Applcation Manual ILab 300 Plus
IL Test TM Glucose (Oxidase)
Kit Configuration
P/N 0018480000
6 x 35 mL GLUCOX
Reagent Preparation
P/N 0018480000 Using a volumetric pipette add 12 mL of deionized or distilled water to one bottle of GLUC OX. This can be done also
by adding the water up to the rim. See the drawing N° 2 page 3 Invert two or three times to mix the solution , then
place the bottle into ILab 300 plus reagent rack in the refrigerated area (position from 14 to 33).
After daily use cap the bottles and store at 2-8 °C.
In Use Stability
When used as described in Reagent Preparation the reagent is stable for: 15 days
Specimen collection and Preparation
Serum
Calibration
Use ReferrILTM G Calibrator (Cat. No. 0018257000). See calibrator insert sheet for lot and instrument specific concentration.
Recalibrate the instrument every 15 days or when a new lot of reagent is used.
Reagent blanking should be performed daily or before patient assays if the reagent is used less frequently.
Quality Control
Serachem® Level 1 (Cat. No. 0018162412) and SeraChem® Level 2 (Cat. No 0018162512).
Calculation and Analytical Results
The result concentration is automatically calculated by the instrument against the Calibrator. For detailed description, refer to the
Instrument settings and to the ILab 300 Plus Operator’s Manual.
To convert mg/dL to SI units (mmol/L) multiply by 0.055.
Reference Interval
Serum: 70 - 105 mg/dL (3.9 - 5.8 mmol/L).
It is recommended that each laboratory establish its own reference range since ranges may vary with age, diet, gender, and
geographical area.
References / Literatur / Bibliografía / Bibliographie / Bibliografia /
See package insert inclosed in the kit
Performance Characteristics
All performance data were obtained on human serum.
Limitation/Interfering Substances
No interference from lipemia up to sample absorbance of 6.8/cm at 660 nm (1100 mg/dL or 12.4 mmo/L triglycerides). No interference
up to 500 mg/dL (0.300 mmol/L) hemoglobin. No interference up to 8 mg/dL (137 µmol/L) bilirubin.
1
For a comprehensive review of interfering substances, refer to the publication by Young.
Precision
Samples/Runs
Mean (mg/dL) CV(%)
Mean (mg/dL) CV (%)
Within Run
5/10
79
2.2
273
0.9
Total
5/10
79
2.5
273
2.2
Method Comparison
Comparison Method (x)
Same reagent
Comparison Instrument
ILab 600
Slope
0.936
y intercept
2.48
Range of x (mg/dL)
52-422
Mean x (mg/dL)
119
Mean y (mg/dL)
114
r
0.999
SE
2.64
N
80
Linearity
0 - 450 mg/dL ( 0.0 - 24.8 mmol/L)
Sensitivity
milliabsorbance change per 1 mg/dL: 2.3
milliabsorbance change per 1 mmmol/L: 41.8
Minimun Detection Limit
0 mg/dL (0.0 mmol/L).
Instrumentation Laboratory SpA – V.le Monza 338 – 20128 Milano (Italy)
Instrumentation Laboratory Company - Lexington, MA 02421-3125 (USA)
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Applcation Manual ILab 300 Plus
IL Test TM Glucose (Oxidase)
Instrument Settings
Reference Range
Description:
Unit:
Decimals:
LIS Code:
Unit Factor:
Slope:
Intercept:
Reaction Type:
Direction:
E.P. Limit (abs):
Depl Limit (abs):
First Limit (abs):
Linear Factor:
Fit:
Glucose OX
mg/dL (mmol/L)
0 (1)
**
1.0
1.00
0.00
End Point
Up
0.2500
N/A
N/A
N/A
N/A
Lin Limit. Low: 0 (0.0)
High: 450 (24.8)
Rerun when Over: Yes
Male:
Female:
Children:
Rerun:
LOW VALUES
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
Low Alert Very Low
Low
No
No
Predilut.-> S.+R. 1->
Times (sec):
0
Dil./Rgt. Code:
GLU
Lot Number:
Ratio/Vol. (ul): 1/1
300
Rinse (ul):
0
Sample (ul):
4
RBL Min (abs): 0.0000
Max (abs): 0.6500
HIGH VALUES
70 (3.9)
105 (5.8) 450 (24.8) 450 (24.8) 450 (24.8)
70 (3.9)
105 (5.8) 450 (24.8) 450 (24.8) 450 (24.8)
70 (3.9)
105 (5.8) 450 (24.8) 450 (24.8) 450 (24.8)
Normal Values
High
Very High High Alert
No
No
Parameter
Reag. 2 -> Reag. 3 ->
0
0
0
0
0
0
Calculation Model: Standard
Factor: N/A
Sample Blank: Yes
**
N/A
Instrumentation Laboratory SpA – V.le Monza 338 – 20128 Milano (Italy)
Instrumentation Laboratory Company - Lexington, MA 02421-3125 (USA)
Incubation ->
Read
80
0
*) = kinetic
Filter 1 (nm): 510
Filter 2 (nm): (none)
Bicr. Factor: 1.00
RBL Stability (days): 1
Calibration Stab. (days): 15
Dinamic Controls (min): None
Operator definable
Not applicable to this test
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