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

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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy adults 18-65 years of age
- Fulfil criteria for plasma donation
Exclusion Criteria:
- Do not fulfil criteria for plasma donation

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
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 |
Study Director: | Rainer Ziermann | Roche Molecular Systems, Inc |
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 |