Specificity Study of Diagnostic for Chagas Disease

Completed

• Conditions: Infectious Diseases

• Registration Number: NCT02544139
• Lead Sponsor: InBios International, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Male and female subjects 18 to 70 years of age

2. Subjects must be able to answer questions concerning:

   1. Clinical symptoms
   2. Blood transfusions
   3. Organ transplants
   4. Travel or residence in Chagas endemic areas

Exclusion Criteria

1. Any subject who knows that they have positive serology for Chagas disease
2. Subjects who are unable to understand verbal of written or oral language of the consent, or require a legal authorized representative for consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of subjects with negative result	one day

Trial Locations

Locations (1)

Johns Hopkins Bloomberg School of Public Health; 🇺🇸 Baltimore, Maryland, United States