NCT02544139

Specificity Study of Diagnostic for Chagas Disease

Determination of Estimated Specificity of Chagas Detect Plus Rapid Tests

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: InBios International, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Infectious Diseases

Interventions

Type	Name	Description
OTHER	Chagas Detect Plus

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-09-09
• Last updated: 2017-08-18

Locations

1 site across 1 country: United States