Clinical trialNCT04862065CompletedInterventional

Alinity s Anti-HCV II - Clinical Evaluation Protocol

SponsorAbbott Transfusion MedicineEnrollment16,388Healthy

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 the Alinity s Anti-HCV II investigational assay in a donor screening environment using clinical samples to evaluate assay performance. The Alinity s Anti-HCV II assay performance will be evaluated utilizing the Food and Drug Administration (FDA) licensed Alinity s Anti-HCV assay as the comparator method. 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.

Jed Gorlin, M.D.
Innovative Blood Resources
Principal Investigator
clinicaltrials.gov ↗
Theresa A Nester, MD
Bloodworks Northwest
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

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

United States

Innovative Blood Resources
Saint Paul, Minnesota, 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: 19 Apr 2021
Primary completion: 21 Jun 2021
Completion: 5 Aug 2021
Last update posted: 14 Oct 2022
Registered enrollment: 16,388
Registry id: NCT04862065

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.