Sensitivity Study of Diagnostic for Detection of Chagas Infection
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|ClinicalTrials.gov Identifier: NCT02134548|
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : December 8, 2015
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1601 participants|
|Official Title:||Determination of Estimated Sensitivity for Chagas Detect Plus Rapid Tests|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
- number of subjects with positive result [ Time Frame: 1 day ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134548
|Universidad Catolica Boliviana San Pablo, Unidad Academica Santa Cruz, (Cei)|
|Santa Cruz, Bolivia|