Clinical trial NCT04054661: Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood
Official title: Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase Deficiency: Diagnostic Accuracy and Repeatability in Capillary Samples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: G6PD Deficiency
Keywords: G6PD Deficiency
Lead sponsor: PATH
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 229
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 the study is to assess the accuracy of the SD Biosensor STANDARD™ point-of-care (POC) G6PD test in measuring G6PD activity and classifying results compared to a reference assay and across repeated measurements in capillary samples.

Detailed description: Cross-sectional diagnostic accuracy study with 250 volunteer participants. The clinic will recruit and consent adult study participants. Clinic staff will draw venous blood and obtain finger stick capillary blood samples. Clinic staff will perform the investigational SD Biosensor STANDARD™ G6PD test for glucose-6-phosphate dehydrogenase (G6PD) deficiency and a HemoCue® hemoglobin test on finger stick capillary blood. An anti-coagulated venous blood sample will be sent to a Clinical Laboratory Improvement Amendments (CLIA) certified lab for G6PD reference testing by the gold standard assays: G6PD measurement by spectrophotometry using the Pointe Scientific G6PD reference assay and hemoglobin measurement by a hematology analyzer.

Individuals identified as G6PD deficient or intermediate by the reference test will be notified of their results by the clinic and referred to their physician for follow-up.

This study includes a nested repeatability study and a nested sample stability study. In the nested repeatability study up to 20 consented participants will provide 4 additional finger stick samples. Clinic staff will perform the SD Biosensor STANDARD™ G6PD test to assess the repeatability of the test in capillary blood over 8 G6PD and hemoglobin measurements on up to 3 different instruments.

In the nested sample stability study up to 8 consented participants will provide an additional venous blood draw sample to be tested at additional time points to document stability of the samples over time when tested by the SD Biosensor STANDARD™ G6PD Test.

Eligibility criteria: Inclusion Criteria:

* Must communicate an understanding of the study protocol.
* Must be able to provide written consent to undergo screening and provide medical history.
* Participants must be afebrile and in general good health in the opinion of the investigator as determined by vital signs, medical history, and physical examination.
* Black/African-American, by self-report.

Exclusion Criteria:

* Blood transfusion in the past 3 months by self-report

Primary outcomes:
measure: Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
timeFrame: All samples were collected on study day 1
measure: Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
timeFrame: All samples were collected on study day 1
measure: Specificity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
timeFrame: All samples were collected on study day 1
measure: Specificity of SD Biosensor STANDARD 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 STANDARD G6PD Test Assay and the Pointe Scientific Test Kit
timeFrame: All samples were collected on study day 1
measure: Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test
timeFrame: All samples were collected on study day 1
measure: Repeatability Substudy: G6PD Levels in Capillary Blood Samples Measured Using the SD Biosensor G6PD Test, by Operator and Analyzer
timeFrame: All samples were collected on study day 1 and tested immediately
measure: Repeatability Substudy: Hemoglobin Levels in Capillary Blood Samples Measured Using the SD Biosensor STANDARD Hemoglobin Test, by Operator and Analyzer
timeFrame: All samples were collected on study day 1 and tested immediately
measure: Sample Stability Substudy: G6PD Levels Measured Over Time After Storage at Room Temperature
timeFrame: Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 2, 4, 6, and 24 hours after collection.
measure: Sample Stability Substudy: G6PD Levels Measured Over Time After Refrigerated Storage
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.
measure: Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Storage at Room Temperature
timeFrame: Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 2, 4, 6, and 24 hours after collection.
measure: Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Refrigerated Storage
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.
Other outcomes:
Locations:
city: Reading
country: United States
facility: BSC corporation
state: Pennsylvania
Study officials:
affiliation: Biological Specialty Company
name: Cheryl Berne, MD
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.