Clinical trial NCT03285295: Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
Official title: Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Abbott Diagnostics Division
Sponsor class: INDUSTRY
First posted: 2017-09-18
Enrollment: 106881
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Evaluation of assay performance characteristics.

Participants:

* Alinity s HBsAg: 17987
* Alinity s HTLV I/II: 17685
* Alinity s Anti-HCV: 17904
* Alinity s HIV Ag/Ab Combo: 19571
* Alinity s Anti-HBc: 16776
* Alinity s Chagas: 16958
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Alinity s HBsAg Assay Specificity
timeFrame: 10 months
measure: Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity
timeFrame: 10 months
measure: Alinity s HTLV I/II Assay Specificity
timeFrame: 10 months
measure: Alinity s HTLV I/II Assay Sensitivity
timeFrame: 10 months
measure: Alinity s Anti-HCV Assay Specificity
timeFrame: 10 months
measure: Alinity s Anti-HCV Assay Sensitivity
timeFrame: 10 months
measure: Alinity s HIV Ag/Ab Combo Assay Specificity
timeFrame: 10 months
measure: Alinity s HIV Ag/Ab Combo Assay Sensitivity
timeFrame: 10 months
measure: Alinity s Anti-HBc Assay Specificity
timeFrame: 10 months
measure: Alinity s Anti-HBc Assay Sensitivity
timeFrame: 10 months
measure: Alinity s Chagas Assay Specificity
timeFrame: 10 months
measure: Alinity s Chagas Assay Sensitivity
timeFrame: 10 months
Secondary outcomes:
measure: Alinity s HBsAg Assay Increased Risk of HBV Infection
timeFrame: 10 months
measure: Alinity s HBsAg Assay Recovered HBV Infection
timeFrame: 10 months
measure: Alinity s HTLV Assay Increased Risk of HTLV Infection
timeFrame: 10 months
measure: Alinity s HTLV I/II Assay Endemics
timeFrame: 10 months
measure: Alinity s Anti-HCV Assay Increased Risk for HCV
timeFrame: 10 months
measure: Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2
timeFrame: 10 months
measure: Alinity s HIV Ag/Ab Combo Assay Endemics
timeFrame: 10 months
measure: Alinity s Anti-HBc Assay Increased Risk for HBV
timeFrame: 10 months
measure: Alinity s Chagas Assay Endemics
timeFrame: 10 months
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Biotest Pharmaceuticals Corporation
state: Florida
city: Saint Louis
country: United States
facility: American Red Cross National Testing Laboratory
state: Missouri
city: Knoxville
country: United States
facility: CSL Plasma Inc.
state: Tennessee
city: San Antonio
country: United States
facility: QualTex Laboratories
state: Texas
city: Renton
country: United States
facility: Bloodworks Northwest
state: Washington
Study officials:
affiliation: Bloodworks Northwest
name: Nancy R Haley, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: QualTex Laboratories
name: Thomas S Jones, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Biotest Pharmaceuticals Corporation
name: Susan S Ganz, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CSL Plasma Inc.
name: Toby L Simon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: American Red Cross National Testing Laboratory
name: Susan L Stramer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: