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Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - CTS

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT01702272
First received: October 3, 2012
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Dengue
 Device: Procleix Dengue Virus Assay

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - Creative Testing Solutions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gen-Probe, Incorporated:

Primary Outcome Measures:
  • 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. [ Time Frame: Approximately three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150000
Study Start Date: January 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dengue Virus Device: Procleix Dengue Virus Assay
in vitro diagnostic assay

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

volunteer blood donors from the US and Puerto Rico

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702272

Locations
United States, Florida
Creative Testing Solutions - Tampa
St Petersburg, Florida, United States, 33716
Sponsors and Collaborators
Gen-Probe, Incorporated
Investigators
Study Director: Jennifer Reid, PhD Gen-Probe, Incorporated
  More Information

No publications provided

Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT01702272     History of Changes
Other Study ID Numbers: DENVTS-US12-002
Study First Received: October 3, 2012
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
 Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral

ClinicalTrials.gov processed this record on May 16, 2013