title: Evaluation of two new commercial tests for the diagnosis of acute dengue virus infection using NS1 antigen detection in human serum.
abstract: BACKGROUND
  We compared the performance of two new commercial tests for the detection of dengue NS1 protein during the clinical phase of dengue virus (DENV) infection-an immunochromatographic test allowing rapid detection of the NS1 antigen, Dengue NS1 Ag STRIP (Bio-Rad Laboratories - Marnes La Coquette, France), and a two-step sandwich-format microplate enzyme-linked immunosorbent assay (ELISA), pan-E Dengue Early ELISA (Panbio - Brisbane, Australia)-with a one-step sandwich-format microplate ELISA, the Platelia Dengue NS1 Ag test (Bio-Rad).
  
  
  METHODS
  We tested 272 serum samples from patients with dengue disease. Of these, 222 were from patients with acute infection of one of the four dengue serotypes, detected by RT-PCR and/or virus isolation. Forty-eight acute-phase serum samples from patients not infected with dengue virus were also included.
  
  
  RESULTS
  The sensitivity of the Platelia Dengue NS1 Ag test on acute serum samples (n = 222) was 87.4% (95% confidence interval: 82.3% to 91.5%); that of Dengue NS1 Ag STRIP was 81.5% (95% CI: 75.8% to 86.4%) after 15 minutes and 82.4% (95% CI: 76.8% to 87.2%) after 30 minutes. Both tests had a specificity of 100% (97.5% CI, one-sided test: 92.6% to 100.0%). The pan-E Dengue Early ELISA had a sensitivity of 60.4% (95% CI: 53.4% to 66.8%) and a specificity of 97.9% (95% CI: 88.9% to 99.9%).
  
  
  CONCLUSIONS
  Our findings support the use of diagnostic tools based on the NS1 antigen detection for the diagnosis of acute DENV infection. The immunochromatographic test, Dengue NS1 Ag STRIP-the first rapid diagnostic test for DENV infection-was highly sensitive and specific, and would therefore be a suitable first-line test in the field. The pan-E Dengue Early ELISA was less sensitive than the Platelia test; this two-step ELISA should be combined with DENV IgM antibody detection for the diagnosis of DENV infection.
authors: Centre National de Référence des Arbovirus et Virus Influenza, Région Antilles-Guyane, Institut Pasteur de la Guyane, Cayenne, French Guiana. pdussart@pasteur-cayenne.fr
authors: Philippe
authors: P
authors: Dussart
authors: Laure
authors: L
authors: Petit
authors: Bhety
authors: B
authors: Labeau
authors: Laetitia
authors: L
authors: Bremand
authors: Alexandre
authors: A
authors: Leduc
authors: David
authors: D
authors: Moua
authors: Séverine
authors: S
authors: Matheus
authors: Laurence
authors: L
authors: Baril
mesh_terms: D000956:Antigens, Viral / Q000276:immunology*; D003715:Dengue / Q000175:diagnosis* / Q000821:virology*; D003716:Dengue Virus / Q000276:immunology* / Q000302:isolation & purification; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D017361:Viral Nonstructural Proteins / Q000276:immunology*
chemical_list: D000956:Antigens, Viral; D011933:Reagent Kits, Diagnostic; D017361:Viral Nonstructural Proteins