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.

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.

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BACKGROUND: The Trypanosoma cruzi satellite DNA (satDNA) OligoC-TesT is a standardised iphone 13 dallas 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% gruvi golden lager (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.