Sensitivity Study of Diagnostic for Detection of Chagas Infection

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.

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Key information

Conditions

Infectious Diseases Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

number of subjects with positive result

Time frame: 1 day

Sponsors and collaborators

Lead sponsor

InBios International, Inc.

Industry

Registry information

Official study title

Determination of Estimated Sensitivity for Chagas Detect Plus Rapid Tests

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: May 9, 2014
Registry last updated: Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed