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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.
This study evaluates the Alinity s Anti-HCV II investigational assay using the Alinity s System.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay. | 404 specimens from subjects at increased risk for HCV infection were obtained from specimen vendors and tested with 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 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% |
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Inclusion Criteria:
Exclusion Criteria:
Note: Frozen samples (sensitivity) provided by Abbott (403 specimens characterized as positive for HCV and 404 specimens with Increased risk of HCV infection) have no specific inclusion/exclusion criteria that the clinical sites need to verify prior to testing. Inclusion and exclusion criteria only apply to specificity specimens.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovative Blood Resources | Saint Paul | Minnesota | 55114 | United States | ||
| CSL Plasma Inc. |
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Alinity s Anti-HCV II: 16,388
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| ID | Title | Description |
|---|---|---|
| FG000 | Specificity | US blood and/or plasmapheresis donor specimens collected as part of routine blood and/or plasma donation were tested with the investigational Alinity s Anti-HCV II assay. |
| FG001 | Sensitivity | Specimens characterized as positive for hepatitis C virus (HCV) obtained from specimen vendors were tested by the investigational Alinity s Anti-HCV II assay. |
| FG002 | Increased Risk Population | Specimens with Increased Risk of Infection for hepatitis C virus (HCV) obtained from specimen vendors were tested with investigational Alinity s Anti-HCV II assay. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
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| Follow-Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Specificity | US blood and/or plasmapheresis donor specimens collected as part of routine blood and/or plasma donation were tested with the investigational Alinity s Anti-HCV II assay. |
| BG001 | Sensitivity |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Units |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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% | 15,526 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s Anti-HCV II assay. | Posted | Count of Units | Specimen | Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day. | Specimen | Specimen |
Subject adverse events related to blood collection during the 4-6 weeks of donor follow-up specimen collection.
Adverse Events (AE) had to be reported for donors who returned to provide follow-up sample specifically collected for the study.
Specificity samples were leftover deidentified specimens from routine blood and plasmapheresis donations, not specifically collected for the study. AEs could not be reported for this population.
Frozen samples provided by Abbott (HCV positive and at increased risk of HCV infection) were obtained from specimen vendors. AEs could not be reported for these populations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alinity s Anti-HCV II Follow-Up Specimen Collection | For all donor specimens with investigational Alinity s results that are discordant with final status after supplemental testing, an attempt was made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis. 6 donors were eligible for follow-up collection for Alinity s Anti-HCV II study. 3 out of 6 were able to provide follow-up specimen. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tuan Bui (Manager Clinical Research) | Abbott Laboratories | 224-668-4702 | tuan.l.bui@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2020 | Aug 4, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Information Sheet | Mar 8, 2021 | Aug 10, 2021 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Follow-Up Consent | Mar 8, 2021 | Aug 10, 2021 | ICF_002.pdf |
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Evaluation of assay performance characteristics.
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|
| Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day. |
| Knoxville |
| Tennessee |
| 37932 |
| United States |
| QualTex Laboratories | San Antonio | Texas | 78201 | United States |
| Bloodworks Northwest | Renton | Washington | 98057 | United States |
| NOT COMPLETED |
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Specimens characterized as positive obtained from specimen vendors were tested by the investigational Alinity s Anti-HCV II assay.
| BG002 | Increased Risk Population | Specimens with Increased Risk of Infection obtained from specimen vendors were tested with investigational Alinity s Anti-HCV II assay. |
| BG003 | Total | Total of all reporting groups |
| Specimens |
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| Specimens |
| Specimens |
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| Sex/Gender, Customized | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Hispanic or Latino counted under Ethnicity section | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Specificity | US blood and/or plasmapheresis donor specimens collected as part of routine blood and/or plasma donation were tested with the investigational Alinity s Anti-HCV II assay. |
|
|
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| Primary | 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% | 403 specimens characterized as positive for Anti-HCV, 3 of which were classified as Acute HCV positive, were tested with Alinity s Anti-HCV II assay. | Posted | Count of Units | Specimen | Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day. | Specimen | Specimen |
|
|
|
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| Secondary | Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay. | 404 specimens from subjects at increased risk for HCV infection were obtained from specimen vendors and tested with 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 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% | A total of 404 specimens from subjects known to be at increased risk for HCV infection were obtained from specimen vendors and tested with investigational Alinity s Anti-HCV II assay. | Posted | Count of Units | Specimen | Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day. | Specimen | Specimen |
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
The PI must provide a copy of any proposed publication/presentation at least 60 days prior to submission for sponsor's review/approval. The PI must incorporate changes as the sponsor requires in order to protect the sponsor's proprietary rights and interests. The sponsor may require the PI to include acknowledgement of the sponsor's role in the study. The PI may be requested to delay publication/presentation an extra 60 days to enable sponsor to secure patent or other proprietary protection.
| Female |
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| Unknown |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Alinity s Anti-HCV II Reactive, Final Status Positive |
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| Alinity s Anti-HCV II Reactive, Final Status Negative |
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| Alinity s Anti-HCV II Reactive, Final Status Indeterminate |
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