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

NCT ID: NCT01656174

Last Updated: 2015-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35035 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dengue

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No Treatment

Procleix Dengue Virus Assay

Intervention Type DEVICE

in vitro diagnostic assay

Interventions

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Procleix Dengue Virus Assay

in vitro diagnostic assay

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gen-Probe, Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renee Wait

Role: STUDY_DIRECTOR

Gen-Probe, Incorporated

Locations

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Creative Testing Solutions

Tempe, Arizona, United States

Site Status

American Red Cross National Testing Laboratory

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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DENVTS-US12-001

Identifier Type: -

Identifier Source: org_study_id

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