Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood

NCT04054661 | Completed Results FDA Device

• 1 other identifier: 1416844
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

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.

Conditions

G6PD Deficiency

Keywords

G6PD Deficiency

Outcome Measures

Primary Outcomes (4)

• Sensitivity of SD Biosensor STANDARD 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 STANDARD 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 STANDARD G6PD test was calculated from both venous and capillary blood samples.

  All samples were collected on study day 1

• Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity

  To investigate the performance of the SD Biosensor STANDARD 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 STANDARD 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 STANDARD 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

• Specificity of SD Biosensor STANDARD 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 STANDARD G6PD test was calculated from both venous and capillary blood samples.

  All samples were collected on study day 1

• Specificity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity

  To investigate the performance of the SD Biosensor STANDARD 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 STANDARD G6PD test was calculated from both venous and capillary blood samples.

  All samples were collected on study day 1

Secondary Outcomes (8)

• Accuracy Between the SD Biosensor STANDARD G6PD Test Assay and the Pointe Scientific Test Kit

  All samples were collected on study day 1

• Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test

  All samples were collected on study day 1

• Repeatability Substudy: G6PD Levels in Capillary Blood Samples Measured Using the SD Biosensor G6PD Test, by Operator and Analyzer

  All samples were collected on study day 1 and tested immediately

• Repeatability Substudy: Hemoglobin Levels in Capillary Blood Samples Measured Using the SD Biosensor STANDARD Hemoglobin Test, by Operator and Analyzer

  All samples were collected on study day 1 and tested immediately

• Sample Stability Substudy: G6PD Levels Measured Over Time After Storage at Room Temperature

  Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 2, 4, 6, and 24 hours after collection.

Study Arms (1)

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 STANDARD point-of-care G6PD test and the point-of-care HemoCue hemoglobin 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 STANDARD G6PD Test; Diagnostic Test: Pointe Scientific Test Kit; Diagnostic Test: HemoCue System

Interventions

SD Biosensor STANDARD G6PD Test DIAGNOSTIC_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.

Also known as: SD Biosensor G6PD Test

G6PD Diagnostic Testing

Pointe Scientific Test Kit DIAGNOSTIC_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.

G6PD Diagnostic Testing

HemoCue System DIAGNOSTIC_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.

G6PD Diagnostic Testing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• PATH: lead

Study Sites (1)

BSC corporation

Reading, Pennsylvania, 19602, United States

Location

Related 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.

  PMID: 34543346 BACKGROUND

MeSH Terms

Conditions

Glucosephosphate Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Pooja Bansil
• Organization: PATH

pbansil@path.org

206 302 4920

Study Officials

• Cheryl Berne, MD

  Biological Specialty Company

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 13, 2019
• Study Start: August 12, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: November 9, 2021
• Results First Posted: October 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)