Development and performance of prototype serologic and molecular tests for hepatitis delta infection
Open Access
- 1 February 2018
- journal article
- research article
- Published by Springer Science and Business Media LLC in Scientific Reports
- Vol. 8 (1), 1-11
- https://doi.org/10.1038/s41598-018-20455-5
Abstract
Worldwide, an estimated 5% of hepatitis B virus (HBV) infected people are coinfected with hepatitis delta virus (HDV). HDV infection leads to increased mortality over HBV mono-infection, yet HDV diagnostics are not widely available. Prototype molecular (RNA) and serologic (IgG) assays were developed for high-throughput testing on the Abbott m2000 and ARCHITECT systems, respectively. RNA detection was achieved through amplification of a ribozyme region target, with a limit of detection of 5 IU/ml. The prototype serology assay (IgG) was developed using peptides derived from HDV large antigen (HDAg), and linear epitopes were further identified by peptide scan. Specificity of an HBV negative population was 100% for both assays. A panel of 145 HBsAg positive samples from Cameroon with unknown HDV status was tested using both assays: 16 (11.0%) had detectable HDV RNA, and 23 (15.7%) were sero-positive including the 16 HDV RNA positive samples. Additionally, an archival serial bleed panel from an HDV superinfected chimpanzee was tested with both prototypes; data was consistent with historic testing data using a commercial total anti-Delta test. Overall, the two prototype assays provide sensitive and specific methods for HDV detection using high throughput automated platforms, allowing opportunity for improved diagnosis of HDV infected patients.This publication has 36 references indexed in Scilit:
- One-step real-time PCR assay for detection and quantitation of hepatitis D virus RNAJournal of Virological Methods, 2013
- Hepatitis delta virusThe Lancet, 2011
- Establishment of a Novel Quantitative Hepatitis D Virus (HDV) RNA Assay Using the Cobas TaqMan Platform To Study HDV RNA KineticsJournal of Clinical Microbiology, 2010
- Hepatitis D virus infection—Not a vanishing disease in Europe!Hepatology, 2007
- Genotypes and Viremia of Hepatitis B and D Viruses Are Associated With Outcomes of Chronic Hepatitis D PatientsGastroenterology, 2006
- Quantification of Hepatitis Delta Virus RNA in Serum by Consensus Real-Time PCR Indicates Different Patterns of Virological Response to Interferon Therapy in Chronically Infected PatientsJournal of Clinical Microbiology, 2005
- Molecular Phylogenetic Analyses Indicate a Wide and Ancient Radiation of African Hepatitis Delta Virus, Suggesting a Deltavirus Genus of at Least Seven Major CladesJournal of Virology, 2004
- Influence of hepatitis delta virus infection on morbidity and mortality in compensated cirrhosis type BGut, 2000
- Hepatitis delta virus as a global health problemVaccine, 1990
- Transmission of Hepatitis B Virus Infection by Transfusion of Frozen-Deglycerolized Red Blood CellsThe New England Journal of Medicine, 1978