T. cruzi OligoC-TesT: a simplified and standardized polymerase chain reaction format for diagnosis of Chagas disease.
BACKGROUND
PCR 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.


METHODS
We 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.


RESULTS
The 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.


CONCLUSIONS
The 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.
Deborggraeve
Stijn
S
Department of Parasitology, Institute of Tropical Medicine Antwerp, Antwerp, Belgium. sdeborggraeve@itg.be
Coronado
Ximena
X
Solari
Aldo
A
Zulantay
Ines
I
Apt
Werner
W
Mertens
Pascal
P
Laurent
Thierry
T
Leclipteux
Thierry
T
Stessens
Tim
T
Dujardin
Jean-Claude
JC
Herdewijn
Piet
P
Büscher
Philippe
P
D000328:Adult; D000818:Animals; D014355:Chagas Disease / Q000175:diagnosis*; D002648:Child; D002675:Child, Preschool; D002677:Chile; D016054:DNA, Protozoan / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D016133:Polymerase Chain Reaction / Q000379:methods* / Q000592:standards; D012377:Rodentia / Q000469:parasitology*; D012680:Sensitivity and Specificity; D014349:Trypanosoma cruzi / Q000235:genetics / Q000302:isolation & purification*; D055815:Young Adult
D016054:DNA, Protozoan