Detection of Dengue Virus in Plasma of Patients in Nepal
- Conditions
- Dengue Fever
- Registration Number
- NCT03620487
- Lead Sponsor
- Karius, Inc.
- Brief Summary
To test whether Karius Infectious Disease Diagnostic Sequencing assay can detect Dengue Virus in plasma from suspected cases of Dengue or Dengue Fever like-illnesses from samples collected as part of a hospital-based multi-site study conducted in Nepal.
- Detailed Description
Blood samples will be obtained from consented subjects as part of a hospital-based multi-site study conducted in Nepal and will be shipped to Karius, Redwood City, CA.
The investigators will test whether the Karius test can detect Dengue Virus in plasma from those suspected cases and measure the performance of the Karius test against standard tests (PCR, ELISA test and neutralization assays) used to determine a final diagnosis of Dengue Fever.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 643
- 18 years and older, suspected of having Dengue or Dengue Fever-like illnesses.
- Inability to understand instructions and comply with study-related procedures, inability to understand and/or sign informed consent, any condition that will prevent the subject from completing the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and Specificity of the Karius Test in detecting the Dengue Virus in plasma. 3 years Test the sensitivity and specificity of the Karius Infectious Disease Diagnostic Sequencing Assay in detecting the Dengue Virus in plasma (measured in molecules per mL) from suspected cases of Dengue Virus from a hospital-based multicentered study conducted in Nepal.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tribhuvan University
🇳🇵Kirtipur, Nepal