BIOLABO
www.biolabo.fr GLUCOSE GOD-PAP
MANUFACTURER:
BIOLABO SA, Reagent for quantitative determination of glucose
Les Hautes Rives in human plasma, serum, cerebrospinal fluid (CSF) or urines
02160, Maizy, France
REF 80009 R1 1 x 500 mL R2 1 x 7.5 mL R3 1 x 5 mL
REF 87109 R1 6 x 250 mL R2 6 x 3.75 mL R3 1 x 5 mL
REF 16GL8 R1 6 x 1000 mL R2 6 x 15 mL R3 1 x 10 mL
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TECHNICAL SUPPORT AND ORDERS
Tel : (33) 03 23 25 15 50
IVD IN VITRO DIAGNOSTIC USE
Fax : (33) 03 23 256 256
CLINICAL SIGNIFICANCE (1) (6) REAGENTS PREPARATION
The glucose level in blood is maintained within a fairly narrow range Vial R1 and R2: If appropriate, use a non-sharp instrument to remove
under diverse conditions (feeding, fasting, or severe exercise) by aluminium cap.
regulatory hormones such as insulin, glucagon, or epinephrin. Using a volumetric flask, measure the volume of demineralised water
Measurement of glucose is one of the most frequently performed stated on the label of the vial R1 (Enzymes-Buffer).
procedures in clinical chemistry laboratories in conjunction with other
Transfer the contents of vial R1 into the flask and mix gently until
tolerance testing (Glucose tolerance test, Glucose 2h post-prandial…).
complete dissolution (approximately 2 minutes). Then, add the
The most frequently encountered disorder of carbohydrate metabolism
contents of vial R2 and mix gently. Store away from light in a plastic
in blood is hyperglycemia due to diabetes mellitus.
bottle free from contamination
Hyperglycemia higher than 300 mg/dL (16.5 mmol/L) may induce keto-
acidosis and hyperosmolar coma.
STABILITY AND STORAGE
In prolonged hypoglycemia, lower than 30 mg/dL (1.7 mmol/L), severe
Store at 2-8°C, away from light.
irreversible encephalic damage may occurs.
• Standard (vial R3): transfer requested quantity, well recap the vial
PRINCIPLE (4) (5) and store at 2-8°C.
Trinder Method. Glucose is oxidised by GOD to gluconic acid and • Reagent R1 (unopened) and reagents R2 and R3 are stable until
expiry date stated on the label of the kit when stored and used as
hydrogen peroxide which in conjunction with POD, reacts with chloro-
described.
4-phenol and PAP to form a red quinoneimine. The absorbance of the
coloured complexe, proportional to the concentration of glucose in the • Once reconstituted, working reagent is stable for at least 2 years
specimen is measured at 500 nm. when free from contamination.
• Discard reagent if cloudy or if reagent blank at 500 nm is > 0.400.
REAGENTS COMPOSITION • Don’t use working reagent after expiry date stated on the label of the
kit.
Vial R1 ENZYMES-BUFFER
SPECIMEN COLLECTION AND HANDLING (2)
Phosphate Buffer 150 mmol/L
Serum or plasma:
Glucose oxidase (GOD) > 20 000 UI/L
Peroxidase (POD) > 1000 UI/L Separate promptly from cells to prevent glycolysis. If fluoride is used
4-Amino-antipyrine (PAP) 0.8 mmol/L as a preservative, a decrease of 9 mg/dL (0.5 mmol/L) is seen within
the first 2 hours, then concentration stabilises.
Vial R2 CHROMOGEN Glucose is stable in serum or heparinised plasma :
Chloro-4-phenol 2 mmol/L • for 8 h at 25°C
• for 72 h at 2-8°C
Vial R3 STANDARD Glucose is stable in plasma (Sodium fluoride or iodoacetate) :
Glucose 100 mg/dL (5.55 mmol/L) • for 24 h at room temperature.
CSF:
SAFETY CAUTIONS Process immediately to avoid falsely low results. Store at –20°C.
BIOLABO reagents are designated for professional, in vitro diagnostic
Urines:
use.
• Verify the integrity of the contents before use Collect in dark bottle and store at 2-8°C. Preserve 24 h urines with
• Use adequate protections (overall, gloves, glasses). 5 mL glacial acetic acid or 5 g sodium benzoate or sodium fluoride.
• Do not pipette by mouth.
• In case of contact with skin or eyes, thoroughly wash affected areas INTERFERENCES (3)
with plenty of water and seek medical advice. Ascorbic acid: No interference up to 10 mg/dL.
• Material Safety Data Sheet is available upon request. Total bilirubin : Negative interference above 20 mg/dL.
• Waste disposal: Respect legislation in force in the country. Direct bilirubin: No interference.
All specimens should be handled as potentially infectious, in Hemolysis: No interference.
accordance with good laboratory practices using appropriate Lipemia: Positive interference above 626 mg/dL of triglycerides.
precautions. Respect legislation in force in the country.
For a more comprehensive review of factors affecting this assay refer
to the publication of Young D.S.
MATERIAL REQUIRED BUT NOT PROVIDED
1. Basic medical analysis laboratory equipment.
2. Normal and pathological control sera.
Made in France Latest revision : www.biolabo.fr Revision : 26/07/2011
CALIBRATION LINEARITY
• Standard enclosed in the Kit (vial R3) or BIOLABO-Multicalibrator The reaction is linear up to at least 500 mg/dL (28 mmol/L).
REF 95015 traceable to SRM 965a. Above, dilute the specimen with saline solution and re-assay taking
• Or any calibrator traceable to a reference method or material. into account dilution factor to calculate the result. Linearity limit
The calibration frequency depends on proper instrument functions and depends on specimen/reagent ratio.
on the preservation of the reagent.
It is recommended to calibrate in the following cases: MANUAL PROCEDURE
1. When changing batch of reagent. Let stand reagents and specimens at room temperature.
2. After maintenance operations on the instrument.
3. If control values are out of range, even after using a new vial of fresh Pipette into well identified Blank Standard Assay
control. test tubes :
Reagent 1 mL 1 mL 1 mL
QUALITY CONTROL
Demineralised water 10 µL
• BIOLABO EXATROL-N (level I) REF 95010.
• BIOLABO EXATROL-P (level II) REF 95011. Standard 10 µL
• Assayed control referring to the same method.
Specimen 10 µL
• External quality control program.
It is recommended to control in the following cases:
Mix. Let stand for 10 minutes at 37°C or 20 minutes at room temperature.
• At least once a run. Read absorbance at 500 nm (460-560) against reagent blank.
• At least once within 24 hours. Coloration is stable for 15-20 minutes at 37°C, and then slowly decreases.
• When changing vial of reagent.
• After maintenance operations on the instrument. Note: Specific procedures are available upon request for automated
If control is out of range, apply following actions: instruments. Please contact BIOLABO technical support.
1. Repeat the test with the same control.
2. If control is still out of range, prepare a fresh control and repeat the
test. CALCULATION
3. If control is still out of range, use a new vial of calibrator or a fresh
calibrator and repeat the test. Calculate the result as follows:
4. If control is still out of range, calibrate with a new vial of reagent.
5. If control is still out of range, please contact BIOLABO technical
Result = Abs (Assay) x Standard concentration
support or your local Agent.
Abs (Standard)
EXPECTED VALUES (2)
REFERENCES
(1) TIETZ Textbook of clinical chemistry. 3rd Ed. C.A. Burtis. E.R. Ashwood.
In serum or plasma : mg/dL [mmol/L]] W.B. Saunders (1999) p. 750-785.
(2) Clinical Guide to Laboratory Test, 4th Ed., N.W. Tietz (2006) p. 444-455
Newborn, 1 day 40-60 [ 2.2-3.3 ] (3) YOUNG D.S.. Effect of Drugs on Clinical laboratory Tests.
4th
Ed. (1995)
Newborn > 1 day 50-80 [ 2.8-4.4 ] p. 3-274 to 3-294.
Children 60-100 [ 3.3-5.6 ] (4) FARRANCE I. Clin. Biochem. reviews (1987). 8. p.55 to 68.
(5) TRINDER P.. Ann. Clin. Biochem.(1969). 6. p.24-27.
Adult 74-106 [ 4.1-5.9 ] (6) BERNARD S., Biochimie clinique, 2cde éd.,Edition Maloine (1989),
60-90 years 82-115 [ 4.6-6.4 ] p.165-167
> 90 years 75-121 [ 4.2-6.7 ] (7) SRM : Standard Reference Material ®
In CSF : mg/dL [mmol/L]]
Infant, Child 60-80 [ 3.3-4.4 ]
Adult 40-70 [ 2.2-3.9 ]
In 24 h urines : 1-15 mg/dL [0.1-0.8 mmol/L]
< 0.5 g/24 hours [<2.78 mmol/24 hours]
Each laboratory should establish its own normal ranges for the
population that it serves.
PERFORMANCES
Within run Normal High level Between run Normal High level
N = 30 level N = 60 level
Mean mg/dL 81 269 Mean mg/dL 81 284
S.D. mg/dL 1.05 1.80 S.D. mg/dL 0.97 3.01
C.V. % 1.3 0.67 C.V. % 1.2 1.06
Detection limit: approximately 10 mg/dL.
Sensitivity for 100 mg/dL: approximately 0.420 Abs at 500 nm.
Comparison with a commercially available reagent :
y = 0.969 x + 1.33 r = 0.9984
IVD REF LOT →
Manufacturer Use by In vitro diagnostic Temperature limitation Catalogue number See insert Batch number Store away from light sufficient for dilute with
Made in France Latest revision : www.biolabo.fr Revision : 26/07/2011
