Clinical trial NCT02134548: Sensitivity Study of Diagnostic for Detection of Chagas Infection
Official title: Determination of Estimated Sensitivity for Chagas Detect Plus Rapid Tests
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Diseases
Lead sponsor: InBios International, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-09
Enrollment: 1601
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
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.

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.


Eligibility 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.

Primary outcomes:
measure: number of subjects with positive result
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Cruz
country: Bolivia
facility: Universidad Catolica Boliviana San Pablo, Unidad Academica Santa Cruz, (Cei)
city: Santiago
country: Chile
facility: Laboratorio SANALAB
Study officials:
References: