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

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.

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Key information

Conditions

Healthy Donors Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Positive HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mississippi Valley Regional Blood Center, Davenport, Iowa, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy donors that have consented to study

Treatment and study plan

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

Device

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.

Primary outcomes

PRISM HIV O Plus Test Data for Specificity

Time frame: 12 months

Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.
PRISM HIV O Plus Test Data for Sensitivity

Time frame: 12 months

Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA).

Sponsors and collaborators

Lead sponsor

Abbott Diagnostics Division

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: May 29, 2008
Registry last updated: Dec 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed