Diagnostic accuracy of 5 different brands of dengue virus non-structural protein 1 (NS1) antigen rapid diagnostic tests (RDT) in Indonesia

Diagn Microbiol Infect Dis. 2020 Oct;98(2):115116. doi: 10.1016/j.diagmicrobio.2020.115116. Epub 2020 Jun 20.

Abstract

Indonesia is hyper-endemic for dengue. Dengue virus non-structural protein 1 (NS1) antigen detection is now increasingly used by clinicians in Indonesia to confirm dengue infection, but many available brands have not had any evaluation on their performance. We evaluated the diagnostic accuracy of 5 different brands of NS1 rapid tests against reference standards consisting of 100 virologically confirmed dengue samples covering all 4 serotypes and 49 non-dengue samples. These rapid tests had sensitivity ranging from 73% to 80%, and specificity of 100%. The tests had better sensitivity for detection during the first 4 days of fever, for DENV-3 serotype, and in primary infections. The evaluated tests can be easily used with adequate sensitivity, very good specificity, and no significant difference in performance between brands. However, certain characteristics such as age, fever day onset, serotype, and immunologic status may affect the accuracy of these tests and need to be taken into consideration.

Keywords: Dengue; Diagnostic accuracy; Indonesia; NS1; Rapid test; Sensitivity; Specificity.

Publication types

  • Evaluation Study

MeSH terms

  • Adolescent
  • Adult
  • Child
  • Child, Preschool
  • Dengue / diagnosis*
  • Dengue / immunology
  • Dengue / virology
  • Dengue Virus / classification
  • Dengue Virus / isolation & purification
  • Diagnostic Tests, Routine / methods*
  • Female
  • Glycoproteins
  • Humans
  • Indonesia
  • Male
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity
  • Viral Nonstructural Proteins / immunology*
  • Young Adult

Substances

  • Glycoproteins
  • NS1 protein, Dengue virus type 2
  • NS1 protein, Dengue virus type 3
  • NS1 protein, Dengue virus type 4
  • NS1 protein, dengue-1 virus
  • Reagent Kits, Diagnostic
  • Viral Nonstructural Proteins