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Sökning: WFRF:(Glenn Jeffrey) > (2020-2024) > HDV RNA Assays :

HDV RNA Assays : Performance characteristics, clinical utility and challenges

Wedemeyer, Heiner (författare)
Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, Hannover, Germany;Excellence Cluster RESIST, Hannover Medical School, Hannover, Germany;D-SOLVE: EU-funded Network on individualized management of hepatitis D;German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Braunschweig, Germany
Leus, Mitchell (författare)
Forum for Collaborative Research, University of California Berkeley, Washington, DC, USA
Battersby, Thomas R. (författare)
Gilead Sciences, Inc., Foster City, CA, USA
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Glenn, Jeffrey (författare)
Departments of Medicine (Division of Gastroenterology and Hepatology) and Microbiology & Immunology, Stanford University School of Medicine, Stanford, CA, USA
Gordien, Emmanuel (författare)
Centre National de Référence pour les virus des hépatites B, C et Delta, Laboratoire de microbiologie clinique, Hôpital Avicenne Assistance Publique – Hôpitaux de Paris, Bobigny, France
Kamili, Saleem (författare)
Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, GA, USA
Kapoor, Hema (författare)
Ex Quest Diagnostics, Secaucus, NJ, USA and currently affiliated HK Healthcare Consultant LLC
Kessler, Harald H. (författare)
Diagnostic and Research Center for Molecular Biomedicine, Medical University of Graz, Graz, Austria
Lenz, Oliver (författare)
Janssen Pharmaceutica NV, Beerse, Belgium
Lütgehetmann, Marc (författare)
Institute for Mikrobiology, Virology and Hygiene, University Medical Center Hamburg Eppendorf (UKE), Hamburg, Germany;German Center for Infection Research (DZIF), Partner Site Hamburg, Lübeck, Kiel, Germany
Mixson-Hayden, Tonya (författare)
Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, GA, USA
Simon, Christian O. (författare)
Roche Diagnostics Solutions, Clinical Development and Medical Affairs, Rotkreuz, CH, Switzerland
Thomson, Michael (författare)
Division of Antivirals, US Food and Drug Administration, Silver Spring, MD, USA
Westman, Gabriel, 1977- (författare)
Uppsala universitet,Infektionsmedicin,Swedish Medical Products Agency, Uppsala, Sweden
Miller, Veronica (författare)
Forum for Collaborative Research, University of California Berkeley, Washington, DC, USA
Terrault, Norah (författare)
Keck School of Medicine, University of Southern California, Los Angeles, CA, USA
Lampertico, Pietro (författare)
Division of Gastroenterology and Hepatology, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy;CRC “A. M. and A. Migliavacca” Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy
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 (creator_code:org_t)
2023
2023
Engelska.
Ingår i: Hepatology. - : Wolters Kluwer. - 0270-9139 .- 1527-3350.
Relaterad länk:
https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
https://urn.kb.se/re...
https://doi.org/10.1...
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  • Forskningsöversikt (refereegranskat)
Abstract Ämnesord
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  • Coinfection with HBV and HDV results in hepatitis D, the most severe form of chronic viral hepatitis, frequently leading to liver decompensation and HCC. Pegylated interferon alpha, the only treatment option for chronic hepatitis D for many years, has limited efficacy. New treatments are in advanced clinical development, with one recent approval. Diagnosis and antiviral treatment response monitoring are based on detection and quantification of HDV RNA. However, the development of reliable HDV RNA assays is challenged by viral heterogeneity (at least 8 different genotypes and several subgenotypes), intrahost viral diversity, rapid viral evolution, and distinct secondary structure features of HDV RNA. Different RNA extraction methodologies, primer/probe design for nucleic acid tests, lack of automation, and overall dearth of standardization across testing laboratories contribute to substantial variability in performance characteristics of research-based and commercial HDV RNA assays. A World Health Organization (WHO) standard for HDV RNA, available for about 10 years, has been used by many laboratories to determine the limit of detection of their assays and facilitates comparisons of RNA levels across study centers. Here we review challenges for robust pan genotype HDV RNA quantification, discuss particular clinical needs and the importance of reliable HDV RNA quantification in the context of drug development and patient monitoring. We summarize distinct technical features and performance characteristics of available HDV RNA assays. Finally, we provide considerations for the use of HDV RNA assays in the context of drug development and patient monitoring.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Infectious Medicine (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Klinisk laboratoriemedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Clinical Laboratory Medicine (hsv//eng)

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