Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT03285295
Status:
COMPLETED
Last Update Posted:
2019-10-09
First Post:
2017-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'george.chen@abbott.com', 'phone': '224-668-9185', 'title': 'George Chen (Associate Director Clinical Affairs)', 'organization': 'Abbott Laboratories'}, 'certainAgreement': {'otherDetails': "The PI must provide a copy of any proposed publication/presentation at least 60 days prior to submission for sponsor's review/approval. The PI must incorporate changes as the sponsor requires in order to protect the sponsor's proprietary rights and interests. The sponsor may require the PI to include acknowledgement of the sponsor's role in the study. The PI may be requested to delay publication/presentation an extra 60 days to enable sponsor to secure patent or other proprietary protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Subject adverse events related to blood collection during the 3-6 months of donor follow-up specimen collection.', 'description': 'Subject adverse event reporting was only applicable to donors that returned for follow-up specimen collection.\n\nAdverse events were not applicable for blood and plasmapheresis donor specimens collected as part of routine blood donation and specimens provided by Abbott to testing sites.\n\nThere were no subject or device adverse events associated with testing.', 'eventGroups': [{'id': 'EG000', 'title': 'Alinity s HBsAg Follow-Up Specimen Collection', 'description': 'For all donor specimens with investigational Alinity s 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.\n\nNo donors required for follow-up collection for Alinity s HBsAg study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Alinity s HTLV I/II Follow-Up Specimen Collection', 'description': 'For all donor specimens with investigational Alinity s 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.\n\n12 donors were eligible for follow-up collection for Alinity s HTLV I/II study. 8 out of 12 were able to provide follow-up specimen.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Alinity s Anti-HCV Follow-Up Specimen Collection', 'description': 'For all donor specimens with investigational Alinity s 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.\n\n20 donors were eligible for follow-up collection for Alinity s Anti-HCV study. 2 out of 20 were able to provide follow-up specimen.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Alinity s HIV Ag/Ab Combo Follow-Up Specimen Collection', 'description': 'For all donor specimens with investigational Alinity s 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.\n\n15 donors were eligible for follow-up collection for Alinity s HIV Ag/Ab Combo study.\n\n4 out of 15 were able to provide follow-up specimen.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Alinity s Anti-HBc Follow-Up Specimen Collection', 'description': 'For all donor specimens with investigational Alinity s 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.\n\n16 donors were eligible for follow-up collection for Alinity s Anti-HBc study. 2 out of 16 were able to provide follow-up specimen.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Alinity s Chagas Follow-Up Specimen Collection', 'description': 'For all donor specimens with investigational Alinity s 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.\n\n14 donors were eligible for follow-up collection for Alinity s Chagas study.\n\n1 out of 14 were able to provide follow-up specimen.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Alinity s HBsAg Assay Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16993', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s HBsAg Assay Specificity', 'description': 'US blood and plasmapheresis donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s assay.'}], 'classes': [{'categories': [{'title': 'Alinity s HBsAg Nonreactive HBsAg Negative', 'measurements': [{'value': '16985', 'groupId': 'OG000'}]}, {'title': 'Alinity s HBsAg Repeatedly Reactive HBsAg Negative', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Alinity s HBsAg Positive', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinical Specificity (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.96', 'ciLowerLimit': '99.92', 'ciUpperLimit': '99.99', 'statisticalMethod': 'Binomial Distribution', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Specificity sample size is a minimum of 15,000 donors.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All blood and plasmapheresis donor specimens tested with Alinity s HBsAg assay per protocol.'}, {'type': 'PRIMARY', 'title': 'Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s HBsAg Nonreactive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HBsAg Reactive Confirmed', 'measurements': [{'value': '432', 'groupId': 'OG000'}]}, {'title': 'Alinity s HBsAg Reactive Not Confirmed', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '99.15', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Sensitivity', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% Confidence Interval provided.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': 'Total of 432 specimens from subjects known to be HBsAg positive were tested with Alinity s HBsAg and HBsAg Confirmatory assay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specimens from 432 individuals known to be positive for HBsAg were tested with Alinity s HBsAg and HBsAg Confirmatory assay per protocol.'}, {'type': 'PRIMARY', 'title': 'Alinity s HTLV I/II Assay Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15877', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s HTLV I/II Assay Specificity', 'description': 'US blood donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s HTLV I/II assay.'}], 'classes': [{'categories': [{'title': 'Alinity s HTLV Nonreactive HTLV Neg', 'measurements': [{'value': '15864', 'groupId': 'OG000'}]}, {'title': 'Alinity s HTLV Repeatedly Reactive HTLV Neg', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'HTLV Positive or Indeterminate', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinical Specificity (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.99', 'ciLowerLimit': '99.95', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Binomial Distribution', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All blood donor specimens tested with Alinity s HTLV I/II assay per protocol.'}, {'type': 'PRIMARY', 'title': 'Alinity s HTLV I/II Assay Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '706', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s HTLV I/II Assay Sensitivity', 'description': '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.\n\nIndividuals 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.'}], 'classes': [{'categories': [{'title': 'Alinity s HTLV I/II Nonreactive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HTLV I/II Repeatedly Reactive', 'measurements': [{'value': '706', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '99.48', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Sensitivity', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% Confidence Interval provided.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': '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:\n\nAnti-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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specimens from 706 individuals known to be positive for HTLV were tested with Alinity s HTLV I/II assay per protocol.'}, {'type': 'PRIMARY', 'title': 'Alinity s Anti-HCV Assay Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16999', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s Anti-HCV Assay Specificity', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s Anti-HCV Nonreactive HCV Negative', 'measurements': [{'value': '16975', 'groupId': 'OG000'}]}, {'title': 'Alinity s Anti-HCV Repeatedly Reactive HCV Neg', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'HCV Positive or Indeterminate', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinical Specificity (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.92', 'ciLowerLimit': '99.86', 'ciUpperLimit': '99.95', 'statisticalMethod': 'Binomial Distribution', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All blood and plasmapheresis donor specimens tested with Alinity s Anti-HCV assay per protocol.'}, {'type': 'PRIMARY', 'title': 'Alinity s Anti-HCV Assay Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s Anti-HCV Assay Sensitivity', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s Anti-HCV Nonreactive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s Anti-HCV Repeatedly Reactive', 'measurements': [{'value': '402', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '99.09', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Sensitivity', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% Confidence Interval provided.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': 'Total of 402 specimens from subjects known to be Anti-HCV positive were tested with Alinity s Anti-HCV assay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specimens from 402 individuals known to be positive for Anti-HCV were tested with Alinity s Anti-HCV assay per protocol.'}, {'type': 'PRIMARY', 'title': 'Alinity s HIV Ag/Ab Combo Assay Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16996', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s HIV Ag/Ab Combo Assay Specificity', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s HIV Nonreactive HIV Negative', 'measurements': [{'value': '16981', 'groupId': 'OG000'}]}, {'title': 'Alinity s HIV Repeatedly Reactive HIV Negative', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'HIV Indeterminate', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinical Specificity (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.92', 'ciLowerLimit': '99.87', 'ciUpperLimit': '99.96', 'statisticalMethod': 'Binomial Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All fresh whole blood and plasmapheresis donor specimens tested with Alinity s HIV Ag/Ab Combo assay per protocol.'}, {'type': 'PRIMARY', 'title': 'Alinity s HIV Ag/Ab Combo Assay Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1336', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s HIV Ag/Ab Combo Assay Sensitivity', 'description': '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).'}], 'classes': [{'categories': [{'title': 'Alinity s HIV Ag/Ab Combo Nonreactive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HIV Ag/Ab Combo Repeatedly Reactive Pos', 'measurements': [{'value': '1336', 'groupId': 'OG000'}]}, {'title': 'Alinity s HIV Ag/Ab Combo Repeatedly Reactive Neg', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '99.72', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Sensitivity', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% Confidence Interval provided.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': 'Total of 1336 specimens from subjects known to be HIV-1/2 positive were tested with Alinity s HIV Ag/Ab Combo assay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specimens from 1336 individuals known to be positive for HIV-1/2 were tested with Alinity s HIV Ag/Ab Combo assay per protocol.'}, {'type': 'PRIMARY', 'title': 'Alinity s Anti-HBc Assay Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15877', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s Anti-HBc Assay Specificity', 'description': 'US blood donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s Anti-HBc assay.'}], 'classes': [{'categories': [{'title': 'Alinity s Anti-HBc Nonreactive Anti-HBc Negative', 'measurements': [{'value': '15833', 'groupId': 'OG000'}]}, {'title': 'Alinity s Anti-HBc Repeatedly Reactive AntiHBc Neg', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Anti-HBc Positive', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinical Specificity (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.90', 'ciLowerLimit': '99.84', 'ciUpperLimit': '99.94', 'statisticalMethod': 'Binomial Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All fresh whole blood donor specimens tested with Alinity s Anti-HBc assay per protocol.'}, {'type': 'PRIMARY', 'title': 'Alinity s Anti-HBc Assay Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s Anti-HBc Assay Sensitivity', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s Anti-HBc Nonreactive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s Anti-HBc Repeatedly Reactive Positive', 'measurements': [{'value': '404', 'groupId': 'OG000'}]}, {'title': 'Alinity s Anti-HBc Repeatedly Reactive Negative', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '99.09', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Sensitivity', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% Confidence Interval provided.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': '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:\n\nAcute Hepatitis B infection n = 28 Chronic Hepatitis B infection n = 97 Recovered Hepatitis B infection n = 279', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specimens from 404 individuals with Hepatitis B infection were tested with Alinity s Anti-HBc assay per protocol.'}, {'type': 'PRIMARY', 'title': 'Alinity s Chagas Assay Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15804', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s Chagas Assay Specificity', 'description': 'US blood donor specimens collected as part of routine blood and plasma donation were tested with the investigational Alinity s Chagas assay.'}], 'classes': [{'categories': [{'title': 'Alinity s Chagas Nonreactive Chagas Negative', 'measurements': [{'value': '15787', 'groupId': 'OG000'}]}, {'title': 'Alinity s Chagas Repeatedly Reactive Chagas Neg', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Chagas Positive or Indeterminate', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinical Specificity (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.98', 'ciLowerLimit': '99.94', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Binomial Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All blood donor specimens tested with Alinity s Chagas assay per protocol.'}, {'type': 'PRIMARY', 'title': 'Alinity s Chagas Assay Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s Chagas Assay Sensitivity', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s Chagas Nonreactive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s Chagas Repeatedly Reactive Positive', 'measurements': [{'value': '320', 'groupId': 'OG000'}]}, {'title': 'Alinity s Chagas Repeatedly Reactive Negative', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '98.85', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Sensitivity', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% Confidence Interval provided.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': 'Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specimens from 320 individuals known to be positive for Chagas were tested with investigational Alinity s Chagas assay per protocol.'}, {'type': 'SECONDARY', 'title': 'Alinity s HBsAg Assay Increased Risk of HBV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s HBsAg Assay Increased Risk of HBV Infection', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s HBsAg Nonreactive Negative', 'measurements': [{'value': '400', 'groupId': 'OG000'}]}, {'title': 'Alinity s HBsAg Nonreactive Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HBsAg Reactive Confirmed', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Alinity s HBsAg Reactive Not Confirmed', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': 'Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s HBsAg assay.\n\nSensitivity and Specificity not applicable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specimens from 403 individuals with increased risk for HBV infection were tested with Alinity s HBsAg assay per protocol.'}, {'type': 'SECONDARY', 'title': 'Alinity s HBsAg Assay Recovered HBV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s HBsAg Assay Recovered HBV Infection', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s HBsAg Nonreactive Negative', 'measurements': [{'value': '51', 'groupId': 'OG000'}]}, {'title': 'Alinity s HBsAg Nonreactive Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HBsAg Reactive Confirmed', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HBsAg Reactive Not Confirmed', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': 'Total of 51 specimens from subjects classified as recovered HBV infection were tested with investigational Alinity s HBsAg assay.\n\nSensitivity/Specificity calculation for this population not applicable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specimens from 51 individuals classified as recovered HBV infection were tested with Alinity s HBsAg assay per protocol.'}, {'type': 'SECONDARY', 'title': 'Alinity s HTLV Assay Increased Risk of HTLV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s HTLV Assay Increased Risk of HTLV-I/II Infection', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s HTLV I/II Nonreactive Negative', 'measurements': [{'value': '491', 'groupId': 'OG000'}]}, {'title': 'Alinity s HTLV I/II Nonreactive Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HTLV I/II Nonreactive Indeterminate', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HTLV I/II Reactive Indeterminate', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HTLV I/II Reactive Positive', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Alinity s HTLV I/II Reactive Negative', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': '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.\n\nSensitivity and Specificity not applicable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specimens from 502 individuals with increased risk for HTLV I/II infection were tested with Alinity s HTLV I/II assay per protocol.'}, {'type': 'SECONDARY', 'title': 'Alinity s HTLV I/II Assay Endemics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s HTLV I/II Assay Endemics', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s HTLV I/II Nonreactive Negative', 'measurements': [{'value': '495', 'groupId': 'OG000'}]}, {'title': 'Alinity s HTLV I/II Nonreactive Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HTLV I/II Nonreactive Indeterminate', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Alinity s HTLV I/II Reactive Indeterminate', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HTLV I/II Reactive Positive', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Alinity s HTLV I/II Reactive Negative', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Alinity s Anti-HCV Assay Increased Risk for HCV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s Anti-HCV Assay Increased Risk for HCV', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s Anti-HCV Nonreactive Negative', 'measurements': [{'value': '316', 'groupId': 'OG000'}]}, {'title': 'Alinity s Anti-HCV Noreactive Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s Anti-HCV Nonreactive Indeterminate', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s Anti-HCV Reactive Indeterminate', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s Anti-HCV Reactive Positive', 'measurements': [{'value': '90', 'groupId': 'OG000'}]}, {'title': 'Alinity s Anti-HCV Reactive Negative', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '95.98', 'ciUpperLimit': '100.00', 'groupDescription': 'Sensitivity', 'statisticalMethod': 'Sensitivity', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% Confidence Interval provided.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': 'Total of 407 specimens from subjects known to be at increased risk for HCV infection were tested with investigational Alinity s Anti-HCV assay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specimens from 407 individuals with increased risk for HCV infection were tested with Alinity s Anti-HCV assay per protocol.'}, {'type': 'SECONDARY', 'title': 'Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s HIV Ag/Ab Combo Assay Increased Risk for HIV-1/2', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s HIV Ag/Ab Combo Nonreactive Negative', 'measurements': [{'value': '582', 'groupId': 'OG000'}]}, {'title': 'Alinity s HIV Ag/Ab Combo Nonreactive Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HIV Ag/Ab Comb Nonreactive Indeterminate', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HIV Ag/Ab Combo Reactive Indeterminate', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HIV Ag/Ab Combo Reactive Positive', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Alinity s HIV Ag/Ab Combo Reactive Negative', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': '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.\n\nSensitivity and Specificity not applicable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specimens from 605 individuals with increased risk for HIV-I/2 infection were tested with Alinity s HIV Ag/Ab Combo assay per protocol.'}, {'type': 'SECONDARY', 'title': 'Alinity s HIV Ag/Ab Combo Assay Endemics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s HIV Ag/Ab Combo Assay Endemics', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s HIV Ag/Ab Combo Nonreactive Negative', 'measurements': [{'value': '472', 'groupId': 'OG000'}]}, {'title': 'Alinity s HIV Ag/Ab Combo Nonreactive Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s HIV Ag/Ab Comb Nonreactive Indeterminate', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Alinity s HIV Ag/Ab Combo Reactive Indeterminate', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Alinity s HIV Ag/Ab Combo Reactive Positive', 'measurements': [{'value': '49', 'groupId': 'OG000'}]}, {'title': 'Alinity s HIV Ag/Ab Combo Reactive Negative', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '92.75', 'ciUpperLimit': '100.00', 'groupDescription': 'Sensitivity', 'statisticalMethod': 'Sensitivity', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% Confidence Interval provided.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Alinity s Anti-HBc Assay Increased Risk for HBV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s Anti-HBc Assay Increased Risk for HBV', 'description': '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'}], 'classes': [{'categories': [{'title': 'Alinity s Anti-HBc Nonreactive Negative', 'measurements': [{'value': '319', 'groupId': 'OG000'}]}, {'title': 'Alinity s Anti-HBc Nonreactive Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s Anti-HBc Reactive Positive', 'measurements': [{'value': '70', 'groupId': 'OG000'}]}, {'title': 'Alinity s Anti-HBc Reactive Negative', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '94.87', 'ciUpperLimit': '100.00', 'groupDescription': 'Sensitivity', 'statisticalMethod': 'Sensitivity', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% Confidence Interval provided.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': 'Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s Anti-HBc assay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specimens from 403 individuals with increased risk for HBV infection were tested with Alinity s Anti-HBc assay per protocol.'}, {'type': 'SECONDARY', 'title': 'Alinity s Chagas Assay Endemics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '615', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alinity s Chagas Assay Endemics', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Alinity s Chagas Nonreactive Negative', 'measurements': [{'value': '466', 'groupId': 'OG000'}]}, {'title': 'Alinity s Chagas Noreactive Positive', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Alinity s Chagas Nonreactive Indeterminate', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s Chagas Reactive Indeterminate', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alinity s Chagas Reactive Positive', 'measurements': [{'value': '146', 'groupId': 'OG000'}]}, {'title': 'Alinity s Chagas Reactive Negative', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Point Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.65', 'ciLowerLimit': '95.20', 'ciUpperLimit': '99.84', 'groupDescription': 'Sensitivity', 'statisticalMethod': 'Sensitivity', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% Confidence Interval provided.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months', 'description': 'Total of 615 specimens from subjects collected from areas known to be endemic for Chagas infection were tested with investigational Alinity s Chagas assay', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specimens from 615 subjects collected from areas known to be endemic for Chagas infection were tested with Alinity s Chagas assay per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Specificity', 'description': '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.'}, {'id': 'FG001', 'title': 'Sensitivity', 'description': '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.'}, {'id': 'FG002', 'title': 'Increased Risk Population', 'description': '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.'}, {'id': 'FG003', 'title': 'Endemic Population', 'description': '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 area.'}, {'id': 'FG004', 'title': 'HBV Recovered Population', 'description': '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.'}], 'periods': [{'title': 'Alinity s HBsAg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17095'}, {'groupId': 'FG001', 'numSubjects': '438'}, {'groupId': 'FG002', 'numSubjects': '403'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16993'}, {'groupId': 'FG001', 'numSubjects': '432'}, {'groupId': 'FG002', 'numSubjects': '403'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'No Result on Comparator Assay', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'No Results Generated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Alinity s HBsAg Confirmatory', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '432'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '432'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Alinity s HBsAg Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Alinity s HTLV I/II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15968'}, {'groupId': 'FG001', 'numSubjects': '706'}, {'groupId': 'FG002', 'numSubjects': '502'}, {'groupId': 'FG003', 'numSubjects': '509'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15877'}, {'groupId': 'FG001', 'numSubjects': '706'}, {'groupId': 'FG002', 'numSubjects': '502'}, {'groupId': 'FG003', 'numSubjects': '509'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'No Result on Comparator Assay', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'No Results Generated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Alinity s HTLV I/II Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, 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'FG004', 'numSubjects': '0'}]}]}, {'title': 'Alinity s Anti-HCV Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Alinity s HIV Ag/Ab Combo', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17095'}, {'groupId': 'FG001', 'numSubjects': '1336'}, {'groupId': 'FG002', 'numSubjects': '605'}, {'comment': 'Individuals at Increased Risk of HIV Infection from HIV-2 Endemic Areas', 'groupId': 'FG003', 'numSubjects': '535'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16996'}, {'groupId': 'FG001', 'numSubjects': '1336'}, {'groupId': 'FG002', 'numSubjects': '605'}, {'comment': 'Individuals at Increased Risk of HIV Infection from HIV-2 Endemic Areas', 'groupId': 'FG003', 'numSubjects': '535'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'No Results on Comparator Assay', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'No Results Generated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Alinity s HIV Ag/Ab Combo Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 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'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98546', 'groupId': 'BG000'}, {'value': '3600', 'groupId': 'BG001'}, {'value': '2320', 'groupId': 'BG002'}, {'value': '1659', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '106176', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Specificity', 'description': '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.'}, {'id': 'BG001', 'title': 'Sensitivity', 'description': '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.'}, {'id': 'BG002', 'title': 'Increased Risk Population', 'description': '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.'}, {'id': 'BG003', 'title': 'Endemic Population', 'description': '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.'}, {'id': 'BG004', 'title': 'HBV Recovered Population', 'description': '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.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '≥16 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98546', 'groupId': 'BG000'}, {'value': '3600', 'groupId': 'BG001'}, {'value': '2320', 'groupId': 'BG002'}, {'value': '1659', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '106176', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Alinity s HBsAg', 'measurements': [{'value': '16993', 'groupId': 'BG000'}, {'value': '432', 'groupId': 'BG001'}, {'value': '403', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '17879', 'groupId': 'BG005'}]}, {'title': 'Alinity s HTLV I/II', 'measurements': [{'value': '15877', 'groupId': 'BG000'}, {'value': '706', 'groupId': 'BG001'}, {'value': '502', 'groupId': 'BG002'}, {'value': '509', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '17594', 'groupId': 'BG005'}]}, {'title': 'Alinity s Anti-HCV', 'measurements': [{'value': '16999', 'groupId': 'BG000'}, {'value': '402', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '17808', 'groupId': 'BG005'}]}, {'title': 'Alinity s HIV Ag/Ab Combo', 'measurements': [{'value': '16996', 'groupId': 'BG000'}, {'value': '1336', 'groupId': 'BG001'}, {'value': '605', 'groupId': 'BG002'}, {'value': '535', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '19472', 'groupId': 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[{'units': 'Participants', 'counts': [{'value': '16999', 'groupId': 'BG000'}, {'value': '402', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '17808', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '532', 'groupId': 'BG005'}]}, {'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '277', 'groupId': 'BG005'}]}, {'title': 'Unknown', 'measurements': [{'value': '16999', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': 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'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s Chagas', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Not collected', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': 'Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '635', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '635', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Alinity s HBsAg', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s HTLV I/II', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '100', 'groupId': 'BG005'}]}, {'title': 'Alinity s Anti-HCV', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s HIV Ag/Ab Combo', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '535', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '535', 'groupId': 'BG005'}]}, {'title': 'Alinity s Anti-HBc', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s Chagas', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Not collected', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': 'Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '109', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Alinity s HBsAg', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s HTLV I/II', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s Anti-HCV', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s HIV Ag/Ab Combo', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s Anti-HBc', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s Chagas', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '109', 'groupId': 'BG005'}]}, {'title': 'Not collected', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': 'South America', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '521', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '718', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Alinity s HBsAg', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s HTLV I/II', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '205', 'groupId': 'BG005'}]}, {'title': 'Alinity s Anti-HCV', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s HIV Ag/Ab Combo', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s Anti-HBc', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s Chagas', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '316', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '513', 'groupId': 'BG005'}]}, {'title': 'Not collected', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': 'Central America', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '199', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Alinity s HBsAg', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s HTLV I/II', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s Anti-HCV', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s HIV Ag/Ab Combo', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s Anti-HBc', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Alinity s Chagas', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '199', 'groupId': 'BG005'}]}, {'title': 'Not collected', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Each row represents a different country with populations within that country as a subset of a total enrollment for each assay.\n\nNot collected represents total number across all Alinity s assays: HBsAg, HTLV I/II, Anti-HCV, HIV Ag/Ab Combo, Anti-HBc, and Chagas.'}], 'populationDescription': 'Donors and pedigree'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-17', 'size': 768236, 'label': 'Informed Consent Form: Alinity s Follow-Up Study - Donor Consent for Central IRB', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-05-14T15:21', 'hasProtocol': False}, {'date': '2017-11-17', 'size': 1450255, 'label': 'Informed Consent Form: Alinity s Follow-Up Study - Donor Consent for Local IRB', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-05-14T15:29', 'hasProtocol': False}, {'date': '2018-04-24', 'size': 1590712, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-08T15:50', 'hasProtocol': True}, {'date': '2017-08-23', 'size': 459263, 'label': 'Informed Consent Form: Information Sheet for Central IRB', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-07-11T18:29', 'hasProtocol': False}, {'date': '2017-11-17', 'size': 592581, 'label': 'Informed Consent Form: Information Sheet for Local IRB', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_004.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-07-11T18:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Evaluation of assay performance characteristics.\n\nParticipants:\n\n* Alinity s HBsAg: 17987\n* Alinity s HTLV I/II: 17685\n* Alinity s Anti-HCV: 17904\n* Alinity s HIV Ag/Ab Combo: 19571\n* Alinity s Anti-HBc: 16776\n* Alinity s Chagas: 16958'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106881}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'dispFirstSubmitDate': '2019-05-03', 'completionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2017-09-12', 'dispFirstSubmitQcDate': '2019-05-15', 'resultsFirstSubmitDate': '2019-07-12', 'studyFirstSubmitQcDate': '2017-09-14', 'dispFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-17', 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alinity s HBsAg Assay Specificity', 'timeFrame': '10 months', 'description': '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.'}, {'measure': 'Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity', 'timeFrame': '10 months', 'description': 'Total of 432 specimens from subjects known to be HBsAg positive were tested with Alinity s HBsAg and HBsAg Confirmatory assay.'}, {'measure': 'Alinity s HTLV I/II Assay Specificity', 'timeFrame': '10 months', 'description': '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.'}, {'measure': 'Alinity s HTLV I/II Assay Sensitivity', 'timeFrame': '10 months', 'description': '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:\n\nAnti-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'}, {'measure': 'Alinity s Anti-HCV Assay Specificity', 'timeFrame': '10 months', 'description': '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.'}, {'measure': 'Alinity s Anti-HCV Assay Sensitivity', 'timeFrame': '10 months', 'description': 'Total of 402 specimens from subjects known to be Anti-HCV positive were tested with Alinity s Anti-HCV assay.'}, {'measure': 'Alinity s HIV Ag/Ab Combo Assay Specificity', 'timeFrame': '10 months', 'description': '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.'}, {'measure': 'Alinity s HIV Ag/Ab Combo Assay Sensitivity', 'timeFrame': '10 months', 'description': 'Total of 1336 specimens from subjects known to be HIV-1/2 positive were tested with Alinity s HIV Ag/Ab Combo assay.'}, {'measure': 'Alinity s Anti-HBc Assay Specificity', 'timeFrame': '10 months', 'description': '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.'}, {'measure': 'Alinity s Anti-HBc Assay Sensitivity', 'timeFrame': '10 months', 'description': '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:\n\nAcute Hepatitis B infection n = 28 Chronic Hepatitis B infection n = 97 Recovered Hepatitis B infection n = 279'}, {'measure': 'Alinity s Chagas Assay Specificity', 'timeFrame': '10 months', 'description': '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.'}, {'measure': 'Alinity s Chagas Assay Sensitivity', 'timeFrame': '10 months', 'description': 'Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.'}], 'secondaryOutcomes': [{'measure': 'Alinity s HBsAg Assay Increased Risk of HBV Infection', 'timeFrame': '10 months', 'description': 'Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s HBsAg assay.\n\nSensitivity and Specificity not applicable.'}, {'measure': 'Alinity s HBsAg Assay Recovered HBV Infection', 'timeFrame': '10 months', 'description': 'Total of 51 specimens from subjects classified as recovered HBV infection were tested with investigational Alinity s HBsAg assay.\n\nSensitivity/Specificity calculation for this population not applicable.'}, {'measure': 'Alinity s HTLV Assay Increased Risk of HTLV Infection', 'timeFrame': '10 months', 'description': '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.\n\nSensitivity and Specificity not applicable.'}, {'measure': 'Alinity s HTLV I/II Assay Endemics', 'timeFrame': '10 months', 'description': '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.'}, {'measure': 'Alinity s Anti-HCV Assay Increased Risk for HCV', 'timeFrame': '10 months', 'description': 'Total of 407 specimens from subjects known to be at increased risk for HCV infection were tested with investigational Alinity s Anti-HCV assay.'}, {'measure': 'Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2', 'timeFrame': '10 months', 'description': '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.\n\nSensitivity and Specificity not applicable.'}, {'measure': 'Alinity s HIV Ag/Ab Combo Assay Endemics', 'timeFrame': '10 months', 'description': '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.'}, {'measure': 'Alinity s Anti-HBc Assay Increased Risk for HBV', 'timeFrame': '10 months', 'description': 'Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s Anti-HBc assay.'}, {'measure': 'Alinity s Chagas Assay Endemics', 'timeFrame': '10 months', 'description': 'Total of 615 specimens from subjects collected from areas known to be endemic for Chagas infection were tested with investigational Alinity s Chagas assay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy donors who consented to participate in the study.\n\nExclusion Criteria:\n\n* 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.\n\nNote: 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.\n\nThe 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.'}, 'identificationModule': {'nctId': 'NCT03285295', 'briefTitle': 'Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Diagnostics Division'}, 'officialTitle': 'Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol', 'orgStudyIdInfo': {'id': '9DY-02-14U01-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening', 'description': '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.', 'interventionNames': ['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']}], 'interventions': [{'name': 'Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Screening']}, {'name': 'Alinity s HTLV I/II Assay', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Screening']}, {'name': 'Alinity s Anti-HCV Assay', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Screening']}, {'name': 'Alinity s HIV Ag/Ab Combo Assay', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Screening']}, {'name': 'Alinity s Anti-HBc Assay', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Screening']}, {'name': 'Alinity s Chagas Assay', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33431', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Biotest Pharmaceuticals Corporation', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'American Red Cross National Testing Laboratory', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '37932', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'CSL Plasma Inc.', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78201', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'QualTex Laboratories', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Bloodworks Northwest', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}], 'overallOfficials': [{'name': 'Nancy R Haley, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bloodworks Northwest'}, {'name': 'Thomas S Jones, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'QualTex Laboratories'}, {'name': 'Susan S Ganz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biotest Pharmaceuticals Corporation'}, {'name': 'Toby L Simon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CSL Plasma Inc.'}, {'name': 'Susan L Stramer, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American Red Cross National Testing Laboratory'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Diagnostics Division', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}