Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - CTS
Completed
- Conditions
- Dengue
- Interventions
- Device: Procleix Dengue Virus Assay
- Registration Number
- NCT01702272
- Lead Sponsor
- Gen-Probe, Incorporated
- Brief Summary
The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150000
Inclusion Criteria
- Donor must meet all the blood collection sites' standard eligibility requirements.
- Donor and/or legally authorized representative must be willing to undergo the site's routine informed consent process prior to study participation.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dengue Virus Procleix Dengue Virus Assay -
- Primary Outcome Measures
Name Time Method Qualitative detection of ribosomal RNA from Dengue Virus in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors. Approximately three years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Creative Testing Solutions - Tampa
🇺🇸St Petersburg, Florida, United States