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

NCT ID: NCT00520273

Last Updated: 2016-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

cobas s 201 TaqScreen MPX Test

Intervention Type DEVICE

Donors testing reactive for one or more of the viral markers will be advised to seek further advice/treatment from their physician.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy adults 18-65 years of age
* Fulfil criteria for plasma donation

Exclusion Criteria

* Do not fulfil criteria for plasma donation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rainer Ziermann

Role: STUDY_DIRECTOR

Roche Molecular Systems, Inc

Locations

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Boca Raton, Florida, United States

Site Status

Raleigh, North Carolina, United States

Site Status

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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CAT-MPX-143

Identifier Type: -

Identifier Source: secondary_id

RD000487

Identifier Type: -

Identifier Source: org_study_id

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