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Tél. : 71 182 500 - Fax : 71 182 250
www.biomaghreb.com
IVD
GLUCOSE
Enzymatic Colorimetric Method (GOD- PAP)
Reagent for the quantitative determination of glucose
in human plasma and cerebrospinal fluid (CSF)
FT En 25 Date of updating: 01/ 2020 Version B
IN VITRO DIAGNOSTIC USE
CLINICAL SIGNIFICANCE
Blood glucose is the level of glucose in the blood. This carbohydrate is the body’s main sugar and
is its main source of energy. Its concentration is regulated by pancreatic hormones: insulin, which
promotes its absorption into the cells; and glucagon, which has the opposite role. This hormonal
control helps maintain normal blood sugar levels. In some cases, however, blood sugar levels can
be higher or lower than the reference values (between 0.7 and 1.05 g/l), which can lead to various
disorders. Hyperglycemia may be a sign of diabetes, hyperthyroidism or following surgery. On the
contrary, hypoglycemia can be a sign of undernutrition, excessive alcohol consumption, adrenal or
pituitary insufficiency or even hypothyroidism.
PRINCIPLE
Enzymatic determination of glucose according to the following reactions:
Glucose oxidase
Glucose + O
2
+ H
2
O Gluconic Acid + H
2
O
2
2H
2
O
2
+ Phenol + 4-Aminoantipyrine
Peroxidase
Quinoneimine + 4H
2
O
REAGENT COMPOSITION
Reagent 1
Buffer
Buffer Tris pH= 7
Phenol
100 mmol/l
0,3 mmol/l
Reagent 2
Enzymes
Glucose oxidase
Peroxidase
Amino-4-antipyrine
10000 U/l
1000 U/l
2,6 mmol/l
Reagent 3
Standard
Standard Glucose
100 mg/dl
1 g/l
5,56 mmol/l
SAFETY CAUTIONS
Biomaghreb reagents are intended for use by qualified personnel for in vitro use (do not pipette by
mouth).
• Refer to the current SDS available on request or at www.biomaghreb.com;
• Verify the integrity of the reagents before use; and
• Disposal of waste: comply with the legislation in force.
For safety reasons, treat any specimen or reagent of biological origin as potentially infectious.
Respect the legislation in force.
REAGENT PREPARATION
Working solution: Dissolve lyophilisate R2 with contents of one vial Buffer R1.
SAMPLE PREPARATION
Serum (not hemolyzed);
Plasma collected on fluoride-heparin or heparin-iodoacetate (non-hemolyzed);
Cerebrospinal fluid.
PRESERVATION AND STABILITY
• Before opening: The reagents are ready to use, stable up to the expiry date indicated on the
label of the box at 2-8°C;
• After opening (Working Solution) :
2 months at 20 -25°C;
8 months at 2-8°C.
Store away from light in a plastic bottle free of any contamination.
ADDITIONAL EQUIPMENT
• Basic equipment of the medical analysis laboratory ;
• Spectrophotometer or Clinical Biochemistry Analyzer.
QUALITY CONTROL
External quality control program.
It is recommended to control in the following cases:
• At least one test per series.
• Change of reagent bottle.
• After maintenance work on the analyzer.
If a control value is outside the confidence limits, repeat the procedure using the same control.
Use normal and pathological control sera.
CALIBRATION
The standard of the kit (Reagent 3) or any calibrator connected to a method or reference material.
The frequency of calibration depends on analyzer performance and reagent storage conditions.
Recalibration is recommended in the following cases:
1. Changing the reagent lot;
2. After maintenance work on the analyzer; and
3. Control values are outside the confidence limits.
LINEARITY
The method is linear up to 5 g/l (500 mg/dl 27.8 mmol/l). If the glucose concentration is higher than
5 g/l, repeat the determination on the sample diluted 1/2 with 9 g/l NaCl solution. Multiply the result
by 2.
PROCEDURE
Wavelength: 505 nm (492 - 550);
Temperature: 37 °C;
Tank: 1 cm thick;
Adjusting the spectrophotometer zero with the reagent blank.
Blank Standard Sample
Standard
- - 10 µl - -
Sample
- - - - 10 µl
Working solution
1 ml 1 ml 1 ml
Mix, read absorbances after 10 minutes incubation at 37 °C or 30
minutes at 20-25 °C. Staining is stable 30 minutes.
CALCUL
Glucose =
OD. Sample
OD. Standard
x n
n = Standard value
n = 100 mg/dl;
n = 1 g/l;
n = 5, 56 mmol/l.
REFERENCE VALUES
Serum
or
plasma
70 - 105 mg/dl
0,70 - 1,05 g/l
3,89 - 5,84 mmol/l
Note :
The following substances do not interfere:
Hemoglobin (up to 4 g/l), Bilirubin (up to 200
mg/l), Creatinine (up to 100 mg/l), Galactose
(up to 1 g/l) and EDTA (up to 2 g/l).
Cerebrospinal uid
50 - 70 mg/dl
0,50 - 0,70 g/l
2,78 - 3,89 mmol/l
REFERENCES
Dingeon B., Ann. Biol. Clin. 33, 3 (1975);
Lott J.A. Clin. Chem. 21. 1754 (1975);
Trinder P.n Ann. Clin. Biochem 6, 24 (1969).
Manufacturer Use by In Vitro Diagnostic Temperature
Limitation
Catalogue number See insert Store away from light Sufcient
for < n > essais
Batch number
