Sensitivity Study of Diagnostic for Detection of Chagas Infection

NCT02134548 | Completed

• 1 other identifier: DSC0226
• Study Type: observational
• Target: 1,601
• Locations: 2 countries
• Sites: 2

Brief Summary

This study is a multi-site trial assessing the sensitivity of Chagas Detect™ Plus rapid test versus standard reference tests (e.g. IFA, IHA, RIPA) for Chagas diagnosis. The Chagas Detect™ Plus rapid test serves as an aid in the clinical laboratory diagnosis of Chagas infection in patients. This test is intended to be used on human whole blood or serum samples. Chagas Detect™ Plus results (positive or negative) must be confirmed by testing with a reference standard test. Subjects will be patients at clinical sites located in Chagas-endemic areas. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected. One is blood from finger prick, and the other is blood from venous puncture (drawn from vein in arm). Rapid tests 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 positive result

  1 day

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Human males and females of varying ages and geographical locations where Chagas infection is endemic. We will use retrospective (archived) and prospective human serum and blood samples. Retrospective (archived) serum samples are not collected specifically for this study and are not individually identifiable to the Investigators. These samples will fall under the category of "leftover" specimens as described by FDA guidance. Prospective whole blood samples will be collected in compliance with human subject protection. The first sample will be collected from finger prick; the second sample will be collected from venous puncture.

You may qualify if:

• All age groups and both sexes for archive samples, adults only and both sexes for prospective samples.
• Samples collected from subjects living in T. cruzi endemic regions.
• Information must be available about symptoms, age, and sex of patient from which samples are collected.
• The location of sample collection must be recorded.

You may not qualify if:

• Archived samples with linked personal identifiers or any sample for which personal information can be discovered.
• Prospective samples from nursing home residents; inmates/subjects in police custody; participants who are unable to understand verbal or written local language in which a certified translation of the informed consent is available, or requires a Legal Authorized Representative (LAR) for consent.
• Subject serum specimens that have undergone more than 2 freeze-thaw cycles or that have not been stored frozen.

Sponsors & Collaborators

• InBios International, Inc.: lead

Study Sites (2)

Universidad Catolica Boliviana San Pablo, Unidad Academica Santa Cruz, (Cei)

Santa Cruz, Bolivia

Location

Laboratorio SANALAB

Santiago, Chile

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
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: June 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

BO (1); CL (1)