Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay; Device: Alinity s HTLV I/II Assay; Device: Alinity s Anti-HCV Assay; Device: Alinity s HIV Ag/Ab Combo Assay; Device: Alinity s Anti-HBc Assay; Device: Alinity s Chagas Assay

Detailed Description

This study evaluates Alinity s investigational assays using the Alinity s System. The Alinity s System is a high-volume, automated, blood-screening analyzer that is designed to determine the presence of specific antigens and antibodies by using chemiluminescent microparticle immunoassay (CMIA) detection technology. The system performs high-throughput routine and stat processing that features continuous access and automated retesting.

The Alinity s System is used for infectious disease marker testing in blood-screening and plasma laboratories for the following assays: Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory and HIV Ag/Ab Combo.

• Study Type: Interventional
• Enrollment (Actual): 106881
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Biotest Pharmaceuticals Corporation
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • American Red Cross National Testing Laboratory
  • Tennessee
    • Knoxville, Tennessee, United States, 37932
      • CSL Plasma Inc.
  • Texas
    • San Antonio, Texas, United States, 78201
      • Qualtex Laboratories
  • Washington
    • Renton, Washington, United States, 98057
      • Bloodworks Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy donors who consented to participate in the study.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Screening; All subjects will be tested with at least one of the investigational Alinity s assays (Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory, HIV Ag/Ab Combo) on Alinity s system.

Device: Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay; For all donor specimens with investigational Alinity s HBsAg and Alinity s HBsAg Confirmatory 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.; Device: Alinity s HTLV I/II Assay; For all donor specimens with investigational Alinity s HTLV I/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.; Device: Alinity s Anti-HCV Assay; For all donor specimens with investigational Alinity s Anti-HCV 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.; Device: Alinity s HIV Ag/Ab Combo Assay; For all donor specimens with investigational Alinity s HIV Ag/Ab Combo 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.; Device: Alinity s Anti-HBc Assay; For all donor specimens with investigational Alinity s Anti-HBc 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.; Device: Alinity s Chagas Assay; For all donor specimens with investigational Alinity s Chagas 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alinity s HBsAg Assay Specificity	Total of 16993 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HBsAg Assay. Repeatedly reactive specimens were further tested with Alinity s HBsAg Confirmatory and supplemental assays, if required.	10 months
Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity	Total of 432 specimens from subjects known to be HBsAg positive were tested with Alinity s HBsAg and HBsAg Confirmatory assay.	10 months
Alinity s HTLV I/II Assay Specificity	Total of 15877 serum and plasma specimens from whole blood donors specimens were tested with Alinity s HTLV I/II Assay. Repeatedly reactive specimens were further tested with Alinity s HTLV I/II and supplemental assays, if required.	10 months
Alinity s HTLV I/II Assay Sensitivity	Total of 706 specimens from subjects known to be HTLV positive were tested with Alinity s HTLV I/II assay. The population consists of the following: Anti-HTLV I Positive n = 461 Anti-HTLV II positive n = 141 Anti-HTLV III positive - Undifferentiated n = 4 Individual with HTLV I/II Associated Diseases n = 100	10 months
Alinity s Anti-HCV Assay Specificity	Total of 16,999 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s Anti-HCV assay. Repeatedly reactive specimens were tested further with supplemental assays, if required.	10 months
Alinity s Anti-HCV Assay Sensitivity	Total of 402 specimens from subjects known to be Anti-HCV positive were tested with Alinity s Anti-HCV assay.	10 months
Alinity s HIV Ag/Ab Combo Assay Specificity	Total of 16996 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HIV Ag/Ab Combo Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.	10 months
Alinity s HIV Ag/Ab Combo Assay Sensitivity	Total of 1336 specimens from subjects known to be HIV-1/2 positive were tested with Alinity s HIV Ag/Ab Combo assay.	10 months
Alinity s Anti-HBc Assay Specificity	Total of 15877 serum and plasma specimens from whole blood donor specimens were tested with Alinity s Anti-HBc Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.	10 months
Alinity s Anti-HBc Assay Sensitivity	Total of 404 specimens from individuals with hepatitis B infection were tested with investigational Alinity s Anti-HBc assay. The population consists of the following: Acute Hepatitis B infection n = 28 Chronic Hepatitis B infection n = 97 Recovered Hepatitis B infection n = 279	10 months
Alinity s Chagas Assay Specificity	Total of 15804 serum and plasma specimens from whole blood donors specimens were tested with Alinity s Chagas Assay. Repeatedly reactive specimens were further tested with Alinity s Chagas and supplemental assays, if required.	10 months
Alinity s Chagas Assay Sensitivity	Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alinity s HBsAg Assay Increased Risk of HBV Infection	Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s HBsAg assay. Sensitivity and Specificity not applicable.	10 months
Alinity s HBsAg Assay Recovered HBV Infection	Total of 51 specimens from subjects classified as recovered HBV infection were tested with investigational Alinity s HBsAg assay. Sensitivity/Specificity calculation for this population not applicable.	10 months
Alinity s HTLV Assay Increased Risk of HTLV Infection	Total of 502 specimens from subjects known to be at increased risk for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay. Sensitivity and Specificity not applicable.	10 months
Alinity s HTLV I/II Assay Endemics	Total of 509 specimens from subjects collected from areas known to be endemic for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay. Sensitivity and Specificity not applicable.	10 months
Alinity s Anti-HCV Assay Increased Risk for HCV	Total of 407 specimens from subjects known to be at increased risk for HCV infection were tested with investigational Alinity s Anti-HCV assay.	10 months
Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2	Total of 605 specimens from subjects known to be at increased risk for HIV-1/2 infection were tested with investigational Alinity s HIV Ag/Ab Combo assay. Sensitivity and Specificity not applicable.	10 months
Alinity s HIV Ag/Ab Combo Assay Endemics	Total of 535 specimens from subjects collected from areas known to be endemic for HIV infection were tested with investigational Alinity s HIV Ag/Ab Combo assay.	10 months
Alinity s Anti-HBc Assay Increased Risk for HBV	Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s Anti-HBc assay.	10 months
Alinity s Chagas Assay Endemics	Total of 615 specimens from subjects collected from areas known to be endemic for Chagas infection were tested with investigational Alinity s Chagas assay	10 months

Collaborators and Investigators

• Sponsor: Abbott Diagnostics Division
• Investigators: Principal Investigator: Nancy R Haley, M.D., Bloodworks Northwest; Principal Investigator: Thomas S Jones, Ph.D., Qualtex Laboratories; Principal Investigator: Susan S Ganz, M.D., Biotest Pharmaceuticals Corporation; Principal Investigator: Toby L Simon, M.D., CSL Plasma Inc.; Principal Investigator: Susan L Stramer, Ph.D., American Red Cross National Testing Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): May 23, 2018
• Study Completion (Actual): June 21, 2018

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Hepatitis C Antibodies
• Other Study ID Numbers: 9DY-02-14U01-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes