Specificity Study of Diagnostic for Early Detection of Dengue Infection
NCT ID: NCT02107677
Last Updated: 2017-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2012-08-31
2014-08-31
Brief Summary
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DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early stages of Dengue infection in patients with clinical symptoms consistent with Dengue infection. This test is intended to be used on sera obtained within the first 7 days of symptoms. DENV Detect™ NS1 ELISA and rapid test results (positive or negative) must be confirmed by testing with a reference standard test.
This study will use archived, leftover human serum samples that have been sequentially collected from areas non-endemic for Dengue infection. Each specimen must have been collected within the first 7 days of symptoms, and must be accompanied by clinical data demonstrating that the individual had symptoms consistent with Dengue infection. The samples will have no personally identifiable information.
ELISAs 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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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Serum samples collected within 1- 7 days of onset of symptoms consistent with Dengue virus infection.
* Information must be available about symptoms, age, and sex of patients from which samples are collected.
Exclusion Criteria
ALL
No
Sponsors
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InBios International, Inc.
INDUSTRY
Responsible Party
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Locations
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State of Florida Dept. of Health Bureau of Laboratories Virology
Jacksonville, Florida, United States
Countries
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Other Identifiers
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DSC0094
Identifier Type: -
Identifier Source: org_study_id
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