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

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. © 2014 de winne et al.