Sensitivity Study of Diagnostic for Detection of Chagas Infection

Infectious Diseases Clinical Trial

Official title:

Determination of Estimated Sensitivity for Chagas Detect Plus Rapid Tests

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134548
• Other study ID #: DSC0226
• Status: Completed
• Phase: N/A
• First received: May 7, 2014
• Last updated: December 4, 2015
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: InBios International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1601
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Diseases

Locations

Country	Name	City	State
Bolivia	Universidad Catolica Boliviana San Pablo, Unidad Academica Santa Cruz, (Cei)	Santa Cruz
Chile	Laboratorio SANALAB	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
InBios International, Inc.

Countries where clinical trial is conducted

Bolivia,  Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of subjects with positive result		1 day	No