Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican Blood Donors - American Red Cross
1 other identifier
observational
35,035
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2012
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMarch 20, 2015
March 1, 2015
2.3 years
July 31, 2012
March 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
No Treatment
Interventions
Eligibility Criteria
volunteer blood donors from Puerto Rico
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Creative Testing Solutions
Tempe, Arizona, 85282, United States
American Red Cross National Testing Laboratory
Charlotte, North Carolina, 28273, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Renee Wait
Gen-Probe, Incorporated
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2012
First Posted
August 2, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2014
Study Completion
January 1, 2015
Last Updated
March 20, 2015
Record last verified: 2015-03