Comparing G6PD Tests Using Capillary Blood Versus Venous Blood

Overview

In this study we propose to determine the correlation in glucose-6phosphate dehydrogenase enzyme activity in capillary blood obtained from a finger stick versus a venous blood specimen. As secondary endpoints we will seek to correlate phenotype as determined by quantitative and qualitative G6PD test, genotype as determined by PCR and DNA sequencing with flow cytometry. The secondary endpoints are critical for the design of G6PD diagnostic test evaluation studies.

Full Title of Study: “Correlation of G6PD Activity Across Different Sample Sources, and Different G6PD Testing Platforms”

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: July 2014

Detailed Description

In this study we propose to determine the correlation in glucose-6 phosphate dehydrogenase enzyme activity in capillary blood obtained from a finger stick versus a venous blood specimen. We will also compare results of different G6PD tests with known G6PD genetic profiles. The results of the study will inform design of future G6PD diagnostic development & evaluations. This research will be conducted in MaeSot Thailand, where G6PD deficiency has a high prevalence. Study participants will be recruited into three groups of 50 volunteers per group: 50 G6PD-deficient individuals, 50 G6PD-normal individuals, and 50 G6PD-intermediate individuals. Following a written informed consent, participants will donate about 3 ml of venous blood and about 4 drops of capillary blood (fingerstick). There will be no direct benefit to research participants.

Interventions

  • Other: G6PD Test
    • All subjects are tested by multiple G6PD tests

Arms, Groups and Cohorts

  • No Intervention: G6PD Testing
    • All subjects receive G6PD test

Clinical Trial Outcome Measures

Primary Measures

  • Correlation of capillary and venous blood results using Trinity quantitative G6PD test
    • Time Frame: Six months
    • Comparison of the performance of the Trinity quantitative test using capillary blood, vs the performance of the same test using venous blood.

Secondary Measures

  • Concordance between a flow cytometry-based G6PD test and the spectrophotometric gold standard
    • Time Frame: six months
    • Percent agreement between the quantitative results of the flow cytometry assay and the quantitative results of the spectrophotometric assay.
  • Categorical accuracy of a flow cytometry-based G6PD test against the spectrophotometric gold standard and genotyping
    • Time Frame: six months
    • Using a predefined cutoff to categorize values from each quantitative test, determine percent agreement within each category between the two tests.
  • Concordance between a qualitative G6PD test and the spectrophotometric gold standard
    • Time Frame: Six months
    • Compare sensitivity & specificity of qualitative results of the G6PD test and the categorical results of the quantitative spectrophotometric assay.
  • Categorical accuracy of qualitative G6PD test against spectrophotometric gold standard
    • Time Frame: six months
    • Percent agreement between the qualitative G6PD test and the categorical results of the spectrophotometric gold standard
  • Association between flow cytometry-based test and sample genotype
    • Time Frame: Six months
    • Determine accuracy of phenotypic results of flow cytometry assay against genetic profile.

Participating in This Clinical Trial

Inclusion Criteria

  • Previous G6PD test at SMRU clinic
  • Patient willing to participate and sign informed consent form
  • Patient willing to allow donated sample to be used in future research
  • Subjects 18 years of age or older

Exclusion Criteria

  • patients with severe malaria or other severe illness
  • Patients who received a blood transfusion in the last 3 months
  • Patients who received primaquine in the past 1 month (this is to ensure that previous characterization of phenotype in the healthy subject has not been influenced by a recent hemolytic reaction)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • PATH
  • Collaborator
    • Mahidol University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Francois Nosten, MD/PhD, Principal Investigator, Shoklo Malaria Research Unit, Mahidol Oxford Research unit
    • Gonzalo Domingo, PhD, Study Chair, PATH
    • Germana Bancone, PhD, Study Chair, Shoklo Malaria Research Unit, Mahidol Oxford Research unit
    • Sarah McGray, MPH, Study Chair, PATH

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