INTENDED USE

This G6PD Test Kit is used for qualitative detection of normal or deficient G6PD enzyme activity in whole blood samples. It is intended for in vitro clinical auxiliary diagnosis of glucose-6-phosphate dehydrogenase deficiency.

SUMMARY

Glucose-6-phosphate dehydrogenase (G6PD) is a hereditary disease caused by a defect in the G6PD enzyme of red blood cell membranes. This defect leads to a decrease in the production of reduced nicotinamide adenine dinucleotide phosphate (NADPH), which is essential for maintaining the stability of red blood cell membranes and protecting against oxidative damage. The deficiency can result in red blood cell destruction and hemolysis. Symptoms often occur after consuming fava beans, a condition known as “favism”. G6PD deficiency is an X-linked genetic disorder, with male carriers usually exhibiting a dominant phenotype. Female carriers with homozygous or compound heterozygous mutations can also manifest as a dominant phenotype. However, most female carriers with a single heterozygous mutation are asymptomatic carriers, and only a small percentage may develop G6PD deficiency. Patients with G6PD deficiency are unable to metabolize glucose properly, as G6PD is the rate-limiting enzyme in the pentose phosphate pathway. Exposure to oxidative substances such as fava beans, aspirin, and sulfonamide drugs can trigger acute hemolytic reactions, leading to symptoms such as jaundice, mental impairment, and, in severe cases, rapid breathing, heart failure, and shock, which can be life-threatening. The measurement of G6PD enzyme activity is of great clinical significance.

PRINCIPLE

The G6PD Test Kit utilizes the glucose-6-phosphate substrate colorimetric method. In this method, glucose-6-phosphate in the sample is oxidized by the G6PD enzyme in the presence of NADP, resulting in the production of 6-phosphogluconic acid lactone and NADPH. The NADPH then reacts with the light yellow nitrotetrazolium blue chloride (NBT), reducing it to insoluble blue-purple crystalline formazan. In the presence of normal G6PD enzyme activity, insoluble blue-purple crystals are formed. The test kit includes a filtration membrane that removes hemoglobin from the sample, allowing the purple crystals to bind to the membrane and form a visible blue-purple circular spot. However, when G6PD enzyme activity is defect, the blue-purple circular spot cannot be formed, indicating a deficiency in G6PD enzyme.