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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01702272
First Posted: October 8, 2012
Last Update Posted: September 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gen-Probe, Incorporated
  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:


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 ]

Estimated Enrollment: 150000
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dengue Virus Device: Procleix Dengue Virus Assay
in vitro diagnostic assay

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT01702272     History of Changes
Other Study ID Numbers: DENVTS-US12-002
First Submitted: October 3, 2012
First Posted: October 8, 2012
Last Update Posted: September 15, 2014
Last Verified: September 2014

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