Infectious Diseases
Conditions
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.
Interventions
OTHERChagas Detect Plus
Sponsors
InBios International, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of subjects with negative result | one day |
Countries
United States
Outcome results
None listed