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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.
Information provided by (Responsible Party):
Gen-Probe, Incorporated Identifier:
First received: October 3, 2012
Last updated: September 11, 2014
Last verified: September 2014
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 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


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

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
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Please refer to this study by its identifier: NCT01702272

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

Responsible Party: Gen-Probe, Incorporated Identifier: NCT01702272     History of Changes
Other Study ID Numbers: DENVTS-US12-002
Study First Received: October 3, 2012
Last Updated: September 11, 2014

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