BXC0101A BXC0101B BXC0101C BXC0101D BXC0101E BXC0101F For In Vitro Diagnostics Use Only

Lot Number
6x60ml 6x125ml 2x500ml 4x250ml 10x500ml 6x1000ml Catalogue Number
Storage Temperature
GLUCOSE STORE AT 2-8°C
Expiry Date (Year / Month)
PRODUCT CODE: BXC0101 Warning, Read Enclosed Documents
INSTRUCTIONS FOR USE
Instructions For Use

FOR IN-VITRO DIAGNOSTIC USE ONLY Manufactured By

back into the original container. Material will be stable to the expiry
GLUCOSE date shown when stored correctly at 2 – 8oC.
Sample: Precision:
GOD-PAP (LIQUID STABLE) – A25/A15
APPLICATION Serum, Heparinised plasma, EDTA plasma. Intra Assay – Within run
Glucose is stable in serum for 24 hours at 2-8 oC if the serum or plasma is Glucose conc
prepared within 30 minutes of collection. n CV%
(mmol/l)
Plasma should be preserved with Sodium fluoride and the resultant 5.89 20 2.19 %
Kit Contents: BXC0101A BXC0101B BXC0101C
stability is 24 hours. A small decrease will however occur in the first 2 14.63 20 1.92 %
hours
R1 Glucose Reagent 6 x 60 ml 6 x 125 ml 2 x 500 ml
Inter Assay – Between Run
R4 Glucose Standard 1 x 5 ml 1 x 5 ml 1 x 5 ml
Stability: 24 hours at 2-8oC Glucose conc
n CV %
(mmol/l)
BXC0101D BXC0101E BXC0101F
5.89 10 3.14 %
Manual Procedure:
14.63 10 2.9 %
R1 Glucose Reagent 4 x 250 ml 10 x 500 ml 6 x 1000 ml
R2 Glucose Standard 1 x 5 ml 1 x 5 ml 1 x 5 ml Wavelength Temperature Cuvette Measurement
These characteristics were established using an AU600 analyser.
500 nm 15-25oC or Against
1 cm light path Results may vary depending on the system in use.
Test Principle: (Hg 546 nm) 37oC reagent blank

Pipette into test tubes as follows: Normal Values (Fasting):

Enzymatic indicator test based on the Trinder reaction quantified by
the formation of a pink quinoneimine dye. In this reaction glucose is Reagent Blank Standard / Sample
determined after enzymatic oxidation in presence of glucose oxidase. Standard / Sample --- 10 µl
The hydrogen peroxide formed is catalysed by peroxidase and reacts Reagent 1 ml 1 ml 4.1-6.4 mmol/l (74-115 mg/dl)
with phenol and 4-aminoantipyrine to form the dye indicator. A serum based calibrator or aqueous glucose standard can be used These values are supplied as a guideline only.
GOD to calibrate the assay. It is recommended that a laboratory establishes it’s own reference
Glucose + O2 + H2O → Gluconic acid + H2O2 Mix and incubate for 10 minutes at 15-25oC in water bath or 5 range,
minutes at 37oC. Measure the absorbance of the standard and which may be dependant on age or diet
POD
samples against the reagent blank.
H2O2 + 4-aminoantipyrine + phenol → quinoneimine + 4 H2O
The end-point is stable for 60 minutes. Limitations - Interferences:

Reagent Concentration: Calculation: No interference was noted up to the following levels:

Glucose Oxidase > 15 U/ml Bilirubin up to 340μmol/l (20mg/dl)
Peroxidase > 1 U/ml Glucose conc. = Sample abs. x Standard conc. Triglycerides up to 14 mmol/l (1240 mg/dl)
4-aminoantipyrine 0.7 mmol/l Standard abs. Haemoglobin up to 750 mg/dl
Glucose
Phenol 11 mmol/l Linearity:
MOPS Buffer 0.05 mol Use on Automated Analysers:
Phosphate Buffer 0.025 mol The test is linear up to 30.0 mmol/l (550 mg/dl)
Standard Glucose 5.55 mmol/l (100 mg/dl) Samples above this concentration should be diluted 1 + 2 with distilled This reagent is suitable for use on a range of automated analysers.
water, re-assayed and the result multiplied by 3. Specific instructions for these applications are available on request
Reagent Handling and Preparation: from our technical department.
Sensitivity:
The reagent and standard are supplied ready to use. For automated use we recommend a serum based calibrator to
Unused portions should be kept tightly capped in the original This method will accurately measure glucose levels down to 0.35 eliminate any matrix bias which may be observed with the aqueous
container. Do not transfer material from reaction vessels or test-tubes mmol/l (6.3mg/dl). standard. The calibrator that is recommended for this assay.

Biorex Diagnostics Limited, Unit 2C Antrim Technology Park, Muckamore, BT41 1QS (United Kingdom)
Tel: +44 (0) 2894 468786 | Fax: +44 (0) 2894 469933 | Website: www.biorexdiagnostics.com BXC0101 – GLUCOSE | RevisIon No.10 MAY/11 | Page 1 of 2
Biorex Calibration Serum cat. No BXC0321K/L/M

Quality Control:
BIOSYSTEMS A25/A15 APPLICATION:
It is recommended that a laboratory uses normal and elevated
reference control sera to verify the performance of the procedure,
A 25 A 15
both performance of the reagent and any instrumentation employed
in the determination. Results obtained should fall within the specified TEST NAME TRIGS TRIGS
ranges. ANALYSIS MODE MONO.ENDPT MONO.ENDPT
SAMPLE TYPE SERUM SERUM
Biorex Normal Bovine Assayed Control Cat No BCX0313A (10x5ml) UNITS mmol/l mmol/l
Biorex Elevated Bovine Assayed Control Cat No BXC0313B (10x5ml) GENERAL
REACTION TYPE INCREASING INCREASING
Biorex Normal Human Assayed Control Cat No BXC0312A (10x5ml)
DECIMALS 1 1
Biorex Elevated Human Assayed Control Cat No BXC0312B (10x5ml)
NO.OF REPLICATES 1 1
Biorex QC materials of human source have been tested at donor level TEST NAME IN PT REP
for HbsAg Antigen, HIV1&2 antibodies and HCV antibody and found to PROCEDURE READING BICHR BICHR
be negative. However no test can offer complete assurance to the VOLUMES SAMPLE 3 3
absence of infectious diseases so all material should be handled and REAGENT 1 300 300
disposed of as if it is potentially infectious.
REAGENT 2
WASHING 1.2 1.2
If results fall outside the acceptable range appropriate action as
determined by the laboratory’s internal quality procedures should be PREDIL FACTOR
taken. POST DIL FACTOR 2 2
FILTERS MAIN 505 505
Some common reasons for incorrect results can be: REFERENCE 670 670
1. Wavelength used for the determination TIMES READING 1 300s 312s
2. Light source READING 2
3. Temperature REAGENT 2
4. Cleanliness, e.g of cuvettes used in measurements
CALIBRATION TYPE MULTIPLE MULTIPLE
5. Bacterial contamination of reagent
6. Reagent expiry CALIBRATOR REPLICATES 3 3
CALIBRATION
7. Calibration frequency BLANK REPLICATES 3 3
CALIBRATION CURVE
Health & Safety: BLANK ABS LIMIT 0.15 0.15
OPTIONS KINETIC BLANK LIMIT
This kit is designed for use by suitably qualified laboratory personnel
only. Exercise the normal precautions required for the handling of LINEARITY LIMIT 11.4 11.4
laboratory reagents. Do not ingest the material. Dispose of material
according to local guidelines.

References:

1. Barham D & Trinder P Analyst 1972:97:142.

2. Teuscher, A & Richterich, P. Schweiz Med Wschr. 1971;
101:345 & 390.
3. Tietz NW, Clinical guide to Laboratory Tests, 3rd Edition.

Biorex Diagnostics Limited, Unit 2C Antrim Technology Park, Muckamore, BT41 1QS (United Kingdom)
Tel: +44 (0) 2894 468786 | Fax: +44 (0) 2894 469933 | Website: www.biorexdiagnostics.com BXC0101 – GLUCOSE | RevisIon No.10 MAY/11 | Page 2 of 2