Sensitivity Study of Diagnostic for Early Detection of Dengue Infection

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
InBios International, Inc. Identifier:
First received: February 7, 2014
Last updated: August 11, 2015
Last verified: August 2015

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.

Infectious Diseases

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Determination of Estimated Sensitivity for Dengue NS1 ELISAs

Resource links provided by NLM:

Further study details as provided by InBios International, Inc.:

Primary Outcome Measures:
  • number of subjects with positive result [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Estimated Enrollment: 250
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Human males and females of varying ages and geographical locations where dengue fever is endemic. We will use retrospective (archived) and prospective human serum samples.

Some study sites will only use retrospective (archived) serum samples not collected specifically for this study and not individually identifiable to the Investigators. These samples will fall under the category of "leftover" specimens as described by FDA guidance. These archived samples will have been collected from patients within 7 days after onset of symptoms consistent with Dengue infection.

In addition paired prospective samples will be collected in compliance with human subject protection. The prospective samples will be collected from patients with symptoms consistent with Dengue infection. The first sample will be collected within the first 7 days of symptom onset; the second sample will be collected: 1) at least seven days later; and 2) between the 10th and 21st day of symptom onset.


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02059122

Leptospira Laboratory
St. Michael, Barbados, BB11150
Universidad de Antioquia
Medellin, Colombia
Bangkok, Thailand, 10400
Sponsors and Collaborators
InBios International, Inc.
  More Information

No publications provided

Responsible Party: InBios International, Inc. Identifier: NCT02059122     History of Changes
Other Study ID Numbers: DSC0202/0093
Study First Received: February 7, 2014
Last Updated: August 11, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Communicable Diseases
Infection processed this record on November 25, 2015