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Trial record 2 of 154 for:    Protocol AB

Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03285295
Recruitment Status : Completed
First Posted : September 18, 2017
Results First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Diagnostics Division

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106881 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Screening
Official Title: Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : May 23, 2018
Actual Study Completion Date : June 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Screening
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.
Device: Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay
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.

Device: Alinity s HTLV I/II Assay
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.

Device: Alinity s Anti-HCV Assay
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.

Device: Alinity s HIV Ag/Ab Combo Assay
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.

Device: Alinity s Anti-HBc Assay
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.

Device: Alinity s Chagas Assay
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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


  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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


  11. 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.

  12. 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.


Secondary Outcome Measures :
  1. Alinity s HBsAg Assay Increased Risk of HBV Infection [ Time Frame: 10 months ]

    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.


  2. Alinity s HBsAg Assay Recovered HBV Infection [ Time Frame: 10 months ]

    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.


  3. Alinity s HTLV Assay Increased Risk of HTLV Infection [ Time Frame: 10 months ]

    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.


  4. Alinity s HTLV I/II Assay Endemics [ Time Frame: 10 months ]
    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.

  5. Alinity s Anti-HCV Assay Increased Risk for HCV [ Time Frame: 10 months ]
    Total of 407 specimens from subjects known to be at increased risk for HCV infection were tested with investigational Alinity s Anti-HCV assay.

  6. Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2 [ Time Frame: 10 months ]

    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.


  7. Alinity s HIV Ag/Ab Combo Assay Endemics [ Time Frame: 10 months ]
    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.

  8. Alinity s Anti-HBc Assay Increased Risk for HBV [ Time Frame: 10 months ]
    Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s Anti-HBc assay.

  9. Alinity s Chagas Assay Endemics [ Time Frame: 10 months ]
    Total of 615 specimens from subjects collected from areas known to be endemic for Chagas infection were tested with investigational Alinity s Chagas assay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy donors who consented to participate in the study.

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285295


Locations
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United States, Florida
Biotest Pharmaceuticals Corporation
Boca Raton, Florida, United States, 33431
United States, Missouri
American Red Cross National Testing Laboratory
Saint Louis, Missouri, United States, 63108
United States, Tennessee
CSL Plasma Inc.
Knoxville, Tennessee, United States, 37932
United States, Texas
QualTex Laboratories
San Antonio, Texas, United States, 78201
United States, Washington
Bloodworks Northwest
Renton, Washington, United States, 98057
Sponsors and Collaborators
Abbott Diagnostics Division
Investigators
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Principal Investigator: Nancy R Haley, M.D. Bloodworks Northwest
Principal Investigator: Thomas S Jones, Ph.D. QualTex Laboratories
Principal Investigator: Susan S Ganz, M.D. Biotest Pharmaceuticals Corporation
Principal Investigator: Toby L Simon, M.D. CSL Plasma Inc.
Principal Investigator: Susan L Stramer, Ph.D. American Red Cross National Testing Laboratory
  Study Documents (Full-Text)
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Responsible Party: Abbott Diagnostics Division
ClinicalTrials.gov Identifier: NCT03285295    
Other Study ID Numbers: 9DY-02-14U01-03
First Posted: September 18, 2017    Key Record Dates
Results First Posted: October 9, 2019
Last Update Posted: October 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hepatitis C Antibodies
Immunologic Factors
Physiological Effects of Drugs