G6PD DeficiencyNCT04010695
Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
A study testing SD Biosensor G6PD Analyzer, Pointe Scientific Test Kit and HemoCue System in people with G6PD Deficiency, run by PATH at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- G6PD Deficiency
- What is being tested?
- SD Biosensor G6PD Analyzer, Pointe Scientific Test Kit and HemoCue System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2019to 19 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Willingness to provide consent
Who cannot join
- -Blood transfusion in the past 90 days by self-report
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchison Prevention Center
Seattle, Washington, 98109
About this study
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.
Read the detailed description
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:
- G6PD measurement by spectrophotometry using the Pointe Scientific G6PD reference assay
- hemoglobin measurement by a hematology analyzer
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.
- Conditions
- G6PD Deficiency
- Being tested
- SD Biosensor G6PD Analyzer, Pointe Scientific Test Kit, HemoCue System
- Keywords
- G6PD deficiency
- Medical subject headings
- Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SD Biosensor G6PD AnalyzerDiagnostic test
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.
Pointe Scientific Test KitDiagnostic test
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.
HemoCue SystemDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| G6PD Diagnostic Testing | Other | 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. Receives: Diagnostic Test: SD Biosensor G6PD Analyzer; Diagnostic Test: Pointe Scientific Test Kit; Diagnostic Test: HemoCue System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: All samples were collected on study day 1
Secondary outcomes (3)
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.
Measured: 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).
Measured: All samples were collected on study day 1
Median G6PD Values Measured by the SD Biosensor G6PD Test for Venous and Capillary Blood Samples
Measured: All samples were collected on study day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start13 May 2019
- Primary completion19 Sep 2019
- Study completion19 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for G6PD DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center
- Responsible party
- Sponsor
- Investigators
- James Kublin, MD, MPH, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010695
- Sponsor's protocol ID
- G6PD Validation Seattle
- Status last verified
- Jun 2021
- First submitted
- 21 May 2019
- Last updated
- 10 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not planning to share IPD to other researchers
Publications
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.
PubMed 34543346
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
- ClinicalTrials.gov ID
- NCT04010695
- Acronym / sponsor ID
- G6PD Validation Seattle
- Conditions
- G6PD Deficiency
- Keywords
- G6PD deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center
- Study start
- 13 May 2019 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Posted 26 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- G6PD measurement by spectrophotometry using the Pointe Scientific G6PD reference assay
- hemoglobin measurement by a hematology analyzer
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G6PD Diagnostic Testing | Other | Diagnostic Test: SD Biosensor G6PD Analyzer, Diagnostic Test: Pointe Scientific Test Kit, Diagnostic Test: HemoCue SystemParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Willingness to provide consent
Key exclusion criteria (1 listed)
- -Blood transfusion in the past 90 days by self-report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SD Biosensor G6PD AnalyzerThe 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. | Diagnostic test | G6PD Diagnostic Testing |
| Pointe Scientific Test KitThe 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. | Diagnostic test | G6PD Diagnostic Testing |
| HemoCue SystemThe 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. | Diagnostic test | G6PD Diagnostic Testing |
Primary outcome
Sensitivity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals
Time frame: All samples were collected on study day 1
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.
Sensitivity of SD Biosensor POC G6PD Test for Identifying Women With Intermediate G6PD Activity
Time frame: All samples were collected on study day 1
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.
Specificity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals
Time frame: All samples were collected on study day 1
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.
Specificity of SD Biosensor G6PD Test for Identifying Women With Intermediate G6PD Activity
Time frame: All samples were collected on study day 1
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.
3 secondary outcomes
Accuracy Between the SD Biosensor POC G6PD Test Assay and the Pointe Scientific Test Kit
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34543346Pal 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.
- Individual participant dataSharing planned: No. Not planning to share IPD to other researchers
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Active, not recruitingObservational study
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Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
Vivax Malaria, G6PD Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Kublin, MD, MPH principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SD Biosensor G6PD Analyzer, Pointe Scientific Test Kit and HemoCue System in people with G6PD Deficiency, run by PATH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals (time frame: All samples were collected on study day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04010695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.