New Book Chapter about RoboGene HDV RNA Quantification Kit

Clinical Evaluation of the RoboGene HDV RNA Quantification Kit

Hepatitis D is a life-threatening liver disease caused by the hepatitis D virus (HDV) that requires the Hepatitis B virus (HBV) for its replication. HDV-HBV co-infection is considered the most aggressive form of chronic viral hepatitis, characterized by rapid progression towards liver-related death and hepatocellular carcinoma.

HDV RNA quantification is a crucial tool to diagnose, treat, and manage HDV infections. A new book, co-published by Professor Mario Rizzetto, the original discoverer of HDV, comprises several new studies about HDV. One chapter in the book, written by AJ Roboscreen’s HDV experts and Prof. Heiner Wedemeyer (University Hospital Essen), describes the procedure of the CE-IVD-certified real-time PCR assay RoboGene HDV RNA Quantification Kit 2.0, and studies that have been performed according to the common technical specifications (CTS) for in vitro diagnostic medical devices (2002/364/EC).

Overall, three evaluation studies including a longitudinal perspective, a sampling of all eight known genotypes and the comparison to different in-house assays have been performed. In conclusion, the RoboGene Kit based on one-step real-time PCR exhibited high specificity, precision, and robustness independent of the real-time PCR platform. The RoboGene Kit is a reliable tool for clinical management of patients with chronic HDV infections that allows follow-up until clearance of the virus independent of the underlying genotype.

Read here:
Clinical evaluation of the RoboGene Kit for HDV RNA quantification. Ute Hofmann, Michael Dietzsch, Ingolf Lachmann, Heiner Wedemeyer; in: „Hepatitis D: Virology, management and methodology“, Mario Rizzetto and Antonina Smedile; 2019; Il Pensiero Scientifico Editore. Rom, Italien. ISBN: 978-88-490-0646-9