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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00520273
First received: August 22, 2007
Last updated: June 10, 2014
Last verified: June 2010
  Purpose

This study will evaluate the 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 10 0,000 individual donor samples in 96-unit pools.


Condition Intervention
Healthy Volunteer
Device: cobas s 201 TaqScreen MPX Test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


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 [ Time Frame: Study duration ] [ Designated as safety issue: No ]

Enrollment: 100000
Study Start Date: August 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
Boca Raton, Florida, United States, FL 33487
United States, North Carolina
Raleigh, North Carolina, United States, 27619
United States, Tennessee
Memphis, Tennessee, United States, TN 38134
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Rainer Ziermann Roche Molecular Systems, Inc
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00520273     History of Changes
Other Study ID Numbers: RD000487, CAT-MPX-143
Study First Received: August 22, 2007
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 18, 2014