T. cruzi OligoC-TesT: A Simplified and Standardized Polymerase Chain Reaction Format for Diagnosis of Chagas Disease |
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Authors: | Stijn Deborggraeve Ximena Coronado Aldo Solari Ines Zulantay Werner Apt Pascal Mertens Thierry Laurent Thierry Leclipteux Tim Stessens Jean-Claude Dujardin Piet Herdewijn Philippe Büscher |
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Institution: | 1. Department of Parasitology, Institute of Tropical Medicine Antwerp, Antwerp, Belgium.; 2. Laboratory of Medicinal Chemistry, Rega Institute for Medicinal Research, Katholieke Universiteit Leuven, Leuven, Belgium.; 3. Program of Molecular and Cellular Biology, Faculty of Medicine, University of Chile, Santiago, Chile.; 4. Coris BioConcept, Gembloux, Belgium.;National Institutes of Health, United States of America |
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Abstract: | BackgroundPCR 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.MethodologyWe 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.Principal FindingsThe 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.ConclusionsThe 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. |
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