NCT02059122

Sensitivity Study of Diagnostic for Early Detection of Dengue Infection

Determination of Estimated Sensitivity for Dengue NS1 ELISAs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 911 (actual)
• Sponsor: InBios International, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is a multi-site trial assessing the sensitivity of DENV Detect™ NS1 ELISA versus standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US and internationally. The 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 results (positive or negative) must be confirmed by testing with a reference standard test. Subjects will be patients who present with symptoms consistent with dengue infection, such as fever and myalgia. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected. The first will be collected within the first 7 days of symptoms onset, and the second will be collected at least 7 days later, between the 10th and 21st days post-onset of symptoms. ELISA 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.

Conditions

• Infectious Diseases

Timeline

• Start date: 2011-04-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2014-02-11
• Last updated: 2018-05-15

Locations

5 sites across 5 countries: Argentina, Barbados, Colombia, Sri Lanka, Thailand