Development of an Oral Fluid Immunoassay to Assess Past and Recent Hepatitis E Virus (HEV) Infection

Details

• Personal Author:
  Detrick B ; Granger DA ; Granger SW ; Heaney CD ; Labrique AB ; Nelson KE ; Pisanic N ; Rahman A ; Saha SK
• Description:
  Background: Hepatitis 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. Objectives: To develop an immunoassay to assess past and recent HEV infection that uses oral fluid instead of serum or plasma. Methods: The assay was validated using paired oral fluid and serum samples collected from141 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) andHEV IgA(recent HEV infection) antibodieswas calculated in reference toWantai's (BeijingWantai) serum-based HEV enzyme-linked immunosorbent assay (ELISA) kits for IgG and IgM antibodies, respectively. Results: The 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. Conclusions: The 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. [Description provided by NIOSH]
• Subjects:
  Antibodies Body Fluids Communicable Diseases Community Health Services Diagnosis Enzymes Immune System Occupational Health Public Health Safety Viral Diseases

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• Keywords:
  Antibody Response Body Fluids Community Based Community Health Diagnostic Techniques ELISA Enzyme-linked Immunosorbent Assay Hepatitis Humans Immunoassays Immunoglobulins Infection Control Infectious Agents Oral Cavity Pathogens Public Health Salivary Glands Sampling Sensitivity Testing Surveillance Viral Diseases Viral Infections

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• ISSN:
  0022-1759
• Document Type:
  Text
• Funding:
  Grant
• Genre:
  Journal Article
• Place as Subject:
  California ; Maryland ; OSHA Region 3 ; OSHA Region 9
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Pages in Document:
  1-8
• Volume:
  448
• NIOSHTIC Number:
  nn:20050111
• Citation:
  J Immunol Methods 2017 Sep; 448:1-8
• Contact Point Address:
  Christopher D. Heaney, Departments of Environmental Health Sciences and Epidemiology, Johns Hopkins Bloomberg School of Public Health, Room W7033B, 615 North Wolfe St, Baltimore, MD 21205
• Email:
  cheaney1@jhu.edu
• Federal Fiscal Year:
  2017
• Performing Organization:
  Johns Hopkins University, Baltimore, Maryland
• Peer Reviewed:
  True
• Start Date:
  20120701
• Source Full Name:
  Journal of Immunological Methods
• End Date:
  20150630
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:6e7e760d740bd50bfd80955516b08e5caf54422ebb54270f27c710b5d8b069a2fe82957a8743f7f8581d0f0840f75e3898a8b64a3727e9c86b47443002b4ef35
• Download URL:
  https://stacks.cdc.gov/view/cdc/210601/cdc_210601_DS1.pdf
• File Type:
  [PDF - 391.61 KB ]