title: Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG.
abstract: BACKGROUND
  Dengue diagnosis is complex and until recently only specialized laboratories were able to definitively confirm dengue infection. Rapid tests are now available commercially making biological diagnosis possible in the field. The aim of this study was to evaluate a combined dengue rapid test for the detection of NS1 and IgM/IgG antibodies. The evaluation was made prospectively in the field conditions and included the study of the impact of its use as a point-of-care test for case management as well as retrospectively against a panel of well-characterized samples in a reference laboratory.
  
  
  RESULTS
  During the prospective study, 157 patients hospitalized for a suspicion of dengue were enrolled. In the hospital laboratories, the overall sensitivity, specificity, PPV and NPV of the NS1/IgM/IgG combination tests were 85.7%, 83.9%, 95.6% and 59.1% respectively, whereas they were 94,4%, 90.0%, 97.5% and 77.1% respectively in the national reference laboratory at Institut Pasteur in Cambodia. These results demonstrate that optimal performances require adequate training and quality assurance. The retrospective study showed that the sensitivity of the combined kit did not vary significantly between the serotypes and was not affected by the immune status or by the interval of time between onset of fever and sample collection. The analysis of the medical records indicates that the physicians did not take into consideration the results obtained with the rapid test including for care management and use of antibiotic therapy.
  
  
  CONCLUSIONS
  In the context of our prospective field study, we demonstrated that if the SD Bioline Dengue Duo kit is correctly used, a positive result highly suggests a dengue case but a negative result doesn't rule out a dengue infection. Nevertheless, Cambodian pediatricians in their daily practice relied on their clinical diagnosis and thus the false negative results obtained did not directly impact on the clinical management.
authors.affiliation: Institut Pasteur du Cambodge, Réseau international des Instituts Pasteur, Phnom Penh, Cambodia.
authors.forename: Anne-Claire
authors.initials: AC
authors.lastname: Andries
authors.forename: Veasna
authors.initials: V
authors.lastname: Duong
authors.forename: Chantha
authors.initials: C
authors.lastname: Ngan
authors.forename: Sivuth
authors.initials: S
authors.lastname: Ong
authors.forename: Rekol
authors.initials: R
authors.lastname: Huy
authors.forename: Kim Kim
authors.initials: KK
authors.lastname: Sroin
authors.forename: Vantha
authors.initials: V
authors.lastname: Te
authors.forename: Bunthin
authors.initials: B
authors.lastname: Y
authors.forename: Patrich Lorn
authors.initials: PL
authors.lastname: Try
authors.forename: Philippe
authors.initials: P
authors.lastname: Buchy
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D000956:Antigens, Viral / Q000097:blood*; D002160:Cambodia; D002648:Child; D002675:Child, Preschool; D019411:Clinical Laboratory Techniques / Q000379:methods*; D003715:Dengue / Q000175:diagnosis*; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007074:Immunoglobulin G / Q000097:blood; D007075:Immunoglobulin M / Q000097:blood; D008297:Male; D019095:Point-of-Care Systems; D011247:Pregnancy; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D017361:Viral Nonstructural Proteins / Q000097:blood
chemical_list: D000914:Antibodies, Viral; D000956:Antigens, Viral; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D011933:Reagent Kits, Diagnostic; D017361:Viral Nonstructural Proteins