Trial Outcomes & Findings for Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US (NCT NCT04010695)
NCT ID: NCT04010695
Last Updated: 2022-05-10
Results Overview
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. Diagnostic 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: Number 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%. Sensitivity of the SD Biosensor POC G6PD test was calculated from both venous and capillary blood samples.
COMPLETED
NA
250 participants
All samples were collected on study day 1
2022-05-10
Participant Flow
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. Participants 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.
Participant milestones
| Measure |
G6PD Diagnostic Testing
Participants provided whole blood samples as well as finger-stick capillary blood samples.
At 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.
At 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.
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|---|---|
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Overall Study
STARTED
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250
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Overall Study
COMPLETED
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250
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
Baseline characteristics by cohort
| Measure |
G6PD Diagnostic Testing
n=213 Participants
Participants provided whole blood samples as well as finger-stick capillary blood samples.
At 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.
At 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.
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Age, Continuous
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35.4 years
STANDARD_DEVIATION 12.3 • n=99 Participants
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Age, Customized
≤ 21 years of age
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7 Participants
n=99 Participants
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Age, Customized
22 - 64 years of age
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203 Participants
n=99 Participants
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Age, Customized
≥ 65 years of age
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3 Participants
n=99 Participants
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Sex: Female, Male
Female
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135 Participants
n=99 Participants
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Sex: Female, Male
Male
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78 Participants
n=99 Participants
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Race/Ethnicity, Customized
Asian
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27 Participants
n=99 Participants
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Race/Ethnicity, Customized
Black/African American
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34 Participants
n=99 Participants
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Race/Ethnicity, Customized
Caucasian/White
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133 Participants
n=99 Participants
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Race/Ethnicity, Customized
More than one race
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15 Participants
n=99 Participants
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Race/Ethnicity, Customized
Other
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4 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: All samples were collected on study day 1Population: The final analytic population with available data
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. Diagnostic 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: Number 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%. Sensitivity of the SD Biosensor POC G6PD test was calculated from both venous and capillary blood samples.
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=212 Participants
Participants provided whole blood samples as well as finger-stick capillary blood samples.
At 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.
At 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.
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Sensitivity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals
Venous Blood
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100.0 percentage of participants
Interval 59.0 to 100.0
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Sensitivity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals
Capillary Blood
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100.0 percentage of participants
Interval 59.0 to 100.0
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PRIMARY outcome
Timeframe: All samples were collected on study day 1Population: Females in the final analytic population with available data
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. Sensitivity 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: Number 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%. Sensitivity of the SD Biosensor G6PD test for identifying females with intermediate G6PD activity was calculated from both venous and capillary blood samples.
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=135 Participants
Participants provided whole blood samples as well as finger-stick capillary blood samples.
At 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.
At 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.
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Sensitivity of SD Biosensor POC G6PD Test for Identifying Women With Intermediate G6PD Activity
Venous Blood
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100.0 percentage of participants
Interval 39.8 to 100.0
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Sensitivity of SD Biosensor POC G6PD Test for Identifying Women With Intermediate G6PD Activity
Capillary Blood
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75.0 percentage of participants
Interval 19.4 to 99.4
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PRIMARY outcome
Timeframe: All samples were collected on study day 1Population: The final analytic population with available data
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. Specificity 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: Number 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%. Specificity of the SD Biosensor G6PD test was calculated from both venous and capillary blood samples.
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=212 Participants
Participants provided whole blood samples as well as finger-stick capillary blood samples.
At 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.
At 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.
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|---|---|
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Specificity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals
Venous Blood
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94.9 percentage of participants
Interval 90.8 to 97.5
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Specificity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals
Capillary Blood
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98.5 percentage of participants
Interval 95.8 to 99.7
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PRIMARY outcome
Timeframe: All samples were collected on study day 1Population: Females in the final analytic population with available data
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. Specificity 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: Number 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%. Specificity of the SD Biosensor G6PD test was calculated from both venous and capillary blood samples.
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=135 Participants
Participants provided whole blood samples as well as finger-stick capillary blood samples.
At 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.
At 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.
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|---|---|
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Specificity of SD Biosensor G6PD Test for Identifying Women With Intermediate G6PD Activity
Venous Blood
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83.7 percentage of participants
Interval 76.2 to 89.6
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Specificity of SD Biosensor G6PD Test for Identifying Women With Intermediate G6PD Activity
Capillary Blood
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92.4 percentage of participants
Interval 86.4 to 96.3
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SECONDARY outcome
Timeframe: All samples were collected on study day 1Population: The final analytic population with available data
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). Accuracy of the SD Biosensor G6PD test was calculated from both venous and capillary blood samples.
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=212 Participants
Participants provided whole blood samples as well as finger-stick capillary blood samples.
At 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.
At 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.
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|---|---|
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Accuracy Between the SD Biosensor POC G6PD Test Assay and the Pointe Scientific Test Kit
Venous blood
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85.7 percentage of participants
Interval 80.1 to 90.2
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Accuracy Between the SD Biosensor POC G6PD Test Assay and the Pointe Scientific Test Kit
Capillary blood
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93.9 percentage of participants
Interval 89.7 to 96.7
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SECONDARY outcome
Timeframe: All samples were collected on study day 1Population: The final analytic population with available data
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).
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=212 Participants
Participants provided whole blood samples as well as finger-stick capillary blood samples.
At 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.
At 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.
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|---|---|
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Accuracy Between the SD Biosensor POC G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test
Venous blood
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97.5 percentage of participants
Interval 94.3 to 99.1
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Accuracy Between the SD Biosensor POC G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test
Capillary blood
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89.6 percentage of participants
Interval 84.7 to 93.4
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SECONDARY outcome
Timeframe: All samples were collected on study day 1Population: The final analytic population with available data
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=213 Participants
Participants provided whole blood samples as well as finger-stick capillary blood samples.
At 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.
At 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.
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Median G6PD Values Measured by the SD Biosensor G6PD Test for Venous and Capillary Blood Samples
Venous blood
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7.6 units / gram of hemoglobin
Interval 6.8 to 8.5
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Median G6PD Values Measured by the SD Biosensor G6PD Test for Venous and Capillary Blood Samples
Capillary blood
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6.8 units / gram of hemoglobin
Interval 6.1 to 7.5
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Adverse Events
G6PD Diagnostic Testing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place