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

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.

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Key information

Conditions

Dengue Arbovirus Infections Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Creative Testing Solutions - Tampa

St. Petersburg, Florida, 33716, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Procleix Dengue Virus Assay

Device

in vitro diagnostic assay

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

Sponsors and collaborators

Lead sponsor

Gen-Probe, Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Oct 8, 2012
Registry last updated: Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed