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Specificity Study of Diagnostic for Chagas Disease

2015-09-10 01:53:24 | BioPortfolio

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Conditions

Infectious Diseases

Intervention

Chagas Detect Plus

Location

Johns Hopkins Bloomberg School of Public Health
Baltimore
Maryland
United States
21205

Status

Active, not recruiting

Source

InBios International, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-09-10T01:53:24-0400

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Medical and Biotech [MESH] Definitions

Infection with the protozoan parasite TRYPANOSOMA CRUZI, a form of TRYPANOSOMIASIS endemic in Central and South America. It is named after the Brazilian physician Carlos Chagas, who discovered the parasite. Infection by the parasite (positive serologic result only) is distinguished from the clinical manifestations that develop years later, such as destruction of PARASYMPATHETIC GANGLIA; CHAGAS CARDIOMYOPATHY; and dysfunction of the ESOPHAGUS or COLON.

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A branch of internal medicine concerned with the diagnosis and treatment of INFECTIOUS DISEASES.

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