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 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 Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Determination of Estimated Specificity of DENV Detect NS1 ELISAs|
- number of subjects with negative result [ Time Frame: one day ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||August 2012|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02107677
|United States, Florida|
|State of Florida Dept. of Health Bureau of Laboratories Virology|
|Jacksonville, Florida, United States, 32208|