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: March 1, 2016
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:
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 (Adult) |
| 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
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
| 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: | March 1, 2016 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on September 23, 2016