COD 11803 COD 11503 COD 11504 COD 11538 GLUCOSE

1 x 50 mL 1 x 200 mL 1 x 500 mL 1x1L

STORE AT 2-8ºC
Reagents for measurement of glucose concentration GLUCOSE
Only for in vitro use in the clinical laboratory GLUCOSE OXIDASE/PEROXIDASE

PRINCIPLE OF THE METHOD According to the National Diabetes Data Group (US)3, elevation of fasting plasma glucose values
Glucose in the sample originates, by means of the coupled reactions described below, a coloured over 140 mg/dL (7.77 mmol/L) on more than one occasion is diagnostic of diabetes mellitus.
complex that can be measured by spectrophotometry1.
QUALITY CONTROL
glucose oxidase
Glucose + ½ O2 + H2O Gluconate + H2O2 It is recommended to use the Biochemistry Control Serum level I (cod. 18005, 18009 and 18042)
peroxidase and II (cod. 18007, 18010 and 18043) to verify the performance of the measurement procedure.
2 H2O2 + 4 – Aminoantipyrine + Phenol Quinoneimine + 4 H2O
Each laboratory should establish its own internal Quality Control scheme and procedures for
CONTENTS corrective action if controls do not recover within the acceptable tolerances.

COD 11803 COD 11503 COD 11504 COD 11538 METROLOGICAL CHARACTERISTICS
A. Reagent 1 x 50 mL 1 x 200 mL 1 x 500 mL 1x1L − Detection limit: 0,23 mg/dL = 0,0126 mmol/L
S. Standard 1 x 5 mL 1 x 5 mL 1 x 5 mL 1 x 5 mL
− Linearity limit: 500 mg/dL = 27.5 mmol/L. For higher values dilute sample 1/4 with distilled
water and repeat measurement.
COMPOSITION
− Repeatibility (within run):
A. Reagent: Phosphate 100 mmol/L, phenol 5 mmol/L, glucose oxidase > 10 U/mL, peroxidase >
1 U/mL, 4-aminoantipyrine 0.4 mmol/L, pH 7.5 Mean Concentration CV n

S. Glucose/Urea/Creatinine Standard. Glucose 100 mg/dL (5.55 mmol/L), urea 50 mg/dL, 88 mg/dL = 4.84 mmol/L 1.2 % 20
creatinine 2 mg/dL. Aqueous primary standard. 326 mg/dL = 17.93 mmol/L 0.9 % 20

STORAGE − Reproducibility (run to run):

Store at 2-8ºC. Mean Concentration CV n

Reagent and Standard are stable until the expiry date shown on the label when stored tightly 88 mg/dL = 4.84 mmol/L 2.7 % 25
closed and if contaminations are prevented during their use. 326 mg/dL = 17.93 mmol/L 1.9 % 25
Indications of deterioration:
− Sensitivity: 4 mA⋅dL/mg = 0.22 mA⋅L/mmol
− Reagent: Presence of particulate material, turbidity, absorbance of the blank over 0.150 at
500 nm (1 cm cuvette). − Trueness: Results obtained with this reagent did not show systematic differences when
− Standard: Presence of particulate material, turbidity. compared with reference reagents (Note 2). Details of the comparison experiments are
available on request.
REAGENT PREPARATION − Interferences: Hemoglobin (> 3 g/L), lipemia (triglycerides > 1.25 g/L) and bilirubin (10 mg/dL)
Reagent and Standard are provided ready to use. may interfere. Other drugs and substances may interfere4.
These metrological characteristics have been obtained using an analyzer. Results may vary if a
ADDITIONAL EQUIPMENT different instrument or a manual procedure are used.
− Thermostatic water bath at 37ºC
− Analyzer, spectrophotometer or photometer able to read at 500 ± 20 nm DIAGNOSTIC CHARACTERISTICS
Glucose is the major source of energy in the body. Insulin, produced by islet cells in the
SAMPLES pancreas, facilitates glucose entry into the tissue cells. A deficiency of insulin or a decrease of its
Serum or plasma collected by standard procedures. Serum or plasma must be separated from effectiveness increases blood glucose.
the red cells promptly to prevent glycolysis. The addition of sodium fluoride to the blood sample Elevated serum or plasma glucose concentration is found in diabetes mellitus (insulin dependent,
prevent glycolysis. non-insulin dependent) and in other conditions and syndromes2,3.
Glucose in serum or plasma is stable for 5 days at 2-8ºC. Heparin, EDTA, oxalate and fluoride Hypoglycemia can occur in response to fasting, or it may be due to drugs, poisons, inborn errors
may be used as anticoagulants. of metabolism or previous gastrectomy2,5.
Clinical dianosis should not be made on the findings of a single test result, but should integrate
PROCEDURE both clinical and laboratory data.
1. Bring the Reagent to room temperature.
NOTES
2. Pipette into labelled test tubes: (Note 1)
1. These reagents may be used in several automatic analysers. Specific instructions for
Blank Standard Sample application in many of them are available on request.
Glucose Standard (S)  10 µL  2. Calibration with the provided aqueous standard may cause a matrix related bias, specially in
Sample   10 µL some analyzers. In these cases, it is recommended to calibrate using a serum based standard
Reagent (A) 1.0 mL 1.0 mL 1.0 mL (Biochemistry Calibrator, cod. 18011 and 18044).
3. Mix thoroughly and incubate the tubes for 10 minutes at room temperature (16-25ºC) or for 5 BIBLIOGRAPHY
minutes at 37ºC.
1. Trinder P. Determination of glucose in blood using glucose oxidase with an alternative oxygen
4. Measure the absorbance (A) of the Standard and the Sample at 500 nm against the Blank. acceptor. Ann Clin Biochem 1969; 6: 24-27.
The colour is stable for at least 2 hours.
2. Tietz NW. Clinical guide to laboratory tests, 2nd ed. Saunders Co, 1991.
CALCULATIONS 3. National Diabetes Data Group: Classification and diagnosis of diabetes mellitus and other
categories of glucose intolerance. Diabetes 1979; 28:1039-1057.
The glucose concentration in the sample is calculated using the following general formula:
A Sample 4. Young DS. Effects of drugs on clinical laboratory tests, 4th ed. AACC Press, 1995.
x C Standard = C Sample 5. Friedman and Young. Effects of disease on clinical laboratory tests, 3th ed. AACC Press,
A Standard
1997.
If the Glucose Standard provided has been used to calibrate (Note 2):
A Sample x 100 = mg/dL glucose
A Standard x 5.55 = mmol/L glucose

REFERENCE VALUES
Serum and plasma2:

Newborn, premature 25-80 mg/dL = 1.39-4.44 mmol/L

Newborn, term 30-90 mg/dL = 1.67-5.00 mmol/L
Children, adult 70-105 mg/dL = 3.89-5.83 mmol/L

These ranges are given for orientation only; each laboratory should establish its own reference
ranges.

M11503i-0514 BioSystems S.A. Costa Brava 30, Barcelona (Spain)

Quality System certified according to
EN ISO 13485 and EN ISO 9001 standards