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Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay

NCT00686205 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24111

Last updated 2011-12-28

Study results available
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Summary

To test blood samples from volunteer donors of whole blood and blood components using a new investigational test that detects human immunodeficiency virus (HIV) infection. Results will be compared to the current HIV screening assay.

Conditions

  • Healthy Donors
  • HIV Positive

Interventions

DEVICE

collection of follow-up sample based on PRISM HIV O Plus result

Test blood samples with investigational HIV assay. If results are reactive, donors may be deferred and asked to return for a follow-up blood draw.

Sponsors & Collaborators

  • Abbott Diagnostics Division

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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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 NCT00686205 on ClinicalTrials.gov