, plasma samples were available for 1964 participants: 1194 stored plasma samples available for analysis from the {C}ambodian cohort, 501 stored samples from the {C}ameroonian cohort, and 269 prospectively collected samples from women in the {B}urkina {F}aso cohort. {I}n the pooled population, the mean age was 28<middle dot>1 years ({SD} 6<middle dot>0), and 382 (20<middle dot>0%) were {HB}e{A}g positive. {T}he {HB}cr{A}g-{RDT} showed an overall sensitivity of 93<middle dot>1% (95% {CI} 90<middle dot>5-95<middle dot>2) and specificity of 94<middle dot>3% (93<middle dot>0-95<middle dot>4). {S}ensitivity and specificity were 93<middle dot>4% (90<middle dot>7-95<middle dot>5) and 94<middle dot>4% (92<middle dot>9-95<middle dot>6) in the retrospective laboratory-based analyses of samples from {C}ambodia and {C}ameroon, and 89<middle dot>7% (75<middle dot>8-97<middle dot>1) and 93<middle dot>9% (90<middle dot>0-96<middle dot>6) in the prospective real-world analysis of samples of {HB}s{A}g-positive women from {B}urkina {F}aso. {T}he {AUROC} for {HB}cr{A}g-{RDT} (0<middle dot>937 [95% {CI} 0<middle dot>924-0<middle dot>950]) in distinguishing high versus low {HBV} {DNA} concentrations at the 200 000 {IU}/m{L} threshold in the pooled data set was significantly higher than that of {HB}e{A}g rapid tests (0<middle dot>822 [0<middle dot>798-0<middle dot>845]; p<0<middle dot>0001) and similar to laboratory-based {HB}e{A}g immunoassays ({ELISA} and chemiluminescence assay; 0<middle dot>926 [0<middle dot>897-0<middle dot>955]; p=0<middle dot>72). {I}n {B}urkina {F}aso, the median turnaround time for {HBV} {DNA} testing was 46 days ({IQR} 31-72), whereas {HB}cr{A}g-{RDT} provided same-day results for all participants. {I}nterpretation {HB}cr{A}g-{RDT} might offer a practical solution for integrating the prevention of vertical transmission of {HBV} into decentralised antenatal care in resource-limited settings, enabling timely identification and management of pregnant individuals who are at high risk of transmission.},
  keywords = {{CAMBODGE} ; {CAMEROUN} ; {BURKINA} {FASO}},
  booktitle = {},
  journal = {{L}ancet {G}astroenterology and {H}epatology},
  volume = {10},
  numero = {5},
  pages = {452--461},
  year = {2025},
  DOI = {10.1016/s2468-1253(25)00015-9},
  URL = {https://www.documentation.ird.fr/hor/fdi:010093456},
}