Phase 3
Completed N=24,111
Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay
Healthy Donors · HIV Positive
Source: ClinicalTrials.gov NCT00686205 ↗
Enrolled (actual)
24,111
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcomePrimary: PRISM HIV O Plus Test Data for Specificity — 10; 15589 participants
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.
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 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy donors that have consented to study
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. Informational only — not medical advice.