Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
1 other identifier
interventional
106,881
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Sep 2017
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2017
CompletedStudy Start
First participant enrolled
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
September 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2018
CompletedResults Posted
Study results publicly available
October 9, 2019
CompletedOctober 9, 2019
September 1, 2019
8 months
September 12, 2017
July 12, 2019
September 17, 2019
Conditions
Outcome Measures
Primary Outcomes (12)
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 Outcomes (9)
Alinity s HBsAg Assay Increased Risk of HBV Infection
10 months
Alinity s HBsAg Assay Recovered HBV Infection
10 months
Alinity s HTLV Assay Increased Risk of HTLV Infection
10 months
Alinity s HTLV I/II Assay Endemics
10 months
Alinity s Anti-HCV Assay Increased Risk for HCV
10 months
- +4 more secondary outcomes
Study Arms (1)
Screening
EXPERIMENTALAll 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.
Interventions
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.
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Healthy donors who consented to participate in the study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Biotest Pharmaceuticals Corporation
Boca Raton, Florida, 33431, United States
American Red Cross National Testing Laboratory
St Louis, Missouri, 63108, United States
CSL Plasma Inc.
Knoxville, Tennessee, 37932, United States
QualTex Laboratories
San Antonio, Texas, 78201, United States
Bloodworks Northwest
Renton, Washington, 98057, United States
Results Point of Contact
- Title
- George Chen (Associate Director Clinical Affairs)
- Organization
- Abbott Laboratories
Study Officials
- 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
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
Study Record Dates
First Submitted
September 12, 2017
First Posted
September 18, 2017
Study Start
September 15, 2017
Primary Completion
May 23, 2018
Study Completion
June 21, 2018
Last Updated
October 9, 2019
Results First Posted
October 9, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share