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

Koen De Winne, Philippe Büscher, Alejandro O Luquetti, Suelene B N Tavares, Rodrigo A Oliveira, Aldo Solari, Ines Zulantay, Werner Apt, Patricio Diosque, Mercedes Monje Rumi, Nuria Gironès, Manuel Fresno, Rogelio Lopez-Velez, José A Perez-Molina, Begoña Monge-Maillo, Lineth Garcia, Stijn Deborggraeve

Research output: Contribution to journalA1: Web of Science-article

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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.

METHODOLOGY/PRINCIPAL FINDINGS: 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/SIGNIFICANCE: 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.

Original languageEnglish
JournalPLoS Neglected Tropical Diseases
Volume8
Issue number1
Pages (from-to)e2633
ISSN1935-2727
DOIs
Publication statusPublished - 2014

Keywords

  • Adolescent
  • Adult
  • Africa
  • Aged
  • Chagas Disease
  • Cohort Studies
  • DNA, Kinetoplast
  • DNA, Satellite
  • Female
  • Humans
  • Male
  • Middle Aged
  • Molecular Diagnostic Techniques
  • Parasitology
  • Prospective Studies
  • Sensitivity and Specificity
  • South America
  • Trypanosoma cruzi
  • Young Adult

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