Specificity Study of Diagnostic for Early Detection of Dengue Infection

Completed

• Conditions: Infectious Diseases

• Registration Number: NCT02107677
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of subjects with negative result	one day

Trial Locations

Locations (1)

State of Florida Dept. of Health Bureau of Laboratories Virology; 🇺🇸 Jacksonville, Florida, United States