Trial Outcomes & Findings for Alinity s Anti-HCV II - Clinical Evaluation Protocol (NCT NCT04862065)
NCT ID: NCT04862065
Last Updated: 2022-10-14
Results Overview
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%
COMPLETED
NA
16388 participants
Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.
2022-10-14
Participant Flow
Alinity s Anti-HCV II: 16,388
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Screening
STARTED
|
15581
|
403
|
404
|
|
Screening
COMPLETED
|
15526
|
403
|
404
|
|
Screening
NOT COMPLETED
|
55
|
0
|
0
|
|
Follow-Up
STARTED
|
6
|
0
|
0
|
|
Follow-Up
COMPLETED
|
3
|
0
|
0
|
|
Follow-Up
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Screening
Protocol Violation
|
54
|
0
|
0
|
|
Screening
Insufficient Sample
|
1
|
0
|
0
|
|
Follow-Up
Lost to Follow-up
|
3
|
0
|
0
|
Baseline Characteristics
Hispanic or Latino counted under Ethnicity section
Baseline characteristics by cohort
| Measure |
Specificity
n=15581 Specimens
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.
|
Sensitivity
n=403 Specimens
Specimens characterized as positive obtained from specimen vendors were tested by the investigational Alinity s Anti-HCV II assay.
|
Increased Risk Population
n=404 Specimens
Specimens with Increased Risk of Infection obtained from specimen vendors were tested with investigational Alinity s Anti-HCV II assay.
|
Total
n=16388 Specimens
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
≥18 Years old
|
15,580 Specimens
n=15581 Specimens
|
397 Specimens
n=403 Specimens
|
404 Specimens
n=404 Specimens
|
16381 Specimens
n=16388 Specimens
|
|
Age, Customized
17 Years old
|
1 Specimens
n=15581 Specimens
|
2 Specimens
n=403 Specimens
|
0 Specimens
n=404 Specimens
|
3 Specimens
n=16388 Specimens
|
|
Age, Customized
16 Years old
|
0 Specimens
n=15581 Specimens
|
2 Specimens
n=403 Specimens
|
0 Specimens
n=404 Specimens
|
2 Specimens
n=16388 Specimens
|
|
Age, Customized
6 Years old
|
0 Specimens
n=15581 Specimens
|
1 Specimens
n=403 Specimens
|
0 Specimens
n=404 Specimens
|
1 Specimens
n=16388 Specimens
|
|
Age, Customized
3 Years old
|
0 Specimens
n=15581 Specimens
|
1 Specimens
n=403 Specimens
|
0 Specimens
n=404 Specimens
|
1 Specimens
n=16388 Specimens
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=15 Participants
|
271 Participants
n=403 Participants
|
247 Participants
n=404 Participants
|
518 Participants
n=16388 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=15 Participants
|
132 Participants
n=403 Participants
|
157 Participants
n=404 Participants
|
289 Participants
n=16388 Participants
|
|
Sex/Gender, Customized
Unknown
|
15,581 Participants
n=15 Participants
|
0 Participants
n=403 Participants
|
0 Participants
n=404 Participants
|
15581 Participants
n=16388 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=15 Participants
|
38 Participants
n=403 Participants
|
35 Participants
n=404 Participants
|
73 Participants
n=16388 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=15 Participants
|
90 Participants
n=403 Participants
|
369 Participants
n=404 Participants
|
459 Participants
n=16388 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15,581 Participants
n=15 Participants
|
275 Participants
n=403 Participants
|
0 Participants
n=404 Participants
|
15856 Participants
n=16388 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants • Hispanic or Latino counted under Ethnicity section
|
2 Participants
n=365 Participants • Hispanic or Latino counted under Ethnicity section
|
1 Participants
n=369 Participants • Hispanic or Latino counted under Ethnicity section
|
3 Participants
n=16315 Participants • Hispanic or Latino counted under Ethnicity section
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants • Hispanic or Latino counted under Ethnicity section
|
2 Participants
n=365 Participants • Hispanic or Latino counted under Ethnicity section
|
2 Participants
n=369 Participants • Hispanic or Latino counted under Ethnicity section
|
4 Participants
n=16315 Participants • Hispanic or Latino counted under Ethnicity section
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants • Hispanic or Latino counted under Ethnicity section
|
0 Participants
n=365 Participants • Hispanic or Latino counted under Ethnicity section
|
0 Participants
n=369 Participants • Hispanic or Latino counted under Ethnicity section
|
0 Participants
n=16315 Participants • Hispanic or Latino counted under Ethnicity section
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants • Hispanic or Latino counted under Ethnicity section
|
43 Participants
n=365 Participants • Hispanic or Latino counted under Ethnicity section
|
262 Participants
n=369 Participants • Hispanic or Latino counted under Ethnicity section
|
305 Participants
n=16315 Participants • Hispanic or Latino counted under Ethnicity section
|
|
Race (NIH/OMB)
White
|
0 Participants
n=15 Participants • Hispanic or Latino counted under Ethnicity section
|
38 Participants
n=365 Participants • Hispanic or Latino counted under Ethnicity section
|
88 Participants
n=369 Participants • Hispanic or Latino counted under Ethnicity section
|
126 Participants
n=16315 Participants • Hispanic or Latino counted under Ethnicity section
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants • Hispanic or Latino counted under Ethnicity section
|
5 Participants
n=365 Participants • Hispanic or Latino counted under Ethnicity section
|
14 Participants
n=369 Participants • Hispanic or Latino counted under Ethnicity section
|
19 Participants
n=16315 Participants • Hispanic or Latino counted under Ethnicity section
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15,581 Participants
n=15 Participants • Hispanic or Latino counted under Ethnicity section
|
275 Participants
n=365 Participants • Hispanic or Latino counted under Ethnicity section
|
2 Participants
n=369 Participants • Hispanic or Latino counted under Ethnicity section
|
15858 Participants
n=16315 Participants • Hispanic or Latino counted under Ethnicity section
|
|
Region of Enrollment
United States
|
15,581 participants
n=15 Participants
|
403 participants
n=403 Participants
|
404 participants
n=404 Participants
|
16388 participants
n=16388 Participants
|
PRIMARY outcome
Timeframe: 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.
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%
Outcome measures
| Measure |
Specificity
n=15526 Specimen
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: 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.
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%
Outcome measures
| Measure |
Specificity
n=403 Specimen
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.
|
|---|---|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: 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.
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%
Outcome measures
| Measure |
Specificity
n=404 Specimen
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Alinity s Anti-HCV II Follow-Up Specimen Collection
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tuan Bui (Manager Clinical Research)
Abbott Laboratories
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER