title: Evaluation of dengue NS1 antigen rapid tests and ELISA kits using clinical samples.
abstract: BACKGROUND
  Early diagnosis of dengue virus (DENV) infection can improve clinical outcomes by ensuring close follow-up, initiating appropriate supportive therapies and raising awareness to the potential of hemorrhage or shock. Non-structural glycoprotein-1 (NS1) has proven to be a useful biomarker for early diagnosis of dengue. A number of rapid diagnostic tests (RDTs) and enzyme-linked immunosorbent assays (ELISAs) targeting NS1 antigen (Ag) are now commercially available. Here we evaluated these tests using a well-characterized panel of clinical samples to determine their effectiveness for early diagnosis.
  
  
  RESULTS
  Retrospective samples from South America were used to evaluate the following tests: (i) "Dengue NS1 Ag STRIP" and (ii) "Platelia Dengue NS1 Ag ELISA" (Bio-Rad, France), (iii) "Dengue NS1 Detect Rapid Test (1st Generation)" and (iv) "DENV Detect NS1 ELISA" (InBios International, United States), (v) "Panbio Dengue Early Rapid (1st generation)" (vi) "Panbio Dengue Early ELISA (2nd generation)" and (vii) "SD Bioline Dengue NS1 Ag Rapid Test" (Alere, United States). Overall, the sensitivity of the RDTs ranged from 71.9%-79.1% while the sensitivity of the ELISAs varied between 85.6-95.9%, using virus isolation as the reference method. Most tests had lower sensitivity for DENV-4 relative to the other three serotypes, were less sensitive in detecting secondary infections, and appeared to be most sensitive on Day 3-4 post symptom onset. The specificity of all evaluated tests ranged from 95%-100%.
  
  
  CONCLUSIONS
  ELISAs had greater overall sensitivity than RDTs. In conjunction with other parameters, the performance data can help determine which dengue diagnostics should be used during the first few days of illness, when the patients are most likely to present to a clinic seeking care.
authors.affiliation: Naval Medical Research Center, Silver Spring, Maryland 20910-7500, United States of America.
authors.forename: Subhamoy
authors.initials: S
authors.lastname: Pal
authors.affiliation: Naval Medical Research Center, Silver Spring, Maryland 20910-7500, United States of America.
authors.forename: Allison L
authors.initials: AL
authors.lastname: Dauner
authors.affiliation: Naval Medical Research Center, Silver Spring, Maryland 20910-7500, United States of America.
authors.forename: Indrani
authors.initials: I
authors.lastname: Mitra
authors.affiliation: U.S. Naval Medical Research Unit, No. 6, Lima, Peru.
authors.forename: Brett M
authors.initials: BM
authors.lastname: Forshey
authors.affiliation: Peruvian Ministry of Health, Instituto Nacional de Salud, Lima, Peru.
authors.forename: Paquita
authors.initials: P
authors.lastname: Garcia
authors.affiliation: U.S. Naval Medical Research Unit, No. 6, Lima, Peru; University of California Davis, Davis, CA, 95616, United States of America.
authors.forename: Amy C
authors.initials: AC
authors.lastname: Morrison
authors.affiliation: U.S. Naval Medical Research Unit, No. 6, Lima, Peru.
authors.forename: Eric S
authors.initials: ES
authors.lastname: Halsey
authors.affiliation: Naval Medical Research Center, Silver Spring, Maryland 20910-7500, United States of America.
authors.forename: Tadeusz J
authors.initials: TJ
authors.lastname: Kochel
authors.affiliation: Naval Medical Research Center, Silver Spring, Maryland 20910-7500, United States of America.
authors.forename: Shuenn-Jue L
authors.initials: SJ
authors.lastname: Wu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000956:Antigens, Viral / Q000032:analysis* / Q000276:immunology; D002648:Child; D003715:Dengue / Q000175:diagnosis* / Q000821:virology; D003716:Dengue Virus / Q000302:isolation & purification / Q000378:metabolism*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D012703:Serotyping; D017361:Viral Nonstructural Proteins / Q000032:analysis* / Q000276:immunology; D055815:Young Adult
chemical_list: D000956:Antigens, Viral; C079340:NS1 protein, Dengue virus type 2; C546113:NS1 protein, Dengue virus type 3; C082515:NS1 protein, dengue-1 virus; D011933:Reagent Kits, Diagnostic; D017361:Viral Nonstructural Proteins