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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01656174

Enrollment

35035

Registered

2012-08-02

Start date

2012-08-31

Completion date

2015-01-31

Last updated

2015-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue

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.

Interventions

DEVICEProcleix Dengue Virus Assay

in vitro diagnostic assay

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026