Sensitivity Study of Diagnostic for Detection of Chagas Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 14 December 2015
• Main ID: NCT02134548
• Date of registration: 07/05/2014
• Prospective Registration: No
• Primary sponsor: InBios International, Inc.
• Public title: Sensitivity Study of Diagnostic for Detection of Chagas Infection
• Scientific title: Determination of Estimated Sensitivity for Chagas Detect Plus Rapid Tests
• Date of first enrolment: June 2013
• Target sample size: 1601
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02134548
• Study type: Observational
• Study design: Observational Model: Case-Only
• Phase: N/A

Countries of recruitment

Bolivia, Chile

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Infectious Diseases

Primary Outcome(s)

number of subjects with positive result [Time Frame: 1 day]

Secondary ID(s)

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Source(s) of Monetary Support

Please refer to primary and secondary sponsors