An interventional study of SD Biosensor G6PD Analyzer and Pointe Scientific Test Kit in G6PD Deficiency, sponsored by PATH. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-10.
Sponsored by PATH · Not applicable, Interventional, and Diagnostic
The primary objective of this study is to assess the accuracy of the SD Biosensor STANDARD G6PD Analyzer in measuring G6PD activity when used by trained health care workers.
This is a cross-sectional diagnostic accuracy study with up to 250 participants with a goal of obtaining 20 deficient and 20 intermediate samples. The clinic will recruit and consent study participants. Clinic staff will draw 3 whole blood samples and obtain finger stick capillary blood.
G6PD activity is reported in terms of grams of hemoglobin (Hb), hence the hemoglobin concentration must be measured.
Clinic staff will perform the investigational Standard Diagnostics (SD) Biosensor point-of-care (POC) test for glucose-6-phosphate dehydrogenase (G6PD) deficiency and a HemoCue® hemoglobin test on finger stick capillary blood and on the venous blood samples.
Another venous blood sample will be sent to a clinical laboratory improvement amendments (CLIA)-certified laboratory for reference testing by the gold standard assays:
Individuals identified as G6PD deficient with the reference test will be notified of their results by the clinic and referred to their physician for follow-up.
34 studies on the registry are indexed under Glucosephosphate Dehydrogenase Deficiency; 4 are open to participants now.
This study's enrollment of 250 is above the median of 103 across 22 interventional studies indexed under Glucosephosphate Dehydrogenase Deficiency.
Browse Glucosephosphate Dehydrogenase Deficiency studies →PATH is the lead sponsor of 111 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
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-Willingness to provide consent
Exclusion Criteria:
-Blood transfusion in the past 90 days by self-report
Participants provided whole blood samples as well as fingerstick capillary blood samples. At 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. 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.
Diagnostic Test: SD Biosensor G6PD Analyzer · Diagnostic Test: Pointe Scientific Test Kit · Diagnostic Test: HemoCue System
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.
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.
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.
Sensitivity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals
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.
Time frame: All samples were collected on study day 1
Sensitivity of SD Biosensor POC G6PD Test for Identifying Women With Intermediate G6PD Activity
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.
Time frame: All samples were collected on study day 1
Specificity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals
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.
Time frame: All samples were collected on study day 1
Specificity of SD Biosensor G6PD Test for Identifying Women With Intermediate G6PD Activity
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.
Time frame: All samples were collected on study day 1
Accuracy Between the SD Biosensor POC G6PD Test Assay and the Pointe Scientific Test Kit
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.
Time frame: All samples were collected on study day 1
Accuracy Between the SD Biosensor POC G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test
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).
Time frame: All samples were collected on study day 1
Median G6PD Values Measured by the SD Biosensor G6PD Test for Venous and Capillary Blood Samples
Time frame: All samples were collected on study day 1
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.
| Milestone | G6PD Diagnostic Testing |
|---|---|
| Started | 250 |
| Completed | 250 |
| Not completed | 0 |
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.
| percentage of participants | G6PD Diagnostic Testing |
|---|---|
| Venous Blood | 100.0 (59.0 to 100.0) |
| Capillary Blood | 100.0 (59.0 to 100.0) |
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.
| percentage of participants | G6PD Diagnostic Testing |
|---|---|
| Venous Blood | 100.0 (39.8 to 100.0) |
| Capillary Blood | 75.0 (19.4 to 99.4) |
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.
| percentage of participants | G6PD Diagnostic Testing |
|---|---|
| Venous Blood | 94.9 (90.8 to 97.5) |
| Capillary Blood | 98.5 (95.8 to 99.7) |
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.
| percentage of participants | G6PD Diagnostic Testing |
|---|---|
| Venous Blood | 83.7 (76.2 to 89.6) |
| Capillary Blood | 92.4 (86.4 to 96.3) |
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.
| percentage of participants | G6PD Diagnostic Testing |
|---|---|
| Venous blood | 85.7 (80.1 to 90.2) |
| Capillary blood | 93.9 (89.7 to 96.7) |
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).
| percentage of participants | G6PD Diagnostic Testing |
|---|---|
| Venous blood | 97.5 (94.3 to 99.1) |
| Capillary blood | 89.6 (84.7 to 93.4) |
| units / gram of hemoglobin | G6PD Diagnostic Testing |
|---|---|
| Venous blood | 7.6 (6.8 to 8.5) |
| Capillary blood | 6.8 (6.1 to 7.5) |
Collected over Approximately 30 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| G6PD Diagnostic Testing | 0/250 (0%) | 0/250 (0%) | 0/250 (0%) |
The final analytic population excludes 36 Normal G6PD Males who were selected and excluded for Threshold Determination. Additionally 1 individual was excluded because venous blood was not collected.
| Age, Continuous(years) | G6PD Diagnostic Testing |
|---|---|
| Mean | 35.4 ± 12.3 |
| Age, Customized(Participants) | G6PD Diagnostic Testing |
|---|---|
| ≤ 21 years of age | 7 |
| 22 - 64 years of age | 203 |
| ≥ 65 years of age | 3 |
| Sex: Female, Male(Participants) | G6PD Diagnostic Testing |
|---|---|
| Female | 135 |
| Male | 78 |
| Race/Ethnicity, Customized(Participants) | G6PD Diagnostic Testing |
|---|---|
| Asian | 27 |
| Black/African American | 34 |
| Caucasian/White | 133 |
| More than one race | 15 |
| Other | 4 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Not planning to share IPD to other researchers
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Glucosephosphate Dehydrogenase Deficiency→
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