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NCT Number: NCT02069236

Comparing G6PD Tests Using Capillary Blood Versus Venous Blood

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.

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Key information

Conditions

Glucose-6 Phosphate Dehydrogenase Deficiency Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Glucosephosphate Dehydrogenase Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shoklo Malaria Research Unit (SMRU)

Mae Sot, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

G6PD Test

Other

All subjects are tested by multiple G6PD tests

Other names: Trinity spectrophotometric assay, Flow cytometry, CareStart, Florescent Spot Test

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

PATH

Other

Collaborators

  • Mahidol University
  • University of Oxford

Registry information

Official study title

Correlation of G6PD Activity Across Different Sample Sources, and Different G6PD Testing Platforms

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 24, 2014
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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