Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-02-09 @ 4:07 AM
Study NCT ID:
NCT04010695
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2019-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005955', 'term': 'Glucosephosphate Dehydrogenase Deficiency'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pbansil@path.org', 'phone': '206 302 4920', 'title': 'Pooja Bansil', 'organization': 'PATH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Approximately 30 minutes', 'eventGroups': [{'id': 'EG000', 'title': 'G6PD Diagnostic Testing', 'description': 'Participants provided whole blood samples as well as finger-stick capillary blood samples.\n\nAt the clinic site lab, study staff performed the SD Biosensor POC G6PD test and the POC HemoCue hemoglobin test on both finger stick blood and whole blood samples.\n\nAt the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer.', 'otherNumAtRisk': 250, 'deathsNumAtRisk': 250, 'otherNumAffected': 0, 'seriousNumAtRisk': 250, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'G6PD Diagnostic Testing', 'description': 'Participants provided whole blood samples as well as finger-stick capillary blood samples.\n\nAt the clinic site lab, study staff performed the SD Biosensor POC G6PD test and the POC HemoCue hemoglobin test on both finger stick blood and whole blood samples.\n\nAt the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer.'}], 'classes': [{'title': 'Venous Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '59.0', 'upperLimit': '100.0'}]}]}, {'title': 'Capillary Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '59.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All samples were collected on study day 1', 'description': 'For the purposes of this study, an individual was considered G6PD deficient if they tested positive in the Pointe Scientific assay. A true positive was defined as a participant with ≤ 30% of normal G6PD activity in circulating venous blood determined by the Pointe Scientific test.\n\nDiagnostic sensitivity of the SD Biosensor G6PD test is defined as the percentage of participants who tested positive for G6PD deficiency on the reference test who were identified by the test assay as positive, calculated as:\n\nNumber of participants who were both test and true positive / (Number of participants who were test and true positive + Number of participants who were test negative but true positive \\[ie false negative\\]) \\* 100%.\n\nSensitivity of the SD Biosensor POC G6PD test was calculated from both venous and capillary blood samples.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The final analytic population with available data'}, {'type': 'PRIMARY', 'title': 'Sensitivity of SD Biosensor POC G6PD Test for Identifying Women With Intermediate G6PD Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'G6PD Diagnostic Testing', 'description': 'Participants provided whole blood samples as well as finger-stick capillary blood samples.\n\nAt the clinic site lab, study staff performed the SD Biosensor POC G6PD test assay and the POC HemoCue hemoglobin test on both finger stick blood and whole blood samples.\n\nAt the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer.'}], 'classes': [{'title': 'Venous Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100.0'}]}]}, {'title': 'Capillary Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '99.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All samples were collected on study day 1', 'description': 'To investigate the performance of the SD Biosensor G6PD test to distinguish females with intermediate G6PD activity from females with normal activity, assay sensitivity was determined at a G6PD activity threshold of 70%. A true positive for intermediate G6PD activity in females was defined as G6PD activity between 30 and 70% of normal in circulating venous blood as determined by the Pointe Scientific test.\n\nSensitivity of the SD Biosensor POC G6PD test is the percentage of women who tested positive for intermediate G6PD activity on the reference test who were identified by the test assay as positive, calculated as:\n\nNumber of women who were both test and true positive / (Number of women who were test and true positive + Number of women who were test negative but true positive \\[ie false negative\\]) \\* 100%.\n\nSensitivity of the SD Biosensor G6PD test for identifying females with intermediate G6PD activity was calculated from both venous and capillary blood samples.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Females in the final analytic population with available data'}, {'type': 'PRIMARY', 'title': 'Specificity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'G6PD Diagnostic Testing', 'description': 'Participants provided whole blood samples as well as finger-stick capillary blood samples.\n\nAt the clinic site lab, study staff performed the SD Biosensor POC G6PD test and the POC HemoCue hemoglobin test on both finger stick blood and whole blood samples.\n\nAt the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer.'}], 'classes': [{'title': 'Venous Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '90.8', 'upperLimit': '97.5'}]}]}, {'title': 'Capillary Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '95.8', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All samples were collected on study day 1', 'description': 'For the purposes of this study, an individual was considered G6PD deficient if they tested positive by the Pointe Scientific assay. A true negative was defined as \\> 30% of normal G6PD activity in circulating venous blood as determined by the Pointe Scientific test.\n\nSpecificity is the percentage of participants who tested negative for G6PD deficiency on the reference test who were identified as negative using the test assay, calculated as:\n\nNumber of participants who were both test and true negative / (Number of participants who were test and true negative + Number of participants who were test positive but true negative \\[ie false positive\\]) \\* 100%.\n\nSpecificity of the SD Biosensor G6PD test was calculated from both venous and capillary blood samples.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The final analytic population with available data'}, {'type': 'PRIMARY', 'title': 'Specificity of SD Biosensor G6PD Test for Identifying Women With Intermediate G6PD Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'G6PD Diagnostic Testing', 'description': 'Participants provided whole blood samples as well as finger-stick capillary blood samples.\n\nAt the clinic site lab, study staff performed the SD Biosensor POC G6PD test and the POC HemoCue hemoglobin test on both finger stick blood and whole blood samples.\n\nAt the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer.'}], 'classes': [{'title': 'Venous Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.7', 'groupId': 'OG000', 'lowerLimit': '76.2', 'upperLimit': '89.6'}]}]}, {'title': 'Capillary Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000', 'lowerLimit': '86.4', 'upperLimit': '96.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All samples were collected on study day 1', 'description': 'To investigate the performance of the SD Biosensor G6PD test to distinguish females with intermediate G6PD activity from females with normal activity, the specificity was determined at a G6PD activity threshold of 70%. A true negative for intermediate G6PD activity in females was defined as G6PD activity \\> 70% of normal in circulating venous blood as determined by the Pointe Scientific test.\n\nSpecificity is the percentage of participants who tested negative for G6PD deficiency on the reference test who were identified as negative using the test assay, calculated as:\n\nNumber of participants who were both test and true negative / (Number of participants who were test and true negative + Number of participants who were test positive but true negative \\[ie false positive\\]) \\* 100%.\n\nSpecificity of the SD Biosensor G6PD test was calculated from both venous and capillary blood samples.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Females in the final analytic population with available data'}, {'type': 'SECONDARY', 'title': 'Accuracy Between the SD Biosensor POC G6PD Test Assay and the Pointe Scientific Test Kit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'G6PD Diagnostic Testing', 'description': 'Participants provided whole blood samples as well as finger-stick capillary blood samples.\n\nAt the clinic site lab, study staff performed the SD Biosensor POC G6PD test and the POC HemoCue hemoglobin test on both finger stick blood and whole blood samples.\n\nAt the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer.'}], 'classes': [{'title': 'Venous blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '80.1', 'upperLimit': '90.2'}]}]}, {'title': 'Capillary blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '96.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All samples were collected on study day 1', 'description': 'Accuracy between the SD Biosensor POC G6PD test assay and the Pointe Scientific G6PD reference assay was calculated as the percent agreement between both G6PD tests, ie, the percentage of participants with the same diagnosis according to both tests (either deficient, intermediate, or normal G6PD levels).\n\nAccuracy of the SD Biosensor G6PD test was calculated from both venous and capillary blood samples.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The final analytic population with available data'}, {'type': 'SECONDARY', 'title': 'Accuracy Between the SD Biosensor POC G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'G6PD Diagnostic Testing', 'description': 'Participants provided whole blood samples as well as finger-stick capillary blood samples.\n\nAt the clinic site lab, study staff performed the SD Biosensor POC G6PD test and the POC HemoCue hemoglobin test on both finger stick blood and whole blood samples.\n\nAt the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer.'}], 'classes': [{'title': 'Venous blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '94.3', 'upperLimit': '99.1'}]}]}, {'title': 'Capillary blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000', 'lowerLimit': '84.7', 'upperLimit': '93.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All samples were collected on study day 1', 'description': 'Accuracy between the SD Biosensor POC G6PD test measure of hemoglobin and the hemoglobin reference assay was calculated as the percentage agreement between both tests, ie, the percentage of participants with the same diagnosis according to both tests (either non/mild anemia, moderate anemia or severe anemia).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The final analytic population with available data'}, {'type': 'SECONDARY', 'title': 'Median G6PD Values Measured by the SD Biosensor G6PD Test for Venous and Capillary Blood Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'G6PD Diagnostic Testing', 'description': 'Participants provided whole blood samples as well as finger-stick capillary blood samples.\n\nAt the clinic site lab, study staff performed the SD Biosensor POC G6PD test and the POC HemoCue hemoglobin test on both finger stick blood and whole blood samples.\n\nAt the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer.'}], 'classes': [{'title': 'Venous blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '8.5'}]}]}, {'title': 'Capillary blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '7.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Comparison of SD Biosensor POC G6PD test results for capillary and venous samples', 'statisticalMethod': 'K-sample test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The p-value was calculated using a nonparametric k-sample test on the equality of medians.'}], 'paramType': 'MEDIAN', 'timeFrame': 'All samples were collected on study day 1', 'unitOfMeasure': 'units / gram of hemoglobin', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The final analytic population with available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'G6PD Diagnostic Testing', 'description': 'Participants provided whole blood samples as well as finger-stick capillary blood samples.\n\nAt the clinic site lab, study staff performed the Standard Diagnostics (SD) Biosensor point-of-care (POC) G6PD test assay and the POC HemoCue hemoglobin test on both finger-stick blood and whole blood samples.\n\nAt the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at the Seattle Malaria Clinical Trials Center (MCTC), based at the Fred Hutch Cancer Research Center and the University of Washington.\n\nParticipants were recruited from the greater Seattle area, and and targeted populations with expected high prevalence of glucose-6-phosphate dehydrogenase activity (G6PD) deficiency, including Southeast Asian populations and African-American populations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'G6PD Diagnostic Testing', 'description': 'Participants provided whole blood samples as well as finger-stick capillary blood samples.\n\nAt the clinic site lab, study staff performed the SD Biosensor POC G6PD test and the POC HemoCue hemoglobin test on both finger stick blood and whole blood samples.\n\nAt the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '12.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '≤ 21 years of age', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '22 - 64 years of age', 'measurements': [{'value': '203', 'groupId': 'BG000'}]}, {'title': '≥ 65 years of age', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '135', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Black/African American', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Caucasian/White', 'measurements': [{'value': '133', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The final analytic population excludes 36 Normal G6PD Males who were selected and excluded for Threshold Determination. Additionally 1 individual was excluded because venous blood was not collected.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-18', 'size': 395680, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-30T02:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2019-05-21', 'resultsFirstSubmitDate': '2021-07-30', 'studyFirstSubmitQcDate': '2019-07-04', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-30', 'studyFirstPostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals', 'timeFrame': 'All samples were collected on study day 1', 'description': 'For the purposes of this study, an individual was considered G6PD deficient if they tested positive in the Pointe Scientific assay. A true positive was defined as a participant with ≤ 30% of normal G6PD activity in circulating venous blood determined by the Pointe Scientific test.\n\nDiagnostic sensitivity of the SD Biosensor G6PD test is defined as the percentage of participants who tested positive for G6PD deficiency on the reference test who were identified by the test assay as positive, calculated as:\n\nNumber of participants who were both test and true positive / (Number of participants who were test and true positive + Number of participants who were test negative but true positive \\[ie false negative\\]) \\* 100%.\n\nSensitivity of the SD Biosensor POC G6PD test was calculated from both venous and capillary blood samples.'}, {'measure': 'Sensitivity of SD Biosensor POC G6PD Test for Identifying Women With Intermediate G6PD Activity', 'timeFrame': 'All samples were collected on study day 1', 'description': 'To investigate the performance of the SD Biosensor G6PD test to distinguish females with intermediate G6PD activity from females with normal activity, assay sensitivity was determined at a G6PD activity threshold of 70%. A true positive for intermediate G6PD activity in females was defined as G6PD activity between 30 and 70% of normal in circulating venous blood as determined by the Pointe Scientific test.\n\nSensitivity of the SD Biosensor POC G6PD test is the percentage of women who tested positive for intermediate G6PD activity on the reference test who were identified by the test assay as positive, calculated as:\n\nNumber of women who were both test and true positive / (Number of women who were test and true positive + Number of women who were test negative but true positive \\[ie false negative\\]) \\* 100%.\n\nSensitivity of the SD Biosensor G6PD test for identifying females with intermediate G6PD activity was calculated from both venous and capillary blood samples.'}, {'measure': 'Specificity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals', 'timeFrame': 'All samples were collected on study day 1', 'description': 'For the purposes of this study, an individual was considered G6PD deficient if they tested positive by the Pointe Scientific assay. A true negative was defined as \\> 30% of normal G6PD activity in circulating venous blood as determined by the Pointe Scientific test.\n\nSpecificity is the percentage of participants who tested negative for G6PD deficiency on the reference test who were identified as negative using the test assay, calculated as:\n\nNumber of participants who were both test and true negative / (Number of participants who were test and true negative + Number of participants who were test positive but true negative \\[ie false positive\\]) \\* 100%.\n\nSpecificity of the SD Biosensor G6PD test was calculated from both venous and capillary blood samples.'}, {'measure': 'Specificity of SD Biosensor G6PD Test for Identifying Women With Intermediate G6PD Activity', 'timeFrame': 'All samples were collected on study day 1', 'description': 'To investigate the performance of the SD Biosensor G6PD test to distinguish females with intermediate G6PD activity from females with normal activity, the specificity was determined at a G6PD activity threshold of 70%. A true negative for intermediate G6PD activity in females was defined as G6PD activity \\> 70% of normal in circulating venous blood as determined by the Pointe Scientific test.\n\nSpecificity is the percentage of participants who tested negative for G6PD deficiency on the reference test who were identified as negative using the test assay, calculated as:\n\nNumber of participants who were both test and true negative / (Number of participants who were test and true negative + Number of participants who were test positive but true negative \\[ie false positive\\]) \\* 100%.\n\nSpecificity of the SD Biosensor G6PD test was calculated from both venous and capillary blood samples.'}], 'secondaryOutcomes': [{'measure': 'Accuracy Between the SD Biosensor POC G6PD Test Assay and the Pointe Scientific Test Kit', 'timeFrame': 'All samples were collected on study day 1', 'description': 'Accuracy between the SD Biosensor POC G6PD test assay and the Pointe Scientific G6PD reference assay was calculated as the percent agreement between both G6PD tests, ie, the percentage of participants with the same diagnosis according to both tests (either deficient, intermediate, or normal G6PD levels).\n\nAccuracy of the SD Biosensor G6PD test was calculated from both venous and capillary blood samples.'}, {'measure': 'Accuracy Between the SD Biosensor POC G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test', 'timeFrame': 'All samples were collected on study day 1', 'description': 'Accuracy between the SD Biosensor POC G6PD test measure of hemoglobin and the hemoglobin reference assay was calculated as the percentage agreement between both tests, ie, the percentage of participants with the same diagnosis according to both tests (either non/mild anemia, moderate anemia or severe anemia).'}, {'measure': 'Median G6PD Values Measured by the SD Biosensor G6PD Test for Venous and Capillary Blood Samples', 'timeFrame': 'All samples were collected on study day 1'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['G6PD deficiency'], 'conditions': ['G6PD Deficiency']}, 'referencesModule': {'references': [{'pmid': '34543346', 'type': 'BACKGROUND', 'citation': 'Pal S, Myburgh J, Bansil P, Hann A, Robertson L, Gerth-Guyette E, Ambler G, Bizilj G, Kahn M, Zobrist S, Manis MR, Styke NA, Allan V, Ansbro R, Akingbade T, Bryan A, Murphy SC, Kublin JG, Layton M, Domingo GJ. Reference and point-of-care testing for G6PD deficiency: Blood disorder interference, contrived specimens, and fingerstick equivalence and precision. PLoS One. 2021 Sep 20;16(9):e0257560. doi: 10.1371/journal.pone.0257560. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the accuracy of the SD Biosensor STANDARD G6PD Analyzer in measuring G6PD activity when used by trained health care workers.', 'detailedDescription': 'This is a cross-sectional diagnostic accuracy study with up to 250 participants with a goal of obtaining 20 deficient and 20 intermediate samples. The clinic will recruit and consent study participants. Clinic staff will draw 3 whole blood samples and obtain finger stick capillary blood.\n\nG6PD activity is reported in terms of grams of hemoglobin (Hb), hence the hemoglobin concentration must be measured.\n\nClinic staff will perform the investigational Standard Diagnostics (SD) Biosensor point-of-care (POC) test for glucose-6-phosphate dehydrogenase (G6PD) deficiency and a HemoCue® hemoglobin test on finger stick capillary blood and on the venous blood samples.\n\nAnother venous blood sample will be sent to a clinical laboratory improvement amendments (CLIA)-certified laboratory for reference testing by the gold standard assays:\n\n* G6PD measurement by spectrophotometry using the Pointe Scientific G6PD reference assay\n* hemoglobin measurement by a hematology analyzer\n\nIndividuals identified as G6PD deficient with the reference test will be notified of their results by the clinic and referred to their physician for follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Willingness to provide consent\n\nExclusion Criteria:\n\n-Blood transfusion in the past 90 days by self-report'}, 'identificationModule': {'nctId': 'NCT04010695', 'briefTitle': 'Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US', 'organization': {'class': 'OTHER', 'fullName': 'PATH'}, 'officialTitle': 'Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US', 'orgStudyIdInfo': {'id': 'G6PD Validation Seattle'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'G6PD Diagnostic Testing', 'description': 'Participants provided whole blood samples as well as fingerstick capillary blood samples.\n\nAt the clinic site lab, study staff conducted the SD Biosensor point-of-care G6PD test and the point-of-care HemoCue Hb test on both finger stick blood and whole blood samples.\n\nAt the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer.', 'interventionNames': ['Diagnostic Test: SD Biosensor G6PD Analyzer', 'Diagnostic Test: Pointe Scientific Test Kit', 'Diagnostic Test: HemoCue System']}], 'interventions': [{'name': 'SD Biosensor G6PD Analyzer', 'type': 'DIAGNOSTIC_TEST', 'description': 'The SD Biosensor G6PD Analyzer is designed to measure the quantitative determination of total hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimens based on reflectometry assays in a point-of-care setting. The test is intended to aid in the identification of people with G6PD deficiency. The test is currently not licensed for use in the US and is considered an investigational product.', 'armGroupLabels': ['G6PD Diagnostic Testing']}, {'name': 'Pointe Scientific Test Kit', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Pointe Scientific test kit will serve as the reference assay to assess G6PD activity. Its intended use is for the quantitative, kinetic determination of G6PD in blood at 340 nm.', 'armGroupLabels': ['G6PD Diagnostic Testing']}, {'name': 'HemoCue System', 'type': 'DIAGNOSTIC_TEST', 'description': 'The HemoCue hemoglobin (Hb) 201+ system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 201+ Analyzer, and specially designed microcuvettes, the HemoCue Hb 201+Microcuvettes.', 'armGroupLabels': ['G6PD Diagnostic Testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchison Prevention Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'James Kublin, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not planning to share IPD to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PATH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}