NCT02134548

Sensitivity Study of Diagnostic for Detection of Chagas Infection

Determination of Estimated Sensitivity for Chagas Detect Plus Rapid Tests

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,601 (actual)
• Sponsor: InBios International, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Infectious Diseases

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-05-09
• Last updated: 2015-12-08

Locations

2 sites across 2 countries: Bolivia, Chile