Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol

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.

• Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay (Device): 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 Assay (Device): 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 Assay (Device): 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 Assay (Device): 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 Assay (Device): 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 Assay (Device): 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 outcomes

• Alinity s HBsAg Assay Specificity [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [10 months]: Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.

Secondary outcomes

• Alinity s HBsAg Assay Increased Risk of HBV Infection [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.
• Alinity s HBsAg Assay Recovered HBV Infection [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.
• Alinity s HTLV Assay Increased Risk of HTLV Infection [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.
• Alinity s HTLV I/II Assay Endemics [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.
• Alinity s Anti-HCV Assay Increased Risk for HCV [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.
• Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2 [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.
• Alinity s HIV Ag/Ab Combo Assay Endemics [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.
• Alinity s Anti-HBc Assay Increased Risk for HBV [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.
• Alinity s Chagas Assay Endemics [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

Sex: All, ages: 16 Years to any, accepts healthy volunteers

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.

Participant flow

Outcome results

• Alinity s HBsAg Assay Specificity (Primary), Count of participants, Participants: Alinity s HBsAg Assay Specificity 16985
• Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity (Primary), Count of participants, Participants: Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity 0
• Alinity s HTLV I/II Assay Specificity (Primary), Count of participants, Participants: Alinity s HTLV I/II Assay Specificity 15864
• Alinity s HTLV I/II Assay Sensitivity (Primary), Count of participants, Participants: Alinity s HTLV I/II Assay Sensitivity 0
• Alinity s Anti-HCV Assay Specificity (Primary), Count of participants, Participants: Alinity s Anti-HCV Assay Specificity 16975
• Alinity s Anti-HCV Assay Sensitivity (Primary), Count of participants, Participants: Alinity s Anti-HCV Assay Sensitivity 0
• Alinity s HIV Ag/Ab Combo Assay Specificity (Primary), Count of participants, Participants: Alinity s HIV Ag/Ab Combo Assay Specificity 16981
• Alinity s HIV Ag/Ab Combo Assay Sensitivity (Primary), Count of participants, Participants: Alinity s HIV Ag/Ab Combo Assay Sensitivity 0
• Alinity s Anti-HBc Assay Specificity (Primary), Count of participants, Participants: Alinity s Anti-HBc Assay Specificity 15833
• Alinity s Anti-HBc Assay Sensitivity (Primary), Count of participants, Participants: Alinity s Anti-HBc Assay Sensitivity 0
• Alinity s Chagas Assay Specificity (Primary), Count of participants, Participants: Alinity s Chagas Assay Specificity 15787
• Alinity s Chagas Assay Sensitivity (Primary), Count of participants, Participants: Alinity s Chagas Assay Sensitivity 0
• Alinity s HBsAg Assay Increased Risk of HBV Infection (Secondary), Count of participants, Participants: Alinity s HBsAg Assay Increased Risk of HBV Infection 400
• Alinity s HBsAg Assay Recovered HBV Infection (Secondary), Count of participants, Participants: Alinity s HBsAg Assay Recovered HBV Infection 51
• Alinity s HTLV Assay Increased Risk of HTLV Infection (Secondary), Count of participants, Participants: Alinity s HTLV Assay Increased Risk of HTLV-I/II Infection 491
• Alinity s HTLV I/II Assay Endemics (Secondary), Count of participants, Participants: Alinity s HTLV I/II Assay Endemics 495
• Alinity s Anti-HCV Assay Increased Risk for HCV (Secondary), Count of participants, Participants: Alinity s Anti-HCV Assay Increased Risk for HCV 316
• Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2 (Secondary), Count of participants, Participants: Alinity s HIV Ag/Ab Combo Assay Increased Risk for HIV-1/2 582
• Alinity s HIV Ag/Ab Combo Assay Endemics (Secondary), Count of participants, Participants: Alinity s HIV Ag/Ab Combo Assay Endemics 472
• Alinity s Anti-HBc Assay Increased Risk for HBV (Secondary), Count of participants, Participants: Alinity s Anti-HBc Assay Increased Risk for HBV 319
• 1 more outcome measures not shown.

Adverse events

Time frame: Subject adverse events related to blood collection during the 3-6 months of donor follow-up specimen collection.

• Informed Consent Form: Alinity s Follow-Up Study - Donor Consent for Central IRB (PDF, 2017-08-17)
• Informed Consent Form: Alinity s Follow-Up Study - Donor Consent for Local IRB (PDF, 2017-11-17)
• Study Protocol and Statistical Analysis Plan (PDF, 2018-04-24)
• Informed Consent Form: Information Sheet for Central IRB (PDF, 2017-08-23)
• Informed Consent Form: Information Sheet for Local IRB (PDF, 2017-11-17)

• 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
• Toby L Simon, M.D., Principal investigator, CSL Plasma Inc.
• Susan L Stramer, Ph.D., Principal investigator, American Red Cross National Testing Laboratory