Alinity s Anti-HCV II - Clinical Evaluation Protocol

NCT04862065 | Completed Results FDA Device

• 1 other identifier: T3M3-02-19H04-01
• Study Type: interventional
• Target: 16,388
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (2)

• Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay.

  A total of 15,526 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with the investigational Alinity s Anti-HCV II assay. Repeatedly reactive specimens were tested further with supplemental assays, if required, to determine final status. Anti-HCV II Repeatedly Reactive, Final Status Indeterminate = B Anti-HCV II Repeatedly Reactive, Final Status Negative = C Anti-HCV II Nonreactive, Final Status Negative = F Specificity is calculated as the proportion of nonreactive specimens from specimens with negative status: F / (C+F) × 100% Specificity can be also calculated as the proportion of nonreactive specimens with negative status from specimens with negative status and repeatedly reactive specimens with indeterminate status: F / (C + B + F) × 100%

  Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.

• Assay Sensitivity Results for Participants (Specimens) Characterized as Positive Tested With Alinity s Anti-HCV II Assay.

  A total of 403 specimens characterized as positive for HCV were obtained from specimen vendors and tested with the investigational Alinity s Anti-HCV II assay. Anti-HCV II Repeatedly Reactive, Final Status Positive = A Anti-HCV II Nonreactive, Final Status Positive = D Anti-HCV II Nonreactive, Final Status Indeterminate = E Sensitivity is calculated as the proportion of repeatedly reactive specimens from specimens with positive final status: A / (A+D) × 100% Sensitivity can also be calculated as the proportion of repeatedly reactive specimens with positive status from specimens with positive status and nonreactive specimens with indeterminate status: A / (A + D + E) × 100%

  Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.

Secondary Outcomes (1)

• Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay.

  Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.

Study Arms (1)

Screening

OTHER

Alinity s Anti-HCV and Alinity s Anti-HCV II. A follow-up visit may be needed if investigational Alinity s Anti-HCV II result is discordant after supplemental testing.

Device: Alinity s Anti-HCV II

Interventions

Alinity s Anti-HCV II DEVICE

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.

Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serum or ethylenediaminetetraacetic acid (EDTA) plasma from a blood donor or a plasma from a plasmapheresis donor.

You may not qualify if:

• Previous participation in this study. Each subject must be represented only once in the study.

Sponsors & Collaborators

• Abbott Transfusion Medicine: lead

Study Sites (4)

Innovative Blood Resources

Saint Paul, Minnesota, 55114, United States

Location

CSL Plasma Inc.

Knoxville, Tennessee, 37932, United States

Location

QualTex Laboratories

San Antonio, Texas, 78201, United States

Location

Bloodworks Northwest

Renton, Washington, 98057, United States

Location

Results Point of Contact

• Title: Tuan Bui (Manager Clinical Research)
• Organization: Abbott Laboratories

tuan.l.bui@abbott.com

224-668-4702

Study Officials

• Theresa A Nester, MD

  Bloodworks Northwest

  PRINCIPAL INVESTIGATOR

• Thomas S Jones, Ph.D.

  QualTex Laboratories

  PRINCIPAL INVESTIGATOR

• Toby L Simon, M.D.

  CSL Plasma Inc.

  PRINCIPAL INVESTIGATOR

• Jed Gorlin, M.D.

  Innovative Blood Resources

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Evaluation of assay performance characteristics.

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 27, 2021
• Study Start: April 19, 2021
• Primary Completion: June 21, 2021
• Study Completion: August 5, 2021
• Last Updated: October 14, 2022
• Results First Posted: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)