Clinical trial NCT04010695: Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
Official title: Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: G6PD Deficiency
Keywords: G6PD deficiency
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Fred Hutchinson Cancer Center
First posted: 2019-07-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

-Willingness to provide consent

Exclusion Criteria:

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

Primary outcomes:
measure: Sensitivity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals
timeFrame: All samples were collected on study day 1
measure: Sensitivity of SD Biosensor POC G6PD Test for Identifying Women With Intermediate G6PD Activity
timeFrame: All samples were collected on study day 1
measure: Specificity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals
timeFrame: All samples were collected on study day 1
measure: Specificity of SD Biosensor G6PD Test for Identifying Women With Intermediate G6PD Activity
timeFrame: All samples were collected on study day 1
Secondary outcomes:
measure: Accuracy Between the SD Biosensor POC G6PD Test Assay and the Pointe Scientific Test Kit
timeFrame: All samples were collected on study day 1
measure: Accuracy Between the SD Biosensor POC G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test
timeFrame: All samples were collected on study day 1
measure: Median G6PD Values Measured by the SD Biosensor G6PD Test for Venous and Capillary Blood Samples
timeFrame: All samples were collected on study day 1
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchison Prevention Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: James Kublin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.