Sensitivity Study of Diagnostic for Detection of Chagas Infection

Determination of Estimated Sensitivity for Chagas Detect Plus Rapid Tests

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.

Study Overview

• Status: Completed
• Conditions: Infectious Diseases

• Study Type: Observational
• Enrollment (Actual): 1601

Contacts and Locations

Study Locations

• Bolivia
  • Santa Cruz, Bolivia
    • Universidad Catolica Boliviana San Pablo, Unidad Academica Santa Cruz, (Cei)
• Chile
  • Santiago, Chile
    • Laboratorio SANALAB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of subjects with positive result	1 day

Collaborators and Investigators

• Sponsor: InBios International, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 7, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Estimate): December 8, 2015
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: DSC0226