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NCT02107677 · ClinicalTrials.gov registry record
Specificity Study of Diagnostic for Early Detection of Dengue Infection
A clinical trial of Infectious Diseases, sponsored by InBios International.
- Completed
- Registry status
- 300
- Enrollment target
- 1
- Study location
NCT02107677: Completed study of Infectious Diseases, sponsored by InBios International.
NCT02107677 is a study of Infectious Diseases that has completed, run by InBios International. The registered enrollment target is 300 participants, below the 775-participant average among 4 other Infectious Diseases trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02107677, a study of Infectious Diseases, has completed, sponsored by InBios International.
- COMPLETED
- Registry status
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
This study assesses the specificity of DENV Detect™ NS1 ELISA versus standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US. 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.
Conditions Studied
Study Locations (1)
Florida
- State of Florida Dept. of Health Bureau of Laboratories Virology - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-08 |
What the finished NCT02107677 record still lists
NCT02107677 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 775-participant average among 4 other Infectious Diseases trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Infectious Diseases appearing as the primary indexed condition, and to 0 interventions.
NCT02107677 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02107677 about?
NCT02107677 is a clinical study titled "Specificity Study of Diagnostic for Early Detection of Dengue Infection". This study assesses the specificity of DENV Detect™ NS1 ELISA versus standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US. DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early stages of Dengue infection in patients with clinical sympto...
What is the current status of trial NCT02107677?
This trial is currently completed. The enrollment target is 300 participants. The study started on 2012-08. Estimated completion is 2014-08.
What conditions does trial NCT02107677 study?
This clinical trial studies the following conditions: Infectious Diseases.
Who is sponsoring clinical trial NCT02107677?
This trial is sponsored by InBios International, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02107677 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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