Evidence map›Paper›PMID 28478117›Full record

ArticleJournal of immunological methods2017

Development of an oral fluid immunoassay to assess past and recent hepatitis E virus (HEV) infection.

Nora Pisanic, Atiqur Rahman, Samir K Saha, Alain B Labrique, Kenrad E Nelson, Douglas A Granger, Steve W Granger, Barbara Detrick, Christopher D Heaney

Open access · greenAbstract readComparative StudyValidation Study
In one paragraph

Article in Journal of immunological methods, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.9field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 21 citations in OpenAlex.

  1. Review
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  5. Evaluation of oral fluids for surveillance of foodborne and zoonotic pathogens in pig farms.Journal of veterinary diagnostic investigation : official publication of the American Association of Veterinary Laboratory Diagnosticians, Inc · 2021
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  12. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 2 countries.

Nora PisanicDepartment of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Atiqur RahmanDepartment of Microbiology, Dhaka Shishu (Children's) Hospital, Dhaka 1207, Bangladesh.
Samir K SahaDepartment of Microbiology, Dhaka Shishu (Children's) Hospital, Dhaka 1207, Bangladesh.
Alain B LabriqueDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Population, Family, and Reproductive, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Kenrad E NelsonDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Douglas A GrangerInstitute for Interdisciplinary Salivary Bioscience, University of California at Irvine, Irvine, CA, USA; Department of Pediatrics, Johns Hopkins University, School of Medicine, Baltimore, MD, USA; Department of Acute and Chronic Care, Johns Hopkins University School of Nursing, Baltimore, MD, USA; Research and Technology Center, Salimetrics, LLC, Carlsbad, CA, USA.
Steve W GrangerResearch and Technology Center, Salimetrics, LLC, Carlsbad, CA, USA.
Barbara DetrickDepartment of Pathology, Johns Hopkins University, School of Medicine, Baltimore, MD, USA.
Christopher D HeaneyDepartment of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Institute for Interdisciplinary Salivary Bioscience, University of California at Irvine, Irvine, CA, USA. Electronic address: cheaney1@jhu.edu.
Johns Hopkins University · USBangladesh Shishu (Children) Hospital & Institute · BD

Funding

Traning Program in Environmental Health SciencesT32ES007141 · NIEHS · JOHNS HOPKINS UNIVERSITY · PI Marsha Wills-Karp · 1985 to 2026
$22.2M
Non-Invasive Zoonotic Pathogen Exposure & Outcome BiomarkersK01OH010193 · OH · JOHNS HOPKINS UNIVERSITY · PI HEANEY, CHRISTOPHER D · 2012 to 2014
$324k
NIEHS NIH HHS T32 ES007141NIOSH CDC HHS K01 OH010193
6 · The paper itself

Abstract

backgroundHepatitis E virus (HEV) infection causes significant morbidity and mortality worldwide, particularly among pregnant women. In clinical settings blood-based testing protocols are commonly used to diagnose HEV infection, but in community settings such invasive sampling can hinder study participation and limit discovery of the ecology and natural history of HEV infection. Oral fluid is a non-invasive biospecimen that can harbor pathogen-specific antibodies and has the potential to replace blood-based testing protocols.

objectivesTo develop an immunoassay to assess past and recent HEV infection that uses oral fluid instead of serum or plasma.

methodsThe assay was validated using paired oral fluid and serum samples collected from 141 patients who presented either with (n=76) or without (n=65) symptoms of acute viral hepatitis at a clinical diagnostics center in Dhaka, Bangladesh. The sensitivity and specificity of the oral fluid-based immunoassay for HEV IgG (past HEV infection) and HEV IgA (recent HEV infection) antibodies was calculated in reference to Wantai's (Beijing Wantai) serum-based HEV enzyme-linked immunosorbent assay (ELISA) kits for IgG and IgM antibodies, respectively.

resultsThe sensitivity and specificity of the oral fluid-based immunoassay for HEV-IgG antibodies were 98.7% and 98.4%, respectively. The sensitivity and specificity of the oral fluid-based immunoassay for HEV IgA were 89.5% and 98.3%, respectively.

conclusionsThe high concordance of our non-invasive oral fluid-based immunoassays (HEV IgG and HEV IgA) with commercial high-performance serum HEV ELISA kits (IgG and IgM) means that population-based surveillance of past and recent HEV infection could be expanded to improve understanding of its ecology and natural history.

Indexed as

AdultAntibodies, ViralBangladeshBiomarkersCase-Control StudiesEnzyme-Linked Immunosorbent AssayFemaleHepatitis EHepatitis E virusHumansImmunoassayImmunoglobulin AImmunoglobulin GImmunoglobulin MMaleMiddle AgedAntibodies, ViralBiomarkersImmunoglobulin AImmunoglobulin GImmunoglobulin M

Identifiers

PMID28478117
PMCPMC5597243
OpenAlexW2611048131

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.