GLUCOSE(GOD-POD)
INTENDED USE 8 Hrs Onboard: 12 weeks if contamination avoided
Glucose reagent is used for the quantitative determination of The above onboard stability is for BC2000. For other
Glucose in serum. This reagent is for use on Fully Automated Analyzers laboratory has to define their own calibration
Biochemistry analyzer. frequency and Onboard stability according to their workload
and laboratory conditions. We recommend every 15 days
CLINICAL SIGNIFICANCE calibration for result accuracy.
Glucose is the major carbohydrate present in the peripheral Recalibration of this test is required when any of these
blood. The oxidation of glucose is the major source of cellular conditions exist:
energy in the body. Glucose determinations are run primarily 1. A reagent lot number has changed or there is an
to aid in the diagnosis and treatment of diabetes mellitus. observed shift in control values.
Elevated levels of glucose levels maybe associated with 2. Major preventative maintenance was performed on
pancreatitis, pituitary or thyroid disfunction, renal failure and the analyzer.
liver disease, whereas low glucose levels may be associated 3. A critical part of instrument was replaced like the lamp
with insulinoma, hypopituitaryism, neoplasms, or insulin or cuvettes etc.
induced hypoglycemia.
SPECIMEN COLLECTION AND STABILITY
METHOD AND PRINCIPLE Glucose in serum, free from hemolysis and bacterial
Early enzymatic methods for glucose determination involved contamination, and without added preservatives, is stable for
glucose oxidase to catalyze the oxidation of glucose. Keston 8 hours when stored at 15 - 25°C, or for up to 72 hours when
modified this method in the early 1950's using glucose
stored at 2 - 8°C.7 Fluoride preserved plasma samples are
oxidase/peroxidase enzyme system and O-dianisidine
stable for 24 hours at 15 - 25°C. Urine specimens should be
chromogen system.Since then, various alternative chromogen
systems have been proposed. The trinder method replaces maintained at 2 - 8°C and analyzed as soon as possible.7
carcinogenico-dianisidine with phenol plus 4- Cerebrospinal fluid can be stored between 2 - 8°C for at least
aminoantipyrine. This method is less influenced by interfering 5 days if protected from evaporation. Specimens that will not
substances and does not suffer from the many drawbacks of be tested within 5 days should be stored frozen ≤ -20°C
earlier methods. immediately after collection.2
The enzymatic reaction sequence employed in the assay of
glucose is as follows: REAGENT REQUIRED BUT NOT PROVIDED WITH KIT
Biochemistry Multicalibrator.
D-Glucose +H2O+O2 ---------------------- H2O2+D-Gluconic acid
CALCULATIONS
H2O2+4AAP+Phenol---------------------- Quinonemine +H2O Results will be calculated against the factor generated after
calibration using Biochemistry multi calibrator.
D-Glucose is oxidized by glucose oxidase to produce D- we recommend Randox Cal Level 3 for Calibration.
gluconic acid and hydrogen peroxide. The hydrogen peroxide
is then oxidatively coupled with 4-aminoantipyrine and WARNINGS AND PRECAUTIONS
phenol in the presence of peroxidase to yield a red Close reagent bottles immediately after use. Do not blow
quinoneimine dye.The amount of colored complex formed is into the reagent bottle.
proportional to glucose concentration and can be
photometrically measured INTERFERENCES
Grossly lipemic or icteric sera will cause false glucose values
REAGENTCOMPOSITION and require the use of a serum blank. Young,etal .give a
1. Glucose (Liquid)Reagent: GlucoseOxidase15IU/ml, comprehensive review of drug interferences.
Peroxidase (horseradish) 1.2 IU/ml. 4-Aminoantipyrene
0.2mM, Phenol 4mM, non-reactive ingredients and QUALITY CONTROL
preservatives. It is recommended that high and low values of glucose
controls be included in each set of assays. Commercially
REAGENT PREPARATION available control material with established glucose values
Reagent is ready to use. may be used for quality control. The assigned value of the
control material must be confirmed by the chosen
REAGENT STORAGE AND STABILITY application. Failure to obtain the proper range of values in the
Glucose reagent should be stored at 2 - 8°C. The reagent assay of control material may indicate either reagent
may be used until the expiration date indicated on the deterioration, instrument malfunction or procedural errors.
package label.
Onboard stability and calibration frequency : EXPECTED VALUES
24 Hrs Onboard: 6 weeks if contamination avoided Serum: Adult 70 – 105 mg/dL
Glucose - Page 1
Newborn 21 – 58 mg/dL
Urine: There should be no detectable glucose in urine
Cerebrospinal fluid: Child 60 - 80 mg/dL
Adult 40 - 70 mg/dL
LIMITATIONS
The reagent is linear to 600 mg/dl glucose. Samples that have
glucose values greater than 600mg/dl should be diluted and
reassayed.
PERFORMANCECHARACTERISTICS
1. Linearity: 600mg/dl.
2. Sensitivity: An absorbance change of 0.001 at 500nm
corresponds to 0.5 mg/dl under the stated condition of
this assay system.
3. Comparison: A comparison between this reagent and
competitor produced a regression equation of:y =1.00x +
2.54 (N= 64) with a coefficient of correlation of 0.99.
4. Precision:
Within Run
Mean(mg/dl) S.D. C.V.(%)
83 4.7 5.6
313 18.8 6.0
Between Run
Mean(mg/dl) S.D. C.V.(%)
83 4.5 4.2
313 19.8 3.8
REFERENCES
1. Holvey,D.N.,ed.:The Merck Manual of Diagnosis and
Therapy, erck and Co., Inc. Rahyway,N.J. (1972).
2. Cooper, G.R., CRC Crit Rev. Clin Lab. Sci.4:101 (1973).
3. Keston,A.S., Colorimetric,"Enzymatic Reagents for
Glucose."
Abstractsof Papers,129th Meeting ACS, 131C (1956).
4. Trinder,P.,"Determinationofbloodglucoseusing4-
aminophenazone."J.Clin. Path. 22:246 (1969).
5. Tietz,N.W.,FundamentalsofClin.Chem.,Philadelphia,W.B.
Saunders (1970).
6. Young, D.S.et al.,Clin. Chem. 21:5 (1975).
Glucose - Page 2
