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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

NCT00520273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100000

Last updated 2016-03-02

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteer

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Rainer Ziermann · Roche Molecular Systems, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00520273 on ClinicalTrials.gov