Sensitivity Study of Diagnostic for Early Detection of Dengue Infection
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.
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.