Comparing G6PD Tests Using Capillary Blood Versus Venous Blood

PATH

Status

Completed

Conditions

Glucose-6 Phosphate Dehydrogenase Deficiency

Treatments

Other: G6PD Test

Study type

Interventional

Funder types

Other

Identifiers

NCT02069236

SMRU 1302

Details and patient eligibility

About

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 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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)