Development and performance of prototype serologic and molecular tests for hepatitis delta infection

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...

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Autores principales:	Kelly E. Coller, Emily K. Butler, Ka-Cheung Luk, Mary A. Rodgers, Michael Cassidy, Jeffrey Gersch, Anne L. McNamara, Mary C. Kuhns, George J. Dawson, Lazare Kaptue, Birgit Bremer, Heiner Wedemeyer, Gavin A. Cloherty
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2018
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/cecdf5f3f90443218de37d948b89f5d9
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spelling	oai:doaj.org-article:cecdf5f3f90443218de37d948b89f5d92021-12-02T15:07:52ZDevelopment and performance of prototype serologic and molecular tests for hepatitis delta infection10.1038/s41598-018-20455-52045-2322https://doaj.org/article/cecdf5f3f90443218de37d948b89f5d92018-02-01T00:00:00Zhttps://doi.org/10.1038/s41598-018-20455-5https://doaj.org/toc/2045-2322Abstract 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.Kelly E. CollerEmily K. ButlerKa-Cheung LukMary A. RodgersMichael CassidyJeffrey GerschAnne L. McNamaraMary C. KuhnsGeorge J. DawsonLazare KaptueBirgit BremerHeiner WedemeyerGavin A. ClohertyNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 8, Iss 1, Pp 1-11 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Kelly E. Coller Emily K. Butler Ka-Cheung Luk Mary A. Rodgers Michael Cassidy Jeffrey Gersch Anne L. McNamara Mary C. Kuhns George J. Dawson Lazare Kaptue Birgit Bremer Heiner Wedemeyer Gavin A. Cloherty Development and performance of prototype serologic and molecular tests for hepatitis delta infection
description	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.
format	article
author	Kelly E. Coller Emily K. Butler Ka-Cheung Luk Mary A. Rodgers Michael Cassidy Jeffrey Gersch Anne L. McNamara Mary C. Kuhns George J. Dawson Lazare Kaptue Birgit Bremer Heiner Wedemeyer Gavin A. Cloherty
author_facet	Kelly E. Coller Emily K. Butler Ka-Cheung Luk Mary A. Rodgers Michael Cassidy Jeffrey Gersch Anne L. McNamara Mary C. Kuhns George J. Dawson Lazare Kaptue Birgit Bremer Heiner Wedemeyer Gavin A. Cloherty
author_sort	Kelly E. Coller
title	Development and performance of prototype serologic and molecular tests for hepatitis delta infection
title_short	Development and performance of prototype serologic and molecular tests for hepatitis delta infection
title_full	Development and performance of prototype serologic and molecular tests for hepatitis delta infection
title_fullStr	Development and performance of prototype serologic and molecular tests for hepatitis delta infection
title_full_unstemmed	Development and performance of prototype serologic and molecular tests for hepatitis delta infection
title_sort	development and performance of prototype serologic and molecular tests for hepatitis delta infection
publisher	Nature Portfolio
publishDate	2018
url	https://doaj.org/article/cecdf5f3f90443218de37d948b89f5d9
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Development and performance of prototype serologic and molecular tests for hepatitis delta infection

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