NCT00520273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 2, 2016

Status Verified

June 1, 2010

Enrollment Period

2 months

First QC Date

August 22, 2007

Last Update Submit

March 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Source plasma donors were screened for the presence of HIV-1 RNA, HBV DNA, and/or HCV RNA

    Study duration

Study Arms (1)

A

EXPERIMENTAL
Device: cobas s 201 TaqScreen MPX Test

Interventions

cobas s 201 TaqScreen MPX TestDEVICE

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

A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Do not fulfil criteria for plasma donation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Boca Raton, Florida, FL 33487, United States

Location

Unknown Facility

Raleigh, North Carolina, 27619, United States

Location

Unknown Facility

Memphis, Tennessee, TN 38134, United States

Location

Study Officials

  • Rainer Ziermann

    Roche Molecular Systems, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 23, 2007

Study Start

August 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

March 2, 2016

Record last verified: 2010-06

Locations

US(3)