HealthyNCT04862065

Alinity s Anti-HCV II - Clinical Evaluation Protocol

A study testing Alinity s Anti-HCV II in people with Healthy, run by Abbott Transfusion Medicine at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Alinity s Anti-HCV II
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16,388 participants
Where: 4 sitesUnited States
Study dates: 19 Apr 2021to 5 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Serum or ethylenediaminetetraacetic acid (EDTA) plasma from a blood donor or a plasma from a plasmapheresis donor.

Who cannot join

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/exclusion criteria that the clinical sites need to verify prior to testing. Inclusion and exclusion criteria only apply to specificity specimens.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

CSL Plasma Inc.
Knoxville, Tennessee, 37932
Bloodworks Northwest
Renton, Washington, 98057
Innovative Blood Resources
Saint Paul, Minnesota, 55114
QualTex Laboratories
San Antonio, Texas, 78201

Other trials in United States

About this study

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.

Read the 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.

Conditions: Healthy
Being tested: Alinity s Anti-HCV II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Alinity s Anti-HCV IIDevice
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.

Study groups in NCT04862065
Study group	Role	What they receive
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. Receives: Device: Alinity s Anti-HCV II

What is being measured

The primary outcome is the main question the study is designed to answer.

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%
Measured: 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%
Measured: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.

Secondary outcomes (1)

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%
Measured: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 20215 Aug 2021

First posted27 Apr 2021
Study start19 Apr 2021
Primary completion21 Jun 2021
Study completion5 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Model description: Evaluation of assay performance characteristics.
Masking: None (open label)
Enrolment: 16,388 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04862065
Sponsor's protocol ID: T3M3-02-19H04-01
Status last verified: Sep 2022
First submitted: 23 Apr 2021
Last updated: 14 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alinity s Anti-HCV II - Clinical Evaluation Protocol
ClinicalTrials.gov ID: NCT04862065
Acronym / sponsor ID: T3M3-02-19H04-01
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 16,388 participants (actual)
Lead sponsor: Abbott Transfusion MedicineIndustry (pharma, biotech, devices)
Study start: 19 Apr 2021 (actual)
Primary completion: 21 Jun 2021 (actual)
Study completion: 5 Aug 2021 (actual)
First posted: 27 Apr 2021 (actual)
Results: Posted 16 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study evaluates the Alinity s Anti-HCV II investigational assay using the Alinity s System.

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.

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Evaluation of assay performance characteristics.

Arm	Type	Receives
Screening	Other	Device: Alinity s Anti-HCV IIAlinity 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Serum or ethylenediaminetetraacetic acid (EDTA) plasma from a blood donor or a plasma from a plasmapheresis donor.

Key exclusion criteria (2 listed)

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/exclusion criteria that the clinical sites need to verify prior to testing. Inclusion and exclusion criteria only apply to specificity specimens.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Alinity s Anti-HCV IIFor 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.	Device	Screening

Primary outcome

Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay.
Time frame: 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.
Time frame: 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%

1 secondary outcome

Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay.
Time frame: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.

Results and safety

Results posted to the registry on 16 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Specificity	15,581	15,526
Sensitivity	403	403
Increased Risk Population	404	404

Primary outcome: Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay.

Time frame: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.. Count of units. Unit: Specimen

Measure	Specificity n = 15,526
Alinity s Anti-HCV II Nonreactive, Final Status Negative	15,506
Alinity s Anti-HCV II Repeatedly Reactive, Final Status Negative	6
Alinity s Anti-HCV II Repeatedly Reactive, Final Status Positive	14

Specificity: Clinical Specificity (%): 99.96 (95% CI 99.92 to 99.99), Binomial Distribution

Population analysed: 15,526 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s Anti-HCV II assay.

Primary outcome: Assay Sensitivity Results for Participants (Specimens) Characterized as Positive Tested With Alinity s Anti-HCV II Assay.

Time frame: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.. Count of units. Unit: Specimen

Measure	Sensitivity n = 403
Alinity s Anti-HCV II Nonreactive	0
Alinity s Anti-HCV II Repeatedly Reactive	403

Sensitivity: Point Estimate: 100.00 (95% CI 99.09 to 100.00), Sensitivity

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Subject adverse events related to blood collection during the 4-6 weeks of donor follow-up specimen collection.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alinity s Anti-HCV II Follow-Up Specimen Collection	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Healthy

Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Theresa A Nester, MD principal investigator

Bloodworks Northwest

Thomas S Jones, Ph.D. principal investigator

QualTex Laboratories

Toby L Simon, M.D. principal investigator

CSL Plasma Inc.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Alinity s Anti-HCV II in people with Healthy, run by Abbott Transfusion Medicine at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay. (time frame: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04862065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.