HealthyNCT03285295

Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol

A study testing Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay, Alinity s HTLV I/II Assay and Alinity s Anti-HCV Assay in people with Healthy, run by Abbott Diagnostics Division at 5 sites in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay, Alinity s HTLV I/II Assay and Alinity s Anti-HCV Assay
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106,881 participants
Where: 5 sitesUnited States
Study dates: 15 Sep 2017to 21 Jun 2018
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 16 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Healthy donors who consented to participate in the study.

Who cannot join

For testing with the Alinity s Chagas assay, exclude donors that have been screened on a previous donation using a licensed test for antibodies to T cruzi.
Note: A subject may participate at different times during the study for separate assay studies, but each subject should be represented only once for each assay.
The protocol does not define an age limit. A donor must be at least 17 years old to donate to the general blood supply, or 16 years old with parental/guardian consent, if allowed by state law.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Biotest Pharmaceuticals Corporation
Boca Raton, Florida, 33431
CSL Plasma Inc.
Knoxville, Tennessee, 37932
Bloodworks Northwest
Renton, Washington, 98057
QualTex Laboratories
San Antonio, Texas, 78201
American Red Cross National Testing Laboratory
St Louis, Missouri, 63108

Other trials in United States

About this study

The objective of this study is to demonstrate the performance and intended use of each of the Alinity s investigational assays in a donor screening environment using clinical specimens to evaluate assay performance characteristics. A comparison of assay performance will be done versus the Food and Drug Administration (FDA) licensed assays. The data will be used to support regulatory submissions and/or publications.

Read the detailed description

This study evaluates Alinity s investigational assays using the Alinity s System. The Alinity s System is a high-volume, automated, blood-screening analyzer that is designed to determine the presence of specific antigens and antibodies by using chemiluminescent microparticle immunoassay (CMIA) detection technology. The system performs high-throughput routine and stat processing that features continuous access and automated retesting.

The Alinity s System is used for infectious disease marker testing in blood-screening and plasma laboratories for the following assays: Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory and HIV Ag/Ab Combo.

Conditions: Healthy
Being tested: Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay, Alinity s HTLV I/II Assay, Alinity s Anti-HCV Assay, Alinity s HIV Ag/Ab Combo Assay, Alinity s Anti-HBc Assay

What participants receive

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

Alinity s HBsAg and Alinity s HBsAg Confirmatory AssayDevice
For all donor specimens with investigational Alinity s HBsAg and Alinity s HBsAg Confirmatory 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.
Alinity s HTLV I/II AssayDevice
For all donor specimens with investigational Alinity s HTLV I/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.
Alinity s Anti-HCV AssayDevice
For all donor specimens with investigational Alinity s Anti-HCV 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.
Alinity s HIV Ag/Ab Combo AssayDevice
For all donor specimens with investigational Alinity s HIV Ag/Ab Combo 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.
Alinity s Anti-HBc AssayDevice
For all donor specimens with investigational Alinity s Anti-HBc 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.
Alinity s Chagas AssayDevice
For all donor specimens with investigational Alinity s Chagas 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 NCT03285295
Study group	Role	What they receive
Screening	Experimental	All subjects will be tested with at least one of the investigational Alinity s assays (Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory, HIV Ag/Ab Combo) on Alinity s system. Receives: Device: Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay; Device: Alinity s HTLV I/II Assay; Device: Alinity s Anti-HCV Assay; Device: Alinity s HIV Ag/Ab Combo Assay; Device: Alinity s Anti-HBc Assay; Device: Alinity s Chagas Assay

What is being measured

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

Alinity s HBsAg Assay Specificity
Total of 16993 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HBsAg Assay. Repeatedly reactive specimens were further tested with Alinity s HBsAg Confirmatory and supplemental assays, if required.
Measured: 10 months
Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity
Total of 432 specimens from subjects known to be HBsAg positive were tested with Alinity s HBsAg and HBsAg Confirmatory assay.
Measured: 10 months
Alinity s HTLV I/II Assay Specificity
Total of 15877 serum and plasma specimens from whole blood donors specimens were tested with Alinity s HTLV I/II Assay. Repeatedly reactive specimens were further tested with Alinity s HTLV I/II and supplemental assays, if required.
Measured: 10 months
Alinity s HTLV I/II Assay Sensitivity
Total of 706 specimens from subjects known to be HTLV positive were tested with Alinity s HTLV I/II assay. The population consists of the following:
Anti-HTLV I Positive n = 461 Anti-HTLV II positive n = 141 Anti-HTLV III positive - Undifferentiated n = 4 Individual with HTLV I/II Associated Diseases n = 100
Measured: 10 months
Alinity s Anti-HCV Assay Specificity
Total of 16,999 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s Anti-HCV assay. Repeatedly reactive specimens were tested further with supplemental assays, if required.
Measured: 10 months
Alinity s Anti-HCV Assay Sensitivity
Total of 402 specimens from subjects known to be Anti-HCV positive were tested with Alinity s Anti-HCV assay.
Measured: 10 months
Alinity s HIV Ag/Ab Combo Assay Specificity
Total of 16996 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HIV Ag/Ab Combo Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.
Measured: 10 months
Alinity s HIV Ag/Ab Combo Assay Sensitivity
Total of 1336 specimens from subjects known to be HIV-1/2 positive were tested with Alinity s HIV Ag/Ab Combo assay.
Measured: 10 months
Alinity s Anti-HBc Assay Specificity
Total of 15877 serum and plasma specimens from whole blood donor specimens were tested with Alinity s Anti-HBc Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.
Measured: 10 months
Alinity s Anti-HBc Assay Sensitivity
Total of 404 specimens from individuals with hepatitis B infection were tested with investigational Alinity s Anti-HBc assay. The population consists of the following:
Acute Hepatitis B infection n = 28 Chronic Hepatitis B infection n = 97 Recovered Hepatitis B infection n = 279
Measured: 10 months
Alinity s Chagas Assay Specificity
Total of 15804 serum and plasma specimens from whole blood donors specimens were tested with Alinity s Chagas Assay. Repeatedly reactive specimens were further tested with Alinity s Chagas and supplemental assays, if required.
Measured: 10 months
Alinity s Chagas Assay Sensitivity
Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.
Measured: 10 months

Secondary outcomes (9)

Alinity s HBsAg Assay Increased Risk of HBV Infection
Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s HBsAg assay.
Sensitivity and Specificity not applicable.
Measured: 10 months
Alinity s HBsAg Assay Recovered HBV Infection
Total of 51 specimens from subjects classified as recovered HBV infection were tested with investigational Alinity s HBsAg assay.
Sensitivity/Specificity calculation for this population not applicable.
Measured: 10 months
Alinity s HTLV Assay Increased Risk of HTLV Infection
Total of 502 specimens from subjects known to be at increased risk for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay.
Sensitivity and Specificity not applicable.
Measured: 10 months
Alinity s HTLV I/II Assay Endemics
Total of 509 specimens from subjects collected from areas known to be endemic for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay. Sensitivity and Specificity not applicable.
Measured: 10 months
Alinity s Anti-HCV Assay Increased Risk for HCV
Total of 407 specimens from subjects known to be at increased risk for HCV infection were tested with investigational Alinity s Anti-HCV assay.
Measured: 10 months
Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2
Total of 605 specimens from subjects known to be at increased risk for HIV-1/2 infection were tested with investigational Alinity s HIV Ag/Ab Combo assay.
Sensitivity and Specificity not applicable.
Measured: 10 months
Alinity s HIV Ag/Ab Combo Assay Endemics
Total of 535 specimens from subjects collected from areas known to be endemic for HIV infection were tested with investigational Alinity s HIV Ag/Ab Combo assay.
Measured: 10 months
Alinity s Anti-HBc Assay Increased Risk for HBV
Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s Anti-HBc assay.
Measured: 10 months
Alinity s Chagas Assay Endemics
Total of 615 specimens from subjects collected from areas known to be endemic for Chagas infection were tested with investigational Alinity s Chagas assay
Measured: 10 months

Timeline

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

15 Sep 201721 Jun 2018

First posted18 Sep 2017
Study start15 Sep 2017
Primary completion23 May 2018
Study completion21 Jun 2018

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. Participants: * Alinity s HBsAg: 17987 * Alinity s HTLV I/II: 17685 * Alinity s Anti-HCV: 17904 * Alinity s HIV Ag/Ab Combo: 19571 * Alinity s Anti-HBc: 16776 * Alinity s Chagas: 16958
Masking: None (open label)
Enrolment: 106,881 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03285295
Sponsor's protocol ID: 9DY-02-14U01-03
Status last verified: Sep 2019
First submitted: 12 Sep 2017
Last updated: 9 Oct 2019
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?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
ClinicalTrials.gov ID: NCT03285295
Acronym / sponsor ID: 9DY-02-14U01-03
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 106,881 participants (actual)
Lead sponsor: Abbott Diagnostics DivisionIndustry (pharma, biotech, devices)
Study start: 15 Sep 2017 (actual)
Primary completion: 23 May 2018 (actual)
Study completion: 21 Jun 2018 (actual)
First posted: 18 Sep 2017 (actual)
Results: Posted 9 Oct 2019

Clinical summary

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

Detailed description

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. Participants: * Alinity s HBsAg: 17987 * Alinity s HTLV I/II: 17685 * Alinity s Anti-HCV: 17904 * Alinity s HIV Ag/Ab Combo: 19571 * Alinity s Anti-HBc: 16776 * Alinity s Chagas: 16958

Arm	Type	Receives
Screening	Experimental	Device: Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay, Device: Alinity s HTLV I/II Assay, Device: Alinity s Anti-HCV Assay, Device: Alinity s HIV Ag/Ab Combo Assay, Device: Alinity s Anti-HBc Assay, Device: Alinity s Chagas AssayAll subjects will be tested with at least one of the investigational Alinity s assays (Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory, HIV Ag/Ab Combo) on Alinity s system.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Healthy donors who consented to participate in the study.

Key exclusion criteria (3 listed)

For testing with the Alinity s Chagas assay, exclude donors that have been screened on a previous donation using a licensed test for antibodies to T cruzi.
Note: A subject may participate at different times during the study for separate assay studies, but each subject should be represented only once for each assay.
The protocol does not define an age limit. A donor must be at least 17 years old to donate to the general blood supply, or 16 years old with parental/guardian consent, if allowed by state law.

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 HBsAg and Alinity s HBsAg Confirmatory AssayFor all donor specimens with investigational Alinity s HBsAg and Alinity s HBsAg Confirmatory 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
Alinity s HTLV I/II AssayFor all donor specimens with investigational Alinity s HTLV I/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
Alinity s Anti-HCV AssayFor all donor specimens with investigational Alinity s Anti-HCV 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
Alinity s HIV Ag/Ab Combo AssayFor all donor specimens with investigational Alinity s HIV Ag/Ab Combo 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
Alinity s Anti-HBc AssayFor all donor specimens with investigational Alinity s Anti-HBc 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
Alinity s Chagas AssayFor all donor specimens with investigational Alinity s Chagas 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

Alinity s HBsAg Assay Specificity
Time frame: 10 months
Total of 16993 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HBsAg Assay. Repeatedly reactive specimens were further tested with Alinity s HBsAg Confirmatory and supplemental assays, if required.
Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity
Time frame: 10 months
Total of 432 specimens from subjects known to be HBsAg positive were tested with Alinity s HBsAg and HBsAg Confirmatory assay.
Alinity s HTLV I/II Assay Specificity
Time frame: 10 months
Total of 15877 serum and plasma specimens from whole blood donors specimens were tested with Alinity s HTLV I/II Assay. Repeatedly reactive specimens were further tested with Alinity s HTLV I/II and supplemental assays, if required.
Alinity s HTLV I/II Assay Sensitivity
Time frame: 10 months
Total of 706 specimens from subjects known to be HTLV positive were tested with Alinity s HTLV I/II assay. The population consists of the following: Anti-HTLV I Positive n = 461 Anti-HTLV II positive n = 141 Anti-HTLV III positive - Undifferentiated n = 4 Individual with HTLV I/II Associated Diseases n = 100
Alinity s Anti-HCV Assay Specificity
Time frame: 10 months
Total of 16,999 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s Anti-HCV assay. Repeatedly reactive specimens were tested further with supplemental assays, if required.
Alinity s Anti-HCV Assay Sensitivity
Time frame: 10 months
Total of 402 specimens from subjects known to be Anti-HCV positive were tested with Alinity s Anti-HCV assay.
Alinity s HIV Ag/Ab Combo Assay Specificity
Time frame: 10 months
Total of 16996 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HIV Ag/Ab Combo Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.
Alinity s HIV Ag/Ab Combo Assay Sensitivity
Time frame: 10 months
Total of 1336 specimens from subjects known to be HIV-1/2 positive were tested with Alinity s HIV Ag/Ab Combo assay.
Alinity s Anti-HBc Assay Specificity
Time frame: 10 months
Total of 15877 serum and plasma specimens from whole blood donor specimens were tested with Alinity s Anti-HBc Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.
Alinity s Anti-HBc Assay Sensitivity
Time frame: 10 months
Total of 404 specimens from individuals with hepatitis B infection were tested with investigational Alinity s Anti-HBc assay. The population consists of the following: Acute Hepatitis B infection n = 28 Chronic Hepatitis B infection n = 97 Recovered Hepatitis B infection n = 279
Alinity s Chagas Assay Specificity
Time frame: 10 months
Total of 15804 serum and plasma specimens from whole blood donors specimens were tested with Alinity s Chagas Assay. Repeatedly reactive specimens were further tested with Alinity s Chagas and supplemental assays, if required.
Alinity s Chagas Assay Sensitivity
Time frame: 10 months
Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.

9 secondary outcomes

Alinity s HBsAg Assay Increased Risk of HBV Infection
Time frame: 10 months
Alinity s HBsAg Assay Recovered HBV Infection
Time frame: 10 months
Alinity s HTLV Assay Increased Risk of HTLV Infection
Time frame: 10 months
Alinity s HTLV I/II Assay Endemics
Time frame: 10 months
Alinity s Anti-HCV Assay Increased Risk for HCV
Time frame: 10 months
Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2
Time frame: 10 months
Alinity s HIV Ag/Ab Combo Assay Endemics
Time frame: 10 months
Alinity s Anti-HBc Assay Increased Risk for HBV
Time frame: 10 months
Alinity s Chagas Assay Endemics
Time frame: 10 months

Results and safety

Results posted to the registry on 9 Oct 2019, 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	17,095	16,993
Sensitivity	438	432
Increased Risk Population	403	403
Endemic Population	0	0
HBV Recovered Population	51	51

Primary outcome: Alinity s HBsAg Assay Specificity

Time frame: 10 months. Count of participants. Unit: Participants

Measure	Alinity s HBsAg Assay Specificity n = 16993
Alinity s HBsAg Nonreactive HBsAg Negative	16985
Alinity s HBsAg Repeatedly Reactive HBsAg Negative	6
Alinity s HBsAg Positive	2

Alinity s HBsAg Assay Specificity: Clinical Specificity (%): 99.96 (95% CI 99.92 to 99.99), Binomial Distribution

Population analysed: All blood and plasmapheresis donor specimens tested with Alinity s HBsAg assay per protocol.

Primary outcome: Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity

Time frame: 10 months. Count of participants. Unit: Participants

Measure	Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity n = 432
Alinity s HBsAg Nonreactive	0
Alinity s HBsAg Reactive Confirmed	432
Alinity s HBsAg Reactive Not Confirmed	0

Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity: Point Estimate: 100.00 (95% CI 99.15 to 100.00), Sensitivity

Population analysed: Specimens from 432 individuals known to be positive for HBsAg were tested with Alinity s HBsAg and HBsAg Confirmatory assay per protocol.

Primary outcome: Alinity s HTLV I/II Assay Specificity

Time frame: 10 months. Count of participants. Unit: Participants

Measure	Alinity s HTLV I/II Assay Specificity n = 15877
Alinity s HTLV Nonreactive HTLV Neg	15864
Alinity s HTLV Repeatedly Reactive HTLV Neg	2
HTLV Positive or Indeterminate	11

Alinity s HTLV I/II Assay Specificity: Clinical Specificity (%): 99.99 (95% CI 99.95 to 100.00), Binomial Distribution

Population analysed: All blood donor specimens tested with Alinity s HTLV I/II assay per protocol.

Primary outcome: Alinity s HTLV I/II Assay Sensitivity

Time frame: 10 months. Count of participants. Unit: Participants

Measure	Alinity s HTLV I/II Assay Sensitivity n = 706
Alinity s HTLV I/II Nonreactive	0
Alinity s HTLV I/II Repeatedly Reactive	706

Alinity s HTLV I/II Assay Sensitivity: Point Estimate: 100.00 (95% CI 99.48 to 100.00), Sensitivity

Population analysed: Specimens from 706 individuals known to be positive for HTLV were tested with Alinity s HTLV I/II assay per protocol.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subject adverse events related to blood collection during the 3-6 months 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 HBsAg Follow-Up Specimen Collection	0 of 0	0 of 0	0
Alinity s HTLV I/II Follow-Up Specimen Collection	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Alinity s Anti-HCV Follow-Up Specimen Collection	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Alinity s HIV Ag/Ab Combo Follow-Up Specimen Collection	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Alinity s Anti-HBc Follow-Up Specimen Collection	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Alinity s Chagas Follow-Up Specimen Collection	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Nancy R Haley, M.D. principal investigator

Bloodworks Northwest

Thomas S Jones, Ph.D. principal investigator

QualTex Laboratories

Susan S Ganz, M.D. principal investigator

Biotest Pharmaceuticals Corporation

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

Questions about this trial

What is this clinical trial studying?

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 3 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 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 9 Oct 2019). 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?

Alinity s HBsAg Assay Specificity (time frame: 10 months). The study lists 12 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 NCT03285295.

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 9 Oct 2019.