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:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00520273
First received: August 22, 2007
Last updated: July 5, 2012
Last verified: June 2010
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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 100,000 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:
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Ribonucleic acid
U.S. FDA Resources
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
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: | July 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 21, 2013