Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-31 @ 12:06 PM
Study NCT ID:
NCT00933933
Status:
COMPLETED
Last Update Posted:
2011-07-12
First Post:
2009-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Diagnostic HIV Ag/Ab Combo Assay
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'barbara.kaesdorf@abbott.com', 'phone': '847-937-8702', 'title': 'Barbara Kaesdorf, Associate Director Clinical Affairs', 'organization': 'Abbott Diagnostic Division'}, 'certainAgreement': {'otherDetails': "The principal investigator (PI) must provide copy of any proposed publication/presentation at least 30 days prior to submission for sponsor review/approval. PI must incorporate changes as the sponosr requires in order to protect the sponsor's proprietary rights and interests. Sponsor may require the PI to include acknowledgement of sponosr's role in the study. PI may be requested to delay publication/presentation an extra 60 days to enable sponor to secure patent or other proprietary protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Device adverse events were collected during the approximate 3 months of testing with Architect HIV Combo assay.', 'description': "Adverse event reporting for follow-up collection (3) and subject's with specimens collected/tested during study (635)were under separate specimens collection protocol. Not applicable for specimens collected and banked or obtained from specimen venders and provided to testing site by Abbott.", 'eventGroups': [{'id': 'EG000', 'title': 'Architect HIV Ag/Ab Combo Specificity', 'description': 'Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.', 'otherNumAtRisk': 586, 'otherNumAffected': 0, 'seriousNumAtRisk': 586, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Architect HIV Ag/Ab Combo Sensitivity', 'description': 'Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Architect HIV Ag/Ab Combo Reactivity', 'description': 'Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.', 'otherNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection', 'description': 'Specimens collected from a population of apparently healthy individuals at low risk for HIV infection.'}], 'classes': [{'title': 'HIV Ag/Ab Combo Reactive, HIV status Positive', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '99.62', 'upperLimit': '99.88'}]}]}, {'title': 'HIV Ag/Ab Combo Reactive, HIV status Negative', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'HIV Ag/Ab Combo Nonreactive HIV status Positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HIV Ag/Ab Combo Nonreactive HIV status Negative', 'categories': [{'measurements': [{'value': '6113', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinical Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.77', 'ciLowerLimit': '99.62', 'ciUpperLimit': '99.88', 'statisticalMethod': 'Exact binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.', 'unitOfMeasure': 'Blood Specimens', 'reportingStatus': 'POSTED', 'populationDescription': 'Specificity determined from 6,164 specimens from apparently healthy individuals (low risk): includes 250 specimens from pregnant females in first trimester and 580 specimens from low risk population prospectively collected and tested fresh during study. Total of 37 confirmed HIV positives by supplemental testing were excluded from analysis.', 'anticipatedPostingDate': '2010-07'}, {'type': 'PRIMARY', 'title': 'Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '1003', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV p24 Antgen Sensitivity', 'description': 'HIV-1 Antigen positive specimens/commercial panel members (HIV Westerm blot negative and confirmed positive by HIV-1 p24 Antigen and/or HIV RNA) and HIV-1 viral isolates.'}, {'id': 'OG001', 'title': 'HIV-1 Antibody Sensitivity', 'description': 'Specimens collected from HIV infected individuals in US population confirmed by HIV-1 Western blot.'}, {'id': 'OG002', 'title': 'HIV-2 Antibody Sensitivity', 'description': 'Specimens collected from HIV infected individuals in Ivory Coast confirmed by HIV-2 Western blot.'}], 'classes': [{'title': 'ARCHITECT HIV Ag/Ab Reactive', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '1003', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}]}, {'title': 'ARCHITECT HIV Ag/Ab Nonreactive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinical Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '94.31', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Exact binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Clinical Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '99.63', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Exact binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Clinical Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '98.18', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Exact binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Positive HIV status was determined by the results of the HIV-1 Western blot, HIV-2 Western blot, and/or HIV-1 ribonucleic acid (RNA) test.', 'unitOfMeasure': 'Blood specimens', 'reportingStatus': 'POSTED', 'populationDescription': 'Sensitivity was determine using confirmed positive specimens/panels for HIV-1 Antigen (63 samples/panels/viral isolates), HIV-1 antibody (1003 US population) and HIV-2 antibody (201 endemic area of Ivory Coast) based on supplemental testing.'}, {'type': 'PRIMARY', 'title': 'Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Architect HIV Ag/Ab Combo Specificity in Pregnant Females', 'description': 'HIV presumed negative specimens from pregnant females tested with investigation HIV test, comparator assay and supplemental tests.'}, {'id': 'OG001', 'title': 'Architect HIV Ag/Ab Combo Sensitivity in Pregnant Females', 'description': 'HIV confirmed positive specimens from pregnant females tested with investigation HIV test, comparator assay and supplement tests.'}], 'classes': [{'title': 'Architect HIV Ag/Ab Reactive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Architect HIV Ag/Ab Nonreactive', 'categories': [{'measurements': [{'value': '448', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinical Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '99.18', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Exact binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Clinical Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '94.48', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Exact binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.', 'unitOfMeasure': 'Blood specimens', 'reportingStatus': 'POSTED', 'populationDescription': 'HIV negative status determined for specimens reactive by investigational assay and/or comparator by supplemental testing algorithm including HIV-1 Western blot, HIV-2 enzyme immunoassay (EIA), HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot. Specimens from pregnant females.'}, {'type': 'PRIMARY', 'title': 'Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '588', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Architect HIV Ag/Ab Combo Specificity in Pediatric Population', 'description': 'Specimens presumed HIV negative tested with investigational HIV test, FDA-licensed comparator assay and supplemental tests. Specimens from individuals between 2 and 21 years of age.'}, {'id': 'OG001', 'title': 'Architect HIV Ag/Ab Combo Sensitivity in Pediatric Population', 'description': 'Specimens confirmed HIV positive by HIV-1 Western blot were tested with investigational HIV test. Specimens from individuals between 2 and 21 years of age.'}], 'classes': [{'title': 'HIV Ag/Ab Combo Reactive HIV Status Positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'HIV Ag/Ab Combo Reactive HIV Status Negative', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HIV Ag/Ab Combo Nonreactive HIV Status Positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HIV Ag/Ab Combo Nonreactive HIV Status Negative', 'categories': [{'measurements': [{'value': '587', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinical Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.83', 'ciLowerLimit': '99.06', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Exact binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Clinical Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '94.40', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Exact binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.', 'unitOfMeasure': 'Blood specimens', 'reportingStatus': 'POSTED', 'populationDescription': 'Specificity determine from 588 specimens: 364 low risk, 95 increased risk, 47 increased risk (HIV-2 endemic area), 44 pregnant females low risk and 38 pregnant females increased risk with HIV negative status. Sensitivity determined from 65 specimens: 60 HIV-1 infected, 2 HIV-1 infected pregnant females, 2 HIV infected from HIV-2 endemic area.', 'anticipatedPostingDate': '2010-06'}, {'type': 'SECONDARY', 'title': 'Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '513', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Increased Risk for HIV in US Population', 'description': 'Specimens collected from 693 individuals in the US population documented as having one or more of the following risk factors: users of injecting drugs, unprotected sex with someone who is infected with HIV, diagnosed or treated for a sexually transmitted disease (STD), hepatitis or tuberculosis, multiple sex partners, men who have sex with men, men who have sex with men and are users of injecting drugs, unprotected sex with someone who has been diagnosed or treated for an STD, risk factor not identified but requested an HIV test. Specimens obtained from specimen vendors and were tested with investigational HIV test.'}, {'id': 'OG001', 'title': 'Increased Risk for HIV From HIV-2 Endemic Area', 'description': "Specimens from 513 individuals documented as being at risk for acquiring HIV that reside in an HIV-2 endemic area (Cote De'Ivoire) having one or more of the following risk factors: unprotected sex with someone who is infected with HIV, multiple sex partners, men who have sex with men, users of injecting drugs. Specimens were obtained from specimen vendors and tested with investigational HIV test."}, {'id': 'OG002', 'title': 'Reactivity in Pregnant Female Population', 'description': 'Specimens collected from 203 pregnant females: 153 specimens collected from pregnant females with documented risk factors for HIV and 50 were surplus serum specimens collected pregnant females from a health clinic offering HIV testing. Spcimens from 55 of the pregnant females with risk for HIV infection were collected under a specimen collection protocol and tested with the investigational and FDA-licensed comparator assay during the study. The remaining specimens were obtained from specimen vendors and tested with the investigational HIV test.'}], 'classes': [{'title': 'HIV Ag/Ab Combo Reactive HIV Status Positive', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'HIV Ag/Ab Combo Reactive HIV Status Negative', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HIV Ag/Ab Combo Nonreactive - HIV Status Positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HIV Ag/Ab Combo Nonreactive HIV Status Negative', 'categories': [{'measurements': [{'value': '622', 'groupId': 'OG000'}, {'value': '424', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Reactivity was determined by the results of the Architect HIV Ag/Ab Combo assay and supplemental testing by HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.', 'unitOfMeasure': 'Blood specimens', 'reportingStatus': 'POSTED', 'populationDescription': 'Final HIV status determined for specimens reactive by investigational assay and/or comparator by supplement testing algorithm. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Architect HIV Ag/Ab Combo Specificity', 'description': 'Specificity populations included:\n\n6164 specimens collected from apparently healthy individuals at low risk for HIV infection (16-89 years of age) which includes 250 specimens from pregnant females in first trimester of pregnancy.\n\n448 specimen from presumed HIV negative pregnant females from 16 to 44 years of age.\n\n588 specimen from pediatric presumed negative for HIV from 2 to 21 years of age.\n\nSpecimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test.'}, {'id': 'FG001', 'title': 'Architect HIV Ag/Ab Combo Sensitivity', 'description': 'Sensitivity populations included:\n\n1287 specimens or commercial panel members HIV-1 p24 Antigen positive, specimens confirmed HIV-1 antibody positive and specimens confirmed HIV-2 antibody positive.\n\n67 specimens from pregnant females from all three trimesters confirmed HIV posiitve by supplemental testing.\n\n64 specimens from pediatric subjects confirmed HIV positive by supplemental testing (2 to 21 years of age).\n\nSpecimens were collected under separate collection protocols or by specimens vendors and tested with investigational HIV test.'}, {'id': 'FG002', 'title': 'Architect HIV Ag/Ab Combo Reactivity', 'description': "Reactivty populations included:\n\n1206 specimens collected from individuals at increased risk for HIV infection (16-89 years of age) from US and Cote D'Ivoire.\n\n203 specimen from pregnant females at risk for HIV infection.\n\nOf these 1409 specimens, 61 were collected from individual that were from 16 up to 21 years of age.\n\nSpecimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test."}], 'periods': [{'title': 'General Population From 16 to 89 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6164'}, {'groupId': 'FG001', 'numSubjects': '1287'}, {'groupId': 'FG002', 'numSubjects': '1206'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6164'}, {'groupId': 'FG001', 'numSubjects': '1267'}, {'groupId': 'FG002', 'numSubjects': '1206'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Did not meet criteria for analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Pregnant Females Between 16-44 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '448'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '203'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '448'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '203'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Specimens classified incorrectly', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Pediatric From 2 to 21 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '588'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'comment': 'Specimens from individuals 16-21 years included reactivity for general population or pregnant women.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '588'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'comment': 'Specimens from individuals 16-21 years included reactivity for general population or pregnant women', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All specimens collected under separate collection protocols or obtained from specimen suppliers: human immunodeficiency virus (HIV) antigen positive samples, HIV-1 antibody positive, specimens collected from individuals at risk for HIV infection in the United States (US), HIV-2 antibody positive and specimens collected from HIV-2 endemic area.', 'preAssignmentDetails': 'All subjects were assigned to one group. There was no pre-screening criteria for this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6252', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '1121', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}, {'value': '1409', 'groupId': 'BG004'}, {'value': '9066', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Architect HIV Ag/Ab Combo Specificity', 'description': 'Specimens collected from apparently healthy individuals under a separate specimen collection protocol (7B5-02-05Z01-01) or obtained from specimen vendors and were tested with investigational HIV test.'}, {'id': 'BG001', 'title': 'Architect HIV Ag/Ab Combo HIV-1 Antigen Sensitivity', 'description': 'Specimens obtained from specimen vendors were tested with investigational HIV test.'}, {'id': 'BG002', 'title': 'Architect Ag/Ab Combo HIV-1 Antibody Sensitivity', 'description': 'Specimens collected from HIV-1 infected individuals under a separate specimen collection protocol (pediatric subjects 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.'}, {'id': 'BG003', 'title': 'Architect HIV Ag/Ab Combo HIV-2 Antibody Sensitivity', 'description': 'Specimens obtained from specimen vendors were tested with investigational HIV test.'}, {'id': 'BG004', 'title': 'Architect HIV Ag/Ab Combo Reactivity', 'description': 'Specimens collected from individuals at increased risk for HIV infection under a separate specimen collection protocol (pregant females 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'between 2 and 21 years', 'categories': [{'measurements': [{'value': '588', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}, {'value': '713', 'groupId': 'BG005'}]}]}, {'title': '>= 21 years', 'categories': [{'measurements': [{'value': '5663', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1057', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1304', 'groupId': 'BG004'}, {'value': '8024', 'groupId': 'BG005'}]}]}, {'title': 'Not collected', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '329', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '4165', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '530', 'groupId': 'BG004'}, {'value': '4926', 'groupId': 'BG005'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '2087', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '890', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '879', 'groupId': 'BG004'}, {'value': '3856', 'groupId': 'BG005'}]}]}, {'title': 'Not collected', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '284', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6252', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '1121', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '896', 'groupId': 'BG004'}, {'value': '8347', 'groupId': 'BG005'}]}]}, {'title': "Côte D'Ivoire", 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}, {'value': '513', 'groupId': 'BG004'}, {'value': '714', 'groupId': 'BG005'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}, {'title': 'Cameroon', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 635}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-05', 'studyFirstSubmitDate': '2009-07-02', 'resultsFirstSubmitDate': '2010-07-19', 'studyFirstSubmitQcDate': '2009-07-02', 'lastUpdatePostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-07-19', 'studyFirstPostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection', 'timeFrame': '3 months', 'description': 'HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.'}, {'measure': 'Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens', 'timeFrame': '3 months', 'description': 'Positive HIV status was determined by the results of the HIV-1 Western blot, HIV-2 Western blot, and/or HIV-1 ribonucleic acid (RNA) test.'}, {'measure': 'Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population', 'timeFrame': '3 months', 'description': 'HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.'}, {'measure': 'Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)', 'timeFrame': '3 months', 'description': 'HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.'}], 'secondaryOutcomes': [{'measure': 'Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations', 'timeFrame': '3 months', 'description': 'Reactivity was determined by the results of the Architect HIV Ag/Ab Combo assay and supplemental testing by HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Human Immunodeficiency Viruses']}, 'descriptionModule': {'briefSummary': 'To test blood specimens using a new investigational test that detects antigen and antibody to human immunodeficiency virus (HIV). Results will be compared to an approved HIV antibody test and supplemental testing performed to determine HIV status.', 'detailedDescription': 'All specimens collected under separate specimen collection protocols or obtained from specimen suppliers will be provided to the clinical sites performing the investigational HIV test.\n\nThis includes 6252 specimens collected from normal healthy individuals (7B5-02-05Z01-01: Collection of Specimens Used in Abbott Laboratories In Vitro Diagnostic HIV and Hepatitis Assays Clinical Studies)and from specimen suppliers. 588 specimens from HIV-infected pediatric subjects and 448 pregnant females at risk for HIV infection collected under protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay)and from specimen suppliers. All specimens were previously collected and frozen, except for a subset of 586 specimens from normal healthy population and 55 specimen from pregnant females at risk for HIV infection which were collected under separate specimen collection protocols and tested as fresh specimens during the study.\n\nIn addition, 83 specimens that were HIV antigen positive, 1121 specimens that were HIV-1 antibody positive, 201 specimens that were HIV-2 antibody positive, and 1409 specimens from US at risk for HIV infection or from HIV-2 endemic area were all obtained from specimen suppliers, except for 11 pediatric specimens collected under a separate protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Normal Healthy Population:\n\nInclusion Criteria:\n\n* Apparently healthy individual at the time of enrollment as affirmed by the subject\n\nExclusion Criteria:\n\n* HIV infection as affirmed by the subject\n\nPregnant Female Population at Risk for HIV Infection:\n\nInclusion Criteria:\n\n* Subject is a pregnant female\n* Subject has risk factor for HIV infection\n\nExclusion Criteria:\n\n* HIV infection as affirmed by the subject\n\nHIV-1 Positive Pregnant Female Subjects\n\nInclusion Criteria:\n\n* Subject is a pregnant female in first, second, or third trimester\n* Subject must have documented HIV infection\n\nExclusion Criteria:\n\n* None\n\nHIV-1 Positive Pediatric Subjects\n\nInclusion Criteria:\n\n* Subject must be 2 years to 16 years of age\n* Subject must have documented HIV infection (e.g., Western blot positive or HIV RNA positive/detectable)\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00933933', 'briefTitle': 'Evaluation of Diagnostic HIV Ag/Ab Combo Assay', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Diagnostics Division'}, 'officialTitle': 'Evaluation of ARCHITECT HIV Ag/Ab Combo Assay', 'orgStudyIdInfo': {'id': '7B5-02-06R01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARCHITECT HIV Ag/Ab Combo Specificity', 'description': 'Specimens collected from normal apparently healthy individuals at low risk for HIV infection will be tested by the investigational HIV test and FDA-licensed HIV test.', 'interventionNames': ['Device: ARCHITECT HIV Ag/Ab Combo']}, {'type': 'NO_INTERVENTION', 'label': 'ARCHITECT HIV Ag/Ab Combo Sensitivity', 'description': 'Specimen with confirmed positive HIV Antigen, HIV-1 antibody, or HIV-2 antibody will be tested by the investigational HIV test.'}, {'type': 'EXPERIMENTAL', 'label': 'ARCHITECT HIV Ag/Ab Combo Reactivity', 'description': 'Specimen collected from individuals at risk for HIV infection will be tested by the investigational HIV test.', 'interventionNames': ['Device: ARCHITECT HIV Ag/Ab Combo']}], 'interventions': [{'name': 'ARCHITECT HIV Ag/Ab Combo', 'type': 'DEVICE', 'description': 'Test blood samples with investigational HIV assay. If results for specimens from the normal healthy population or pregnant female population at risk for HIV infection are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw.', 'armGroupLabels': ['ARCHITECT HIV Ag/Ab Combo Specificity']}, {'name': 'ARCHITECT HIV Ag/Ab Combo', 'type': 'DEVICE', 'description': 'Test blood samples with investigational HIV assay. If results for specimens from the at risk population are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw when possible.', 'armGroupLabels': ['ARCHITECT HIV Ag/Ab Combo Reactivity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Pinellas County Health Dept, Florida Department of Health', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '62703', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Springfield Clinic, LLP', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Medical Research Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '117777', 'city': 'Port Jefferson', 'state': 'New York', 'country': 'United States', 'facility': 'John T. Mather Memorial Hospital', 'geoPoint': {'lat': 40.94649, 'lon': -73.06927}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobi Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'M.S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '77555-0609', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch at Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Planned Parenthood of Houston and Southeast Texas, Inc.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84108-1221', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'ARUP Laboratories', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53209', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Midwest Research Specialists, LLC', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53295', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Clement J. Zablocki VA Medical Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'William Roberts, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ARUP Laboratories'}, {'name': 'Laurence Demers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.S. Hershey Medical Center'}, {'name': 'Fred Apple, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hennepin Healthcare Research Institute'}, {'name': 'Michael Loeffelholz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Medical Branch at Galveston'}, {'name': 'John Heffner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clement J. Zablocki VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Diagnostics Division', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Barbara Kaesdorf, Clinical Project Manager', 'oldOrganization': 'Abbott Diagnostics Division'}}}}