STORAGE AND STABILITY 8. After incubation the color is stable between 15-30min.

 All components of the kit are stable until the CALCULATIONS

Glucose (Mono Reagent) expiration date on the label when stored tightly
(GOD/POD method) closed at 2-8°C, protected from light and Glucose (mg/dl) = (A) Sample x100(Standard Conc.)
contaminants during their use. (A) STD
For in vitro diagnostic use only  Do not use reagents beyond the expiration date. Conversion factor: mg/dL x 0.0555= mmol/L.
 Signs of reagent deterioration:
Store at 2-8°C
 Presence of particles and turbidity. QUALITY CONTROL
INTENDED USE  Blank absorbance against water is more than  To ensure adequate quality control, it is
For the determination of glucose in serum or plasma. 0.2. recommended that each run includes assayed normal
and abnormal controls.
INTRODUCTION COLLECTING AND HANDLING OF SPECIMENS  If control values are found outside the defined range,
Glucose is the major carbohydrate present in blood. Its Use serum, or plasma free of hemolysis.
check the instrument calibration, and reagent for
oxidation in cells is the source of energy for the body. When blood is drawn and permitted to clot and to stand problems.
Increased levels of glucose are found in diabetes mellitus, uncentrifuged at room temperature, the average decrease in
 Each laboratory should establish its own Quality
hyperparathyroidism, pancreatitis, and renal failure. serum glucose is 7%/1h (5-10mg/dl).
Control scheme and corrective actions if controls do
Decreased levels are found in insulinoma, hypothyroidism, In separated, unhemolyzed serum, glucose concentration is
not meet the acceptable tolerances.
hypopituitarism, and extensive liver disease. generally stable up to 8h at 25°C or 72h at 4°C, if kept free of
bacterial contamination.
REFERENCE VALUES
PRINCIPLE OF THE METHOD
ASSAY PARAMETER Serum or plasma:
Glucose oxidase (GOD) catalyses the oxidation of glucose to
Reaction End point Interval ---- 60-110 mg/dL = 3.33-6.11 mmol /L
gluconate. The formed hydrogen peroxide (H2O2) is detected by a
Wavelength 505nm Sample Vol. 0.01ml These values are for guidance purposes; each laboratory should
chromogenic oxygen acceptor, phenol, 4-Aminophenazone (4-AP)
Blank Reagent blank Reagent 1.0ml establish its own reference range, according to its own
in the presence of peroxidase (POD):
Vol. geographic area.
β-D-Glucose + O2 + H2O GOD Gluconate + H 2O2
Incub. Temp. 37°C/15-25°C Standard 100mg/dl
PERFORMANCE CHARACTERISTICS
H2O2 + Phenol + (4-AP) POD Red Quinone dye + H 2O Incub. Time 5min/10min Factor -----
Measuring range (Linearity):
Reac. Slope increasing linearity Up to
The assay is linear between 10mg/dl and 600 mg/dl.
The intensity of the color formed is proportional to glucose 600mg/dl
If the results obtained were greater than 600mg/dl, dilute the
concentration in serum. Units mg/dl
sample to half with Nacl 9g/L and multiply the result by 2.
REAGENTS COMPOSITION ASSAY PROCEDURE
R GOD 15ku/L 1. Wavelength………………………………….…505nm (500-510) Sensitivity:
POD 1.0ku/L 2. Cuvette…………………………….……………..…1cm.light path 1 mg/dl = 0.0032 (A)
Phenol 0.3mmol/L 3. Temperature……………………………….………37°C/15-25°C.
4-AP 2.6mmol/L 4. Adjust the instrument to zero with distilled water. Accuracy:
BufferpH7.55 92mmol/L 5. Pipette into clean dry test tubes labeled as Blank (B), Results obtained using the reagent compared well with other
Stabilizers and activators Standard(S), and Sample: commercial reagents.
GLUCOSE Glucose aqueous primary standard Addition Blank Standard Sample
STD 100mg/dl Sequence Precision:
EQUIPMENTS NEEDED BUT NOT PROVIDED Glucose mono 1.0ml 1.0ml 1.0ml Intra-assay(n=20 ) Inter-assay(n=20 )
 Spectrophotometer or colorimeter measuring at reagent Mean(mg/dl) 91.73 228.51 97.68 244.17
505nm. Glucose - 0.01ml - STD 3.51 10.64 3.42 10.69
 Matched cuvettes 1.0 cm light path. standard C.V% 3.83 4.66 3.50 4.38
 General laboratory equipment. Sample - - 0.01ml The results of the performance characteristics depend on the
6. Mix well and incubate at 37°C for 5 min or at 15-25°C. analyzer used.
PREPARATION
(25°C) for 10 min.
 Reagent and standard provided are ready to use. INTERFERENCES
7. Measure the absorbance of the standard and test
sample against blank. The following compounds will affect glucose results if found in
the sample at the following concentrations: Atlas Medical
Ascorbic acid: 250mg/L,L-Cysteine: 1.5g/L,Citric acid: 15g/L,
Ludwig-Erhard Ring 3
Uric acid: 150mg/L and L-Dopa:100mg/L.
15827 Blankenfelde-Mahlow
REFERENCES Germany
1. Kaplan L.A. Clinical Chemistry. The C.V. Mosby Co. St. Tel: +49 - 33708 – 3550 30
Louis. Baltimore. Philadelphia. Toronto. 854-856, 1989. Email: [email protected]
2. Norbert W. Tietz. Clinical Chemistry third edition. W.B.
Saunders Co. 427-429, 1987 PPI1419A01
3. Banauch, D, Brummer, W, Ebling, W, et al: Z Kiln Chem. Rev A (02.09.2019)
Kiln Biochem 13:101-107, 1975.
4. Vormbrock, R: Clin Chem 29:1224(A), 1983. Catalogue Number Temperature limit
5. Bjorkhem, I, Blomstrand, R, Falk, O, and Ohman, G: Clin In Vitro diagnostic
Chem. Acta 72:353-362, 1976. Caution
medical device
6. Mary Ellen Wedding, Medical Lab. Procedure, F.A. Davis Contains sufficient for
Consult instructions
CO. 405, 1992. <n> tests and Relative
for use (IFU)
7. Trinder, P. Ann. Clin.Biochem. 6, 24, 1969. size
8. Dingeon, B. Ann. Biol. Clin. 33, 3, 1975 Batch code Manufacturer
9. Lott, J.A. Clin.Chem. 21, 1754, 1975.
Fragile,
Use-by date
handle with care
Manufacturer fax Do not use if package
number is damaged
Manufacturer
Date of Manufacture
telephone number
Keep away from
Keep dry
sunlight