Trial Outcomes & Findings for Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood (NCT NCT04054661)
NCT ID: NCT04054661
Last Updated: 2021-11-09
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 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: 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 STANDARD G6PD test was calculated from both venous and capillary blood samples.
COMPLETED
NA
229 participants
All samples were collected on study day 1
2021-11-09
Participant Flow
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. The 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.
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 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.
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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229
|
|
Overall Study
Enrolled in Repeatability Sub-study
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15
|
|
Overall Study
Enrolled in Sample Stability Sub-study
|
3
|
|
Overall Study
COMPLETED
|
229
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood
Baseline characteristics by cohort
| Measure |
G6PD Diagnostic Testing
n=221 Participants
Participants provided whole blood samples as well as finger stick capillary blood samples.
At 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.
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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Age, Continuous
|
37.5 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Age, Customized
21 years or less
|
15 Participants
n=5 Participants
|
|
Age, Customized
22 - 64 years
|
205 Participants
n=5 Participants
|
|
Age, Customized
65 years or older
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
163 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
194 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
221 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: All samples were collected on study day 1Population: 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 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: 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 STANDARD G6PD test was calculated from both venous and capillary blood samples.
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=221 Participants
Participants provided whole blood samples as well as finger stick capillary blood samples.
At 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.
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.
|
Heparin-anti-coagulated Blood
Heparin-anti-coagulated whole blood samples stored at room temperature.
|
ACD-anti-coagulated Blood
ACD-anti-coagulated whole blood samples stored at room temperature.
|
|---|---|---|---|
|
Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
Venous blood
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
—
|
—
|
|
Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
Capillary blood
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
—
|
—
|
PRIMARY outcome
Timeframe: All samples were collected on study day 1Population: Females in the final analytic population
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. Sensitivity 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: 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 STANDARD 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=58 Participants
Participants provided whole blood samples as well as finger stick capillary blood samples.
At 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.
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.
|
Heparin-anti-coagulated Blood
Heparin-anti-coagulated whole blood samples stored at room temperature.
|
ACD-anti-coagulated Blood
ACD-anti-coagulated whole blood samples stored at room temperature.
|
|---|---|---|---|
|
Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
Venous blood
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
—
|
—
|
|
Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
Capillary blood
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
—
|
—
|
PRIMARY outcome
Timeframe: All samples were collected on study day 1Population: 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 STANDARD G6PD test was calculated from both venous and capillary blood samples.
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=221 Participants
Participants provided whole blood samples as well as finger stick capillary blood samples.
At 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.
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.
|
Heparin-anti-coagulated Blood
Heparin-anti-coagulated whole blood samples stored at room temperature.
|
ACD-anti-coagulated Blood
ACD-anti-coagulated whole blood samples stored at room temperature.
|
|---|---|---|---|
|
Specificity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
Venous blood
|
98.0 percentage of participants
Interval 95.1 to 99.5
|
—
|
—
|
|
Specificity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
Capillary blood
|
99.0 percentage of participants
Interval 96.5 to 99.7
|
—
|
—
|
PRIMARY outcome
Timeframe: All samples were collected on study day 1Population: Females in the final analytic population
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. 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 STANDARD G6PD test was calculated from both venous and capillary blood samples.
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=58 Participants
Participants provided whole blood samples as well as finger stick capillary blood samples.
At 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.
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.
|
Heparin-anti-coagulated Blood
Heparin-anti-coagulated whole blood samples stored at room temperature.
|
ACD-anti-coagulated Blood
ACD-anti-coagulated whole blood samples stored at room temperature.
|
|---|---|---|---|
|
Specificity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
Venous blood
|
94.2 percentage of participants
Interval 84.1 to 98.8
|
—
|
—
|
|
Specificity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
Capillary blood
|
100.0 percentage of participants
Interval 93.2 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: All samples were collected on study day 1Population: The final analytic population with available data
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). Accuracy of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples.
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=221 Participants
Participants provided whole blood samples as well as finger stick capillary blood samples.
At 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.
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.
|
Heparin-anti-coagulated Blood
Heparin-anti-coagulated whole blood samples stored at room temperature.
|
ACD-anti-coagulated Blood
ACD-anti-coagulated whole blood samples stored at room temperature.
|
|---|---|---|---|
|
Accuracy Between the SD Biosensor STANDARD G6PD Test Assay and the Pointe Scientific Test Kit
Venous samples
|
96.8 percentage of participants
Interval 93.6 to 98.7
|
—
|
—
|
|
Accuracy Between the SD Biosensor STANDARD G6PD Test Assay and the Pointe Scientific Test Kit
Capillary samples
|
98.2 percentage of participants
Interval 95.4 to 99.5
|
—
|
—
|
SECONDARY outcome
Timeframe: All samples were collected on study day 1Population: The final analytic population with available data
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).
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=221 Participants
Participants provided whole blood samples as well as finger stick capillary blood samples.
At 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.
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.
|
Heparin-anti-coagulated Blood
Heparin-anti-coagulated whole blood samples stored at room temperature.
|
ACD-anti-coagulated Blood
ACD-anti-coagulated whole blood samples stored at room temperature.
|
|---|---|---|---|
|
Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test
Venous samples
|
96.4 percentage of participants
Interval 93.0 to 98.4
|
—
|
—
|
|
Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test
Capillary samples
|
78.6 percentage of participants
Interval 72.6 to 83.9
|
—
|
—
|
SECONDARY outcome
Timeframe: All samples were collected on study day 1 and tested immediatelyPopulation: Participants in the repeatability substudy population. Each participant provided 8 finger stick (capillary) blood samples.
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.
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=120 Finger stick samples
Participants provided whole blood samples as well as finger stick capillary blood samples.
At 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.
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.
|
Heparin-anti-coagulated Blood
Heparin-anti-coagulated whole blood samples stored at room temperature.
|
ACD-anti-coagulated Blood
ACD-anti-coagulated whole blood samples stored at room temperature.
|
|---|---|---|---|
|
Repeatability Substudy: G6PD Levels in Capillary Blood Samples Measured Using the SD Biosensor G6PD Test, by Operator and Analyzer
Overall
|
5.1 units / gram of hemoglobin
Standard Deviation 2.6
|
—
|
—
|
|
Repeatability Substudy: G6PD Levels in Capillary Blood Samples Measured Using the SD Biosensor G6PD Test, by Operator and Analyzer
Operator 1
|
4.7 units / gram of hemoglobin
Standard Deviation 2.4
|
—
|
—
|
|
Repeatability Substudy: G6PD Levels in Capillary Blood Samples Measured Using the SD Biosensor G6PD Test, by Operator and Analyzer
Operator 2
|
5.4 units / gram of hemoglobin
Standard Deviation 2.8
|
—
|
—
|
|
Repeatability Substudy: G6PD Levels in Capillary Blood Samples Measured Using the SD Biosensor G6PD Test, by Operator and Analyzer
Operator 3
|
6.6 units / gram of hemoglobin
Standard Deviation 0.6
|
—
|
—
|
|
Repeatability Substudy: G6PD Levels in Capillary Blood Samples Measured Using the SD Biosensor G6PD Test, by Operator and Analyzer
Instrument 1
|
5.4 units / gram of hemoglobin
Standard Deviation 2.8
|
—
|
—
|
|
Repeatability Substudy: G6PD Levels in Capillary Blood Samples Measured Using the SD Biosensor G6PD Test, by Operator and Analyzer
Instrument 2
|
4.7 units / gram of hemoglobin
Standard Deviation 1.3
|
—
|
—
|
|
Repeatability Substudy: G6PD Levels in Capillary Blood Samples Measured Using the SD Biosensor G6PD Test, by Operator and Analyzer
Instrument 3
|
7.6 units / gram of hemoglobin
Standard Deviation 0.6
|
—
|
—
|
SECONDARY outcome
Timeframe: All samples were collected on study day 1 and tested immediatelyPopulation: Participants in the repeatability substudy population. Each participant provided 8 finger stick (capillary) blood samples.
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.
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=120 Finger stick samples
Participants provided whole blood samples as well as finger stick capillary blood samples.
At 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.
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.
|
Heparin-anti-coagulated Blood
Heparin-anti-coagulated whole blood samples stored at room temperature.
|
ACD-anti-coagulated Blood
ACD-anti-coagulated whole blood samples stored at room temperature.
|
|---|---|---|---|
|
Repeatability Substudy: Hemoglobin Levels in Capillary Blood Samples Measured Using the SD Biosensor STANDARD Hemoglobin Test, by Operator and Analyzer
Overall
|
11.9 g/dL
Standard Deviation 2.0
|
—
|
—
|
|
Repeatability Substudy: Hemoglobin Levels in Capillary Blood Samples Measured Using the SD Biosensor STANDARD Hemoglobin Test, by Operator and Analyzer
Operator 1
|
12.0 g/dL
Standard Deviation 2.3
|
—
|
—
|
|
Repeatability Substudy: Hemoglobin Levels in Capillary Blood Samples Measured Using the SD Biosensor STANDARD Hemoglobin Test, by Operator and Analyzer
Operator 2
|
11.8 g/dL
Standard Deviation 1.8
|
—
|
—
|
|
Repeatability Substudy: Hemoglobin Levels in Capillary Blood Samples Measured Using the SD Biosensor STANDARD Hemoglobin Test, by Operator and Analyzer
Operator 3
|
12.3 g/dL
Standard Deviation 1.1
|
—
|
—
|
|
Repeatability Substudy: Hemoglobin Levels in Capillary Blood Samples Measured Using the SD Biosensor STANDARD Hemoglobin Test, by Operator and Analyzer
Instrument 1
|
11.6 g/dL
Standard Deviation 1.9
|
—
|
—
|
|
Repeatability Substudy: Hemoglobin Levels in Capillary Blood Samples Measured Using the SD Biosensor STANDARD Hemoglobin Test, by Operator and Analyzer
Instrument 2
|
12.2 g/dL
Standard Deviation 2.2
|
—
|
—
|
|
Repeatability Substudy: Hemoglobin Levels in Capillary Blood Samples Measured Using the SD Biosensor STANDARD Hemoglobin Test, by Operator and Analyzer
Instrument 3
|
12.1 g/dL
Standard Deviation 2.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 2, 4, 6, and 24 hours after collection.Population: Stability substudy participants
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: * ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood * heparin-anti-coagulated blood * acid citrate dextrose (ACD)-anti-coagulated blood
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=3 Participants
Participants provided whole blood samples as well as finger stick capillary blood samples.
At 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.
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.
|
Heparin-anti-coagulated Blood
n=3 Participants
Heparin-anti-coagulated whole blood samples stored at room temperature.
|
ACD-anti-coagulated Blood
n=3 Participants
ACD-anti-coagulated whole blood samples stored at room temperature.
|
|---|---|---|---|
|
Sample Stability Substudy: G6PD Levels Measured Over Time After Storage at Room Temperature
6 hours
|
5.82 units / gram hemoglobin
Standard Deviation 3.33
|
5.48 units / gram hemoglobin
Standard Deviation 2.97
|
5.62 units / gram hemoglobin
Standard Deviation 3.38
|
|
Sample Stability Substudy: G6PD Levels Measured Over Time After Storage at Room Temperature
0 hours
|
5.63 units / gram hemoglobin
Standard Deviation 3.35
|
5.44 units / gram hemoglobin
Standard Deviation 3.21
|
5.52 units / gram hemoglobin
Standard Deviation 3.35
|
|
Sample Stability Substudy: G6PD Levels Measured Over Time After Storage at Room Temperature
2 hours
|
5.82 units / gram hemoglobin
Standard Deviation 3.42
|
5.61 units / gram hemoglobin
Standard Deviation 3.20
|
5.78 units / gram hemoglobin
Standard Deviation 3.36
|
|
Sample Stability Substudy: G6PD Levels Measured Over Time After Storage at Room Temperature
4 hours
|
5.94 units / gram hemoglobin
Standard Deviation 3.11
|
5.76 units / gram hemoglobin
Standard Deviation 3.01
|
5.74 units / gram hemoglobin
Standard Deviation 3.11
|
|
Sample Stability Substudy: G6PD Levels Measured Over Time After Storage at Room Temperature
24 hours
|
5.26 units / gram hemoglobin
Standard Deviation 3.53
|
5.53 units / gram hemoglobin
Standard Deviation 3.65
|
5.36 units / gram hemoglobin
Standard Deviation 3.76
|
SECONDARY outcome
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.Population: Stability substudy participants
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: * ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood * heparin-anti-coagulated blood * acid citrate dextrose (ACD)-anti-coagulated blood
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=3 Participants
Participants provided whole blood samples as well as finger stick capillary blood samples.
At 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.
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.
|
Heparin-anti-coagulated Blood
n=3 Participants
Heparin-anti-coagulated whole blood samples stored at room temperature.
|
ACD-anti-coagulated Blood
n=3 Participants
ACD-anti-coagulated whole blood samples stored at room temperature.
|
|---|---|---|---|
|
Sample Stability Substudy: G6PD Levels Measured Over Time After Refrigerated Storage
72 hours
|
9.5 units / gram hemoglobin
Standard Deviation 0.8
|
2.7 units / gram hemoglobin
Standard Deviation 0.2
|
5.1 units / gram hemoglobin
Standard Deviation 0.5
|
|
Sample Stability Substudy: G6PD Levels Measured Over Time After Refrigerated Storage
168 hours
|
5.2 units / gram hemoglobin
Standard Deviation 2.8
|
4.9 units / gram hemoglobin
Standard Deviation 2.8
|
5.1 units / gram hemoglobin
Standard Deviation 3.0
|
|
Sample Stability Substudy: G6PD Levels Measured Over Time After Refrigerated Storage
0 hours
|
5.6 units / gram hemoglobin
Standard Deviation 3.4
|
5.4 units / gram hemoglobin
Standard Deviation 3.2
|
5.5 units / gram hemoglobin
Standard Deviation 3.4
|
|
Sample Stability Substudy: G6PD Levels Measured Over Time After Refrigerated Storage
24 hours
|
5.9 units / gram hemoglobin
Standard Deviation 3.5
|
5.7 units / gram hemoglobin
Standard Deviation 3.0
|
5.4 units / gram hemoglobin
Standard Deviation 3.1
|
|
Sample Stability Substudy: G6PD Levels Measured Over Time After Refrigerated Storage
48 hours
|
4.9 units / gram hemoglobin
Standard Deviation 2.7
|
5.2 units / gram hemoglobin
Standard Deviation 3.1
|
5.1 units / gram hemoglobin
Standard Deviation 3.0
|
|
Sample Stability Substudy: G6PD Levels Measured Over Time After Refrigerated Storage
96 hours
|
9.1 units / gram hemoglobin
Standard Deviation 0.9
|
2.4 units / gram hemoglobin
Standard Deviation 0.1
|
4.7 units / gram hemoglobin
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 2, 4, 6, and 24 hours after collection.Population: Stability substudy participants
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: * ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood * heparin-anti-coagulated blood * acid citrate dextrose (ACD)-anti-coagulated blood
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=3 Participants
Participants provided whole blood samples as well as finger stick capillary blood samples.
At 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.
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.
|
Heparin-anti-coagulated Blood
n=3 Participants
Heparin-anti-coagulated whole blood samples stored at room temperature.
|
ACD-anti-coagulated Blood
n=3 Participants
ACD-anti-coagulated whole blood samples stored at room temperature.
|
|---|---|---|---|
|
Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Storage at Room Temperature
0 hours
|
13.9 g/dL
Standard Deviation 1.9
|
14.2 g/dL
Standard Deviation 2.6
|
12.6 g/dL
Standard Deviation 2.2
|
|
Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Storage at Room Temperature
2 hours
|
14.2 g/dL
Standard Deviation 2.5
|
13.8 g/dL
Standard Deviation 2.5
|
13.0 g/dL
Standard Deviation 2.4
|
|
Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Storage at Room Temperature
4 hours
|
14.1 g/dL
Standard Deviation 2.6
|
14.1 g/dL
Standard Deviation 2.4
|
12.6 g/dL
Standard Deviation 2.1
|
|
Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Storage at Room Temperature
6 hours
|
14.2 g/dL
Standard Deviation 2.3
|
14.1 g/dL
Standard Deviation 2.3
|
12.8 g/dL
Standard Deviation 2.3
|
|
Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Storage at Room Temperature
24 hours
|
14.6 g/dL
Standard Deviation 2.3
|
14.1 g/dL
Standard Deviation 2.6
|
13.1 g/dL
Standard Deviation 2.2
|
SECONDARY outcome
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.Population: Stability substudy participants
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: * ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood * heparin-anti-coagulated blood * acid citrate dextrose (ACD)-anti-coagulated blood
Outcome measures
| Measure |
G6PD Diagnostic Testing
n=3 Participants
Participants provided whole blood samples as well as finger stick capillary blood samples.
At 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.
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.
|
Heparin-anti-coagulated Blood
n=3 Participants
Heparin-anti-coagulated whole blood samples stored at room temperature.
|
ACD-anti-coagulated Blood
n=3 Participants
ACD-anti-coagulated whole blood samples stored at room temperature.
|
|---|---|---|---|
|
Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Refrigerated Storage
24 hours
|
14.4 g/dL
Standard Deviation 2.3
|
14.3 g/dL
Standard Deviation 2.7
|
13.1 g/dL
Standard Deviation 2.6
|
|
Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Refrigerated Storage
96 hours
|
15.9 g/dL
Standard Deviation 1.2
|
14.5 g/dL
Standard Deviation 0.8
|
11.2 g/dL
Standard Deviation 1.1
|
|
Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Refrigerated Storage
72 hours
|
16.2 g/dL
Standard Deviation 1.1
|
14.6 g/dL
Standard Deviation 1.1
|
10.2 g/dL
Standard Deviation 1.1
|
|
Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Refrigerated Storage
0 hours
|
13.9 g/dL
Standard Deviation 1.9
|
14.2 g/dL
Standard Deviation 2.6
|
12.6 g/dL
Standard Deviation 2.2
|
|
Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Refrigerated Storage
48 hours
|
14.1 g/dL
Standard Deviation 2.1
|
13.8 g/dL
Standard Deviation 2.4
|
12.7 g/dL
Standard Deviation 3.0
|
|
Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Refrigerated Storage
168 hours
|
15.0 g/dL
Standard Deviation 2.6
|
14.6 g/dL
Standard Deviation 2.3
|
13.5 g/dL
Standard Deviation 2.7
|
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