Nationwide Implementation of Double Reflex Testing for Hepatitis Delta in Spain: Results From the Retrospective Phase of the Spain‐DDR Study

ABSTRACT Background: Hepatitis delta virus accelerates liver disease progression in chronic hepatitis B, yet remains underdiagnosed. Guidelines recommend double reflex diagnostic testing with antibody testing followed by viral load testing, but uptake remains inconsistent. Aims: To evaluate double r...

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Detalles Bibliográficos
Autores: Alberola, Ana, de Salazar, Adolfo, Fuentes, Ana, Carracedo, Raquel, Illescas‐López, Marta, Rodríguez Baños, María del Carmen, Freyre, Carolina, Becerril, Berta, Viciana, Isabel, López‐Rodríguez, Inmaculada, Montiel, Natalia, Domínguez Castaño, Ana María, Luzón‐García, María Pilar, Ramírez Arellano, Encarnación, Liébana‐Martos, Carmen, Franco Álvarez de Luna, Francisco, Lozano, María del Carmen, Palop, Begoña, Sampedro, Antonio, Pérez, Ana Belén, Algarate, Sonia, Rojo Alba, Susana, Fraile-Ribot, Pablo, Ocete, Dolores, Alcaraz, María Jesús, Rodríguez, Juan Carlos, Hernández‐Felices, Francisco Javier, Martínez, Olalla, Domínguez, Victoria, Orta, Nieves, Gómez, Dolores, Cortell, Carmen, Camacho, Jorge, Sabater, Susana, Iglesias Sánchez, Luis Ángel, Martín, Yasmina, Vallejo, Aldara, Molina, Lourdes, Aroca, María, Castro, Beatriz, Lara, Magdalena, Pena, María José, Rodríguez‐Fernández, Ana, González Praetorius, Alejandro, Blas, José Joaquín, Beteta, Alicia, Gómez, César, Rodríguez, María José, Illescas, Soledad, Abreu, Melanie, García Díez, Julio, Beltrán, Inocencio, Sandoval Torrientes, Marta, Sáez, Ruth, Martín, Teresa, Tajada Alegre, Pilar, Lorenzo, Belén, García Valero, María Teresa, Jiménez Sansegundo, Isabel, García‐de Cruz, Susana, Garcinuño, Sonsoles, Sáiz, Miguel Ángel, Muñoz, Santiago, Fernández, Isabel, Lorenzo Juanes, Helena Miriam, Vidal‐Acuña, María Reyes, Moldes, Luz María, Calvo, Noelia, Trigo, Matilde, Gude, María José, Ordóñez, Patricia, Cortizo, Sandra, Blasco, Miriam, Sigcha, Mayra, Falces, Iker, Galán, Juan Carlos, Arribi, Ana, Alonso, Roberto, Iborra, Asunción, del Amor Espín, María Jesús, Cascales, Eva, Pérez, Cayetano, Fernández, Pablo, Navarro, María Dolores, Nuñez, María Luz, Galán Ros, Jorge, Gil‐Gallardo, Luis Javier, Miqueleiz, Ana, Reina, Gabriel, Elorduy, Luis, Macho, Mikele, Gómez, Carmen, Liendo, Paloma, Salicio, Yolanda, Aguilera, Antonio, García, Federico
Tipo de recurso: artículo
Fecha de publicación:2026
País:España
Institución:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositorio:Docusalut
Idioma:inglés
OAI Identifier:oai:docusalut.com:20.500.13003/26637
Acceso en línea:https://hdl.handle.net/20.500.13003/26637
Access Level:acceso abierto
Palabra clave:HDV‐RNA
anti‐HDV
hepatitis delta virus
prevalence
reflex diagnostic
Descripción
Sumario:ABSTRACT Background: Hepatitis delta virus accelerates liver disease progression in chronic hepatitis B, yet remains underdiagnosed. Guidelines recommend double reflex diagnostic testing with antibody testing followed by viral load testing, but uptake remains inconsistent. Aims: To evaluate double reflex diagnostic implementation in Spain during the retrospective phase of the Spain Double Reflex Diagnostic study. Methods: Nationwide, multicenter retrospective analysis of individuals positive for hepatitis B surface antigen (2022–2024) from 80 centers. Laboratory data included hepatitis B surface antigen, hepatitis delta virus antibody and hepatitis delta virus viral load. Uptake rates, hepatitis delta virus antibody positivity, viral load confirmation and viral load‐confirmed prevalence were calculated with 95% confidence intervals. Results Among 65,763 individuals positive for hepatitis B surface antigen, hepatitis delta virus antibody testing uptake increased from 55.1% (54.4–55.8) in 2022 ( n  = 18,986) to 72.5% (71.9–73.1) in 2023 ( n  = 22,463) and 85.8% (85.1–86.4) in 2024 ( n  = 24,314; p  < 0.0001). Antibody positivity remained stable (5.6%, 4.9%, 5.3%). Viral load confirmation among antibody‐positive patients improved from 72.6% in 2022 to 90.8% in 2023 and 91.0% in 2024. Viral load‐confirmed prevalence among antibody‐positive individuals was 40.3% in 2022, 31.6% in 2023, and 30.1% in 2024. Regional heterogeneity was marked, with several autonomous communities achieving near‐universal uptake (> 95%). Conclusion: Between 2022 and 2024, double reflex diagnostic implementation expanded rapidly, demonstrating national feasibility and describing hepatitis D virus seroprevalence. However, regional inequities persist. Sustained uptake will require standardised reflex protocols, harmonization of viral load assays and continuous training to reduce underdiagnosis and improve care of coinfected patients.

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