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

Completed

• Conditions: Dengue

• Registration Number: NCT01656174
• Lead Sponsor: Gen-Probe, Incorporated

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2012-07-31
• Study First Submitted QC: 2012-07-31
• Study Start: 2012-08
• Study First Posted: 2012-08-02
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35035

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Approximately three years

Trial Locations

Locations (2)

Creative Testing Solutions; 🇺🇸 Tempe, Arizona, United States

American Red Cross National Testing Laboratory; 🇺🇸 Charlotte, North Carolina, United States