Evaluation of a Diagnostic to Identify G6PD Deficiency in Brazil

Overview

Cross-sectional diagnostic accuracy study with 2,000 patient participants and 15 health worker participants. The participant population will be recruited at clinics and through a household survey using an enriched sample of a population with known G6PD status, established through previous epidemiological studies. The health worker participants will include trained intended users of the G6PD tests. Health workers will take capillary blood samples and conduct two point of care tests: 1) hemoglobin test, and 2) investigational point-of-care (POC) G6PD test. A thick blood slide will also be prepared for malaria microscopy. Venous blood will be collected and transferred to a laboratory where reference assays will be performed on venous samples using the Pointe Scientific G6PD Analyzer and hemoglobin tests. Trained health workers will also be surveyed to assess product usability through a questionnaire to assess label and packing comprehension as well as results interpretation.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 27, 2020

Detailed Description

Primary Objective: To assess the accuracy and reliability of G6PD tests in detecting G6PD activity and classifying results when used by trained health care workers in Brazil.

Component Objectives:

- To determine the performance of G6PD tests in detecting G6PD activity and hemoglobin (Hb) compared to a reference assay

- To assess the comprehension of the G6PD test packaging and labelling among intended users

- To assess the usability of G6PD test result outputs among intended users

Interventions

  • Diagnostic Test: STANDARD G6PD Test
    • The STANDARD G6PD Analyzer is designed to measure the quantitative determination of total-hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimen 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 Brazil and is considered an investigational product. PATH has conducted some initial laboratory evaluations which suggest that the test aligns to performance specifications outlined in the target product profile. The test has CE mark and is registered for use in South Korea, India, and Thailand.

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- in addition to routine case. The investigational test will not be used to determine any treatment or case-management

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity 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

  • Label comprehension
    • Time Frame: 1 week
    • To assess the comprehension of the G6PD test packaging and labeling among intended users. This will be assessed through a standardized questionnaire. Users who achieve 85% questions correct or higher will be considered to have successfully comprehended the label.
  • Result interpretation usability
    • Time Frame: 1 week
    • To assess the usability of G6PD test result outputs among intended users. This will be assessed through a standardized questionnaire. Users who achieve 85% questions correct or higher will be considered to have successfully interpreted test results.

Participating in This Clinical Trial

1. Participant with unknown G6PD status

Inclusion Criteria

  • Seeking care at the Manaus or Porto Velho clinics
  • 2 years age or older
  • Willing to provide informed consent

Exclusion Criteria

  • Younger than 2 years of age
  • Participants who received a blood transfusion in the last 3 months, self report
  • Unwilling to provide informed consent

2. Participant with known G6PD status

Inclusion Criteria

  • Included in previous G6PD surveys and provided consent to be contacted again
  • 2 years of age or older
  • Willing to provide informed consent or assent

Exclusion Criteria

  • Younger than 2 years of age
  • Participants who received a blood transfusion in the last 3 months, self report
  • Unwilling to provide informed consent or assent or unavailable during study visit

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • PATH
  • Collaborator
    • Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marcus Lacerda, MD, PhD, Principal Investigator, FMT/HVD
  • Overall Contact(s)
    • Gonzalo Domingo, PhD, 2062853500, gdomingo@path.org

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