An interventional study of Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay and Alinity s HTLV I/II Assay in Healthy, sponsored by Abbott Diagnostics Division. Completed at 5 sites in United States. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-09.
Sponsored by Abbott Diagnostics Division · Not applicable, Interventional, and Screening
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.
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.
Exclusion Criteria:
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.
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 · 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
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.
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.
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 10 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 10 months
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
| Milestone | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population |
|---|---|---|---|---|---|
| Started | 17095 | 438 | 403 | 0 | 51 |
| Completed | 16993 | 432 | 403 | 0 | 51 |
| Not completed | 102 | 6 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 11 | 0 | 0 | 0 | 0 |
| Withdrew: No result on comparator assay | 17 | 0 | 0 | 0 | 0 |
| Withdrew: No results generated | 74 | 6 | 0 | 0 | 0 |
| Milestone | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population |
|---|---|---|---|---|---|
| Started | 8 | 432 | 3 | 0 | 0 |
| Completed | 8 | 432 | 3 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population |
|---|---|---|---|---|---|
| Started | 15968 | 706 | 502 | 509 | 0 |
| Completed | 15877 | 706 | 502 | 509 | 0 |
| Not completed | 91 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 6 | 0 | 0 | 0 | 0 |
| Withdrew: No result on comparator assay | 15 | 0 | 0 | 0 | 0 |
| Withdrew: No results generated | 70 | 0 | 0 | 0 | 0 |
| Milestone | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population |
|---|---|---|---|---|---|
| Started | 12 | 0 | 0 | 0 | 0 |
| Completed | 8 | 0 | 0 | 0 | 0 |
| Not completed | 4 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 4 | 0 | 0 | 0 | 0 |
| Milestone | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population |
|---|---|---|---|---|---|
| Started | 17095 | 402 | 407 | 0 | 0 |
| Completed | 16999 | 402 | 407 | 0 | 0 |
| Not completed | 96 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 12 | 0 | 0 | 0 | 0 |
| Withdrew: No results on comparator assay | 13 | 0 | 0 | 0 | 0 |
| Withdrew: No results generated | 71 | 0 | 0 | 0 | 0 |
| Milestone | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population |
|---|---|---|---|---|---|
| Started | 20 | 0 | 0 | 0 | 0 |
| Completed | 2 | 0 | 0 | 0 | 0 |
| Not completed | 18 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 18 | 0 | 0 | 0 | 0 |
| Milestone | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population |
|---|---|---|---|---|---|
| Started | 17095 | 1336 | 605 | 535 | 0 |
| Completed | 16996 | 1336 | 605 | 535 | 0 |
| Not completed | 99 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 11 | 0 | 0 | 0 | 0 |
| Withdrew: No results on comparator assay | 16 | 0 | 0 | 0 | 0 |
| Withdrew: No results generated | 72 | 0 | 0 | 0 | 0 |
| Milestone | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population |
|---|---|---|---|---|---|
| Started | 15 | 0 | 0 | 0 | 0 |
| Completed | 4 | 0 | 0 | 0 | 0 |
| Not completed | 11 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 11 | 0 | 0 | 0 | 0 |
| Milestone | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population |
|---|---|---|---|---|---|
| Started | 15968 | 405 | 403 | 0 | 0 |
| Completed | 15877 | 404 | 403 | 0 | 0 |
| Not completed | 91 | 1 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 8 | 0 | 0 | 0 | 0 |
| Withdrew: No results on comparator assay | 13 | 1 | 0 | 0 | 0 |
| Withdrew: No results generated | 70 | 0 | 0 | 0 | 0 |
| Milestone | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population |
|---|---|---|---|---|---|
| Started | 16 | 0 | 0 | 0 | 0 |
| Completed | 2 | 0 | 0 | 0 | 0 |
| Not completed | 14 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 14 | 0 | 0 | 0 | 0 |
| Milestone | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population |
|---|---|---|---|---|---|
| Started | 16023 | 320 | 0 | 615 | 0 |
| Completed | 15804 | 320 | 0 | 615 | 0 |
| Not completed | 219 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 76 | 0 | 0 | 0 | 0 |
| Withdrew: No results on comparator assay | 38 | 0 | 0 | 0 | 0 |
| Withdrew: No results generated | 105 | 0 | 0 | 0 | 0 |
| Milestone | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population |
|---|---|---|---|---|---|
| Started | 14 | 0 | 0 | 0 | 0 |
| Completed | 1 | 0 | 0 | 0 | 0 |
| Not completed | 13 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 13 | 0 | 0 | 0 | 0 |
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.
| Participants | Alinity s HBsAg Assay Specificity |
|---|---|
| Alinity s HBsAg Nonreactive HBsAg Negative | 16985 |
| Alinity s HBsAg Repeatedly Reactive HBsAg Negative | 6 |
| Alinity s HBsAg Positive | 2 |
Total of 432 specimens from subjects known to be HBsAg positive were tested with Alinity s HBsAg and HBsAg Confirmatory assay.
| Participants | Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity |
|---|---|
| Alinity s HBsAg Nonreactive | 0 |
| Alinity s HBsAg Reactive Confirmed | 432 |
| Alinity s HBsAg Reactive Not Confirmed | 0 |
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.
| Participants | Alinity s HTLV I/II Assay Specificity |
|---|---|
| Alinity s HTLV Nonreactive HTLV Neg | 15864 |
| Alinity s HTLV Repeatedly Reactive HTLV Neg | 2 |
| HTLV Positive or Indeterminate | 11 |
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
| Participants | Alinity s HTLV I/II Assay Sensitivity |
|---|---|
| Alinity s HTLV I/II Nonreactive | 0 |
| Alinity s HTLV I/II Repeatedly Reactive | 706 |
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.
| Participants | Alinity s Anti-HCV Assay Specificity |
|---|---|
| Alinity s Anti-HCV Nonreactive HCV Negative | 16975 |
| Alinity s Anti-HCV Repeatedly Reactive HCV Neg | 14 |
| HCV Positive or Indeterminate | 10 |
Total of 402 specimens from subjects known to be Anti-HCV positive were tested with Alinity s Anti-HCV assay.
| Participants | Alinity s Anti-HCV Assay Sensitivity |
|---|---|
| Alinity s Anti-HCV Nonreactive | 0 |
| Alinity s Anti-HCV Repeatedly Reactive | 402 |
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.
| Participants | Alinity s HIV Ag/Ab Combo Assay Specificity |
|---|---|
| Alinity s HIV Nonreactive HIV Negative | 16981 |
| Alinity s HIV Repeatedly Reactive HIV Negative | 13 |
| HIV Indeterminate | 2 |
Total of 1336 specimens from subjects known to be HIV-1/2 positive were tested with Alinity s HIV Ag/Ab Combo assay.
| Participants | Alinity s HIV Ag/Ab Combo Assay Sensitivity |
|---|---|
| Alinity s HIV Ag/Ab Combo Nonreactive | 0 |
| Alinity s HIV Ag/Ab Combo Repeatedly Reactive Pos | 1336 |
| Alinity s HIV Ag/Ab Combo Repeatedly Reactive Neg | 0 |
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.
| Participants | Alinity s Anti-HBc Assay Specificity |
|---|---|
| Alinity s Anti-HBc Nonreactive Anti-HBc Negative | 15833 |
| Alinity s Anti-HBc Repeatedly Reactive AntiHBc Neg | 16 |
| Anti-HBc Positive | 28 |
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
| Participants | Alinity s Anti-HBc Assay Sensitivity |
|---|---|
| Alinity s Anti-HBc Nonreactive | 0 |
| Alinity s Anti-HBc Repeatedly Reactive Positive | 404 |
| Alinity s Anti-HBc Repeatedly Reactive Negative | 0 |
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.
| Participants | Alinity s Chagas Assay Specificity |
|---|---|
| Alinity s Chagas Nonreactive Chagas Negative | 15787 |
| Alinity s Chagas Repeatedly Reactive Chagas Neg | 3 |
| Chagas Positive or Indeterminate | 14 |
Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.
| Participants | Alinity s Chagas Assay Sensitivity |
|---|---|
| Alinity s Chagas Nonreactive | 0 |
| Alinity s Chagas Repeatedly Reactive Positive | 320 |
| Alinity s Chagas Repeatedly Reactive Negative | 0 |
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.
| Participants | Alinity s HBsAg Assay Increased Risk of HBV Infection |
|---|---|
| Alinity s HBsAg Nonreactive Negative | 400 |
| Alinity s HBsAg Nonreactive Positive | 0 |
| Alinity s HBsAg Reactive Confirmed | 3 |
| Alinity s HBsAg Reactive Not Confirmed | 0 |
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.
| Participants | Alinity s HBsAg Assay Recovered HBV Infection |
|---|---|
| Alinity s HBsAg Nonreactive Negative | 51 |
| Alinity s HBsAg Nonreactive Positive | 0 |
| Alinity s HBsAg Reactive Confirmed | 0 |
| Alinity s HBsAg Reactive Not Confirmed | 0 |
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.
| Participants | Alinity s HTLV Assay Increased Risk of HTLV-I/II Infection |
|---|---|
| Alinity s HTLV I/II Nonreactive Negative | 491 |
| Alinity s HTLV I/II Nonreactive Positive | 0 |
| Alinity s HTLV I/II Nonreactive Indeterminate | 0 |
| Alinity s HTLV I/II Reactive Indeterminate | 0 |
| Alinity s HTLV I/II Reactive Positive | 11 |
| Alinity s HTLV I/II Reactive Negative | 0 |
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.
| Participants | Alinity s HTLV I/II Assay Endemics |
|---|---|
| Alinity s HTLV I/II Nonreactive Negative | 495 |
| Alinity s HTLV I/II Nonreactive Positive | 0 |
| Alinity s HTLV I/II Nonreactive Indeterminate | 4 |
| Alinity s HTLV I/II Reactive Indeterminate | 0 |
| Alinity s HTLV I/II Reactive Positive | 10 |
| Alinity s HTLV I/II Reactive Negative | 0 |
Total of 407 specimens from subjects known to be at increased risk for HCV infection were tested with investigational Alinity s Anti-HCV assay.
| Participants | Alinity s Anti-HCV Assay Increased Risk for HCV |
|---|---|
| Alinity s Anti-HCV Nonreactive Negative | 316 |
| Alinity s Anti-HCV Noreactive Positive | 0 |
| Alinity s Anti-HCV Nonreactive Indeterminate | 0 |
| Alinity s Anti-HCV Reactive Indeterminate | 0 |
| Alinity s Anti-HCV Reactive Positive | 90 |
| Alinity s Anti-HCV Reactive Negative | 1 |
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.
| Participants | Alinity s HIV Ag/Ab Combo Assay Increased Risk for HIV-1/2 |
|---|---|
| Alinity s HIV Ag/Ab Combo Nonreactive Negative | 582 |
| Alinity s HIV Ag/Ab Combo Nonreactive Positive | 0 |
| Alinity s HIV Ag/Ab Comb Nonreactive Indeterminate | 0 |
| Alinity s HIV Ag/Ab Combo Reactive Indeterminate | 0 |
| Alinity s HIV Ag/Ab Combo Reactive Positive | 21 |
| Alinity s HIV Ag/Ab Combo Reactive Negative | 2 |
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.
| Participants | Alinity s HIV Ag/Ab Combo Assay Endemics |
|---|---|
| Alinity s HIV Ag/Ab Combo Nonreactive Negative | 472 |
| Alinity s HIV Ag/Ab Combo Nonreactive Positive | 0 |
| Alinity s HIV Ag/Ab Comb Nonreactive Indeterminate | 2 |
| Alinity s HIV Ag/Ab Combo Reactive Indeterminate | 10 |
| Alinity s HIV Ag/Ab Combo Reactive Positive | 49 |
| Alinity s HIV Ag/Ab Combo Reactive Negative | 2 |
Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s Anti-HBc assay.
| Participants | Alinity s Anti-HBc Assay Increased Risk for HBV |
|---|---|
| Alinity s Anti-HBc Nonreactive Negative | 319 |
| Alinity s Anti-HBc Nonreactive Positive | 0 |
| Alinity s Anti-HBc Reactive Positive | 70 |
| Alinity s Anti-HBc Reactive Negative | 14 |
Total of 615 specimens from subjects collected from areas known to be endemic for Chagas infection were tested with investigational Alinity s Chagas assay
| Participants | Alinity s Chagas Assay Endemics |
|---|---|
| Alinity s Chagas Nonreactive Negative | 466 |
| Alinity s Chagas Noreactive Positive | 2 |
| Alinity s Chagas Nonreactive Indeterminate | 0 |
| Alinity s Chagas Reactive Indeterminate | 0 |
| Alinity s Chagas Reactive Positive | 146 |
| Alinity s Chagas Reactive Negative | 1 |
Collected over Subject adverse events related to blood collection during the 3-6 months of donor follow-up specimen collection.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alinity s HBsAg Follow-Up Specimen Collection | — | — | — |
| Alinity s HTLV I/II Follow-Up Specimen Collection | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Alinity s Anti-HCV Follow-Up Specimen Collection | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Alinity s HIV Ag/Ab Combo Follow-Up Specimen Collection | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Alinity s Anti-HBc Follow-Up Specimen Collection | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Alinity s Chagas Follow-Up Specimen Collection | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
Donors and pedigree
| Age, Customized(Participants) | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population | Total |
|---|---|---|---|---|---|---|
| ≥16 years — Alinity s HBsAg | 16993 | 432 | 403 | 0 | 51 | 17879 |
| ≥16 years — Alinity s HTLV I/II | 15877 | 706 | 502 | 509 | 0 | 17594 |
| ≥16 years — Alinity s Anti-HCV | 16999 | 402 | 407 | 0 | 0 | 17808 |
| ≥16 years — Alinity s HIV Ag/Ab Combo | 16996 | 1336 | 605 | 535 | 0 | 19472 |
| ≥16 years — Alinity s Anti-HBc | 15877 | 404 | 403 | 0 | 0 | 16684 |
| ≥16 years — Alinity s Chagas | 15804 | 320 | 0 | 615 | 0 | 16739 |
| Sex/Gender, Customized(Participants) | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population | Total |
|---|---|---|---|---|---|---|
| Alinity s HBsAg Gender — Male | 0 | 312 | 288 | 0 | 23 | 623 |
| Alinity s HBsAg Gender — Female | 0 | 92 | 115 | 0 | 28 | 235 |
| Alinity s HBsAg Gender — Unknown | 16993 | 28 | 0 | 0 | 0 | 17021 |
| Alinity s HTLV I/II Gender — Male | 0 | 182 | 335 | 316 | 0 | 833 |
| Alinity s HTLV I/II Gender — Female | 0 | 290 | 167 | 193 | 0 | 650 |
| Alinity s HTLV I/II Gender — Unknown | 15877 | 234 | 0 | 0 | 0 | 16111 |
| Alinity s Anti-HCV Gender — Male | 0 | 241 | 291 | 0 | 0 | 532 |
| Alinity s Anti-HCV Gender — Female | 0 | 161 | 116 | 0 | 0 | 277 |
| Alinity s Anti-HCV Gender — Unknown | 16999 | 0 | 0 | 0 | 0 | 16999 |
| Alinity s HIV Ag/Ab Combo Gender — Male | 0 | 891 | 420 | 279 | 0 | 1590 |
| Alinity s HIV Ag/Ab Combo Gender — Female | 0 | 222 | 185 | 256 | 0 | 663 |
| Alinity s HIV Ag/Ab Combo Gender — Unknown | 16996 | 223 | 0 | 0 | 0 | 17219 |
| Alinity s Anti-HBc Gender — Male | 0 | 230 | 288 | 0 | 0 | 518 |
| Alinity s Anti-HBc Gender — Female | 0 | 165 | 115 | 0 | 0 | 280 |
| Alinity s Anti-HBc Gender — Unknown | 15877 | 9 | 0 | 0 | 0 | 15886 |
| Alinity s Chagas Gender — Male | 0 | 104 | 0 | 216 | 0 | 320 |
| Alinity s Chagas Gender — Female | 0 | 102 | 0 | 399 | 0 | 501 |
| Alinity s Chagas Gender — Unknown | 15804 | 114 | 0 | 0 | 0 | 15918 |
| Race/Ethnicity, Customized(Participants) | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population | Total |
|---|---|---|---|---|---|---|
| Alinity s HBsAg Race/Ethnicity — Asian | 0 | 24 | 3 | 0 | 1 | 28 |
| Alinity s HBsAg Race/Ethnicity — Black or African American | 0 | 123 | 244 | 0 | 6 | 373 |
| Alinity s HBsAg Race/Ethnicity — White | 0 | 45 | 79 | 0 | 13 | 137 |
| Alinity s HBsAg Race/Ethnicity — Hispanic or Latino | 0 | 33 | 71 | 0 | 2 | 106 |
| Alinity s HBsAg Race/Ethnicity — American Indian or Alaskan Native | 0 | 0 | 3 | 0 | 0 | 3 |
| Alinity s HBsAg Race/Ethnicity — Other | 0 | 23 | 3 | 0 | 2 | 28 |
| Alinity s HBsAg Race/Ethnicity — Unknown | 16993 | 184 | 0 | 0 | 27 | 17204 |
| Alinity s HTLV I/II Race/Ethnicity — Asian | 0 | 26 | 4 | 0 | 0 | 30 |
| Alinity s HTLV I/II Race/Ethnicity — Black or African American | 0 | 63 | 154 | 305 | 0 | 522 |
| Alinity s HTLV I/II Race/Ethnicity — White | 0 | 114 | 256 | 0 | 0 | 370 |
| Alinity s HTLV I/II Race/Ethnicity — Hispanic or Latino | 0 | 224 | 87 | 204 | 0 | 515 |
| Alinity s HTLV I/II Race/Ethnicity — American Indian or Alaskan Native | 0 | 5 | 1 | 0 | 0 | 6 |
| Alinity s HTLV I/II Race/Ethnicity — Other | 0 | 7 | 0 | 0 | 0 | 7 |
| Alinity s HTLV I/II Race/Ethnicity — Unknown | 15877 | 267 | 0 | 0 | 0 | 16144 |
| Alinity s Anti-HCV Race/Ethnicity — Asian | 0 | 0 | 2 | 0 | 0 | 2 |
| Alinity s Anti-HCV Race/Ethnicity — Black or African American | 0 | 95 | 239 | 0 | 0 | 334 |
| Alinity s Anti-HCV Race/Ethnicity — White | 0 | 14 | 100 | 0 | 0 | 114 |
| Alinity s Anti-HCV Race/Ethnicity — Hispanic or Latino | 0 | 12 | 62 | 0 | 0 | 74 |
| Alinity s Anti-HCV Race/Ethnicity — American Indian or Alaskan Native | 0 | 0 | 1 | 0 | 0 | 1 |
| Alinity s Anti-HCV Race/Ethnicity — Other | 0 | 0 | 1 | 0 | 0 | 1 |
| Alinity s Anti-HCV Race/Ethnicity — Unknown | 16999 | 281 | 2 | 0 | 0 | 17282 |
| Alinity s HIV Ag/Ab Combo Race/Ethnicity — Asian | 0 | 4 | 5 | 0 | 0 | 9 |
| Alinity s HIV Ag/Ab Combo Race/Ethnicity — Black or African American | 0 | 364 | 404 | 535 | 0 | 1303 |
| Alinity s HIV Ag/Ab Combo Race/Ethnicity — White | 0 | 286 | 115 | 0 | 0 | 401 |
| Alinity s HIV Ag/Ab Combo Race/Ethnicity — Hispanic or Latino | 0 | 430 | 81 | 0 | 0 | 511 |
| Alinity s HIV Ag/Ab Combo Race/Ethnicity — American Indian or Alaskan Native | 0 | 5 | 0 | 0 | 0 | 5 |
| Alinity s HIV Ag/Ab Combo Race/Ethnicity — Other | 0 | 4 | 0 | 0 | 0 | 4 |
| Alinity s HIV Ag/Ab Combo Race/Ethnicity — Unknown | 16996 | 243 | 0 | 0 | 0 | 17239 |
| Alinity s Anti-HBc Race/Ethnicity — Asian | 0 | 5 | 3 | 0 | 0 | 8 |
| Alinity s Anti-HBc Race/Ethnicity — Black or African American | 0 | 40 | 244 | 0 | 0 | 284 |
| Alinity s Anti-HBc Race/Ethnicity — White | 0 | 39 | 79 | 0 | 0 | 118 |
| Alinity s Anti-HBc Race/Ethnicity — Hispanic or Latino | 0 | 4 | 71 | 0 | 0 | 75 |
| Alinity s Anti-HBc Race/Ethnicity — American Indian or Alaskan Native | 0 | 1 | 3 | 0 | 0 | 4 |
| Alinity s Anti-HBc Race/Ethnicity — Other | 0 | 18 | 3 | 0 | 0 | 21 |
| Alinity s Anti-HBc Race/Ethnicity — Unknown | 15877 | 297 | 0 | 0 | 0 | 16174 |
| Alinity s Chagas Race/Ethnicity — Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Alinity s Chagas Race/Ethnicity — Black or African American | 0 | 0 | 0 | 0 | 0 | 0 |
| Alinity s Chagas Race/Ethnicity — White | 0 | 1 | 0 | 9 | 0 | 10 |
| Alinity s Chagas Race/Ethnicity — Hispanic or Latino | 0 | 205 | 0 | 576 | 0 | 781 |
| Alinity s Chagas Race/Ethnicity — American Indian or Alaskan Native | 0 | 0 | 0 | 30 | 0 | 30 |
| Alinity s Chagas Race/Ethnicity — Other | 0 | 0 | 0 | 0 | 0 | 0 |
| Alinity s Chagas Race/Ethnicity — Unknown | 15804 | 114 | 0 | 0 | 0 | 15918 |
| Region of Enrollment(Participants) | Specificity | Sensitivity | Increased Risk Population | Endemic Population | HBV Recovered Population | Total |
|---|---|---|---|---|---|---|
| United States — Alinity s HBsAg | 16993 | 0 | 403 | 0 | 0 | 17396 |
| United States — Alinity s HTLV I/II | 15877 | 0 | 0 | 0 | 0 | 15877 |
| United States — Alinity s Anti-HCV | 16999 | 0 | 407 | 0 | 0 | 17406 |
| United States — Alinity s HIV Ag/Ab Combo | 16996 | 0 | 605 | 0 | 0 | 17601 |
| United States — Alinity s Anti-HBc | 15877 | 0 | 403 | 0 | 0 | 16280 |
| United States — Alinity s Chagas | 15804 | 114 | 0 | 0 | 0 | 15918 |
| United States — Not collected | 0 | 3280 | 502 | 0 | 51 | 3833 |
| Haiti — Alinity s HBsAg | 0 | 0 | 0 | 0 | 0 | 0 |
| Haiti — Alinity s HTLV I/II | 0 | 0 | 0 | 204 | 0 | 204 |
| Haiti — Alinity s Anti-HCV | 0 | 0 | 0 | 0 | 0 | 0 |
| Haiti — Alinity s HIV Ag/Ab Combo | 0 | 0 | 0 | 0 | 0 | 0 |
| Haiti — Alinity s Anti-HBc | 0 | 0 | 0 | 0 | 0 | 0 |
| Haiti — Alinity s Chagas | 0 | 0 | 0 | 0 | 0 | 0 |
| Haiti — Not collected | 0 | 0 | 0 | 0 | 0 | 0 |
| Africa — Alinity s HBsAg | 0 | 0 | 0 | 0 | 0 | 0 |
| Africa — Alinity s HTLV I/II | 0 | 0 | 0 | 100 | 0 | 100 |
| Africa — Alinity s Anti-HCV | 0 | 0 | 0 | 0 | 0 | 0 |
| Africa — Alinity s HIV Ag/Ab Combo | 0 | 0 | 0 | 535 | 0 | 535 |
| Africa — Alinity s Anti-HBc | 0 | 0 | 0 | 0 | 0 | 0 |
| Africa — Alinity s Chagas | 0 | 0 | 0 | 0 | 0 | 0 |
| Africa — Not collected | 0 | 0 | 0 | 0 | 0 | 0 |
| Mexico — Alinity s HBsAg | 0 | 0 | 0 | 0 | 0 | 0 |
| Mexico — Alinity s HTLV I/II | 0 | 0 | 0 | 0 | 0 | 0 |
| Mexico — Alinity s Anti-HCV | 0 | 0 | 0 | 0 | 0 | 0 |
| Mexico — Alinity s HIV Ag/Ab Combo | 0 | 0 | 0 | 0 | 0 | 0 |
| Mexico — Alinity s Anti-HBc | 0 | 0 | 0 | 0 | 0 | 0 |
| Mexico — Alinity s Chagas | 0 | 9 | 0 | 100 | 0 | 109 |
| Mexico — Not collected | 0 | 0 | 0 | 0 | 0 | 0 |
| South America — Alinity s HBsAg | 0 | 0 | 0 | 0 | 0 | 0 |
| South America — Alinity s HTLV I/II | 0 | 0 | 0 | 205 | 0 | 205 |
| South America — Alinity s Anti-HCV | 0 | 0 | 0 | 0 | 0 | 0 |
| South America — Alinity s HIV Ag/Ab Combo | 0 | 0 | 0 | 0 | 0 | 0 |
| South America — Alinity s Anti-HBc | 0 | 0 | 0 | 0 | 0 | 0 |
| South America — Alinity s Chagas | 0 | 197 | 0 | 316 | 0 | 513 |
| South America — Not collected | 0 | 0 | 0 | 0 | 0 | 0 |
| Central America — Alinity s HBsAg | 0 | 0 | 0 | 0 | 0 | 0 |
| Central America — Alinity s HTLV I/II | 0 | 0 | 0 | 0 | 0 | 0 |
| Central America — Alinity s Anti-HCV | 0 | 0 | 0 | 0 | 0 | 0 |
| Central America — Alinity s HIV Ag/Ab Combo | 0 | 0 | 0 | 0 | 0 | 0 |
| Central America — Alinity s Anti-HBc | 0 | 0 | 0 | 0 | 0 | 0 |
| Central America — Alinity s Chagas | 0 | 0 | 0 | 199 | 0 | 199 |
| Central America — Not collected | 0 | 0 | 0 | 0 | 0 | 0 |
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Abbott Diagnostics Division