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.
Highlights
Accurate diagnosis of Chagas disease, the most important parasitic disease in the Americas [1], is challenging due to the latent character of the infection
Analytical sensitivity The detection limit of the T. cruzi OligoC-TesT was evaluated on three independent tenfold serial dilutions of T. cruzi strain Y DNA in water containing 0.1 mg/ml acetylated bovine serum albumin (BSA)
The analytical sensitivity was evaluated on DNA extracted from three independent blood sample series spiked with decreasing numbers of living T. cruzi epimastigotes
Summary
Accurate diagnosis of Chagas disease, the most important parasitic disease in the Americas [1], is challenging due to the latent character of the infection. Oral T. cruzi transmission by the consumption of contaminated food is linked to localized outbreaks of acute Chagas disease [3]. T. cruzi I is associated with domestic and sylvatic transmission cycles, while IIa and IIc seem to be restricted to sylvatic cycles and IIb, IId and IIe to domestic cycles [4]. Both lineages are associated with cardiac lesions in human infection, but it seems that digestive tract lesions only occur in infection with T. cruzi II [5]. General use of the technique is hampered by its complexity and the lack of standardization
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
