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Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican Blood Donors - American Red Cross

This study has been completed.
Information provided by (Responsible Party):
Gen-Probe, Incorporated Identifier:
First received: July 31, 2012
Last updated: March 19, 2015
Last verified: March 2015
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
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 Blood Donors - American Red Cross

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 ]

Enrollment: 35035
Study Start Date: August 2012
Study Completion Date: January 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No Treatment Device: Procleix Dengue Virus Assay
in vitro diagnostic assay


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 Puerto Rico

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01656174

United States, Arizona
Creative Testing Solutions
Tempe, Arizona, United States, 85282
United States, North Carolina
American Red Cross National Testing Laboratory
Charlotte, North Carolina, United States, 28273
Sponsors and Collaborators
Gen-Probe, Incorporated
Study Director: Renee Wait Gen-Probe, Incorporated
  More Information

Responsible Party: Gen-Probe, Incorporated Identifier: NCT01656174     History of Changes
Other Study ID Numbers: DENVTS-US12-001
Study First Received: July 31, 2012
Last Updated: March 19, 2015

Additional relevant MeSH terms:
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral processed this record on May 25, 2017