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Alinity s Anti-HCV II - Clinical Evaluation Protocol

NCT04862065 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16388

Last updated 2022-10-14

Study results available
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Summary

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.

Conditions

  • Healthy

Interventions

DEVICE

Alinity s Anti-HCV II

For all donor specimens with investigational Alinity s Anti-HCV II results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.

Sponsors & Collaborators

  • Abbott Transfusion Medicine

    lead INDUSTRY

Principal Investigators

  • Theresa A Nester, MD · Bloodworks Northwest

  • Thomas S Jones, Ph.D. · QualTex Laboratories

  • Toby L Simon, M.D. · CSL Plasma Inc.

  • Jed Gorlin, M.D. · Innovative Blood Resources

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2021-06-21
Completion
2021-08-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04862065 on ClinicalTrials.gov