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Biosensors: Validation of New G6PD Point of Care Tests Against Gold Standard Quantitative

Sponsor
University of Oxford (Other)
Overall Status
Completed
CT.gov ID
NCT02625285
Collaborator
PATH (Other)
150
Enrollment
1
Location
12.2
Actual Duration (Months)
12.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a laboratory research to evaluate performances of quantitative POC G6PD tests (Biosensors) against gold standard quantitative laboratory based tests and genotyping.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Radical cure of P. vivax malaria can be achieved using large doses of primaquine which have shown to cause some degree of hemolysis even in subjects who tested normal by the conventional qualitative G6PD tests. Different regimens of drug might be more appropriate in subjects with intermediate G6PD activity which can be currently measured only in well equipped laboratories. Validation of new qualitative and quantitative point-of-care tests is essential to for safe deployment of standard and new radical cure regimens against Plasmodium vivax.

    This study will evaluate performances of quantitative POC G6PD tests (Biosensors) against gold standard quantitative laboratory based tests and genotyping. Patients will be searched from the electronic record database to identify up to 150 patients with the following characteristics: approximately 50 G6PD-deficient men and women (however only a very small percent of deficients are homozygous women) approximately 50 G6PD-heterozygous women with intermediate activity, and approximately 50 G6PD-normal individuals and patients who meet the screening criteria will be contacted at their home by a clinic staff member. The home visitor will explain study details and invite to participate in the study. If the patients express interest in participating, they will be directed to visit the following month at the clinic where they usually receive care.

    After signing the informed consent form, two blood samples will be withdrawn; one sample will be taken by finger-stick (200 µl) and one sample (0.5 ml) will be taken by arm venipuncture. The blood from capillary sample will be used to assess G6PD activity using the POC tests, CBC and laboratory based quantitative tests. The venous blood will be used for reference standard quantitative G6PD assays, Hb typing analysis, CBC and buffy-coat will be stored for DNA extraction for G6PD genotyping only; leftover blood will be discarded.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Validation of New G6PD Point of Care Tests (Biosensors) Against Gold Standard Quantitative Spectrophotometry and Genotyping
    Actual Study Start Date :
    Jan 24, 2017
    Actual Primary Completion Date :
    Jan 31, 2018
    Actual Study Completion Date :
    Jan 31, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    G6PD Deficient Volunteers

    Subjects with age ≥ 18 years Male and female Previously tested G6PD deficient at SMRU clinic
    G6PD Intermediate or Heterozygous Volunteers

    Subjects with age ≥ 18 years Female Previously tested G6PD intermediate or heterozygous for G6PD variants at SMRU clinic
    G6PD-Normal Volunteers

    Subjects with age ≥ 18 years Male and female Previously tested G6PD normal at SMRU clinic

    Outcome Measures

    Primary Outcome Measures

    1. correlation in G6PD activity [at enrollment]

      determined by the Biosensors and the spectrophotometric gold standard.

    Secondary Outcome Measures

    1. correlation in Hemoglobin levels [at enrollment]

      determined by the Biosensors and the automated blood analyzer.

    2. Determine association between one or more quantitative POC G6PD test (Biosensor) and the flow cytometry-based G6PD test [at enrollment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Subjects with age ≥ 18 years

    • Subjects willing to participate and sign informed consent form

    • Male and Female

    • Previously tested G6PD deficient, G6PD normal and G6PD intermediate or heterozygous for G6PD variants at SMRU clinic

    Exclusion Criteria:

    • Patients with severe malaria or other severe or any acute 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)

    • Patients who have not had a critical illness or received other hemolytic drugs (this is to ensure that previous characterization of phenotype in the healthy subject has not been influenced by a recent hemolytic reaction)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shoklo Malaria Research Unit, Mae Sot Tak Thailand

    Sponsors and Collaborators

    • University of Oxford
    • PATH

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT02625285
    Other Study ID Numbers:
    • SMRU1501
    First Posted:
    Dec 9, 2015
    Last Update Posted:
    Feb 19, 2018
    Last Verified:
    Feb 1, 2018

    Study Results

    No Results Posted as of Feb 19, 2018