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Trial record 5 of 7 for:    "Noonan syndrome 1"

Specificity Study of Diagnostic for Early Detection of Dengue Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02107677
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : August 18, 2017
Information provided by (Responsible Party):
InBios International, Inc.

Brief 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.

Condition or disease
Infectious Diseases

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Determination of Estimated Specificity of DENV Detect NS1 ELISAs
Study Start Date : August 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Primary Outcome Measures :
  1. number of subjects with negative result [ Time Frame: one day ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02107677

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United States, Florida
State of Florida Dept. of Health Bureau of Laboratories Virology
Jacksonville, Florida, United States, 32208
Sponsors and Collaborators
InBios International, Inc.

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Responsible Party: InBios International, Inc. Identifier: NCT02107677     History of Changes
Other Study ID Numbers: DSC0094
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
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Communicable Diseases