Specificity Study of Diagnostic for Early Detection of Dengue Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
InBios International, Inc.
ClinicalTrials.gov Identifier:
NCT02107677
First received: April 4, 2014
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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
Infectious Diseases

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Determination of Estimated Specificity of DENV Detect NS1 ELISAs

Resource links provided by NLM:


Further study details as provided by InBios International, Inc.:

Primary Outcome Measures:
  • number of subjects with negative result [ Time Frame: one day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 300
Study Start Date: August 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02107677

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

No publications provided

Responsible Party: InBios International, Inc.
ClinicalTrials.gov Identifier: NCT02107677     History of Changes
Other Study ID Numbers: DSC0094
Study First Received: April 4, 2014
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on July 24, 2014