Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-27 @ 4:01 PM
Study NCT ID:
NCT04054661
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2019-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood
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 60 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 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.', 'otherNumAtRisk': 229, 'deathsNumAtRisk': 229, 'otherNumAffected': 0, 'seriousNumAtRisk': 229, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', '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 conducted the SD Biosensor STANDARD G6PD test and the 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.'}], 'classes': [{'title': 'Venous blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '79.4', 'upperLimit': '100.0'}]}]}, {'title': 'Capillary blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '79.4', '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 STANDARD 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 STANDARD G6PD test was calculated from both venous and capillary blood samples.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Final analytic population with available data'}, {'type': 'PRIMARY', 'title': 'Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', '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 conducted the SD Biosensor STANDARD G6PD test and the 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.'}], 'classes': [{'title': 'Venous blood', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '35.9', 'upperLimit': '99.6'}]}]}, {'title': 'Capillary blood', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '22.3', 'upperLimit': '95.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All samples were collected on study day 1', 'description': 'To investigate the performance of the SD Biosensor STANDARD 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 STANDARD 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 STANDARD 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'}, {'type': 'PRIMARY', 'title': 'Specificity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', '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 conducted the SD Biosensor STANDARD G6PD test and the 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.'}], 'classes': [{'title': 'Venous blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.5'}]}]}, {'title': 'Capillary blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000', 'lowerLimit': '96.5', '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 STANDARD G6PD test was calculated from both venous and capillary blood samples.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Final analytic population with available data'}, {'type': 'PRIMARY', 'title': 'Specificity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', '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 conducted the SD Biosensor STANDARD G6PD test and the 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.'}], 'classes': [{'title': 'Venous blood', 'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000', 'lowerLimit': '84.1', 'upperLimit': '98.8'}]}]}, {'title': 'Capillary blood', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.2', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All samples were collected on study day 1', 'description': 'To investigate the performance of the SD Biosensor STANDARD 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 STANDARD 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'}, {'type': 'SECONDARY', 'title': 'Accuracy Between the SD Biosensor STANDARD G6PD Test Assay and the Pointe Scientific Test Kit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', '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 conducted the SD Biosensor STANDARD G6PD test and the 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.'}], 'classes': [{'title': 'Venous samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '93.6', 'upperLimit': '98.7'}]}]}, {'title': 'Capillary samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '99.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All samples were collected on study day 1', 'description': 'Accuracy between the SD Biosensor STANDARD 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 STANDARD 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 STANDARD G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '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.'}], 'classes': [{'title': 'Venous samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '93.0', 'upperLimit': '98.4'}]}]}, {'title': 'Capillary samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000', 'lowerLimit': '72.6', 'upperLimit': '83.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All samples were collected on study day 1', 'description': 'Accuracy between the SD Biosensor STANDARD 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': 'Repeatability Substudy: G6PD Levels in Capillary Blood Samples Measured Using the SD Biosensor G6PD Test, by Operator and Analyzer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'G6PD Diagnostic Testing', 'description': 'Participants in the repeatability substudy provided 8 finger stick capillary blood samples which were tested for G6PD activity using the SD Biosensor STANDARD G6PD test.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Operator 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Operator 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Operator 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.6', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Instrument 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Instrument 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Instrument 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.6', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'All samples were collected on study day 1 and tested immediately', 'description': 'Capillary blood samples were collected in duplicate from four different fingers on the participants hands, for a total of eight samples. Within each duplicate, a sample was tested on 1 of 2 SD Biosensor G6PD instruments by 1 of 2 operators. Overall there were 3 instruments used in the testing and 3 operators.', 'unitOfMeasure': 'units / gram of hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Finger stick samples', 'denomUnitsSelected': 'Finger stick samples', 'populationDescription': 'Participants in the repeatability substudy population. Each participant provided 8 finger stick (capillary) blood samples.'}, {'type': 'SECONDARY', 'title': 'Repeatability Substudy: Hemoglobin Levels in Capillary Blood Samples Measured Using the SD Biosensor STANDARD Hemoglobin Test, by Operator and Analyzer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'G6PD Diagnostic Testing', 'description': 'Participants in the repeatability substudy provided 8 finger stick capillary blood samples which were tested for hemoglobin levels using the SD Biosensor STANDARD test.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.9', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Operator 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Operator 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.8', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Operator 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Instrument 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.6', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Instrument 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.2', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Instrument 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}, {'units': 'Finger stick samples', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.1', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'All samples were collected on study day 1 and tested immediately', 'description': 'Capillary blood samples were collected in duplicate from four different fingers on the participants hands, for a total of eight samples. Within each duplicate, a sample was tested on 1 of 2 SD Biosensor instruments by 1 of 2 operators. Overall there were 3 instruments used in the testing and 3 operators.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Finger stick samples', 'denomUnitsSelected': 'Finger stick samples', 'populationDescription': 'Participants in the repeatability substudy population. Each participant provided 8 finger stick (capillary) blood samples.'}, {'type': 'SECONDARY', 'title': 'Sample Stability Substudy: G6PD Levels Measured Over Time After Storage at Room Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EDTA-anti-coagulated Blood', 'description': 'EDTA-anti-coagulated whole blood samples stored at room temperature.'}, {'id': 'OG001', 'title': 'Heparin-anti-coagulated Blood', 'description': 'Heparin-anti-coagulated whole blood samples stored at room temperature.'}, {'id': 'OG002', 'title': 'ACD-anti-coagulated Blood', 'description': 'ACD-anti-coagulated whole blood samples stored at room temperature.'}], 'classes': [{'title': '0 hours', 'categories': [{'measurements': [{'value': '5.63', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '5.44', 'spread': '3.21', 'groupId': 'OG001'}, {'value': '5.52', 'spread': '3.35', 'groupId': 'OG002'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '5.82', 'spread': '3.42', 'groupId': 'OG000'}, {'value': '5.61', 'spread': '3.20', 'groupId': 'OG001'}, {'value': '5.78', 'spread': '3.36', 'groupId': 'OG002'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '5.94', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '5.76', 'spread': '3.01', 'groupId': 'OG001'}, {'value': '5.74', 'spread': '3.11', 'groupId': 'OG002'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '5.82', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '5.48', 'spread': '2.97', 'groupId': 'OG001'}, {'value': '5.62', 'spread': '3.38', 'groupId': 'OG002'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '5.26', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '5.53', 'spread': '3.65', 'groupId': 'OG001'}, {'value': '5.36', 'spread': '3.76', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 2, 4, 6, and 24 hours after collection.', 'description': 'Each participant in the sample stability substudy underwent an additional blood draw in 3 different anti-coagulants which were stored at room temperature (15-30°C/59-86°F). The freshly collected venous whole blood samples were tested at the clinic site lab using the SD Biosensor STANDARD G6PD test within 1 hour of collection for baseline (0 hour) and at 4 additional time points, up to 2 days (48 hours) after collection. The anti-coagulants included:\n\n* ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood\n* heparin-anti-coagulated blood\n* acid citrate dextrose (ACD)-anti-coagulated blood', 'unitOfMeasure': 'units / gram hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Stability substudy participants'}, {'type': 'SECONDARY', 'title': 'Sample Stability Substudy: G6PD Levels Measured Over Time After Refrigerated Storage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EDTA-anti-coagulated Blood', 'description': 'EDTA-anti-coagulated whole blood samples stored in a refrigerator.'}, {'id': 'OG001', 'title': 'Heparin-anti-coagulated Blood', 'description': 'Heparin-anti-coagulated whole blood samples stored in a refrigerator.'}, {'id': 'OG002', 'title': 'ACD-anti-coagulated Blood', 'description': 'ACD-anti-coagulated whole blood samples stored in a refrigerator.'}], 'classes': [{'title': '0 hours', 'categories': [{'measurements': [{'value': '5.6', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '3.4', 'groupId': 'OG002'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '5.9', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '3.1', 'groupId': 'OG002'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '4.9', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '3.0', 'groupId': 'OG002'}]}]}, {'title': '72 hours', 'categories': [{'measurements': [{'value': '9.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': '96 hours', 'categories': [{'measurements': [{'value': '9.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': '168 hours', 'categories': [{'measurements': [{'value': '5.2', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '3.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 24, 48, 72, 96, and 168 hours after collection.', 'description': 'Each participant in the sample stability substudy underwent an additional blood draw in 3 different anti-coagulants which were stored in a refrigerator (2-8°C/25-46°F). The freshly collected venous whole blood samples were tested at the clinic site lab using the SD Biosensor STANDARD G6PD test within 1 hour of collection for baseline (0 hour) and at 5 additional time points, up to 7 days (168 hours) after collection. The anti-coagulants included:\n\n* ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood\n* heparin-anti-coagulated blood\n* acid citrate dextrose (ACD)-anti-coagulated blood', 'unitOfMeasure': 'units / gram hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Stability substudy participants'}, {'type': 'SECONDARY', 'title': 'Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Storage at Room Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EDTA-anti-coagulated Blood', 'description': 'EDTA-anti-coagulated whole blood samples stored at room temperature.'}, {'id': 'OG001', 'title': 'Heparin-anti-coagulated Blood', 'description': 'Heparin-anti-coagulated whole blood samples stored at room temperature.'}, {'id': 'OG002', 'title': 'ACD-anti-coagulated Blood', 'description': 'ACD-anti-coagulated whole blood samples stored at room temperature.'}], 'classes': [{'title': '0 hours', 'categories': [{'measurements': [{'value': '13.9', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '12.6', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '14.2', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '2.4', 'groupId': 'OG002'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '14.1', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '12.6', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '14.2', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '12.8', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '14.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '13.1', 'spread': '2.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 2, 4, 6, and 24 hours after collection.', 'description': 'Each participant in the sample stability substudy underwent a blood draw in 3 different anti-coagulants which were stored at room temperature (15-30°C/59-86°F). Hemoglobin levels were measured from the freshly collected venous whole blood samples at the clinic site lab using the SD Biosensor STANDARD hemoglobin test within 1 hour of collection for baseline (0 hour) and at 4 additional time points, up to 24 hours after collection. The anti-coagulants included:\n\n* ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood\n* heparin-anti-coagulated blood\n* acid citrate dextrose (ACD)-anti-coagulated blood', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Stability substudy participants'}, {'type': 'SECONDARY', 'title': 'Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Refrigerated Storage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EDTA-anti-coagulated Blood', 'description': 'EDTA-anti-coagulated whole blood samples stored in a refrigerator.'}, {'id': 'OG001', 'title': 'Heparin-anti-coagulated Blood', 'description': 'Heparin-anti-coagulated whole blood samples stored in a refrigerator.'}, {'id': 'OG002', 'title': 'ACD-anti-coagulated Blood', 'description': 'ACD-anti-coagulated whole blood samples stored in a refrigerator.'}], 'classes': [{'title': '0 hours', 'categories': [{'measurements': [{'value': '13.9', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '12.6', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '14.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '13.1', 'spread': '2.6', 'groupId': 'OG002'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '14.1', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '12.7', 'spread': '3.0', 'groupId': 'OG002'}]}]}, {'title': '72 hours', 'categories': [{'measurements': [{'value': '16.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': '96 hours', 'categories': [{'measurements': [{'value': '15.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '11.2', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': '168 hours', 'categories': [{'measurements': [{'value': '15.0', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '13.5', 'spread': '2.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 24, 48, 72, 96, and 168 hours after collection.', 'description': 'Each participant in the sample stability substudy underwent an additional blood draw in 3 different anti-coagulants which were stored in a refrigerator (2-8°C/25-46°F). Hemoglobin levels were measured from the freshly collected venous whole blood samples at the clinic site lab using the SD Biosensor STANDARD hemoglobin test within 1 hour of collection for baseline (0 hour) and at 5 additional time points, up to 7 days (168 hours) after collection. The anti-coagulants included:\n\n* ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood\n* heparin-anti-coagulated blood\n* acid citrate dextrose (ACD)-anti-coagulated blood', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Stability substudy participants'}]}, '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 conducted the SD Biosensor STANDARD™ point-of-care (POC) G6PD test and the POC HemoCue hemoglobin (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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}]}, {'type': 'Enrolled in Repeatability Sub-study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Enrolled in Sample Stability Sub-study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was performed at a single US clinical study site in Pennsylvania. Participants were recruited for the study among donors who presented at the blood donation center.\n\nThe study included a nested repeatability study, and a nested sample stability study. For both sub-studies participants were recruited based on their glucose-6-phosphate dehydrogenase (G6PD) test results.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '221', '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 conducted the SD Biosensor STANDARD G6PD test and the 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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '21 years or less', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '22 - 64 years', 'measurements': [{'value': '205', 'groupId': 'BG000'}]}, {'title': '65 years or older', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '163', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '194', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '221', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Final analytic population includes all participants that were not previously enrolled, met eligibility criteria, and their STANDARD Test results were not affected by STANDARD Test Kit Recall.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-16', 'size': 556271, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-07T12:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-15', 'studyFirstSubmitDate': '2019-08-12', 'resultsFirstSubmitDate': '2021-09-07', 'studyFirstSubmitQcDate': '2019-08-12', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-07', 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of SD Biosensor STANDARD 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 STANDARD 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 STANDARD G6PD test was calculated from both venous and capillary blood samples.'}, {'measure': 'Sensitivity of SD Biosensor STANDARD 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 STANDARD 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 STANDARD 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 STANDARD G6PD test for identifying females with intermediate G6PD activity was calculated from both venous and capillary blood samples.'}, {'measure': 'Specificity of SD Biosensor STANDARD 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 STANDARD G6PD test was calculated from both venous and capillary blood samples.'}, {'measure': 'Specificity of SD Biosensor STANDARD 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 STANDARD 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 STANDARD G6PD test was calculated from both venous and capillary blood samples.'}], 'secondaryOutcomes': [{'measure': 'Accuracy Between the SD Biosensor STANDARD G6PD Test Assay and the Pointe Scientific Test Kit', 'timeFrame': 'All samples were collected on study day 1', 'description': 'Accuracy between the SD Biosensor STANDARD 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 STANDARD G6PD test was calculated from both venous and capillary blood samples.'}, {'measure': 'Accuracy Between the SD Biosensor STANDARD 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 STANDARD 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': 'Repeatability Substudy: G6PD Levels in Capillary Blood Samples Measured Using the SD Biosensor G6PD Test, by Operator and Analyzer', 'timeFrame': 'All samples were collected on study day 1 and tested immediately', 'description': 'Capillary blood samples were collected in duplicate from four different fingers on the participants hands, for a total of eight samples. Within each duplicate, a sample was tested on 1 of 2 SD Biosensor G6PD instruments by 1 of 2 operators. Overall there were 3 instruments used in the testing and 3 operators.'}, {'measure': 'Repeatability Substudy: Hemoglobin Levels in Capillary Blood Samples Measured Using the SD Biosensor STANDARD Hemoglobin Test, by Operator and Analyzer', 'timeFrame': 'All samples were collected on study day 1 and tested immediately', 'description': 'Capillary blood samples were collected in duplicate from four different fingers on the participants hands, for a total of eight samples. Within each duplicate, a sample was tested on 1 of 2 SD Biosensor instruments by 1 of 2 operators. Overall there were 3 instruments used in the testing and 3 operators.'}, {'measure': 'Sample Stability Substudy: G6PD Levels Measured Over Time After Storage at Room Temperature', 'timeFrame': 'Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 2, 4, 6, and 24 hours after collection.', 'description': 'Each participant in the sample stability substudy underwent an additional blood draw in 3 different anti-coagulants which were stored at room temperature (15-30°C/59-86°F). The freshly collected venous whole blood samples were tested at the clinic site lab using the SD Biosensor STANDARD G6PD test within 1 hour of collection for baseline (0 hour) and at 4 additional time points, up to 2 days (48 hours) after collection. The anti-coagulants included:\n\n* ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood\n* heparin-anti-coagulated blood\n* acid citrate dextrose (ACD)-anti-coagulated blood'}, {'measure': 'Sample Stability Substudy: G6PD Levels Measured Over Time After Refrigerated Storage', 'timeFrame': 'Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 24, 48, 72, 96, and 168 hours after collection.', 'description': 'Each participant in the sample stability substudy underwent an additional blood draw in 3 different anti-coagulants which were stored in a refrigerator (2-8°C/25-46°F). The freshly collected venous whole blood samples were tested at the clinic site lab using the SD Biosensor STANDARD G6PD test within 1 hour of collection for baseline (0 hour) and at 5 additional time points, up to 7 days (168 hours) after collection. The anti-coagulants included:\n\n* ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood\n* heparin-anti-coagulated blood\n* acid citrate dextrose (ACD)-anti-coagulated blood'}, {'measure': 'Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Storage at Room Temperature', 'timeFrame': 'Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 2, 4, 6, and 24 hours after collection.', 'description': 'Each participant in the sample stability substudy underwent a blood draw in 3 different anti-coagulants which were stored at room temperature (15-30°C/59-86°F). Hemoglobin levels were measured from the freshly collected venous whole blood samples at the clinic site lab using the SD Biosensor STANDARD hemoglobin test within 1 hour of collection for baseline (0 hour) and at 4 additional time points, up to 24 hours after collection. The anti-coagulants included:\n\n* ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood\n* heparin-anti-coagulated blood\n* acid citrate dextrose (ACD)-anti-coagulated blood'}, {'measure': 'Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Refrigerated Storage', 'timeFrame': 'Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 24, 48, 72, 96, and 168 hours after collection.', 'description': 'Each participant in the sample stability substudy underwent an additional blood draw in 3 different anti-coagulants which were stored in a refrigerator (2-8°C/25-46°F). Hemoglobin levels were measured from the freshly collected venous whole blood samples at the clinic site lab using the SD Biosensor STANDARD hemoglobin test within 1 hour of collection for baseline (0 hour) and at 5 additional time points, up to 7 days (168 hours) after collection. The anti-coagulants included:\n\n* ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood\n* heparin-anti-coagulated blood\n* acid citrate dextrose (ACD)-anti-coagulated blood'}]}, '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 the study is to assess the accuracy of the SD Biosensor STANDARD™ point-of-care (POC) G6PD test in measuring G6PD activity and classifying results compared to a reference assay and across repeated measurements in capillary samples.', 'detailedDescription': 'Cross-sectional diagnostic accuracy study with 250 volunteer participants. The clinic will recruit and consent adult study participants. Clinic staff will draw venous blood and obtain finger stick capillary blood samples. Clinic staff will perform the investigational SD Biosensor STANDARD™ G6PD test for glucose-6-phosphate dehydrogenase (G6PD) deficiency and a HemoCue® hemoglobin test on finger stick capillary blood. An anti-coagulated venous blood sample will be sent to a Clinical Laboratory Improvement Amendments (CLIA) certified lab for G6PD reference testing by the gold standard assays: G6PD measurement by spectrophotometry using the Pointe Scientific G6PD reference assay and hemoglobin measurement by a hematology analyzer.\n\nIndividuals identified as G6PD deficient or intermediate by the reference test will be notified of their results by the clinic and referred to their physician for follow-up.\n\nThis study includes a nested repeatability study and a nested sample stability study. In the nested repeatability study up to 20 consented participants will provide 4 additional finger stick samples. Clinic staff will perform the SD Biosensor STANDARD™ G6PD test to assess the repeatability of the test in capillary blood over 8 G6PD and hemoglobin measurements on up to 3 different instruments.\n\nIn the nested sample stability study up to 8 consented participants will provide an additional venous blood draw sample to be tested at additional time points to document stability of the samples over time when tested by the SD Biosensor STANDARD™ G6PD Test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must communicate an understanding of the study protocol.\n* Must be able to provide written consent to undergo screening and provide medical history.\n* Participants must be afebrile and in general good health in the opinion of the investigator as determined by vital signs, medical history, and physical examination.\n* Black/African-American, by self-report.\n\nExclusion Criteria:\n\n* Blood transfusion in the past 3 months by self-report'}, 'identificationModule': {'nctId': 'NCT04054661', 'briefTitle': 'Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood', 'organization': {'class': 'OTHER', 'fullName': 'PATH'}, 'officialTitle': 'Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase Deficiency: Diagnostic Accuracy and Repeatability in Capillary Samples', 'orgStudyIdInfo': {'id': '1416844'}}, '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 STANDARD point-of-care G6PD test and the point-of-care 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.', 'interventionNames': ['Diagnostic Test: SD Biosensor STANDARD G6PD Test', 'Diagnostic Test: Pointe Scientific Test Kit', 'Diagnostic Test: HemoCue System']}], 'interventions': [{'name': 'SD Biosensor STANDARD G6PD Test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['SD Biosensor G6PD 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': '19602', 'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'BSC corporation', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}], 'overallOfficials': [{'name': 'Cheryl Berne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biological Specialty Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not planning to share IPD to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PATH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}