Sensitivity Study of Diagnostic for Early Detection of Dengue Infection

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.

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Key information

Conditions

Infectious Diseases Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad Nacional de Misiones (UNaM), Posadas, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

number of subjects with positive result

Time frame: 1 day

Sponsors and collaborators

Lead sponsor

InBios International, Inc.

Industry

Registry information

Official study title

Determination of Estimated Sensitivity for Dengue NS1 ELISAs

Important dates

Study start: 2011
Primary completion: 2018
Study completion: 2018
First posted: Feb 11, 2014
Registry last updated: May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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