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Sensitivity Study of Diagnostic for Detection of Chagas Infection

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ClinicalTrials.gov Identifier: NCT02134548
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
InBios International, Inc.

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.


Condition or disease
Infectious Diseases

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Study Type : Observational
Actual Enrollment : 1601 participants
Observational Model: Case-Only
Official Title: Determination of Estimated Sensitivity for Chagas Detect Plus Rapid Tests
Study Start Date : June 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015



Primary Outcome Measures :
  1. number of subjects with positive result [ Time Frame: 1 day ]

Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134548


Locations
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Bolivia
Universidad Catolica Boliviana San Pablo, Unidad Academica Santa Cruz, (Cei)
Santa Cruz, Bolivia
Chile
Laboratorio SANALAB
Santiago, Chile
Sponsors and Collaborators
InBios International, Inc.
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Responsible Party: InBios International, Inc.
ClinicalTrials.gov Identifier: NCT02134548    
Other Study ID Numbers: DSC0226
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Communicable Diseases
Infection