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

Gen-Probe, Incorporated35,035 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

35,035

Conditions

Dengue

Interventions

Procleix Dengue Virus AssayDEVICE

in vitro diagnostic assay

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Creative Testing Solutions

Tempe, Arizona, United States

American Red Cross National Testing Laboratory

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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