Aa Pro Elserie Cala 1

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CALCIUM ARSENAZO

Instruction for use : Ref : CALA-0250 12 x 20 mL


Convertion Factor : mg/dL x 0.25 = mmol/L CALA-0600 2 x 125 mL
mg/dL x 10 = mg/L

APPLICATION Selectra Pro Serie & Flexor EL Serie


General Sample types
Name CALCIUM ARSENAZO Normal
Abbreviated name CALA Allowed Yes
Code 240 Predilution No 0

Mode End point monochromatic Reference values


Wavelength 660 nm 0 Male XXX - XXX mg/dL
Test parameters 1

Units mg/dL Female XXX - XXX mg/dL


Decimals 2 Pediatric XXX - XXX mg/dL
Test repeats 1 Panic XXX - XXX mg/dL
Controls
Control 1 XXX
Concentration limits 5.00 - 15.00 mg/dL Control 2 XXX
Calibrator name XXX Control 3 XXX
Correlation
Prozone check No Correlation factor 1.000
Correlation offset 0.000 mg/dL

General Measurement
Name CALCIUM ARSENAZO Slope Blank No 0 0
P dil ti
Predilution N
No 0 IIncubation
b ti titime 4.5
45 min
i 0
Sample
Sample blank No 0 0
normal volume rerun volume* Factor 1.00
Test parameters 2

6.0 µL 6.0 µl Absorbance limits


Reagents Absorbance 0.100 - 2.500 Abs
Reagent blank Yes 3 R. Absorbance 0.050 - 1.000 Abs
normal volume rerun volume*
Reagent addition at - 2.25 minutes (R1) 0 9.000 0
300 µL 300 µl
Reagent addition at 2.90 minutes (R2) 0
0 µL 0 µl 0 9.000 0 9.000 0
Reagent addition at 4.70 minutes (R3) 0 9.000 0 9.000 0
0 µL 0 µl 0 9.000 0

Calibrator Predilution
Name XXX Auto predilution No
Number of standards 1 0
Calibration accepted - 0 0
Calibration

Repeats 3 Cut-off
Interval 28 days Cut-off No
Curvefit 0
0 0 0
0 0 0 9.000 9.000
Auto accept calibration Yes 0 9.000 9.000

N° Used Concentration 0 0
#1 Standard #1 xxx 0 FAUX
0 0 FAUX
0 0 FAUX XXX: Enter data by the user
0 0 FAUX * : For information only
0 0 FAUX
0 0 FAUX
0 0 FAUX (01/2011)
AA-PRO/ELserie-CALA-1
 Modification from the previous version 1/2
CALCIUM ARSENAZO
Instruction for use : Ref : CALA-0250 12 x 20 mL
Convertion Factor : mg/dL x 0.25 = mmol/L CALA-0600 2 x 125 mL
mg/dL x 10 = mg/L

APPLICATION Selectra Pro Serie & Flexor EL Serie


0 0 FAUX
0 0 FAUX

PERFORMANCE DATA

Analytical range
The reagent is linear from 5 to 15 mg/dL.

Detection limit
Determined according to SFBC protocol, the detection limit is equal to 0.03 mg/dL.

Precision
Within run reproducibility Between run reproducibility

N Mean (mg/dL) CV% N Mean (mg/dL) CV%


Level 1 20 6.50 0.5% Level 1 20 7.10 4.1%
Level 2 20 9.71 0.3% Level 2 20 9.96 2.2%
Level 3 20 13 66
13.66 0 2%
0.2% Level 3 20 14 38
14.38 2 5%
2.5%

Correlation
A comparative study has been performed on 60 human serum samples.
The sample concentrations cover the linearity range.
The parameters of linear regression are as follows :
Correlation coefficient (r) :0.9952
Linear regression : y= 1.0133 x + 0.09 mg/dL

Interferences
According to SFBC recommendations, some studies have been performed to determine the level of interference
from different compounds:
Unconjugated bilirubin :Positive bias from 3 mg/dL.
Conjugated bilirubin :No significant interference up to 24.5 mg/dL.
Haemoglobin:Positive bias from 450 mg/dL.
Turbidity : Positive bias from 400 mg/dL Triglycerides equivalent.
Other compounds may interfere (see product insert).

On board stability / Calibration frequency (refrigerated position)


On board stability: 28 days
Calibration frequency: 28 days
Make a new calibration when reagent lots change, when quality control results fall outside the established range
and after a maintenance operation.

(01/2011)
AA-PRO/ELserie-CALA-1
 Modification from the previous version 2/2

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