Sensitivity Study of Diagnostic for Early Detection of Dengue Infection

Infectious Diseases Clinical Trial

Official title:

Determination of Estimated Sensitivity for Dengue NS1 ELISAs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059122
• Other study ID #: DSC0202/0093
• Status: Completed
• Start date: April 2011
• Est. completion date: April 2018

Study information

• Verified date: May 2018
• Source: InBios International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 911
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Diseases

Locations

Country	Name	City	State
Argentina	Universidad Nacional de Misiones (UNaM)	Posadas
Barbados	Leptospira Laboratory	Bridgetown
Colombia	Universidad de Antioquia	Medellin
Sri Lanka	Ruhuna University	Galle
Thailand	AFRIMS	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
InBios International, Inc.

Countries where clinical trial is conducted

Argentina,  Barbados,  Colombia,  Sri Lanka,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of subjects with positive result		1 day