Evaluation of a pan-serotype point-of-care rapid diagnostic assay for accurate detection of acute dengue infection

Diagn Microbiol Infect Dis. 2017 Mar;87(3):229-234. doi: 10.1016/j.diagmicrobio.2016.09.020. Epub 2016 Sep 30.

Abstract

The catastrophic rise in dengue infections in India and globally has created a need for an accurate, validated low-cost rapid diagnostic test (RDT) for dengue. We prospectively evaluated the diagnostic performance of NS1/IgM RDT (dengue day 1) using 211 samples from a pediatric dengue cohort representing all 4 serotypes in southern India. The dengue-positive panel consisted of 179 dengue real-time polymerase chain reaction (RT-PCR) positive samples from symptomatic children. The dengue-negative panel consisted of 32 samples from dengue-negative febrile children and asymptomatic individuals that were negative for dengue RT-PCR/NS1 enzyme-linked immunosorbent assay/IgM/IgG. NS1/IgM RDT sensitivity was 89.4% and specificity was 93.8%. The NS1/IgM RDT showed high sensitivity throughout the acute phase of illness, in primary and secondary infections, in different severity groups, and detected all 4 dengue serotypes, including coinfections. This NS1/IgM RDT is a useful point-of-care assay for rapid and reliable diagnosis of acute dengue and an excellent surveillance tool in our battle against dengue.

Keywords: Dengue; Diagnostics; Evaluation; NS1 protein; Rapid diagnostic test.

MeSH terms

  • Adolescent
  • Antibodies, Viral / blood*
  • Antigens, Viral / immunology
  • Child
  • Child, Preschool
  • Communicable Diseases / diagnosis
  • Dengue / diagnosis*
  • Dengue Virus / genetics
  • Dengue Virus / immunology
  • Diagnostic Tests, Routine / methods*
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Female
  • Humans
  • Immunoglobulin M / blood*
  • Immunoglobulin M / immunology
  • India
  • Infant
  • Male
  • Point-of-Care Systems*
  • Prospective Studies
  • Real-Time Polymerase Chain Reaction
  • Sensitivity and Specificity
  • Viral Nonstructural Proteins / genetics
  • Viral Nonstructural Proteins / immunology*

Substances

  • Antibodies, Viral
  • Antigens, Viral
  • Immunoglobulin M
  • NS1 protein, Dengue virus type 2
  • NS1 protein, Dengue virus type 3
  • NS1 protein, dengue-1 virus
  • Viral Nonstructural Proteins