Herta Toni, Joachim-Richter Anna, Petroff David, Wölk Benno, Wolffram Ingmar, Berg Thomas, Kramer Jan, Bätz Olaf, Wiegand Johannes
Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, Leipzig, Germany.
Department of Hepatology and Gastroenterology, Campus Virchow-Klinikum and Campus Charité Mitte, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Aliment Pharmacol Ther. 2025 Feb;61(4):651-657. doi: 10.1111/apt.18424. Epub 2024 Dec 4.
Despite European guidelines recommending anti-hepatitis D virus (HDV) screening for all hepatitis B surface antigen (HBsAg)-positive cases, screening rates remain insufficient.
We analysed anti-HDV screening rates in primary care and implemented prospective HDV screening in HBsAg-positive cases identified in the preventive medical examination from the age of 35 ("Check-Up 35+").
From 2012 to 2021, we reviewed anti-HDV and HDV RNA test rates in HBsAg-positive patients at 11 sites of a large German laboratory group. From 2022 to 2023, we prospectively screened HBsAg-positive samples from the "Check-Up 35+" for anti-HDV. Anti-HDV positive patients were then contacted again for HDV RNA testing.
Retrospectively, 2792/13,905 (20%) HBsAg-positive cases were tested for anti-HDV, with 142/2792 (5.1%) being positive. HDV RNA was tested in 57/142 (40%) anti-HDV-positive cases, with 26/57 (46%) being positive. In the prospective screening, 1159/225,901 (0.51%) individuals were HBsAg-positive. Of these, 700 (60%) were tested for anti-HDV, with 18/700 (2.6%) positive test results. 4/18 (22%) were successfully contacted again for HDV RNA analysis, with one case testing positive. Neither the HBsAg nor the anti-HDV positive result was known prior to screening in these cases. Anti-HDV testing could not be performed in 459/1159 (40%) HBsAg-positive cases, primarily due to insufficient blood sample volume (310/459 cases, 68%), with others missed due to logistical errors.
Retrospective data show insufficient anti-HDV screening in clinical routine. The prospective anti-HDV screening provides a blueprint for using existing hepatitis B virus screening programms for population-based HDV double reflex testing, provided that adequate logistical prerequisites are established.
German Clinical Trial Register: DRKS00029180.
尽管欧洲指南建议对所有乙肝表面抗原（HBsAg）阳性病例进行丁型肝炎病毒（HDV）筛查，但筛查率仍然不足。
我们分析了初级保健中的抗HDV筛查率，并对35岁及以上预防性体检中发现的HBsAg阳性病例实施前瞻性HDV筛查（“35岁以上体检”）。
2012年至2021年，我们回顾了德国一个大型实验室集团11个地点HBsAg阳性患者的抗HDV和HDV RNA检测率。2022年至2023年，我们对“35岁以上体检”中的HBsAg阳性样本进行前瞻性抗HDV筛查。然后再次联系抗HDV阳性患者进行HDV RNA检测。
回顾性分析显示，2792/13905（20%）例HBsAg阳性病例进行了抗HDV检测，其中142/2792（5.1%）例呈阳性。57/142（40%）例抗HDV阳性病例进行了HDV RNA检测，其中26/57（46%）例呈阳性。在前瞻性筛查中，1159/225901（0.51%）例个体HBsAg阳性。其中，700例（60%）进行了抗HDV检测，18/700（2.6%）检测结果呈阳性。4/18（22%）例成功再次联系进行HDV RNA分析，1例检测呈阳性。在这些病例中，筛查前均不知道HBsAg和抗HDV阳性结果。459/1159（40%）例HBsAg阳性病例无法进行抗HDV检测，主要原因是血样量不足（310/459例，68%），其他因后勤错误遗漏。
回顾性数据显示临床常规中抗HDV筛查不足。前瞻性抗HDV筛查为利用现有的乙肝病毒筛查项目进行基于人群的HDV双重反射检测提供了蓝图，前提是建立了足够的后勤条件。
德国临床试验注册中心：DRKS00029180。
