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

March 19, 2015 updated by: Gen-Probe, Incorporated
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35035

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85282
        • Creative Testing Solutions
    • North Carolina
      • Charlotte, North Carolina, United States, 28273
        • American Red Cross National Testing Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

volunteer blood donors from Puerto Rico

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No Treatment
Device: Procleix Dengue Virus Assay
in vitro diagnostic assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Approximately three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gen-Probe, Incorporated

Investigators

  • Study Director: Renee Wait, Gen-Probe, Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

July 31, 2012

First Posted (Estimate)

August 2, 2012

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DENVTS-US12-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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