Infectious Diseases Clinical Trial
Official title:
Determination of Estimated Specificity of Chagas Detect Plus Rapid Tests
This study assesses the specificity of Chagas Detect™ Plus (CDP) rapid test versus standard
reference tests (e.g. RIPA or IFA) for Chagas diagnosis in the US.
The Chagas Detect™ Plus Rapid Test is a rapid immunochromotagraphic strip assay for the
qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum or whole
blood samples. Reactive assay results are presumptive evidence of Chagas infection.
This study will enroll males and females 18-70 years of age from areas non-endemic for Chagas
infection. A fingerprick blood sample and a venous blood sample (for processing to serum)
will be collected from each subject. Subject age, gender, and symptoms will be recorded. For
this study, samples will have no personally identifiable information.
CDP and reference tests will be performed by different operators who are laboratory staff
members. These staff members, blinded to each other's results, will evaluate the samples from
each method independently.
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