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

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...

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Autores principales: Coller, Kelly E., Butler, Emily K., Luk, Ka-Cheung, Rodgers, Mary A., Cassidy, Michael, Gersch, Jeffrey, McNamara, Anne L., Kuhns, Mary C., Dawson, George J., Kaptue, Lazare, Bremer, Birgit, Wedemeyer, Heiner, Cloherty, Gavin A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5794785/
https://www.ncbi.nlm.nih.gov/pubmed/29391553
http://dx.doi.org/10.1038/s41598-018-20455-5
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author Coller, Kelly E.
Butler, Emily K.
Luk, Ka-Cheung
Rodgers, Mary A.
Cassidy, Michael
Gersch, Jeffrey
McNamara, Anne L.
Kuhns, Mary C.
Dawson, George J.
Kaptue, Lazare
Bremer, Birgit
Wedemeyer, Heiner
Cloherty, Gavin A.
author_facet Coller, Kelly E.
Butler, Emily K.
Luk, Ka-Cheung
Rodgers, Mary A.
Cassidy, Michael
Gersch, Jeffrey
McNamara, Anne L.
Kuhns, Mary C.
Dawson, George J.
Kaptue, Lazare
Bremer, Birgit
Wedemeyer, Heiner
Cloherty, Gavin A.
author_sort Coller, Kelly E.
collection PubMed
description 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.
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spelling pubmed-57947852018-02-12 Development and performance of prototype serologic and molecular tests for hepatitis delta infection Coller, Kelly E. Butler, Emily K. Luk, Ka-Cheung Rodgers, Mary A. Cassidy, Michael Gersch, Jeffrey McNamara, Anne L. Kuhns, Mary C. Dawson, George J. Kaptue, Lazare Bremer, Birgit Wedemeyer, Heiner Cloherty, Gavin A. Sci Rep Article 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. Nature Publishing Group UK 2018-02-01 /pmc/articles/PMC5794785/ /pubmed/29391553 http://dx.doi.org/10.1038/s41598-018-20455-5 Text en © The Author(s) 2018 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Article
Coller, Kelly E.
Butler, Emily K.
Luk, Ka-Cheung
Rodgers, Mary A.
Cassidy, Michael
Gersch, Jeffrey
McNamara, Anne L.
Kuhns, Mary C.
Dawson, George J.
Kaptue, Lazare
Bremer, Birgit
Wedemeyer, Heiner
Cloherty, Gavin A.
Development and performance of prototype serologic and molecular tests for hepatitis delta infection
title 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_short 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5794785/
https://www.ncbi.nlm.nih.gov/pubmed/29391553
http://dx.doi.org/10.1038/s41598-018-20455-5
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