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

NCT02625285 | Completed

• 1 other identifier: SMRU1501
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Validation; Biosensors; Genotyping

Outcome Measures

Primary Outcomes (1)

• correlation in G6PD activity

  determined by the Biosensors and the spectrophotometric gold standard.

  at enrollment

Secondary Outcomes (2)

• correlation in Hemoglobin levels

  at enrollment

• Determine association between one or more quantitative POC G6PD test (Biosensor) and the flow cytometry-based G6PD test

  at enrollment

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The total sample size will be 150 patients, using targeted enrollment to achieve a convenience sample of approximately 50 G6PD deficient volunteers (male and female), approximately 50 G6PD intermediate or heterozygous female volunteers, and the remaining will be G6PD-normal volunteers with a 1:1 male/female ratio.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead
• PATH: collaborator

Study Sites (1)

Shoklo Malaria Research Unit,

Mae Sot, Changwat Tak, Thailand

Location

Biospecimen

Retention: SAMPLES WITH DNA

Two blood samples will be withdrawn from participants; 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
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 9, 2015
• Study Start: January 24, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

TH (1)