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

Roche

Status: Completed

Conditions: Healthy Volunteer

Treatments: Device: cobas s 201 TaqScreen MPX Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT00520273

RD000487

CAT-MPX-143

Details and patient eligibility

About

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.

Enrollment: 100,000 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Do not fulfil criteria for plasma donation

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100,000 participants in 1 patient group

A

Experimental group

Treatment:

Device: cobas s 201 TaqScreen MPX Test