Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US

G6PD Deficiency Clinical Trial

Official title:

Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04010695
• Other study ID #: G6PD Validation Seattle
• Status: Completed
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: September 19, 2019

Study information

• Verified date: June 2021
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 19, 2019
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

-Willingness to provide consent

Exclusion Criteria:

-Blood transfusion in the past 90 days by self-report

Related Conditions & MeSH terms

• G6PD Deficiency
• Glucosephosphate Dehydrogenase Deficiency

Intervention

Diagnostic Test:
• SD Biosensor G6PD Analyzer
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 Kit
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 System
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.

Locations

Country	Name	City	State
United States	Fred Hutchison Prevention Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
PATH	Fred Hutchinson Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	All samples were collected on study day 1
Primary	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.	All samples were collected on study day 1
Primary	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.	All samples were collected on study day 1
Primary	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.	All samples were collected on study day 1
Secondary	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.	All samples were collected on study day 1
Secondary	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).	All samples were collected on study day 1
Secondary	Median G6PD Values Measured by the SD Biosensor G6PD Test for Venous and Capillary Blood Samples		All samples were collected on study day 1