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 GIRONÉS, MANUEL FRESNO, ROGELIO LOPEZ-VELEZ, JOSÉ A. PEREZ-MOLINA, BEGOÑA MONGE-MAILLO, LINETH GARCIA, STIJN DEBORGGRAEVE

PLOS NEGLECTED TROPICAL DISEASES

PUBLIC LIBRARY SCIENCE

Lugar: San Francisco; Año: 2014 vol. 8 p. 2633 - 2633

1935-2735

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.