Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - CTS

Gen-Probe

Status: Completed

Conditions: Dengue

Treatments: Device: Procleix Dengue Virus Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT01702272

DENVTS-US12-002

Details and patient eligibility

About

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.

Enrollment: 150,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

150,000 participants in 1 patient group

Dengue Virus

Treatment:

Device: Procleix Dengue Virus Assay