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

Dengue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656174
• Other study ID #: DENVTS-US12-001
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: March 19, 2015
• Start date: August 2012
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Gen-Probe, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35035
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dengue

Intervention

Device:
• Procleix Dengue Virus Assay
in vitro diagnostic assay

Locations

Country	Name	City	State
United States	American Red Cross National Testing Laboratory	Charlotte	North Carolina
United States	Creative Testing Solutions	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Gen-Probe, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No