A Study to Evaluate the Specificity of the Cobas TaqScreen MPX Test for Screening Plasma Pools - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00520273

Purpose

This study will evaluate te specificity of the cobas TaqScreen MPX Test for the simultaneous detection of HBV DNA, HCV RNA and HIV-1 Group M in a minimum of 100,000 individual donor samples in 96-unit pools.

Condition	Intervention
Healthy	Device: cobas s 201 TaqScreen MPX Test

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Prospective Study to Evaluate the Specificity of the Cobas TaqScreen MPX Test for Use on the Cobas s 201 System for Screening Plasma Pools From Source Plasma Donors for the Presence of HBV DNA, HCV RNA, and HIV-1 RNA

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Source plasma donors were screened for the presence of HIV-1 RNA, HBV DNA, and/or HCV RNA.

Study Start Date:	August 2007
Estimated Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: cobas s 201 TaqScreen MPX Test Donors testing reactive for one or more of the viral markers will be advised to seek further advice/treatment from their physician.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy adults 18-65 years of age;
fulfil criteria for plasma donation.

Exclusion Criteria:

do not fulfil criteria for plasma donation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520273

Locations

United States, Florida

Boca Raton, Florida, United States
United States, North Carolina

Raleigh, North Carolina, United States
United States, Tennessee

Memphis, Tennessee, United States

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	CAT-MPX-143, RD000000487-2007
Study First Received:	August 22, 2007
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00520273
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

HIV Infections
Acquired Immunodeficiency Syndrome
Healthy

ClinicalTrials.gov processed this record on January 16, 2009