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

Abbott

Status and phase: Completed; Phase 3

Conditions: HIV Positive; Healthy Donors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00686205

7B5-02-05R05

Details and patient eligibility

About

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.

Enrollment: 24,111 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy donors that have consented to study

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24,111 participants in 2 patient groups

ABBOTT PRISM HIV O Plus assay for Specificity

Experimental group

Description:

All subjects will have their blood tested by the investigational HIV test.

Treatment:

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

ABBOTT PRISM HIV O Plus Assay for Sensitivity

No Intervention group

Description:

Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.