Performance of a New Microfluidic Dengue NS1 Immuno-magnetic Agglutination Assay for the Rapid Diagnosis of Dengue Infection in Adults

Am J Trop Med Hyg. 2021 Jul 19;105(3):771-776. doi: 10.4269/ajtmh.20-1558.

Abstract

Dengue (DENV) infections are a public health concern worldwide and thus early diagnosis is important to ensure appropriate clinical management. The rapid diagnostic test (RDT) targets nonstructural protein 1 (NS1) detection and is the main tool used for diagnostic purpose. In this study, we evaluated the performance of a new rapid and semi-quantitative microfluidic DENV NS1 immuno-magnetic agglutination assay or IMA (ViroTrack Dengue Acute, BluSense Diagnostics, Copenhagen, Denmark). We studied 233 subjects confirmed to have DENV infection (by a real-time reverse transcriptase polymerase chain reaction) and 200 control samples were taken from patients with confirmed diagnoses of other febrile illnesses, in Thailand. Samples were tested using the NS1 antigen (Ag) detection methods: in-house NS1 Ag ELISA (ELISA), SD BIOLINE Dengue NS1 Ag RDT (ICT), and ViroTrack Dengue Acute (IMA). Sensitivities of these tests were 86.3%, 78.9%, and 85.5%, respectively. All tests showed high specificity (100%, 99%, and 97% for ELISA, ICT, and IMA, respectively). The sensitivities of both RDTs were affected by the low sensitivity to DENV-2 and DENV-4. NS1 Ag was detected in every patient on day 1 and day 2 after onset of illness by ELISA and IMA with a decline in detection rates over time after day 6 of illness. NS1 detection rate using ICT decreased from 100% on day 1 of illness to 98.6% on day 2 after onset of illness. By day 6, the detection rate was 45.9%. Thus, IMA performed better than ICT for early and rapid diagnosis of DENV infections in endemic countries.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Agglutination Tests
  • Antigens, Viral / blood
  • Antigens, Viral / immunology*
  • Dengue / blood
  • Dengue / diagnosis*
  • Dengue Virus / immunology*
  • Female
  • Glycoproteins / blood
  • Glycoproteins / immunology
  • Humans
  • Lab-On-A-Chip Devices
  • Magnets
  • Male
  • Microchip Analytical Procedures
  • Middle Aged
  • Sensitivity and Specificity
  • Serologic Tests
  • Viral Nonstructural Proteins / blood
  • Viral Nonstructural Proteins / immunology*
  • Young Adult

Substances

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