Healthy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAlinity 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.
Sponsors
Abbott Transfusion Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Evaluation of assay performance characteristics.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Serum or ethylenediaminetetraacetic acid (EDTA) plasma from a blood donor or a plasma from a plasmapheresis donor.
Exclusion criteria
* Previous participation in this study. Each subject must be represented only once in the study. 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay. | Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day. | 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% |
| Assay Sensitivity Results for Participants (Specimens) Characterized as Positive Tested With Alinity s Anti-HCV II Assay. | Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day. | 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% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay. | Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day. | 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% |
Countries
United States
Participant flow
Recruitment details
Alinity s Anti-HCV II: 16,388
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15,581 |
| Sensitivity Specimens characterized as positive obtained from specimen vendors were tested by the investigational Alinity s Anti-HCV II assay. | 403 |
| Sensitivity Specimens characterized as positive obtained from specimen vendors were tested by the investigational Alinity s Anti-HCV II assay. | 403 |
| Increased Risk Population Specimens with Increased Risk of Infection obtained from specimen vendors were tested with investigational Alinity s Anti-HCV II assay. | 404 |
| Increased Risk Population Specimens with Increased Risk of Infection obtained from specimen vendors were tested with investigational Alinity s Anti-HCV II assay. | 404 |
| Total | 17,210 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Follow-Up | Lost to Follow-up | 3 | 0 | 0 |
| Screening | Insufficient Sample | 1 | 0 | 0 |
| Screening | Protocol Violation | 54 | 0 | 0 |
Baseline characteristics
| Characteristic | Specificity | Sensitivity | Increased Risk Population | Total |
|---|---|---|---|---|
| Age, Customized 16 Years old | 0 Specimens | 2 Specimens | 0 Specimens | 2 Specimens |
| Age, Customized 17 Years old | 1 Specimens | 2 Specimens | 0 Specimens | 3 Specimens |
| Age, Customized ≥18 Years old | 15,580 Specimens | 397 Specimens | 404 Specimens | 16381 Specimens |
| Age, Customized 3 Years old | 0 Specimens | 1 Specimens | 0 Specimens | 1 Specimens |
| Age, Customized 6 Years old | 0 Specimens | 1 Specimens | 0 Specimens | 1 Specimens |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 38 Participants | 35 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 90 Participants | 369 Participants | 459 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15,581 Participants | 275 Participants | 0 Participants | 15856 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 43 Participants | 262 Participants | 305 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 5 Participants | 14 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15,581 Participants | 275 Participants | 2 Participants | 15858 Participants |
| Race (NIH/OMB) White | 0 Participants | 38 Participants | 88 Participants | 126 Participants |
| Region of Enrollment United States | 15,581 participants | 403 participants | 404 participants | 16388 participants |
| Sex/Gender, Customized Female | 0 Participants | 132 Participants | 157 Participants | 289 Participants |
| Sex/Gender, Customized Male | 0 Participants | 271 Participants | 247 Participants | 518 Participants |
| Sex/Gender, Customized Unknown | 15,581 Participants | 0 Participants | 0 Participants | 15581 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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%
Time frame: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Specificity | Assay Sensitivity Results for Participants (Specimens) Characterized as Positive Tested With Alinity s Anti-HCV II Assay. | Alinity s Anti-HCV II Nonreactive | 0 Specimen |
| Specificity | Assay Sensitivity Results for Participants (Specimens) Characterized as Positive Tested With Alinity s Anti-HCV II Assay. | Alinity s Anti-HCV II Repeatedly Reactive | 403 Specimen |
95% CI: [99.09, 100]Sensitivity
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%
Time frame: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.
Population: 15,526 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s Anti-HCV II assay.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Specificity | Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay. | Alinity s Anti-HCV II Nonreactive, Final Status Negative | 15,506 Specimen |
| Specificity | Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay. | Alinity s Anti-HCV II Repeatedly Reactive, Final Status Negative | 6 Specimen |
| Specificity | Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay. | Alinity s Anti-HCV II Repeatedly Reactive, Final Status Positive | 14 Specimen |
95% CI: [99.92, 99.99]Binomial Distribution
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%
Time frame: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Specificity | Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay. | Alinity s Anti-HCV II Nonreactive, Final Status Negative | 324 Specimen |
| Specificity | Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay. | Alinity s Anti-HCV II Nonreactive, Final Status Positive | 0 Specimen |
| Specificity | Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay. | Alinity s Anti-HCV II Nonreactive, Final Status Indeterminate | 0 Specimen |
| Specificity | Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay. | Alinity s Anti-HCV II Reactive, Final Status Positive | 70 Specimen |
| Specificity | Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay. | Alinity s Anti-HCV II Reactive, Final Status Negative | 10 Specimen |
| Specificity | Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay. | Alinity s Anti-HCV II Reactive, Final Status Indeterminate | 0 Specimen |
Comparison: Sensitivity95% CI: [94.87, 100]Sensitivity