An observational study in Infectious Diseases, sponsored by InBios International, Inc.. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-08-18.
Sponsored by InBios International, Inc. · Observational
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.
4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.
This study's enrollment of 300 is above the median of 244 across 1,499 observational studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →InBios International, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Human males and females of varying ages and geographical locations where dengue fever is non-endemic. We will use retrospective (archived) human serum samples, not collected specifically for this study and not individually identifiable to the Investigators. These samples will fall under the category of "leftover" specimens as described by FDA guidance. These archived samples will have been collected from patients within 7 days after onset of symptoms consistent with Dengue infection.
Exclusion Criteria:
number of subjects with negative result
Time frame: one day
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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InBios International, Inc.