Healthy
Conditions
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.
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.
Interventions
DEVICEAlinity 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.
DEVICEAlinity 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.
DEVICEAlinity 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.
DEVICEAlinity 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.
DEVICEAlinity 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.
DEVICEAlinity 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.
Sponsors
Abbott Diagnostics Division
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Specificity US blood and/or plasmapheresis donor specimens collected as part of routine blood and/or plasma donation were tested with the investigational Alinity s HBsAg and HBsAg Confirmatory, HTLV I/II, Anti-HCV, HIV Ag/Ab Combo, Anti-HBc, and Chagas assays. | 98,546 |
| Sensitivity Specimens characterized as positive obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s HBsAg and HBsAg Confirmatory, HTLV I/II, Anti-HCV, HIV Ag/Ab Combo, Anti-HBc, and Chagas assays. | 3,600 |
| Increased Risk Population Specimens with Increased Risk of Infection obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from US population with risk for HBV, HTLV I/II, HCV, and HIV infection. | 2,320 |
| Endemic Population Specimens from endemic areas obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s assays. This population includes specimens from individuals which reside in an HTLV I/II, HIV, and Chagas endemic areas. | 1,659 |
| HBV Recovered Population Specimens classified as recovered HBV Infection based on 4 marker hepatitis testing obtained from specimen vendors or collected under separate specimen collection protocols were tested with investigational Alinity s HBsAg assay. | 51 |
| Total | 106,176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Alinity s Anti-HBc | No Results Generated | 70 | 0 | 0 | 0 | 0 |
| Alinity s Anti-HBc | No Results on Comparator Assay | 13 | 1 | 0 | 0 | 0 |
| Alinity s Anti-HBc | Protocol Violation | 8 | 0 | 0 | 0 | 0 |
| Alinity s Anti-HBc Follow-Up | Lost to Follow-up | 14 | 0 | 0 | 0 | 0 |
| Alinity s Anti-HCV | No Results Generated | 71 | 0 | 0 | 0 | 0 |
| Alinity s Anti-HCV | No Results on Comparator Assay | 13 | 0 | 0 | 0 | 0 |
| Alinity s Anti-HCV | Protocol Violation | 12 | 0 | 0 | 0 | 0 |
| Alinity s Anti-HCV Follow-Up | Lost to Follow-up | 18 | 0 | 0 | 0 | 0 |
| Alinity s Chagas | No Results Generated | 105 | 0 | 0 | 0 | 0 |
| Alinity s Chagas | No Results on Comparator Assay | 38 | 0 | 0 | 0 | 0 |
| Alinity s Chagas | Protocol Violation | 76 | 0 | 0 | 0 | 0 |
| Alinity s Chagas Follow-Up | Lost to Follow-up | 13 | 0 | 0 | 0 | 0 |
| Alinity s HBsAg | No Result on Comparator Assay | 17 | 0 | 0 | 0 | 0 |
| Alinity s HBsAg | No Results Generated | 74 | 6 | 0 | 0 | 0 |
| Alinity s HBsAg | Protocol Violation | 11 | 0 | 0 | 0 | 0 |
| Alinity s HIV Ag/Ab Combo | No Results Generated | 72 | 0 | 0 | 0 | 0 |
| Alinity s HIV Ag/Ab Combo | No Results on Comparator Assay | 16 | 0 | 0 | 0 | 0 |
| Alinity s HIV Ag/Ab Combo | Protocol Violation | 11 | 0 | 0 | 0 | 0 |
| Alinity s HIV Ag/Ab Combo Follow-Up | Lost to Follow-up | 11 | 0 | 0 | 0 | 0 |
| Alinity s HTLV I/II | No Result on Comparator Assay | 15 | 0 | 0 | 0 | 0 |
| Alinity s HTLV I/II | No Results Generated | 70 | 0 | 0 | 0 | 0 |
| Alinity s HTLV I/II | Protocol Violation | 6 | 0 | 0 | 0 | 0 |
| Alinity s HTLV I/II Follow-Up | Lost to Follow-up | 4 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Specificity | Total | HBV Recovered Population | Endemic Population | Increased Risk Population | Sensitivity |
|---|---|---|---|---|---|---|
| Age, Customized ≥16 years Alinity s Anti-HBc | 15877 Participants | 16684 Participants | 0 Participants | 0 Participants | 403 Participants | 404 Participants |
| Age, Customized ≥16 years Alinity s Anti-HCV | 16999 Participants | 17808 Participants | 0 Participants | 0 Participants | 407 Participants | 402 Participants |
| Age, Customized ≥16 years Alinity s Chagas | 15804 Participants | 16739 Participants | 0 Participants | 615 Participants | 0 Participants | 320 Participants |
| Age, Customized ≥16 years Alinity s HBsAg | 16993 Participants | 17879 Participants | 51 Participants | 0 Participants | 403 Participants | 432 Participants |
| Age, Customized ≥16 years Alinity s HIV Ag/Ab Combo | 16996 Participants | 19472 Participants | 0 Participants | 535 Participants | 605 Participants | 1336 Participants |
| Age, Customized ≥16 years Alinity s HTLV I/II | 15877 Participants | 17594 Participants | 0 Participants | 509 Participants | 502 Participants | 706 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HBc Race/Ethnicity American Indian or Alaskan Native | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HBc Race/Ethnicity Asian | 0 Participants | 8 Participants | 0 Participants | 0 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HBc Race/Ethnicity Black or African American | 0 Participants | 284 Participants | 0 Participants | 0 Participants | 244 Participants | 40 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HBc Race/Ethnicity Hispanic or Latino | 0 Participants | 75 Participants | 0 Participants | 0 Participants | 71 Participants | 4 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HBc Race/Ethnicity Other | 0 Participants | 21 Participants | 0 Participants | 0 Participants | 3 Participants | 18 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HBc Race/Ethnicity Unknown | 15877 Participants | 16174 Participants | 0 Participants | 0 Participants | 0 Participants | 297 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HBc Race/Ethnicity White | 0 Participants | 118 Participants | 0 Participants | 0 Participants | 79 Participants | 39 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HCV Race/Ethnicity American Indian or Alaskan Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HCV Race/Ethnicity Asian | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HCV Race/Ethnicity Black or African American | 0 Participants | 334 Participants | 0 Participants | 0 Participants | 239 Participants | 95 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HCV Race/Ethnicity Hispanic or Latino | 0 Participants | 74 Participants | 0 Participants | 0 Participants | 62 Participants | 12 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HCV Race/Ethnicity Other | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HCV Race/Ethnicity Unknown | 16999 Participants | 17282 Participants | 0 Participants | 0 Participants | 2 Participants | 281 Participants |
| Race/Ethnicity, Customized Alinity s Anti-HCV Race/Ethnicity White | 0 Participants | 114 Participants | 0 Participants | 0 Participants | 100 Participants | 14 Participants |
| Race/Ethnicity, Customized Alinity s Chagas Race/Ethnicity American Indian or Alaskan Native | 0 Participants | 30 Participants | 0 Participants | 30 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Alinity s Chagas Race/Ethnicity Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Alinity s Chagas Race/Ethnicity Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Alinity s Chagas Race/Ethnicity Hispanic or Latino | 0 Participants | 781 Participants | 0 Participants | 576 Participants | 0 Participants | 205 Participants |
| Race/Ethnicity, Customized Alinity s Chagas Race/Ethnicity Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Alinity s Chagas Race/Ethnicity Unknown | 15804 Participants | 15918 Participants | 0 Participants | 0 Participants | 0 Participants | 114 Participants |
| Race/Ethnicity, Customized Alinity s Chagas Race/Ethnicity White | 0 Participants | 10 Participants | 0 Participants | 9 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Alinity s HBsAg Race/Ethnicity American Indian or Alaskan Native | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Alinity s HBsAg Race/Ethnicity Asian | 0 Participants | 28 Participants | 1 Participants | 0 Participants | 3 Participants | 24 Participants |
| Race/Ethnicity, Customized Alinity s HBsAg Race/Ethnicity Black or African American | 0 Participants | 373 Participants | 6 Participants | 0 Participants | 244 Participants | 123 Participants |
| Race/Ethnicity, Customized Alinity s HBsAg Race/Ethnicity Hispanic or Latino | 0 Participants | 106 Participants | 2 Participants | 0 Participants | 71 Participants | 33 Participants |
| Race/Ethnicity, Customized Alinity s HBsAg Race/Ethnicity Other | 0 Participants | 28 Participants | 2 Participants | 0 Participants | 3 Participants | 23 Participants |
| Race/Ethnicity, Customized Alinity s HBsAg Race/Ethnicity Unknown | 16993 Participants | 17204 Participants | 27 Participants | 0 Participants | 0 Participants | 184 Participants |
| Race/Ethnicity, Customized Alinity s HBsAg Race/Ethnicity White | 0 Participants | 137 Participants | 13 Participants | 0 Participants | 79 Participants | 45 Participants |
| Race/Ethnicity, Customized Alinity s HIV Ag/Ab Combo Race/Ethnicity American Indian or Alaskan Native | 0 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Alinity s HIV Ag/Ab Combo Race/Ethnicity Asian | 0 Participants | 9 Participants | 0 Participants | 0 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Alinity s HIV Ag/Ab Combo Race/Ethnicity Black or African American | 0 Participants | 1303 Participants | 0 Participants | 535 Participants | 404 Participants | 364 Participants |
| Race/Ethnicity, Customized Alinity s HIV Ag/Ab Combo Race/Ethnicity Hispanic or Latino | 0 Participants | 511 Participants | 0 Participants | 0 Participants | 81 Participants | 430 Participants |
| Race/Ethnicity, Customized Alinity s HIV Ag/Ab Combo Race/Ethnicity Other | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Alinity s HIV Ag/Ab Combo Race/Ethnicity Unknown | 16996 Participants | 17239 Participants | 0 Participants | 0 Participants | 0 Participants | 243 Participants |
| Race/Ethnicity, Customized Alinity s HIV Ag/Ab Combo Race/Ethnicity White | 0 Participants | 401 Participants | 0 Participants | 0 Participants | 115 Participants | 286 Participants |
| Race/Ethnicity, Customized Alinity s HTLV I/II Race/Ethnicity American Indian or Alaskan Native | 0 Participants | 6 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Alinity s HTLV I/II Race/Ethnicity Asian | 0 Participants | 30 Participants | 0 Participants | 0 Participants | 4 Participants | 26 Participants |
| Race/Ethnicity, Customized Alinity s HTLV I/II Race/Ethnicity Black or African American | 0 Participants | 522 Participants | 0 Participants | 305 Participants | 154 Participants | 63 Participants |
| Race/Ethnicity, Customized Alinity s HTLV I/II Race/Ethnicity Hispanic or Latino | 0 Participants | 515 Participants | 0 Participants | 204 Participants | 87 Participants | 224 Participants |
| Race/Ethnicity, Customized Alinity s HTLV I/II Race/Ethnicity Other | 0 Participants | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized Alinity s HTLV I/II Race/Ethnicity Unknown | 15877 Participants | 16144 Participants | 0 Participants | 0 Participants | 0 Participants | 267 Participants |
| Race/Ethnicity, Customized Alinity s HTLV I/II Race/Ethnicity White | 0 Participants | 370 Participants | 0 Participants | 0 Participants | 256 Participants | 114 Participants |
| Region of Enrollment Africa Alinity s Anti-HBc | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Africa Alinity s Anti-HCV | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Africa Alinity s Chagas | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Africa Alinity s HBsAg | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Africa Alinity s HIV Ag/Ab Combo | 0 Participants | 535 Participants | 0 Participants | 535 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Africa Alinity s HTLV I/II | 0 Participants | 100 Participants | 0 Participants | 100 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Africa Not collected | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Central America Alinity s Anti-HBc | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Central America Alinity s Anti-HCV | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Central America Alinity s Chagas | 0 Participants | 199 Participants | 0 Participants | 199 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Central America Alinity s HBsAg | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Central America Alinity s HIV Ag/Ab Combo | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Central America Alinity s HTLV I/II | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Central America Not collected | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Haiti Alinity s Anti-HBc | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Haiti Alinity s Anti-HCV | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Haiti Alinity s Chagas | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Haiti Alinity s HBsAg | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Haiti Alinity s HIV Ag/Ab Combo | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Haiti Alinity s HTLV I/II | 0 Participants | 204 Participants | 0 Participants | 204 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Haiti Not collected | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Mexico Alinity s Anti-HBc | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Mexico Alinity s Anti-HCV | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Mexico Alinity s Chagas | 0 Participants | 109 Participants | 0 Participants | 100 Participants | 0 Participants | 9 Participants |
| Region of Enrollment Mexico Alinity s HBsAg | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Mexico Alinity s HIV Ag/Ab Combo | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Mexico Alinity s HTLV I/II | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Mexico Not collected | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South America Alinity s Anti-HBc | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South America Alinity s Anti-HCV | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South America Alinity s Chagas | 0 Participants | 513 Participants | 0 Participants | 316 Participants | 0 Participants | 197 Participants |
| Region of Enrollment South America Alinity s HBsAg | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South America Alinity s HIV Ag/Ab Combo | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South America Alinity s HTLV I/II | 0 Participants | 205 Participants | 0 Participants | 205 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South America Not collected | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States Alinity s Anti-HBc | 15877 Participants | 16280 Participants | 0 Participants | 0 Participants | 403 Participants | 0 Participants |
| Region of Enrollment United States Alinity s Anti-HCV | 16999 Participants | 17406 Participants | 0 Participants | 0 Participants | 407 Participants | 0 Participants |
| Region of Enrollment United States Alinity s Chagas | 15804 Participants | 15918 Participants | 0 Participants | 0 Participants | 0 Participants | 114 Participants |
| Region of Enrollment United States Alinity s HBsAg | 16993 Participants | 17396 Participants | 0 Participants | 0 Participants | 403 Participants | 0 Participants |
| Region of Enrollment United States Alinity s HIV Ag/Ab Combo | 16996 Participants | 17601 Participants | 0 Participants | 0 Participants | 605 Participants | 0 Participants |
| Region of Enrollment United States Alinity s HTLV I/II | 15877 Participants | 15877 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States Not collected | 0 Participants | 3833 Participants | 51 Participants | 0 Participants | 502 Participants | 3280 Participants |
| Sex/Gender, Customized Alinity s Anti-HBc Gender Female | 0 Participants | 280 Participants | 0 Participants | 0 Participants | 115 Participants | 165 Participants |
| Sex/Gender, Customized Alinity s Anti-HBc Gender Male | 0 Participants | 518 Participants | 0 Participants | 0 Participants | 288 Participants | 230 Participants |
| Sex/Gender, Customized Alinity s Anti-HBc Gender Unknown | 15877 Participants | 15886 Participants | 0 Participants | 0 Participants | 0 Participants | 9 Participants |
| Sex/Gender, Customized Alinity s Anti-HCV Gender Female | 0 Participants | 277 Participants | 0 Participants | 0 Participants | 116 Participants | 161 Participants |
| Sex/Gender, Customized Alinity s Anti-HCV Gender Male | 0 Participants | 532 Participants | 0 Participants | 0 Participants | 291 Participants | 241 Participants |
| Sex/Gender, Customized Alinity s Anti-HCV Gender Unknown | 16999 Participants | 16999 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Alinity s Chagas Gender Female | 0 Participants | 501 Participants | 0 Participants | 399 Participants | 0 Participants | 102 Participants |
| Sex/Gender, Customized Alinity s Chagas Gender Male | 0 Participants | 320 Participants | 0 Participants | 216 Participants | 0 Participants | 104 Participants |
| Sex/Gender, Customized Alinity s Chagas Gender Unknown | 15804 Participants | 15918 Participants | 0 Participants | 0 Participants | 0 Participants | 114 Participants |
| Sex/Gender, Customized Alinity s HBsAg Gender Female | 0 Participants | 235 Participants | 28 Participants | 0 Participants | 115 Participants | 92 Participants |
| Sex/Gender, Customized Alinity s HBsAg Gender Male | 0 Participants | 623 Participants | 23 Participants | 0 Participants | 288 Participants | 312 Participants |
| Sex/Gender, Customized Alinity s HBsAg Gender Unknown | 16993 Participants | 17021 Participants | 0 Participants | 0 Participants | 0 Participants | 28 Participants |
| Sex/Gender, Customized Alinity s HIV Ag/Ab Combo Gender Female | 0 Participants | 663 Participants | 0 Participants | 256 Participants | 185 Participants | 222 Participants |
| Sex/Gender, Customized Alinity s HIV Ag/Ab Combo Gender Male | 0 Participants | 1590 Participants | 0 Participants | 279 Participants | 420 Participants | 891 Participants |
| Sex/Gender, Customized Alinity s HIV Ag/Ab Combo Gender Unknown | 16996 Participants | 17219 Participants | 0 Participants | 0 Participants | 0 Participants | 223 Participants |
| Sex/Gender, Customized Alinity s HTLV I/II Gender Female | 0 Participants | 650 Participants | 0 Participants | 193 Participants | 167 Participants | 290 Participants |
| Sex/Gender, Customized Alinity s HTLV I/II Gender Male | 0 Participants | 833 Participants | 0 Participants | 316 Participants | 335 Participants | 182 Participants |
| Sex/Gender, Customized Alinity s HTLV I/II Gender Unknown | 15877 Participants | 16111 Participants | 0 Participants | 0 Participants | 0 Participants | 234 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 8 | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 8 | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 8 | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 1 |
Outcome results
Primary
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
Population: Specimens from 404 individuals with Hepatitis B infection were tested with Alinity s Anti-HBc assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HBc Assay Sensitivity | Alinity s Anti-HBc Nonreactive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HBc Assay Sensitivity | Alinity s Anti-HBc Repeatedly Reactive Positive | 404 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HBc Assay Sensitivity | Alinity s Anti-HBc Repeatedly Reactive Negative | 0 Participants |
95% CI: [99.09, 100]Sensitivity
Primary
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
Population: All fresh whole blood donor specimens tested with Alinity s Anti-HBc assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HBc Assay Specificity | Alinity s Anti-HBc Nonreactive Anti-HBc Negative | 15833 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HBc Assay Specificity | Alinity s Anti-HBc Repeatedly Reactive AntiHBc Neg | 16 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HBc Assay Specificity | Anti-HBc Positive | 28 Participants |
95% CI: [99.84, 99.94]Binomial Exact
Primary
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
Population: Specimens from 402 individuals known to be positive for Anti-HCV were tested with Alinity s Anti-HCV assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HCV Assay Sensitivity | Alinity s Anti-HCV Nonreactive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HCV Assay Sensitivity | Alinity s Anti-HCV Repeatedly Reactive | 402 Participants |
95% CI: [99.09, 100]Sensitivity
Primary
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
Population: All blood and plasmapheresis donor specimens tested with Alinity s Anti-HCV assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HCV Assay Specificity | Alinity s Anti-HCV Nonreactive HCV Negative | 16975 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HCV Assay Specificity | Alinity s Anti-HCV Repeatedly Reactive HCV Neg | 14 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HCV Assay Specificity | HCV Positive or Indeterminate | 10 Participants |
95% CI: [99.86, 99.95]Binomial Distribution
Primary
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
Population: Specimens from 320 individuals known to be positive for Chagas were tested with investigational Alinity s Chagas assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s Chagas Assay Sensitivity | Alinity s Chagas Nonreactive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Chagas Assay Sensitivity | Alinity s Chagas Repeatedly Reactive Positive | 320 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Chagas Assay Sensitivity | Alinity s Chagas Repeatedly Reactive Negative | 0 Participants |
95% CI: [98.85, 100]Sensitivity
Primary
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
Population: All blood donor specimens tested with Alinity s Chagas assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s Chagas Assay Specificity | Alinity s Chagas Nonreactive Chagas Negative | 15787 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Chagas Assay Specificity | Alinity s Chagas Repeatedly Reactive Chagas Neg | 3 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Chagas Assay Specificity | Chagas Positive or Indeterminate | 14 Participants |
95% CI: [99.94, 100]Binomial Exact
Primary
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
Population: Specimens from 432 individuals known to be positive for HBsAg were tested with Alinity s HBsAg and HBsAg Confirmatory assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity | Alinity s HBsAg Nonreactive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity | Alinity s HBsAg Reactive Confirmed | 432 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity | Alinity s HBsAg Reactive Not Confirmed | 0 Participants |
95% CI: [99.15, 100]Sensitivity
Primary
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
Population: All blood and plasmapheresis donor specimens tested with Alinity s HBsAg assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg Assay Specificity | Alinity s HBsAg Nonreactive HBsAg Negative | 16985 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg Assay Specificity | Alinity s HBsAg Repeatedly Reactive HBsAg Negative | 6 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg Assay Specificity | Alinity s HBsAg Positive | 2 Participants |
95% CI: [99.92, 99.99]Binomial Distribution
Primary
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
Population: Specimens from 1336 individuals known to be positive for HIV-1/2 were tested with Alinity s HIV Ag/Ab Combo assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Sensitivity | Alinity s HIV Ag/Ab Combo Nonreactive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Sensitivity | Alinity s HIV Ag/Ab Combo Repeatedly Reactive Pos | 1336 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Sensitivity | Alinity s HIV Ag/Ab Combo Repeatedly Reactive Neg | 0 Participants |
95% CI: [99.72, 100]Sensitivity
Primary
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
Population: All fresh whole blood and plasmapheresis donor specimens tested with Alinity s HIV Ag/Ab Combo assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Specificity | Alinity s HIV Nonreactive HIV Negative | 16981 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Specificity | Alinity s HIV Repeatedly Reactive HIV Negative | 13 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Specificity | HIV Indeterminate | 2 Participants |
95% CI: [99.87, 99.96]Binomial Exact
Primary
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
Population: Specimens from 706 individuals known to be positive for HTLV were tested with Alinity s HTLV I/II assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s HTLV I/II Assay Sensitivity | Alinity s HTLV I/II Nonreactive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HTLV I/II Assay Sensitivity | Alinity s HTLV I/II Repeatedly Reactive | 706 Participants |
95% CI: [99.48, 100]Sensitivity
Primary
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
Population: All blood donor specimens tested with Alinity s HTLV I/II assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s HTLV I/II Assay Specificity | Alinity s HTLV Nonreactive HTLV Neg | 15864 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HTLV I/II Assay Specificity | Alinity s HTLV Repeatedly Reactive HTLV Neg | 2 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HTLV I/II Assay Specificity | HTLV Positive or Indeterminate | 11 Participants |
95% CI: [99.95, 100]Binomial Distribution
Secondary
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
Population: Specimens from 403 individuals with increased risk for HBV infection were tested with Alinity s Anti-HBc assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HBc Assay Increased Risk for HBV | Alinity s Anti-HBc Nonreactive Negative | 319 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HBc Assay Increased Risk for HBV | Alinity s Anti-HBc Nonreactive Positive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HBc Assay Increased Risk for HBV | Alinity s Anti-HBc Reactive Positive | 70 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HBc Assay Increased Risk for HBV | Alinity s Anti-HBc Reactive Negative | 14 Participants |
Comparison: Sensitivity95% CI: [94.87, 100]Sensitivity
Secondary
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
Population: Specimens from 407 individuals with increased risk for HCV infection were tested with Alinity s Anti-HCV assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HCV Assay Increased Risk for HCV | Alinity s Anti-HCV Nonreactive Negative | 316 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HCV Assay Increased Risk for HCV | Alinity s Anti-HCV Noreactive Positive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HCV Assay Increased Risk for HCV | Alinity s Anti-HCV Nonreactive Indeterminate | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HCV Assay Increased Risk for HCV | Alinity s Anti-HCV Reactive Indeterminate | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HCV Assay Increased Risk for HCV | Alinity s Anti-HCV Reactive Positive | 90 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Anti-HCV Assay Increased Risk for HCV | Alinity s Anti-HCV Reactive Negative | 1 Participants |
Comparison: Sensitivity95% CI: [95.98, 100]Sensitivity
Secondary
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
Population: Specimens from 615 subjects collected from areas known to be endemic for Chagas infection were tested with Alinity s Chagas assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s Chagas Assay Endemics | Alinity s Chagas Nonreactive Negative | 466 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Chagas Assay Endemics | Alinity s Chagas Noreactive Positive | 2 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Chagas Assay Endemics | Alinity s Chagas Nonreactive Indeterminate | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Chagas Assay Endemics | Alinity s Chagas Reactive Indeterminate | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Chagas Assay Endemics | Alinity s Chagas Reactive Positive | 146 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s Chagas Assay Endemics | Alinity s Chagas Reactive Negative | 1 Participants |
Comparison: Sensitivity95% CI: [95.2, 99.84]Sensitivity
Secondary
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
Population: Specimens from 403 individuals with increased risk for HBV infection were tested with Alinity s HBsAg assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg Assay Increased Risk of HBV Infection | Alinity s HBsAg Nonreactive Negative | 400 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg Assay Increased Risk of HBV Infection | Alinity s HBsAg Nonreactive Positive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg Assay Increased Risk of HBV Infection | Alinity s HBsAg Reactive Confirmed | 3 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg Assay Increased Risk of HBV Infection | Alinity s HBsAg Reactive Not Confirmed | 0 Participants |
Secondary
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
Population: Specimens from 51 individuals classified as recovered HBV infection were tested with Alinity s HBsAg assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg Assay Recovered HBV Infection | Alinity s HBsAg Nonreactive Negative | 51 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg Assay Recovered HBV Infection | Alinity s HBsAg Nonreactive Positive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg Assay Recovered HBV Infection | Alinity s HBsAg Reactive Confirmed | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HBsAg Assay Recovered HBV Infection | Alinity s HBsAg Reactive Not Confirmed | 0 Participants |
Secondary
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
Population: Specimens from 535 individuals collected from areas known to be endemic for HIV infection were tested with Alinity s HIV Ag/Ab Combo assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Endemics | Alinity s HIV Ag/Ab Combo Nonreactive Negative | 472 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Endemics | Alinity s HIV Ag/Ab Combo Nonreactive Positive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Endemics | Alinity s HIV Ag/Ab Comb Nonreactive Indeterminate | 2 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Endemics | Alinity s HIV Ag/Ab Combo Reactive Indeterminate | 10 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Endemics | Alinity s HIV Ag/Ab Combo Reactive Positive | 49 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Endemics | Alinity s HIV Ag/Ab Combo Reactive Negative | 2 Participants |
Comparison: Sensitivity95% CI: [92.75, 100]Sensitivity
Secondary
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
Population: Specimens from 605 individuals with increased risk for HIV-I/2 infection were tested with Alinity s HIV Ag/Ab Combo assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2 | Alinity s HIV Ag/Ab Combo Nonreactive Negative | 582 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2 | Alinity s HIV Ag/Ab Combo Nonreactive Positive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2 | Alinity s HIV Ag/Ab Comb Nonreactive Indeterminate | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2 | Alinity s HIV Ag/Ab Combo Reactive Indeterminate | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2 | Alinity s HIV Ag/Ab Combo Reactive Positive | 21 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2 | Alinity s HIV Ag/Ab Combo Reactive Negative | 2 Participants |
Secondary
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
Population: Specimens from 502 individuals with increased risk for HTLV I/II infection were tested with Alinity s HTLV I/II assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s HTLV Assay Increased Risk of HTLV Infection | Alinity s HTLV I/II Nonreactive Negative | 491 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HTLV Assay Increased Risk of HTLV Infection | Alinity s HTLV I/II Nonreactive Positive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HTLV Assay Increased Risk of HTLV Infection | Alinity s HTLV I/II Nonreactive Indeterminate | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HTLV Assay Increased Risk of HTLV Infection | Alinity s HTLV I/II Reactive Indeterminate | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HTLV Assay Increased Risk of HTLV Infection | Alinity s HTLV I/II Reactive Positive | 11 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HTLV Assay Increased Risk of HTLV Infection | Alinity s HTLV I/II Reactive Negative | 0 Participants |
Secondary
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
Population: Specimens from 509 individuals collected from areas known to be endemic for HTLV I/II infection were tested with Alinity s HTLV I/II assay per protocol.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alinity s HBsAg Assay Specificity | Alinity s HTLV I/II Assay Endemics | Alinity s HTLV I/II Nonreactive Negative | 495 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HTLV I/II Assay Endemics | Alinity s HTLV I/II Nonreactive Positive | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HTLV I/II Assay Endemics | Alinity s HTLV I/II Nonreactive Indeterminate | 4 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HTLV I/II Assay Endemics | Alinity s HTLV I/II Reactive Indeterminate | 0 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HTLV I/II Assay Endemics | Alinity s HTLV I/II Reactive Positive | 10 Participants |
| Alinity s HBsAg Assay Specificity | Alinity s HTLV I/II Assay Endemics | Alinity s HTLV I/II Reactive Negative | 0 Participants |