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<p>This study aims to evaluate the prevalence of undiagnosed hepatitis delta in southern Spain (Andalusia) and assess the effectiveness and cost-efficiency of implementing reflex testing for hepatitis D detection in HBsAg-positive patients. A multicenter ambispective study was conducted in 17 Andalusian hospitals. The retrospective phase (January 2018–June 2022) analyzed diagnostic processes for hepatitis delta in HBsAg-positive patients. The prospective phase (October 2022–March 2023) implemented reflex testing, performing anti-HDV serology on all HBsAg-positive patients without prior testing. HDV RNA testing followed for those who tested anti-HDV-positive. In the retrospective phase, out of 18,583 HBsAg-positive patients, anti-HDV tests were performed on 3,436 (18%), identifying 205 (6%) positive cases. HDV RNA was tested in 158 (77%) anti-HDV-positive patients, with 69 (44%) testing positive. In the prospective phase, out of 2,384 HBsAg-positive patients without prior anti-HDV testing, 2,293 (96%) were tested, identifying 109 (4.7%) positive cases. HDV RNA was analyzed in 97 (89%) anti-HDV-positive patients, with 30 (31%) testing positive. Reflex testing increased anti-HDV detection by 77%, resulting in a fourfold increase in detecting anti-HDV-positive patients and a threefold increase in detecting HDV RNA-positive patients, reducing undiagnosed HDV RNA-positive cases to 4% compared to 45% with clinical practice. Cost analysis indicated a saving of €265,954 with reflex testing. Reflex testing improves HDV detection, reduces costs, and simplifies diagnosis, making it an efficient strategy for managing chronic hepatitis D patients.</p>

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Double reflex testing improves the efficacy and cost effectiveness of hepatitis delta diagnosis in southern Spain

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月2日

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  • Ana Fuentes,
  • Matías Estévez-Escobar,
  • Adolfo De Salazar,
  • Elena Ruiz Escolano,
  • Natalia Montiel,
  • Manuel Macías,
  • Juan Carlos Alados,
  • Juan Cristóbal Aguilar,
  • Ana Belén Pérez,
  • Pilar Barrera Baena,
  • Teresa Cabezas,
  • Anny Camelo-Castillo,
  • Begoña Palop,
  • Rocío González Grande,
  • Isabel Viciana,
  • José M Pinazo Bandera,
  • Fernando Fernández Sánchez,
  • María del Carmen Lozano,
  • Álvaro Giráldez,
  • María del Carmen Domínguez,
  • Carlota Jimeno Maté,
  • Encarnación Ramírez Arellano,
  • Patricia Cordero,
  • Francisco Franco Álvarez De Luna,
  • Pilar del Pino,
  • Alberto De la Iglesia Salgado,
  • Domingo Pérez,
  • Antonio Sampedro,
  • Mª Ángeles López Garrido,
  • María Pilar Luzón-García,
  • Joaquín Salas-Coronas,
  • Carolina Roldán,
  • Fernando García,
  • Carolina Freyre,
  • Germán Santamaría Rodríguez,
  • José Miguel Rosales-Zabal,
  • Raquel Domínguez-Hernández,
  • Marta Casado,
  • Federico García

摘要

This study aims to evaluate the prevalence of undiagnosed hepatitis delta in southern Spain (Andalusia) and assess the effectiveness and cost-efficiency of implementing reflex testing for hepatitis D detection in HBsAg-positive patients. A multicenter ambispective study was conducted in 17 Andalusian hospitals. The retrospective phase (January 2018–June 2022) analyzed diagnostic processes for hepatitis delta in HBsAg-positive patients. The prospective phase (October 2022–March 2023) implemented reflex testing, performing anti-HDV serology on all HBsAg-positive patients without prior testing. HDV RNA testing followed for those who tested anti-HDV-positive. In the retrospective phase, out of 18,583 HBsAg-positive patients, anti-HDV tests were performed on 3,436 (18%), identifying 205 (6%) positive cases. HDV RNA was tested in 158 (77%) anti-HDV-positive patients, with 69 (44%) testing positive. In the prospective phase, out of 2,384 HBsAg-positive patients without prior anti-HDV testing, 2,293 (96%) were tested, identifying 109 (4.7%) positive cases. HDV RNA was analyzed in 97 (89%) anti-HDV-positive patients, with 30 (31%) testing positive. Reflex testing increased anti-HDV detection by 77%, resulting in a fourfold increase in detecting anti-HDV-positive patients and a threefold increase in detecting HDV RNA-positive patients, reducing undiagnosed HDV RNA-positive cases to 4% compared to 45% with clinical practice. Cost analysis indicated a saving of €265,954 with reflex testing. Reflex testing improves HDV detection, reduces costs, and simplifies diagnosis, making it an efficient strategy for managing chronic hepatitis D patients.