title: The Trypanosoma cruzi satellite DNA OligoC-TesT and Trypanosoma cruzi kinetoplast DNA OligoC-TesT for diagnosis of Chagas disease: a multi-cohort comparative evaluation study.
abstract: BACKGROUND
  The Trypanosoma cruzi satellite DNA (satDNA) OligoC-TesT is a standardised PCR format for diagnosis of Chagas disease. The sensitivity of the test is lower for discrete typing unit (DTU) TcI than for TcII-VI and the test has not been evaluated in chronic Chagas disease patients.
  
  
  RESULTS
  We developed a new prototype of the OligoC-TesT based on kinetoplast DNA (kDNA) detection. We evaluated the satDNA and kDNA OligoC-TesTs in a multi-cohort study with 187 chronic Chagas patients and 88 healthy endemic controls recruited in Argentina, Chile and Spain and 26 diseased non-endemic controls from D.R. Congo and Sudan. All specimens were tested in duplicate. The overall specificity in the controls was 99.1% (95% CI 95.2%-99.8%) for the satDNA OligoC-TesT and 97.4% (95% CI 92.6%-99.1%) for the kDNA OligoC-TesT. The overall sensitivity in the patients was 67.9% (95% CI 60.9%-74.2%) for the satDNA OligoC-TesT and 79.1% (95% CI 72.8%-84.4%) for the kDNA OligoC-Test.
  
  
  CONCLUSIONS
  Specificities of the two T. cruzi OligoC-TesT prototypes are high on non-endemic and endemic controls. Sensitivities are moderate but significantly (p = 0.0004) higher for the kDNA OligoC-TesT compared to the satDNA OligoC-TesT.
authors.affiliation: Department of Biomedical Sciences, Parasite Diagnostics Unit, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Koen
authors.initials: K
authors.lastname: De Winne
authors.affiliation: Department of Biomedical Sciences, Parasite Diagnostics Unit, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Philippe
authors.initials: P
authors.lastname: Büscher
authors.affiliation: Instituto de Patología Tropical e Saúde Pública and Hospital das Clínicas, Universidade Federal de Goiás, Goiania, Brazil.
authors.forename: Alejandro O
authors.initials: AO
authors.lastname: Luquetti
authors.affiliation: Instituto de Patología Tropical e Saúde Pública and Hospital das Clínicas, Universidade Federal de Goiás, Goiania, Brazil.
authors.forename: Suelene B N
authors.initials: SB
authors.lastname: Tavares
authors.affiliation: Instituto de Patología Tropical e Saúde Pública and Hospital das Clínicas, Universidade Federal de Goiás, Goiania, Brazil.
authors.forename: Rodrigo A
authors.initials: RA
authors.lastname: Oliveira
authors.affiliation: Programa de Biología Celular y Molecular, ICBM, Facultad de Medicina, Universidad de Chile, Santiago, Chile.
authors.forename: Aldo
authors.initials: A
authors.lastname: Solari
authors.affiliation: Programa de Biología Celular y Molecular, ICBM, Facultad de Medicina, Universidad de Chile, Santiago, Chile.
authors.forename: Ines
authors.initials: I
authors.lastname: Zulantay
authors.affiliation: Programa de Biología Celular y Molecular, ICBM, Facultad de Medicina, Universidad de Chile, Santiago, Chile.
authors.forename: Werner
authors.initials: W
authors.lastname: Apt
authors.affiliation: Unidad de Epidemiología Molecular (UEM), Instituto de Patología Experimental, Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Salta, Argentina.
authors.forename: Patricio
authors.initials: P
authors.lastname: Diosque
authors.affiliation: Unidad de Epidemiología Molecular (UEM), Instituto de Patología Experimental, Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Salta, Argentina.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Monje Rumi
authors.affiliation: Centro de Biología Molecular Severo Ochoa, Consejo Superior de Investigaciones Cientificas (CSIC)-Universidad Autónoma de Madrid (UAM), Cantoblanco, Madrid, Spain.
authors.forename: Nuria
authors.initials: N
authors.lastname: Gironès
authors.affiliation: Centro de Biología Molecular Severo Ochoa, Consejo Superior de Investigaciones Cientificas (CSIC)-Universidad Autónoma de Madrid (UAM), Cantoblanco, Madrid, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Fresno
authors.affiliation: Tropical Medicine & Clinical Parasitology, Infectious Diseases Department, Ramón y Cajal Hospital, Madrid, Spain.
authors.forename: Rogelio
authors.initials: R
authors.lastname: Lopez-Velez
authors.affiliation: Tropical Medicine & Clinical Parasitology, Infectious Diseases Department, Ramón y Cajal Hospital, Madrid, Spain.
authors.forename: José A
authors.initials: JA
authors.lastname: Perez-Molina
authors.affiliation: Tropical Medicine & Clinical Parasitology, Infectious Diseases Department, Ramón y Cajal Hospital, Madrid, Spain.
authors.forename: Begoña
authors.initials: B
authors.lastname: Monge-Maillo
authors.affiliation: Facultad de Medicina, Universidad Mayor de San Simón, Cochabamba, Bolivia.
authors.forename: Lineth
authors.initials: L
authors.lastname: Garcia
authors.affiliation: Department of Biomedical Sciences, Parasite Diagnostics Unit, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Stijn
authors.initials: S
authors.lastname: Deborggraeve
mesh_terms: D000293:Adolescent; D000328:Adult; D000349:Africa; D000368:Aged; D014355:Chagas Disease / Q000175:diagnosis* / Q000469:parasitology; D015331:Cohort Studies; D018105:DNA, Kinetoplast / Q000235:genetics*; D004276:DNA, Satellite / Q000235:genetics*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D010274:Parasitology / Q000379:methods*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013020:South America; D014349:Trypanosoma cruzi / Q000235:genetics / Q000302:isolation & purification*; D055815:Young Adult
chemical_list: D018105:DNA, Kinetoplast; D004276:DNA, Satellite