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OpenTrials
Completed

NCT Number: NCT02544139

Specificity Study of Diagnostic for Chagas Disease

This study assesses the specificity of Chagas Detect™ Plus (CDP) rapid test versus standard reference tests (e.g. RIPA or IFA) for Chagas diagnosis in the US.

The Chagas Detect™ Plus Rapid Test is a rapid immunochromotagraphic strip assay for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum or whole blood samples. Reactive assay results are presumptive evidence of Chagas infection.

This study will enroll males and females 18-70 years of age from areas non-endemic for Chagas infection. A fingerprick blood sample and a venous blood sample (for processing to serum) will be collected from each subject. Subject age, gender, and symptoms will be recorded. For this study, samples will have no personally identifiable information.

CDP 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

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and female subjects 18 to 70 years of age
  • Subjects must be able to answer questions concerning:
  • Clinical symptoms
  • Blood transfusions
  • Organ transplants
  • Travel or residence in Chagas endemic areas

Exclusion criteria

  • Any subject who knows that they have positive serology for Chagas disease
  • Subjects who are unable to understand verbal of written or oral language of the consent, or require a legal authorized representative for consent.

Treatment and study plan

Chagas Detect Plus

Other

Primary outcomes

  1. number of subjects with negative result

    Time frame: one day

Sponsors and collaborators

Lead sponsor

InBios International, Inc.

Industry

Registry information

Official study title

Determination of Estimated Specificity of Chagas Detect Plus Rapid Tests

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2015
Registry last updated
Aug 18, 2017

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.

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