Study Results
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View full resultsBasic Information
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COMPLETED
NA
16388 participants
INTERVENTIONAL
2021-04-19
2021-08-05
Brief Summary
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Detailed Description
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The Alinity s Anti-HCV II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma specimens on the Alinity s System. The Alinity s Anti-HCV II assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HCV.
The performance of the Alinity s Anti-HCV II assay will be evaluated by performing specificity, and sensitivity testing of the Alinity s Anti-HCV II assay.
To evaluate specificity, approximately 15,000 random unique donor specimens will be collected.
To evaluate sensitivity, Abbott will provide a minimum of 400 frozen samples from U.S. individuals characterized as HCV positive and a minimum of 400 frozen specimens from U.S. individuals at increased risk for HCV infection.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Screening
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Abbott Transfusion Medicine
INDUSTRY
Responsible Party
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Principal Investigators
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Theresa A Nester, MD
Role: PRINCIPAL_INVESTIGATOR
Bloodworks Northwest
Thomas S Jones, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
QualTex Laboratories
Toby L Simon, M.D.
Role: PRINCIPAL_INVESTIGATOR
CSL Plasma Inc.
Jed Gorlin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Innovative Blood Resources
Locations
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Innovative Blood Resources
Saint Paul, Minnesota, United States
CSL Plasma Inc.
Knoxville, Tennessee, United States
QualTex Laboratories
San Antonio, Texas, United States
Bloodworks Northwest
Renton, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Information Sheet
Document Type: Informed Consent Form: Follow-Up Consent
Other Identifiers
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T3M3-02-19H04-01
Identifier Type: -
Identifier Source: org_study_id
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