Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-25 @ 9:42 PM
Study NCT ID:
NCT05334758
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2022-04-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chang@themegaco.com', 'phone': '202-679-2112', 'title': 'Chang Turkmani', 'organization': 'BioTeke USA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'description': 'This study was deemed to have a less than significant risk by IRB assessment, and no sites reported any adverse events during or after the study enrollment period.', 'eventGroups': [{'id': 'EG000', 'title': 'At Least 30 Children Between 2 - 13 Years of Age', 'description': 'Subjects less than 14 years of age, where the Parent or legal guardian collects a sample from their child (e.g., ages 2-13) and performs the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.\n\nBio-Self COVID-19 Antigen Home Test: At home COVID-19 antigen test kit\n\nStandard of Care COVID-19 Test: Standard of care\n\nRT-PCR Test: High Sensitivity RT-PCR COVID-19 Test', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Subjects 14 - 90 Years of Age', 'description': 'The subject will self collect and test using the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.\n\nBio-Self COVID-19 Antigen Home Test: At home COVID-19 antigen test kit\n\nStandard of Care COVID-19 Test: Standard of care\n\nRT-PCR Test: High Sensitivity RT-PCR COVID-19 Test', 'otherNumAtRisk': 252, 'deathsNumAtRisk': 252, 'otherNumAffected': 0, 'seriousNumAtRisk': 252, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Positive Percent Agreement - Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Performance Data Set', 'description': "In the initial PEUA, the Agency confirmed that the EUA authorized high-sensitivity PerkinElmer New Coronavirus Nucleic Acid Detection Kit was an acceptable RT-PCR comparator for this study. In a follow-up email to the Agency on 18 July 2022, BioTeke asked if the chosen PerkinElmer RT-PCR kit could be utilized with a separately authorized extraction method (i.e., ThermoFisher KingFisher), which had been internally validated by the CLIA laboratory but was not included in the PerkinElmer's Instructions for Use. Of note, the initial subject samples had been tested using this extraction kit. The FDA responded that this would not be an acceptable approach, as the comparator method had to use the authorized extraction method outlined in the manufacturer's authorized instructions. In response to the Agency's decision, the central CLIA testing laboratory, DevLab Bio, internally validated the extraction method using the Chemagic 360 as specified in the PerkinElmer instructions. The intent was to re-test those samples previously tested using the ThermoFisher extraction method and test all future samples using only this authorized process.\n\nWhen preparing to re-test the initial subject samples, it was found that a number of samples had been discarded in error. These samples were not included in the performance analysis."}], 'classes': [{'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '87.2', 'upperLimit': '99'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hours', 'description': 'The sensitivity is computed as the proportion of positive samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also positive as called by the Bio-Self COVID-19 Antigen Home Test.', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Symptomatic Subjects'}, {'type': 'PRIMARY', 'title': 'Negative Percent Agreement - Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Performance Data Set', 'description': "In the initial PEUA, the Agency confirmed that the EUA authorized high-sensitivity PerkinElmer New Coronavirus Nucleic Acid Detection Kit was an acceptable RT-PCR comparator for this study. In a follow-up email to the Agency on 18 July 2022, BioTeke asked if the chosen PerkinElmer RT-PCR kit could be utilized with a separately authorized extraction method (i.e., ThermoFisher KingFisher), which had been internally validated by the CLIA laboratory but was not included in the PerkinElmer's Instructions for Use. Of note, the initial subject samples had been tested using this extraction kit. The FDA responded that this would not be an acceptable approach, as the comparator method had to use the authorized extraction method outlined in the manufacturer's authorized instructions. In response to the Agency's decision, the central CLIA testing laboratory, DevLab Bio, internally validated the extraction method using the Chemagic 360 as specified in the PerkinElmer instructions. The intent was to re-test those samples previously tested using the ThermoFisher extraction method and test all future samples using only this authorized process.\n\nWhen preparing to re-test the initial subject samples, it was found that a number of samples had been discarded in error. These samples were not included in the performance analysis."}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96.4', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hours', 'description': 'The specificity is computed as the proportion of negative samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also negative as called by the Bio-Self COVID-19 Antigen Home Test.', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Specificity for symptomatic subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'At Least 30 Children Between 2 - 13 Years of Age', 'description': 'Subjects less than 14 years of age, where the Parent or legal guardian collects a sample from their child (e.g., ages 2-13) and performs the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.\n\nBio-Self COVID-19 Antigen Home Test: At home COVID-19 antigen test kit\n\nStandard of Care COVID-19 Test: Standard of care\n\nRT-PCR Test: High Sensitivity RT-PCR COVID-19 Test'}, {'id': 'FG001', 'title': 'Subjects 14 - 90 Years of Age', 'description': 'The subject will self collect and test using the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.\n\nBio-Self COVID-19 Antigen Home Test: At home COVID-19 antigen test kit\n\nStandard of Care COVID-19 Test: Standard of care\n\nRT-PCR Test: High Sensitivity RT-PCR COVID-19 Test'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '252'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '252'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Date of First Enrollment: 12 May 2022 Date of Last Completed: 25 July 2022\n\nThe first 50 subjects presenting to the sites for COVID-19 testing were consecutively enrolled (i.e., all comers) including those who were either asymptomatic or symptomatic for COVID-19. Following this enrollment, only subjects who were symptomatic for COVID-19 were enrolled until 30 RT-PCR confirmed positive samples were collected. Then enrollment resumed for all comers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Performance Data Set', 'description': "In the initial PEUA, the Agency confirmed that the EUA authorized high-sensitivity PerkinElmer New Coronavirus Nucleic Acid Detection Kit was an acceptable RT-PCR comparator for this study. In a follow-up email to the Agency on 18 July 2022, BioTeke asked if the chosen PerkinElmer RT-PCR kit could be utilized with a separately authorized extraction method (i.e., ThermoFisher KingFisher), which had been internally validated by the CLIA laboratory but was not included in the PerkinElmer's Instructions for Use. Of note, the initial subject samples had been tested using this extraction kit. The FDA responded that this would not be an acceptable approach, as the comparator method had to use the authorized extraction method outlined in the manufacturer's authorized instructions. In response to the Agency's decision, the central CLIA testing laboratory, DevLab Bio, internally validated the extraction method using the Chemagic 360 as specified in the PerkinElmer instructions. The intent was to re-test those samples previously tested using the ThermoFisher extraction method and test all future samples using only this authorized process.\n\nWhen preparing to re-test the initial subject samples, it was found that a number of samples had been discarded in error. These samples were not included in the performance analysis.\n\nPerformance analysis was based on 253 subjects rather than the 282 enrolled."}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'title': '< 14 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': '14 - 24 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '25 - 64 years', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}, {'title': '≥ 65 years', 'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '148', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '132', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '121', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '222', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '253', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Symptomatic', 'classes': [{'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Performance analysis was based on 253 subjects rather than the 282 enrolled due to loss of samples. See Arm/Group Description for more details.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-05', 'size': 487957, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-12T12:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is an open label, prospective study to evaluate the sensitivity and specificity of the Bio-Self COVID-19 Antigen Home Test when a lay person conducts the test on themselves or another study participant. Potential subjects will be those presenting for COVID-19 testing. The study will evaluate the performance of the Bio-Self COVID-19 Antigen Home Test by comparing it to a high sensitivity EUA SARS-CoV-2 RT-PCR assay to calculate both the positive percent agreement \\[(PPA) sensitivity\\] and negative percent agreement \\[(NPA) specificity\\].'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 282}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2022-04-15', 'resultsFirstSubmitDate': '2024-02-12', 'studyFirstSubmitQcDate': '2022-04-15', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-11', 'studyFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Percent Agreement - Sensitivity', 'timeFrame': '48 hours', 'description': 'The sensitivity is computed as the proportion of positive samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also positive as called by the Bio-Self COVID-19 Antigen Home Test.'}, {'measure': 'Negative Percent Agreement - Specificity', 'timeFrame': '48 hours', 'description': 'The specificity is computed as the proportion of negative samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also negative as called by the Bio-Self COVID-19 Antigen Home Test.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Covid, Covid 19, Virus'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the performance of the Bio-Self COVID-19 Antigen Home Test. The study will evaluate the accuracy (sensitivity and specificity) in a simulated home use environment when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.', 'detailedDescription': 'The Bio-Self COVID-19 Antigen Home Test is immunochromatographic and uses double-antibody sandwich method to detect SARS-CoV-2 antigen from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. The test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult collected anterior nares swab samples from individuals ages 2 to 13.\n\nThe primary objective of this study is to determine the accuracy of the Bio-Self COVID-19 Antigen Home Test when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '94 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. An Institutional Review Board (IRB) approved informed consent and assent, if applicable, is signed and dated prior to any study-related activities.\n2. Male and female Subjects 2 years of age and older.\n3. Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult.)\n4. Subject is willing to have a nasal swab collected by a healthcare professional.\n5. Subject agrees to complete all aspects of the study.\n\nExclusion Criteria:\n\n1. Subject has a visual impairment that cannot be restored with glasses or contact lenses.\n2. Subject has prior medical or laboratory training.\n3. Subject had a positive COVID-19 test in past three (3) months.\n4. Subject uses home diagnostics, e.g., HIV Tests, glucose meters, etc.'}, 'identificationModule': {'nctId': 'NCT05334758', 'briefTitle': 'Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioTeke USA, LLC'}, 'officialTitle': 'Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test', 'orgStudyIdInfo': {'id': 'BTK-01-1002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'At least 30 children between 2 - 13 years of age', 'description': 'Subjects less than 14 years of age, where the Parent or legal guardian collects a sample from their child (e.g., ages 2-13) and performs the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.', 'interventionNames': ['Device: Bio-Self COVID-19 Antigen Home Test', 'Device: Standard of Care COVID-19 Test', 'Diagnostic Test: RT-PCR Test']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects 14 - 90 years of age', 'description': 'The subject will self collect and test using the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.', 'interventionNames': ['Device: Bio-Self COVID-19 Antigen Home Test', 'Device: Standard of Care COVID-19 Test', 'Diagnostic Test: RT-PCR Test']}], 'interventions': [{'name': 'Bio-Self COVID-19 Antigen Home Test', 'type': 'DEVICE', 'description': 'At home COVID-19 antigen test kit', 'armGroupLabels': ['At least 30 children between 2 - 13 years of age', 'Subjects 14 - 90 years of age']}, {'name': 'Standard of Care COVID-19 Test', 'type': 'DEVICE', 'description': 'Standard of care', 'armGroupLabels': ['At least 30 children between 2 - 13 years of age', 'Subjects 14 - 90 years of age']}, {'name': 'RT-PCR Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'High Sensitivity RT-PCR COVID-19 Test', 'armGroupLabels': ['At least 30 children between 2 - 13 years of age', 'Subjects 14 - 90 years of age']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33142', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'L&A Morales Healthcare, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'CDR Health', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '21075', 'city': 'Elkridge', 'state': 'Maryland', 'country': 'United States', 'facility': 'Centennial Medical', 'geoPoint': {'lat': 39.21261, 'lon': -76.71358}}], 'overallOfficials': [{'name': 'Steven Geller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centennial Medical Group'}, {'name': 'Enrique Villa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'L&A Morales Healthcare'}, {'name': 'Narendra Kini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CDR Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioTeke USA, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CSSi Life Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}