Sensitivity Study of Diagnostic for Early Detection of Dengue Infection

NCT ID: NCT02059122

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 911 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2018-04-30

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• All age groups and both sexes.
• Initial serum samples must be collected within 1- 7 days of onset of symptoms consistent with Dengue virus infection.
• Information must be available about symptoms, age, and sex of patient from which samples are collected.
• The location of sample collection must be recorded.
• Archived samples that have been sent to reference labs for dengue or flavivirus testing should be considered for inclusion as test specimens in this study. If these specimens are included in this study, then they must have a documented history that the specimen was obtained within the first 7 days of onset of subject symptoms consistent with dengue infection.

Exclusion Criteria

• Archived samples with linked personal identifiers or any sample for which personal information can be discovered.
• Prospective samples from nursing home residents; inmates/subjects in police custody; participants who are unable to understand verbal or written local language in which a certified translation of the informed consent is available, or requires a Legal Authorized Representative (LAR) for consent.
• Subject serum specimens that have undergone more than 2 freeze-thaw cycles or that have not been stored frozen.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InBios International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universidad Nacional de Misiones (UNaM)

Posadas, , Argentina

Leptospira Laboratory

Bridgetown, , Barbados

Universidad de Antioquia

Medellín, , Colombia

Ruhuna University

Galle, , Sri Lanka

AFRIMS

Bangkok, , Thailand

Countries

Argentina; Barbados; Colombia; Sri Lanka; Thailand

Other Identifiers

DSC0202/0093

Identifier Type: -

Identifier Source: org_study_id