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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

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ClinicalTrials.gov Identifier: NCT00520273
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 100,000 individual donor samples in 96-unit pools.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Device: cobas s 201 TaqScreen MPX Test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Source plasma donors were screened for the presence of HIV-1 RNA, HBV DNA, and/or HCV RNA [ Time Frame: Study duration ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00520273     History of Changes
Other Study ID Numbers: RD000487
CAT-MPX-143
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: June 2010