Sensitivity and specificity of commercially available rapid diagnostic tests for viral hepatitis B and C screening in serum samples.

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  • Additional Information
    • Source:
      Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
    • Publication Information:
      Original Publication: San Francisco, CA : Public Library of Science
    • Subject Terms:
      Hepatitis B/*diagnosis ; Hepatitis C/*diagnosis ; Mass Screening/*methods ; Reagent Kits, Diagnostic/*standards; Adolescent ; Adult ; Aged ; Female ; Hepatitis B Surface Antigens/blood ; Hepatitis C Antibodies/blood ; Humans ; Male ; Mass Screening/economics ; Middle Aged ; Prospective Studies ; Sensitivity and Specificity
    • Abstract:
      Early diagnosis of chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections is pivotal for optimal disease management. Sensitivity and specificity of 19 rapid diagnostic test (RDT) kits by different manufacturers (ABON, CTK Biotech, Cypress Diagnostics, Green Gross, Human Diagnostic, Humasis, InTec, OraSure, SD Bioline, Wondfo) were assessed on serum samples of 270 Mongolians (90 seropositive for hepatitis B surface antigen (HBsAg), 90 seropositive for hepatitis C antibody (HCV-Ab), 90 healthy subjects). All tested RDTs for detection of HBsAg performed with average sensitivities and specificities of 100% and 99%, respectively. Albeit, overall sensitivity and specificity of RDTs for detection of HCV-Ab was somewhat lower compared to that of HBsAg RDTs (average sensitivity 98.9%, average specificity 96.7%). Specificity of RDTs for detection of HCV-Ab was dramatically lower among HBsAg positive individuals, who were 10.2 times more likely to show false positive test results. The results of our prospective study demonstrate that inexpensive, easy to handle RDTs are a promising tool in effective HBV- and HCV-screening especially in resource-limited settings.
      Competing Interests: The authors have declared that no competing interests exist.
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    • Molecular Sequence:
      figshare 10.6084/m9.figshare.9724157
    • Accession Number:
      0 (Hepatitis B Surface Antigens)
      0 (Hepatitis C Antibodies)
      0 (Reagent Kits, Diagnostic)
    • Publication Date:
      Date Created: 20200716 Date Completed: 20200915 Latest Revision: 20200915
    • Publication Date:
      20231215
    • Accession Number:
      PMC7363090
    • Accession Number:
      10.1371/journal.pone.0235036
    • Accession Number:
      32667957