Specificity Study of Diagnostic for Chagas Disease

NCT02544139 | Completed

• 1 other identifier: DSC0227
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Diseases

Outcome Measures

Primary Outcomes (1)

• number of subjects with negative result

  one day

Interventions

Chagas Detect Plus OTHER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will enroll male and female subjects between 18 and 70 years of age without known risk factors for Chagas. Typically Chagas disease is a chronic, asymptomatic disease.

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.

Sponsors & Collaborators

• InBios International, Inc.: lead

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 9, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

US (1)