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

N/ACompletedNCT00520273

Hoffmann-La Roche100,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100,000

Conditions

Healthy Volunteer

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adults 18-65 years of age * Fulfil criteria for plasma donation Exclusion Criteria: * Do not fulfil criteria for plasma donation

Locations (3)

Unnamed facility

Boca Raton, Florida, United States

Unnamed facility

Raleigh, North Carolina, United States

Unnamed facility

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

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

Time frame: Study duration

Data from ClinicalTrials.gov

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