Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol

Completed · Not applicable

Conditions studied: Healthy

In brief

The objective of this study is to demonstrate the performance and intended use of each of the Alinity s investigational assays in a donor screening environment using clinical specimens to evaluate assay performance characteristics. A comparison of assay performance will be done versus the Food and Drug Administration (FDA) licensed assays. The data will be used to support regulatory submissions and/or publications.

Key facts

Study ID

NCT03285295

Run by

Abbott Diagnostics Division

People needed

106881

Starts

2017-09-15

Expected to finish

2018-06-21

Last updated by the study team

2019-10-09

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy donors who consented to participate in the study.

You may not qualify if…

• For testing with the Alinity s Chagas assay, exclude donors that have been screened on a previous donation using a licensed test for antibodies to T cruzi.
• Note: A subject may participate at different times during the study for separate assay studies, but each subject should be represented only once for each assay.
• The protocol does not define an age limit. A donor must be at least 17 years old to donate to the general blood supply, or 16 years old with parental/guardian consent, if allowed by state law.

Where it is running

• Biotest Pharmaceuticals Corporation — Boca Raton, Florida, United States
• American Red Cross National Testing Laboratory — St Louis, Missouri, United States
• CSL Plasma Inc. — Knoxville, Tennessee, United States
• QualTex Laboratories — San Antonio, Texas, United States
• Bloodworks Northwest — Renton, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.