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Clinical evaluation of the Altostar HDV RT-PCR Kit 1.5.

Julia Carolin Eichholz1, Birgit Bremer1, Heiner Wedemeyer2

  • 1Department of Gastroenterology, Hepatology, Infectious Diseases, and Endocrinology, Hannover Medical School, Hannover, Germany.

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
|July 1, 2026
PubMed
Summary

The Altostar HDV RT-PCR Kit 1.5 accurately quantifies hepatitis D virus RNA, showing comparable results to the standard assay. This sensitive assay may detect more cases, and treatment response during bulevirtide therapy was unaffected by the kit used.

Keywords:
BulevirtideDiagnosisHDV RNA assayHepatitis DQuantification

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Area of Science:

  • Virology
  • Molecular Diagnostics
  • Hepatology

Background:

  • Accurate detection and quantification of hepatitis D virus (HDV) RNA are critical for managing chronic HDV infection.
  • Bulevirtide (BLV) is a therapeutic agent used in treating HDV infection.
  • Evaluating diagnostic kit performance in real-world clinical settings is essential.

Purpose of the Study:

  • To assess the diagnostic performance of the Altostar HDV RT-PCR Kit 1.5.
  • To compare the Altostar kit with a local standard assay (RoboGene HDV RNA Quantification Kit 2.0).
  • To evaluate the impact of BLV treatment on HDV RNA quantification using both assays.

Main Methods:

  • Analysis of plasma samples from 40 patients with chronic HDV infection.
  • Comparison of Altostar HDV RT-PCR Kit 1.5 with RoboGene HDV RNA Quantification Kit 2.0.
  • Quantification of HDV RNA in samples before and during BLV therapy.

Main Results:

  • A significant positive correlation was observed between HDV RNA levels quantified by both assays.
  • The Altostar 1.5 kit detected HDV RNA in all samples, while the RoboGene 2.0 kit missed two.
  • Virological response rates during BLV therapy were similar between the two assays, but Altostar 1.5 showed a higher proportion of undetectable samples at follow-up.

Conclusions:

  • The Altostar HDV RT-PCR Kit 1.5 demonstrates comparable performance to the local standard for HDV RNA quantification.
  • The Altostar kit's higher sensitivity may lead to detection of more samples, though potential false positives warrant consideration.
  • Assay choice did not influence the assessment of treatment response during bulevirtide therapy.