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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00520273 |
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 |
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Healthy |
Device: cobas s 201 TaqScreen MPX Test |
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 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Boca Raton, Florida, United States | |
United States, North Carolina | |
Raleigh, North Carolina, United States | |
United States, Tennessee | |
Memphis, Tennessee, United States |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
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 |
HIV Infections Acquired Immunodeficiency Syndrome Healthy |