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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
October 3, 2012
October 8, 2012
September 15, 2014
January 2013
January 2014   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01702272 on ClinicalTrials.gov Archive Site
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Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - CTS
Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - Creative Testing Solutions
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
volunteer blood donors from the US and Puerto Rico
Dengue
Device: Procleix Dengue Virus Assay
in vitro diagnostic assay
Dengue Virus
Intervention: Device: Procleix Dengue Virus Assay
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150000
January 2014
January 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01702272
DENVTS-US12-002
No
Not Provided
Not Provided
Gen-Probe, Incorporated
Gen-Probe, Incorporated
Not Provided
Study Director: Jennifer Reid, PhD Gen-Probe, Incorporated
Gen-Probe, Incorporated
September 2014