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

PLoS Negl Trop Dis. 2014 Jan 2;8(1):e2633. doi: 10.1371/journal.pntd.0002633. eCollection 2014.

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.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Africa
  • Aged
  • Chagas Disease / diagnosis*
  • Chagas Disease / parasitology
  • Cohort Studies
  • DNA, Kinetoplast / genetics*
  • DNA, Satellite / genetics*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Molecular Diagnostic Techniques / methods*
  • Parasitology / methods*
  • Prospective Studies
  • Sensitivity and Specificity
  • South America
  • Trypanosoma cruzi / genetics
  • Trypanosoma cruzi / isolation & purification*
  • Young Adult

Substances

  • DNA, Kinetoplast
  • DNA, Satellite

Grants and funding

This work was financially supported by the European Commission Seventh Framework Programme, ChagasEpiNet project, grant number 223034. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.