Infectious Diseases Clinical Trial
Official title:
Determination of Estimated Sensitivity for Chagas Detect Plus Rapid Tests
This study is a multi-site trial assessing the sensitivity of Chagas Detect™ Plus rapid test
versus standard reference tests (e.g. IFA, IHA, RIPA) for Chagas diagnosis.
The Chagas Detect™ Plus rapid test serves as an aid in the clinical laboratory diagnosis of
Chagas infection in patients. This test is intended to be used on human whole blood or serum
samples. Chagas Detect™ Plus results (positive or negative) must be confirmed by testing
with a reference standard test.
Subjects will be patients at clinical sites located in Chagas-endemic areas. After informed
consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will
be collected. One is blood from finger prick, and the other is blood from venous puncture
(drawn from vein in arm).
Rapid tests 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.
n/a
Observational Model: Case-Only
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