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: August 26, 2014
Last verified: June 2010

August 22, 2007
August 26, 2014
August 2007
October 2007   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00520273 on ClinicalTrials.gov Archive Site
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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
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 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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Healthy Volunteer
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.
Experimental: A
Intervention: Device: cobas s 201 TaqScreen MPX Test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100000
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy adults 18-65 years of age
  • Fulfil criteria for plasma donation

Exclusion Criteria:

  • Do not fulfil criteria for plasma donation
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00520273
RD000487, CAT-MPX-143
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Rainer Ziermann Roche Molecular Systems, Inc
Hoffmann-La Roche
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP