title: Comparative evaluation of validity and cost-benefit analysis of rapid diagnostic test (RDT) kits in diagnosis of dengue infection using composite reference criteria: A cross-sectional study from south India.
abstract: OBJECTIVE
  Rapid diagnostic test (RDT) kits are widely used in India for the diagnosis of dengue infection. It is important to evaluate the validity and reliability of these RDTs. The study was aimed to determine the sensitivity, specificity and predictive value of four commercially available RDTs [Panbio Dengue Duo cassette, Standard Diagnostics (SD) Bioline Dengue Duo, J. Mitra Dengue Day-1 test and Reckon Dengue IgG/IgM] against composite reference criteria (CRC), and compare the cost of the tests.
  
  
  METHODS
  In this prospective observational study for diagnostic accuracy, we tested stored blood samples from 132 cases of dengue and 149 controls of other infections as classified based on CRC, with all the four RDTs. The CRC was based on the epidemiological considerations, common clinical features and laboratory abnormalities. The non-dengue controls were the cases of proven alternative diagnosis. The diagnostic performances of the tests were compared in terms of sensitivity, specificity and predictive value along with the cost involved per test.
  
  
  RESULTS
  The sensitivity of the Panbio and SD RDT kits was found to be 97.7 and 64.3% respectively, and the specificities were 87.8 and 96.6% respectively. The sensitivity of the NS1 antigen capture by SD Duo, Reckon, J. Mitra RDTs was 20.9, 18.6 and 27.1% respectively. The prevalence of dengue specific IgG antibody with Panbio RDT kits was 49.3%. The cost per test for Panbio, SD, Reckon and J. Mitra is US$ 6.90, 4.27, 3.29 and 3.61 respectively.
  
  
  CONCLUSIONS
  It was concluded that in dengue outbreak, Panbio IgM capture RDT alone is reliable and easily available test which can be used in acute phase of dengue infection in any resource limited set up. NS1 capture rates by any of the other three RDTs might not be reliable for the diagnosis of acute dengue infection.
authors.affiliation: Department of Accident and Emergency Medicine, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Shubhanker
authors.initials: S
authors.lastname: Mitra
authors.forename: Rajat
authors.initials: R
authors.lastname: Choudhari
authors.forename: Harshita
authors.initials: H
authors.lastname: Nori
authors.forename: Kundavaram Paul Prabhakar
authors.initials: KP
authors.lastname: Abhilash
authors.forename: Vishalakshi
authors.initials: V
authors.lastname: Jayaseelan
authors.forename: A M
authors.initials: AM
authors.lastname: Abraham
authors.forename: Abraham O
authors.initials: AO
authors.lastname: Cherian
authors.forename: J A J
authors.initials: JA
authors.lastname: Prakash
authors.forename: Jayaprakash
authors.initials: J
authors.lastname: Muliyil
mesh_terms: D000328:Adult; D000818:Animals; D002846:Chromatography, Affinity / Q000191:economics / Q000379:methods; D003362:Cost-Benefit Analysis; D003430:Cross-Sectional Studies; D003715:Dengue / Q000175:diagnosis*; D003955:Diagnostic Tests, Routine / Q000191:economics* / Q000379:methods*; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013997:Time Factors; D055815:Young Adult