- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02107677
Specificity Study of Diagnostic for Early Detection of Dengue Infection
Determination of Estimated Specificity of DENV Detect NS1 ELISAs
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32208
- State of Florida Dept. of Health Bureau of Laboratories Virology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All age groups and both sexes.
- 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:
- Any sample(s) with linked personal identifiers or any sample for which personal information can be discovered will be excluded.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of subjects with negative result
Time Frame: one day
|
one day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSC0094
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infectious Diseases
-
Central Hospital, Nancy, FranceEnrolling by invitationInfectious; Spondylitis
-
National Institute of Allergy and Infectious Diseases...RecruitingOccupational Accidents | Incubation Period, Infectious DiseseUnited States
-
Invirsa, Inc.Biomedical Advanced Research and Development AuthorityRecruitingAcute Infectious KeratoconjunctivitisUnited States, Thailand
-
Groupe Hospitalier Diaconesses Croix Saint-SimonFondation Ophtalmologique Adolphe de RothschildCompletedArthritis, Infectious | Bone Diseases, InfectiousFrance
-
Carecubes, Inc.University of NebraskaCompletedInfectious DiseasesUnited States
-
King Saud Medical CityUnknown
-
BayerCompletedInfectious DiseasesItaly
-
Universidad de GuanajuatoAntisepsia CentralCompleted
-
LG Life SciencesCompleted
-
Cosmo Technologies LtdCompletedInfectious Diarrhoea