Applcation Manual ILab 600/650
IL Test TM LDL Cholesterol
Kit Configuration
P/N 0018256040
4 x 18 mL LDL- Cholesterol R1
4 x 6 mL LDL- Cholesterol R2
P/N 0018482700
6 x 9 mL LDL R1
6 x 3 mL LDL R2
Reagent Preparation
P/N 0018256040: the reagents are supplied ready to use. Uncap the containers of LDL Cholesterol R1 and of LDL Cholesterol R2 and
place them into ILab reagent tray
P/N 0018482700: the reagents are supplied ready to use. Uncap the containers of LDL R1 and of LDL R2 and place them into ILab
reagent tray
In Use Stability
On board:.
LDL Cholesterol R1: 30 days; LDL Cholesterol R2: 30 days.
Specimen
Serun
Calibration
Use ReferrIL™ LDL Cholesterol calibrator, Cat. No. 0018256100. The calibrator value is specific to the lot and can be found on the vial
label. This value is assigned by procedures traceable to the CDC (U.S. Center for Disease Control). Recalibrate every 30 days, 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 of Analytical Results
The results concentration is automaticallycalculated 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 S.I. units (mmol/L), multiply by 0.0259.
Reference Interval
76 - 218 mg/dL (1.97 – 5.65 mmol/L)
According to the NCEP (U.S. National Cholesterol Education Program) .
LDL-C values equal to or below 130 mg/dL ( 3.37 mmol/L) are considered desirable.
LDL-C values between 130-159 mg/dL (3.37-4.12 mmol/L) are considered border line high risk for coronary heart disease.
LDL-C values equal to or greater than 160 mg/dL ( 4.14 mmol/L) are considered high risk for coronary heart disease.
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 3.0 at 660 nm (500 mg/dL or 5.6 mmol/L triglycerides). No interference
up to 30 mg/dL ( 510 µmol/L) bilirubin. No interference up to 400 mg/dL ( 0.240 mmol/L) hemoglobin. No interference up to 100 mg/dL (
1
5.68 mmol/L) ascorbic acid. 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
85
0.81
135
0.76
Total
5/10
85
1.08
135
1.18
Method Comparison
Note: This assay has not been validated against the CDC (U.S. Center for Disease Control) described reference method for
determination of LDL-Cholesterol.
Comparison Method (x)
homogeneous, direct method
Comparison Instrument
Hitachi 917
Slope
0.954
y intercept
1.63
Range of x (mg/dL)
49-219
Mean x (mg/dL)
141
Mean y (mg/dL)
136
r
0.9926
SE
4.34
n
122
Linearity
no rerun 0-400 mg/dL ( 0- 10.4 mmol/L); with rerun 0-600 mg/dL ( 0- 15.5 mmol/L)
Sensitivity
milliabsorbance change per 1 mg/dL 1.63; milliabsorbance change per 1 mmol/L 63
Minimun Detection Limit
Instrumentation Laboratory SpA – V.le Monza 338 – 20128 Milano (Italy))
Instrumentation Laboratory Company - Lexington, MA 02421-3125 (USA)
50 of 117
Applcation Manual ILab 600/650
IL Test TM LDL Cholesterol
0.34 mg/dL (0.01 mmol/L)
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
09
LDL-C, LDL-C
Serum
mg/dL (mmol/L), 0 (1)
Standard
OFF
End Point, 15/32
2 Wavelength
600/700
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
76 -218 (2.0 -5.7)
76 -218 (2.0 -5.7)
**
0 - 400 (0.00-10.4)
***
Positive
Above, 3500
N/A
N/A
1/0
OFF
1 Point, Linear, 3 Reps
30
ReferrIL LDL-C, *
2500
***
***
***
N/A
ON
ON
Lot dependent
operator definable
optional
not applicable to this test
01091
270/10, ON
***
30
01092
90/10, ON
***
30
Instrumentation Laboratory SpA – V.le Monza 338 – 20128 Milano (Italy))
Instrumentation Laboratory Company - Lexington, MA 02421-3125 (USA)
51 of 117