Diagnosing dengue at the point-of-care: utility of a rapid combined diagnostic kit in Singapore

PLoS One. 2014 Mar 19;9(3):e90037. doi: 10.1371/journal.pone.0090037. eCollection 2014.

Abstract

WHO recommendations for dengue diagnosis require laboratory facilities. Antibody-based rapid diagnostic tests (RDTs) have performed poorly, and clinical diagnosis remains the mainstay in dengue-endemic countries. We evaluated a combination antigen-antibody RDT for point-of-care testing in a high-prevalence setting. In this prospective cohort study, adults were enrolled from a tertiary infectious disease centre for evaluation of undifferentiated febrile illness from October 2011 to May 2012. SD Bioline Dengue Duo was evaluated at point-of-care against a WHO-based reference standard of viral isolation, RT-PCR, NS1-, IgM-, and IgG-ELISA. 246 adults were enrolled (median age 34 years, range 18-69), of which 197 could be confirmed definitively as either dengue or non-dengue. DENV-2 was the predominant serotype (79.5%) and the ratio of primary to secondary cases was 1∶1.1. There were no test failures and minimal interobserver variation with a Fleiss' kappa of 0.983 (95% CI 0.827-1.00). Overall sensitivity and specificity were 93.9% (95% CI 88.8-96.8%) and 92.0% (95% CI 81.2-96.9%) respectively. Using WHO clinical criteria alone for diagnosis had similar sensitivities (95.9%, 95% CI 91.4-98.1%) and lower specificities (20.0%, 95% CI 11.2-33.0%). No significant difference in performance was found when testing early versus late presenters, primary versus secondary cases, or DENV-1 versus DENV-2 infections. The use of a combination RDT fulfills WHO ASSURED criteria for point-of-care testing and can enhance dengue diagnosis in an endemic setting. This has the potential to markedly improve clinical management of dengue in the field.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antibodies, Viral / blood*
  • Antigens, Viral / blood*
  • Dengue / blood
  • Dengue / diagnosis*
  • Dengue / immunology
  • Dengue Virus / immunology
  • Dengue Virus / isolation & purification*
  • Female
  • Humans
  • Immunoglobulin G
  • Immunoglobulin M / blood
  • Male
  • Middle Aged
  • Point-of-Care Systems
  • Prospective Studies
  • Reagent Kits, Diagnostic / standards
  • Reagent Kits, Diagnostic / statistics & numerical data*
  • Sensitivity and Specificity
  • Singapore

Substances

  • Antibodies, Viral
  • Antigens, Viral
  • Immunoglobulin G
  • Immunoglobulin M
  • Reagent Kits, Diagnostic

Grants and funding

This research is supported by the Singapore National Research Foundation under its TCR Flagship Programmes (NMRC/TCR/005) and administered by the Singapore Ministry of Health’s National Medical Research Council. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.