BinaxNOW® G6PD Test is a rapid test
for the qualitative detection of G6PD enzyme activity in human
venous whole blood. The simple, three step test provides results in
less than 10 minutes, allowing for prompt treatment decisions.
Intended Use
The BinaxNOW® G6PD
(Glucose-6-Phosphate Dehydrogenase) Test is an in vitro
enzyme chromatographic test for the qualitative detection of G6PD
enzyme activity in human venous whole blood, collected in heparin
or ethylenediaminetetraacetic acid (EDTA).
The BinaxNOW® G6PD Test is a visual
screening test used for differentiating normal from deficient G6PD
activity levels in whole blood and is intended to aid in the
identification of people with G6PD deficiency. Samples which
generate deficient results should be assayed using a quantitative
G6PD test method to verify the deficiency.
Product details
| Sample type: |
Venous Whole blood |
| Time to result: |
Heparin treated samples: 5 minutes
|
| |
EDTA treated samples: 7 minutes |
| Kit size: |
25 tests |
| Performance data*: |
Heparin samples |
| |
Deficient result
percent agreement:
98% |
| |
Normal result percent agreement: 97.9% |
| Peformance data: |
EDTA samples |
| |
Deficient result percent agreement: 98.0% |
| |
Normal result percent agreement: 97.4% |
| Regulatory: |
Cleared for distribution by the FDA |
| |
Not CE marked |
| |
Available in english |
*compared to a
commercially available quantitative G6PD test
For instructions for use, see package insert
About G6PD deficiency
G6PD is an enzyme that is part of the hexose
monophosphate shunt and is the first enzyme of the pentose pathway.
The enzyme is involved in the catalytic conversion of glucose to 6
phospho-gluconate, which produces an energy equivalent (NADPH) in
the process.
G6PD deficiency is the largest and most
widespread enzymopathy in the world, affecting some 200 million
people. There are approximately 400 variants and deficiency of the
enzyme is frequently seen in males. The highest known gene
frequency is 0.65 among Kurdish Jews. Prevalence is approximately
21% in West Africa and 11% in some Asian countries such as
Thailand1. In middle and northern Europe the frequency
of G6PD deficiency is about 0.0005. In the United States, the gene
frequency of enzyme deficiency is 10 - 11% among African American
males2.
Although much of the research on G6PD has
focused on its function in red blood cells and its importance in
cellular metabolism, it is equally important in providing defense
mechanisms for erythrocyte membranes against oxidative stress.
When strong oxidizing agents such as those
found in many commonly used drugs (anti-malarial drugs, sulfa
drugs, and ascorbic acid) 3 are administered, a
deficiency in red cell G6PD does not allow for the production of
sufficient reducing equivalents to prevent clinical complications
such as acute spherocytic hemolytic anemia. It is therefore
important that individuals with this deficiency be identified prior
to the use of certain therapeutic agents.
For more information about G6PD deficiency, please see the links
below:
G6PD deficiency website: http://g6pddeficiency.org/
G6PD deficiency favism association http://www.g6pd.org/
References
1. Erbağci A.B. and N.
Yilmaz. 2002. Erythrocyte Glucose 6-Phosphate Dehydrogenase
Deficiency Frequency in Gaziantep, Turkey. Eastern Journal
of Medicine 7 (1): 15-18.
2. Ernest Beutler.
1994. G6PD Deficiency. Blood 84 (11): 3613-3636.
3. Stiene EA. 1972. Red
cell enzyme deficiencies: A Review. Am J Med
Tech.38:454.