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

Overview

Cross-sectional diagnostic accuracy study with up to 250 patient 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 ethylenediaminetetraacetic acid (EDTA) whole blood tubes and obtain finger stick capillary blood. 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 EDTA anti-coagulated venous blood samples. Another 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. 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.

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: September 18, 2019

Detailed Description

Objective To assess the accuracy of a POC G6PD test as compared to a reference assay in detecting G6PD activity Endpoints – 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 – Accuracy between the SD Biosensor POC G6PD test measure of G6PD activity and the Pointe Scientific test kit – Accuracy between the SD Biosensor POC G6PD test measure of hemoglobin (Hb) and HemoCue 201+, a point of care reference haemoglobin assay – Comparison of the SD Biosensor POC G6PD test results for capillary and venous samples. Population 250 male and female participants 18-65 years of age presenting at the clinic for care. Individuals who have received a blood transfusion within the last 3 months, according to self-report, will be excluded. Study sites Prevention Center, Fred Hutch Cancer Research Center University of Washington

Interventions

  • Diagnostic Test: STANDARD G6PD
    • 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: screening with STANDARD 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

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity and specificity of the POC G6PD test
    • Time Frame: 6 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

Participating in This Clinical Trial

Inclusion Criteria

-Willingness to provide consent Exclusion Criteria:

-Blood transfusion in the past 90 days 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
  • Collaborator
    • Fred Hutchinson Cancer Research Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • James Kublin, MD, MPH, Principal Investigator, Fred Hutchinson Cancer Research Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.