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

Not Applicable

Completed

• Conditions: Healthy Volunteer
• Interventions: Device: cobas s 201 TaqScreen MPX Test

• Registration Number: NCT00520273
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-22
• Study First Submitted QC: 2007-08-22
• Study First Posted: 2007-08-23
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2010-06
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100000

Inclusion Criteria

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

Exclusion Criteria

• Do not fulfil criteria for plasma donation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	cobas s 201 TaqScreen MPX Test	-

Primary Outcome Measures

Name	Time	Method
Source plasma donors were screened for the presence of HIV-1 RNA, HBV DNA, and/or HCV RNA	Study duration