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Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens

NCT00552214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10290

Last updated 2021-02-21

No results posted yet for this study

Summary

The purpose of this study is to validate the performance characteristics of an assay that tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration submission.

Conditions

  • Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations

Interventions

DEVICE

Blood test

Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens

Sponsors & Collaborators

Principal Investigators

  • Study Director · Grifols Biologicals, LLC

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-08-08
Primary Completion
2008-07-01
Completion
2008-07-01

Countries

  • Taiwan

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 NCT00552214 on ClinicalTrials.gov