title: T. cruzi OligoC-TesT: a simplified and standardized polymerase chain reaction format for diagnosis of Chagas disease.
abstract: BACKGROUND
  PCR has evolved into one of the most promising tools for T. cruzi detection in the diagnosis and control of Chagas disease. However, general use of the technique is hampered by its complexity and the lack of standardization.
  
  
  METHODS
  We here present the development and phase I evaluation of the T. cruzi OligoC-TesT, a simple and standardized dipstick format for detection of PCR amplified T. cruzi DNA. The specificity and sensitivity of the assay were evaluated on blood samples from 60 Chagas non-endemic and 48 endemic control persons and on biological samples from 33 patients, 7 reservoir animals, and 14 vectors collected in Chile.
  
  
  RESULTS
  The lower detection limits of the T. cruzi OligoC-TesT were 1 pg and 1 to 10 fg of DNA from T. cruzi lineage I and II, respectively. The test showed a specificity of 100% (95% confidence interval [CI]: 96.6%-100%) on the control samples and a sensitivity of 93.9% (95% CI: 80.4%-98.3%), 100% (95% CI: 64.6%-100%), and 100% (95% CI: 78.5%-100%) on the human, rodent, and vector samples, respectively.
  
  
  CONCLUSIONS
  The T. cruzi OligoC-TesT showed high sensitivity and specificity on a diverse panel of biological samples. The new tool is an important step towards simplified and standardized molecular diagnosis of Chagas disease.
authors.affiliation: Department of Parasitology, Institute of Tropical Medicine Antwerp, Antwerp, Belgium. sdeborggraeve@itg.be
authors.forename: Stijn
authors.initials: S
authors.lastname: Deborggraeve
authors.forename: Ximena
authors.initials: X
authors.lastname: Coronado
authors.forename: Aldo
authors.initials: A
authors.lastname: Solari
authors.forename: Ines
authors.initials: I
authors.lastname: Zulantay
authors.forename: Werner
authors.initials: W
authors.lastname: Apt
authors.forename: Pascal
authors.initials: P
authors.lastname: Mertens
authors.forename: Thierry
authors.initials: T
authors.lastname: Laurent
authors.forename: Thierry
authors.initials: T
authors.lastname: Leclipteux
authors.forename: Tim
authors.initials: T
authors.lastname: Stessens
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Dujardin
authors.forename: Piet
authors.initials: P
authors.lastname: Herdewijn
authors.forename: Philippe
authors.initials: P
authors.lastname: Büscher
mesh_terms: D000328:Adult; D000818:Animals; D014355:Chagas Disease / Q000175:diagnosis*; D002648:Child; D002675:Child, Preschool; D002677:Chile; D016054:DNA, Protozoan / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D016133:Polymerase Chain Reaction / Q000379:methods* / Q000592:standards; D012377:Rodentia / Q000469:parasitology*; D012680:Sensitivity and Specificity; D014349:Trypanosoma cruzi / Q000235:genetics / Q000302:isolation & purification*; D055815:Young Adult
chemical_list: D016054:DNA, Protozoan