Phase 3 N=24,111 Screening

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

Healthy Donors · HIV Positive

Bottom Line

View on ClinicalTrials.gov: NCT00686205 ↗

Enrolled (actual)

24,111

Serious AEs

0.0%

Results posted

Jul 2010

Primary outcome: Primary: PRISM HIV O Plus Test Data for Specificity — 10; 15589 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: collection of follow-up sample based on PRISM HIV O Plus result (Device)
Age: Pediatric, Adult, Older Adult · 17+ yrs
Sex: All
Sponsor: Abbott Diagnostics Division
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY PRISM HIV O Plus Test Data for Specificity	10; 15589	—
PRIMARY PRISM HIV O Plus Test Data for Sensitivity	1524; 0	—

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.

Eligibility Criteria

Inclusion Criteria

Healthy donors that have consented to study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00686205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.