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