TPP: Tests for glucose-6-phosphate dehydrogenase activity
Tests for glucose-6-phosphate dehydrogenase activity: target product profiles
14 November 2022
Indication
Glucosephosphate Dehydrogenase Deficiency
Intended use
Determining in vitro G6PD activity in individuals (male and female).
Target population
All individuals at the time of presentation at the point of care.
Sample type and volume
Minimal: Finger- (+ heel-) prick (capillary) blood sample and venous whole blood. Autofill device ≤ 30 µL
Optimal: Same + cord blood. Autofill or direct to device ≤ 10 µL
Use setting
Minimal: Finger- (+ heel-) prick (capillary) blood sample and venous whole blood. Autofill device ≤ 30 µL
Optimal: Same + cord blood. Autofill or direct to device ≤ 10 µL
Performance
Analyte
Minimal: Whole blood G6PD activity Optimal: Same + standalone Hb concentration
Limit of quantification
Minimal: G6PD ≤ 1.2 U/g Hb Optimal: ≤ 0.4 U/g Hb for a specimen of 12 g/dL Hb (equivalent to commonly used commercial reference methods)
Safety
Universal precautions for a point-of-care/clinical laboratory test. No toxic constituents or waste.
Disease
Malaria
Product type
Diagnostic
Author
WHO
Status
Active