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

Overview

Cross-sectional diagnostic accuracy study with 250 volunteer participants to evaluate the performance of a diagnostic test for glucose-6-phosphate dehydrogenase.

Full Title of Study: “Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase Deficiency: Diagnostic Accuracy and Repeatability in Capillary Samples”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 31, 2020

Detailed Description

Cross-sectional diagnostic accuracy study with 250 volunteer participants. The clinic will recruit and consent adult study participants (all comers). Clinic staff will draw 2 ethylenediaminetetraacetic acid (EDTA) tubes, 1 heparin tube, and 1 acid citrate dextrose (ACD) tube from venous blood and obtain finger stick capillary blood. 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 EDTA 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 assay: G6PD measurement by spectrophotometry; this sample will also have a hemoglobin measurement by a hematology analyzer. Deidentified blood samples collected in tubes with other anti-coagulants will be evaluated for equivalency across anti-coagulant types. 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.

Interventions

  • Diagnostic Test: STANDARD G6PD test
    • The STANDARD G6PD Analyzer is designed to measure the quantitative determination of total Hb concentration and G6PD enzymatic activity in fresh human whole blood specimens based on reflectometry assays. 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. System components shall be labeled in accordance with regulatory requirements, including the following statement, “For Investigational Use Only. The performance characteristics of this product have not been established.”

Arms, Groups and Cohorts

  • Other: evaluation of a G6PD test
    • all participants recruited in the study will be screened with an investigational IVD- STANDARD G6PD Test. The investigational test will not be used to determine any treatment or case-management. Participants will be tested on venous and fingerstick blood. Venous blood will be sent to a clinical laboratory for confirmatory testing on a reference assay

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity and specificity of the POC G6PD test
    • Time Frame: 4 months
    • Sensitivity and specificity of SD Biosensor POC G6PD test compared to the Pointe Scientific test kit for identifying G6PD deficient individuals and women with intermediate G6PD activity

Secondary Measures

  • Repeatability of the STANDARD G6PD test
    • Time Frame: 4 months
    • repeatability of the STANDARD G6PD test on fingerstick samples across two operators and two instruments

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • PATH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cheryl Berne, MD, Principal Investigator, Biological Specialty Company

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