| 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. | All blood and plasmapheresis donor specimens tested with Alinity s HBsAg assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s HBsAg Assay Specificity | US blood and plasmapheresis donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s assay. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| Alinity s HBsAg Nonreactive HBsAg Negative | | | Alinity s HBsAg Repeatedly Reactive HBsAg Negative | | | Alinity s HBsAg Positive | |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Binomial Distribution | Specificity sample size is a minimum of 15,000 donors. | | | Clinical Specificity (%) | 99.96 | | | 2-Sided | 95 | 99.92 | 99.99 | | | | | Superiority | | |
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| 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. | Specimens from 432 individuals known to be positive for HBsAg were tested with Alinity s HBsAg and HBsAg Confirmatory assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity | Preselected HBsAg positive samples were obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s HBsAg and HBsAg Confirmatory assays. This population included individuals with acute hepatitis B infection, and individuals with chronic hepatitis B infection. HBV classification was determined using 4 HBV reference marker testing or medically diagnosed. |
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| 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. | All blood donor specimens tested with Alinity s HTLV I/II assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s HTLV I/II Assay Specificity | US blood donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s HTLV I/II assay. |
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| 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 | Specimens from 706 individuals known to be positive for HTLV were tested with Alinity s HTLV I/II assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s HTLV I/II Assay Sensitivity | This population includes both archived and leftover not individually identifiable specimens that are extensively characterized. The specimens were confirmed positive by research use only HTLV-I Western blot and HTLV-I and HTLV-II radioimmunoprecipitation assay (RIPA) and typed as HTLV-I or HTLV-II by immunofluorescence assay (IFA) titration. Individuals with HTLV-I/II Associated Diseases includes specimens prospectively collected from individuals diagnosed with adult T-cell leukemia/lymphoma (ATL) or HTLV-I associated myelopathy/tropical spastic paraparesis (HAM/TSP) using IRB-approved protocols sponsored by specimen vendors. |
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| 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. | All blood and plasmapheresis donor specimens tested with Alinity s Anti-HCV assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s Anti-HCV Assay Specificity | US blood and plasmapheresis donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s Anti-HCV assay. |
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| 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. | Specimens from 402 individuals known to be positive for Anti-HCV were tested with Alinity s Anti-HCV assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s Anti-HCV Assay Sensitivity | This population includes specimens prospectively collected using IRB-approved protocols sponsored by Abbott Laboratories and vendor-collected leftover specimens that were not individually identifiable. A subset of these specimens was confirmed positive by an HCV recombinant immunoblot assay (RIBA). The remaining specimens were collected from subjects with a medical diagnosis of chronic HCV infection and history of greater than 6 months of HCV RNA/anti-HCV positivity. For these specimens, a current anti-HCV result was obtained. |
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| 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. | All fresh whole blood and plasmapheresis donor specimens tested with Alinity s HIV Ag/Ab Combo assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s HIV Ag/Ab Combo Assay Specificity | US blood and plasmapheresis donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s HIV Ag/Ab Combo assay. |
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| 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. | Specimens from 1336 individuals known to be positive for HIV-1/2 were tested with Alinity s HIV Ag/Ab Combo assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s HIV Ag/Ab Combo Assay Sensitivity | Preselected HIV-1/2 positive samples were obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s HIV Ag/Ab Combo assays. This population included individuals with HIV-1 and HIV-2 infection. The HIV-1 specimens were confirmed positive by HIV-1 Western blot and categorized by revised surveillance case definitions for HIV infection (2008) as stage 1 (n=488), stage 2 (n=427) or stage 3 (n=101) using CD4 counts and associated diagnosis. The specimens were confirmed positive for HIV-2 by HIV-2 Western blot and typed as HIV-2 only by Bio-Rad Multispot HIV-1/HIV-2 Rapid Test.The remaining are for Anti-HIV 2 (n=232), HIV-1 antigen (n=35), and HIV-1 viral isolates (n=53). |
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| 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. | All fresh whole blood donor specimens tested with Alinity s Anti-HBc assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s Anti-HBc Assay Specificity | US blood donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s Anti-HBc assay. |
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| 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 | Specimens from 404 individuals with Hepatitis B infection were tested with Alinity s Anti-HBc assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s Anti-HBc Assay Sensitivity | Preselected Anti-HBc Positive specimens were obtained from individuals with acute hepatitis B infection, individuals with chronic hepatitis B infection, and individuals with recovered hepatitis B infection. |
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| 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. | All blood donor specimens tested with Alinity s Chagas assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s Chagas Assay Specificity | US blood donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s Chagas assay. |
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| 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. | Specimens from 320 individuals known to be positive for Chagas were tested with investigational Alinity s Chagas assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s Chagas Assay Sensitivity | Preselected T cruzi Parasitology Positive (n = 112) and preselected T cruzi Serology Positive (n = 208) samples were obtained from specimen vendors or collected under separate specimen collection protocols were tested by the investigational Alinity s Chagas assay. |
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| 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. | Specimens from 403 individuals with increased risk for HBV infection were tested with Alinity s HBsAg assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s HBsAg Assay Increased Risk of HBV Infection | 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 infection. |
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| 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. | Specimens from 51 individuals classified as recovered HBV infection were tested with Alinity s HBsAg assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s HBsAg Assay Recovered HBV Infection | 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. |
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| 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. | Specimens from 502 individuals with increased risk for HTLV I/II infection were tested with Alinity s HTLV I/II assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s HTLV Assay Increased Risk of HTLV-I/II Infection | 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 HTLV I/II infection. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s HTLV I/II Assay Endemics | 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 endemic area. |
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| 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. | Specimens from 407 individuals with increased risk for HCV infection were tested with Alinity s Anti-HCV assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s Anti-HCV Assay Increased Risk for HCV | 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 HCV infection. |
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| 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. | Specimens from 605 individuals with increased risk for HIV-I/2 infection were tested with Alinity s HIV Ag/Ab Combo assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s HIV Ag/Ab Combo Assay Increased Risk for HIV-1/2 | 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 HIV infection. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s HIV Ag/Ab Combo Assay Endemics | 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 HIV endemic area. |
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| 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. | Specimens from 403 individuals with increased risk for HBV infection were tested with Alinity s Anti-HBc assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s Anti-HBc Assay Increased Risk for HBV | 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 infection |
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| 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 | Specimens from 615 subjects collected from areas known to be endemic for Chagas infection were tested with Alinity s Chagas assay per protocol. | Posted | | Count of Participants | | Participants | | 10 months | | | | ID | Title | Description |
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| OG000 | Alinity s Chagas Assay Endemics | 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 Chagas endemic area. |
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