Anti-HDV reflex testing in HBsAg-positive subjects: An efficacious strategy to identify HDV infection

Liver Int. 2024 Jan;44(1):148-154. doi: 10.1111/liv.15746. Epub 2023 Oct 3.

Abstract

Background and aims: The prevalence of HDV infection in HBsAg carriers is about 9.9% in Italy. However, the real prevalence is underestimated because the anti-HDV test is not performed routinely in all HBsAg carriers. The aim of this study was to compare the prevalence and the absolute number of HDV infection identified in HBsAg-positive subjects tested at University Hospital Federico II before and after the introduction of anti-HDV reflex testing.

Methods: From January to December 2022, reflex test for the detection of total HDV antibodies was performed in all HBsAg-positive subjects tested at University Hospital Federico II. The control group consisted of all the HBsAg-positive subjects tested at the same laboratory in 2019, before the implementation of anti-HDV reflex testing. Sera were evaluated with ADVIA Centaur HBsAgII Qualitative, Liaison Murex HBsAg Quantitative and Liaison Murex Total Anti-HDV Qualitative.

Results: Before reflex testing, anti-HDV had been tested in 16.4% (84/512) of HBsAg-positive subjects, while after its implementation, 100% (484/484) of HBsAg-positive patients was tested for anti-HDV. The anti-HDV positive prevalence was lower than before the introduction of reflex test (10.7% vs. 16.6%) but the absolute number of anti-HDV positive patients increased (14 vs. 52 subjects). HDV-RNA was detectable in 26 (53%) of 49 tested subjects.

Conclusions: Our data showed that the implementation of anti-HDV reflex testing increased the diagnoses of HDV infection. In this setting, due to the approval of specific anti-HDV drugs, a reflex test for anti-HDV should be implemented to early identify patients with HBV/HDV infection.

Keywords: HBV; HDV screening; anti-HDV reflex testing; epidemiology.

MeSH terms

  • Hepatitis Antibodies*
  • Hepatitis B Surface Antigens*
  • Hepatitis Delta Virus / genetics
  • Humans
  • Italy / epidemiology
  • Mass Screening
  • Prevalence
  • Reflex

Substances

  • Hepatitis Antibodies
  • Hepatitis B Surface Antigens