Intended use

Application Manual ILab 600/650
IL Test TM Magnesium
Kit Configuration
P/N 0018256240
5 x 20 mL Magnesium
Reagent Preparation
P/N 0018256240: The reagents is supplied ready-to-use. Uncap and place container into reagent tray.
In Use Stability
On board: 30 days
Specimen
Serum.
Prompt separation of red cells is essential. Magnesium in serum is stable for several days if the specimen is separated
from the red cells and stored at 2-8°C.
Calibration
Use ReferrILTM G Calibrator (Cat. No.0018257000).See calibrator chart for lot and instrument specific concentration.
Recalibrate every 7 days. 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 results concentration is automatically calculated by the instrument against the Calibrator. For detailed description, refer to the
Instrument settings and to the ILab 600/650 Operator Manual.
To convert mg/dL to SI units (mmol/L) multiply by 0.4114.
Reference Interval
Male: 1.6 – 2.6 mg/dL (0.66 – 1.07 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 enclosed in the kit
Performance Characteristics
Limitation/Interfering Substances
No interference from lipemia up to sample absorbances/cm of 3.5 at 660 nm (440 mg/dL, 5 mmol/L triglycerides).
No interference up to 400 mg/dL (0.24 mmol/L) hemoglobin. No interference up to 14 mg/dL (240 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
1.98
1.4
3.64
1.7
Total
5/10
1.98
2.5
3.64
2.7
Method Comparison
Comparison
Method (x)
Comparison Instrument
Slope
Intercept
Range x (mg/dL)
Mean x (mg/dL)
Mean y (mg/dL)
r2
SE
n
Linearity
no rerun
with rerun
Calmagite reagent
PN 0018251040
ILab 600
1.040
-0.11
0.75 – 4.83
2.27
2.25
0.997
0.06
79
0.05 - 5.00 mg/dL (0.02 – 2.06 mmol/L)
0.05 - 7.50 mg/dL (0.02 – 3.09 mmol/L)
Sensitivity
milliabsorbance change per 1 mg/dL: 120
milliabsorbance change per 1 mmol/L 292
Minimun Detection Limit
0.05 mg/dL (0.02 mmol/L).
Instrumentation Laboratory SpA – V.le Monza 338 – 20128 Milano (Italy))
Instrumentation Laboratory Company - Lexington, MA 02421-3125 (USA)
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Application Manual ILab 600/650
IL Test TM Magnesium
Instrument Settings
Photometric Test Parameters
Test No.
Test Name, Test Code
Sample Type
Reporting Unit, Decimal Points
Reation Cycle
Twin Analysis
Methodology Type, Measuring Point
Photometric Methodology
Primary/Secondary Wavelenght
Sampling Conditions
Sampling 1
Sample Vol.
Sample/Diluent Vol.
Sampling 2
Sample Vol.
Sample/Diluent Vol.
Sampling 3
Sample Vol.
Sample/Diluent Vol.
Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
High!, ABS!
Sample Volume Reduction
Reagent Volumes
R1
Code
Rgt/Dil. Vol. Stirring
Low Vol. Warning Limit
Stability (days)
R2
Code
Rgt/Dil. Vol. Stirring
Low Vol. Warning Limit
Stability (days)
Serum
2
Magnesium, Mg
Serum
mg/dL (mmol/L), 2 (2)
Standard
OFF
End Point, 21
2 Wavelength
510/700
3
0/0
2
0/0
***
0/0
***
N/A
N/A
Sampling 1
***
***
Sampling 2
Sampling 1
N/A
Sampling 2
**
Ranges and Evaluation Criteria
Normal Range-Male
Normal Range-Female
Normal Range-Other
Valid Range
Hemolysis/Icterus/Lipemia Limit
Reaction Slope
Absorbance Limit
Prozone Limit
Non Linear Limit
Slope/Intercept Correction
Qualitative Report
Calibration Conditions
Calibration
Stability (days)
Calibrator, Concentration
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min Cal. Response (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Reagent Blank
Auto R-Blank by Bottle
*
**
***
N/A
Serum
1.60 - 2.60 (0.66 - 1.07)
1.60 - 2.60 (0.66 - 1.07)
**
0.05-5.00 (0.02-2.06)
***
Positive
Above, 3500
N/A
N/A
1/0
OFF
1 Point, Linear, 3 Reps
7
Ref G, *
***
***
***
***
N/A
ON
ON
Lot dependent
operator definable
optional
not applicable to this test
01021
350/10, ON
***
30
N/A
N/A
N/A
N/A
Instrumentation Laboratory SpA – V.le Monza 338 – 20128 Milano (Italy))
Instrumentation Laboratory Company - Lexington, MA 02421-3125 (USA)
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