Specificity Study of Diagnostic for Chagas Disease
Completed
Conditions studied: Infectious Diseases
In brief
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.
Key facts
- Study ID
- NCT02544139
- Run by
- InBios International, Inc.
- People needed
- 200
- Starts
- 2015-07-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2017-08-18
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male and female subjects 18 to 70 years of age
- Subjects must be able to answer questions concerning:
- Clinical symptoms
- Blood transfusions
- Organ transplants
- Travel or residence in Chagas endemic areas
You may not qualify if…
- Any subject who knows that they have positive serology for Chagas disease
- Subjects who are unable to understand verbal of written or oral language of the consent, or require a legal authorized representative for consent.
Where it is running
- Johns Hopkins Bloomberg School of Public Health — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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