Clinical trialNCT03285295CompletedInterventional

Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol

SponsorAbbott Diagnostics DivisionEnrollment106,881Healthy

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Nancy R Haley, M.D.
Bloodworks Northwest
Principal Investigator
clinicaltrials.gov ↗
Susan L Stramer, Ph.D.
American Red Cross National Testing Laboratory
Principal Investigator
clinicaltrials.gov ↗
Susan S Ganz, M.D.
Biotest Pharmaceuticals Corporation
Principal Investigator
clinicaltrials.gov ↗
Thomas S Jones, Ph.D.
QualTex Laboratories
Principal Investigator
clinicaltrials.gov ↗
Toby L Simon, M.D.
CSL Plasma Inc.
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 Sept 2017
Primary completion: 23 May 2018
Completion: 21 Jun 2018
Last update posted: 9 Oct 2019
Registered enrollment: 106,881
Registry id: NCT03285295

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.