Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
Field performance and acceptability of the hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) for detecting high viral load among pregnant women in The Gambia (PROTECT-B).
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Famiglietti Alexandra M, Drammeh Sainabou, Vo-Quang Erwan, Dibba Bakary, Jammeh Kitabu, Jallow Abdoulie E, Touray Alhagie B, Keita Saikou, Gaye Yassin, Manneh Baboucarr, Sallah Yahya, Badjie Sheriff, Boyer Sylvie, Périères Lauren, Petitfour Laurène, Khan Saba, Guingané Alice N, Tiendrebeogo Abdoul, Kania Dramane, D'Alessandro Umberto, Tanaka Yasuhito, Lemoine Maud, Ndow Gibril, Shimakawa Yusuke
Аннотация
BACKGROUND: Mother-to-child transmission remains a major source of chronic hepatitis B virus (HBV) infection globally. Identifying pregnant women eligible for antiviral prophylaxis requires HBV DNA testing, which is often inaccessible in resource-limited settings. The hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) may offer a point-of-care alternative, yet prospective evaluation in antenatal care is lacking. We assessed its diagnostic performance, clinical impact, and user acceptability within an HIV/syphilis/HBV triple elimination program.
METHODS: In this multicenter prospective cross-sectional study, treatment-naïve, HBsAg-positive pregnant women were enrolled across four antenatal services in The Gambia. Diagnostic accuracy of the HBcrAg-RDT for detecting high viral load (≥200,000 IU/mL) was evaluated using plasma and capillary whole blood samples, with GeneXpert HBV viral load as the reference standard.
RESULTS: 5.5% of 343 HBsAg-positive pregnant women had high viral load. The HBcrAg-RDT demonstrated 89.5% (95%CI 66.9-98.7) sensitivity and 98.5% (95%CI 96.4-99.5) specificity with plasma, and 88.2% (95%CI 63.6-98.5) sensitivity and 98.7% (95%CI 96.6-99.6) specificity with capillary blood. At one site implementing universal tenofovir prophylaxis, 77 women started treatment, of whom only four had HBV DNA ≥200,000 IU/mL. An HBcrAg-RDT-guided strategy would have identified all eligible women (4/4) while reducing unnecessary treatment from 100% (73/73) to 4.1% (3/73). Users rated the test highly for ease of use, although incubation time modestly increased workload.
CONCLUSION: The HBcrAg-RDT accurately identified pregnant women requiring antiviral prophylaxis and was accepted by users. It represents a feasible, lower-cost alternative to HBV DNA testing and may reduce unnecessary tenofovir use compared with universal prophylaxis strategies.
METHODS: In this multicenter prospective cross-sectional study, treatment-naïve, HBsAg-positive pregnant women were enrolled across four antenatal services in The Gambia. Diagnostic accuracy of the HBcrAg-RDT for detecting high viral load (≥200,000 IU/mL) was evaluated using plasma and capillary whole blood samples, with GeneXpert HBV viral load as the reference standard.
RESULTS: 5.5% of 343 HBsAg-positive pregnant women had high viral load. The HBcrAg-RDT demonstrated 89.5% (95%CI 66.9-98.7) sensitivity and 98.5% (95%CI 96.4-99.5) specificity with plasma, and 88.2% (95%CI 63.6-98.5) sensitivity and 98.7% (95%CI 96.6-99.6) specificity with capillary blood. At one site implementing universal tenofovir prophylaxis, 77 women started treatment, of whom only four had HBV DNA ≥200,000 IU/mL. An HBcrAg-RDT-guided strategy would have identified all eligible women (4/4) while reducing unnecessary treatment from 100% (73/73) to 4.1% (3/73). Users rated the test highly for ease of use, although incubation time modestly increased workload.
CONCLUSION: The HBcrAg-RDT accurately identified pregnant women requiring antiviral prophylaxis and was accepted by users. It represents a feasible, lower-cost alternative to HBV DNA testing and may reduce unnecessary tenofovir use compared with universal prophylaxis strategies.