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NCT02107677 Clinical Trial

Specificity Study of Diagnostic for Early Detection of Dengue Infection

Infectious Diseases Clinical Trial

Official title:
Determination of Estimated Specificity of DENV Detect NS1 ELISAs

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02107677
Other study ID # DSC0094
Secondary ID
Status Completed
Phase N/A
First received April 4, 2014
Last updated August 15, 2017
Start date August 2012
Est. completion date August 2014

Study information
Verified date August 2017
Source InBios International, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States State of Florida Dept. of Health Bureau of Laboratories Virology Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
InBios International, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of subjects with negative result one day
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