LDL DIRECT

REAGENT PREPARATION PRECISION

Cat. No. Pack Name Packaging (Content)
Reagents R1 and R2 are liquid, ready to use.
Intra-assay precision Mean SD CV
XSYS0044 LDL C 80 R1: 2 x 30 ml, R2: 2 x 10 ml Within run (n=20) (mg/dl) (mg/dl) (%)
STABILITY AND STORAGE
EN IVD Sample 1 50.346 0.885 1.72
The unopened reagents are stable till the expiry date stated on the bottle and
kit label when stored at 2–8°C. Sample 2 82.308 1.808 2.21
INTENDED USE On board stability: min. 30 days if refrigerated (2–10°C) and not contaminated.
Diagnostic reagent for quantitative in vitro determination of LDL Cholesterol in Once opened both reagents R1 & R2 are stable for 60 days at 2–8°C, when pro-
human serum and plasma. tected from contamination. Inter-assay precision Mean SD CV
CLINICAL SIGNIFICANCE Reagents are light-sensitive. Do not let bottles remain open. Keep containers Run to run (n=20) (mg/dl) (mg/dl) (%)
Low Density Lipoproteins (LDL) are synthesized in the liver by the action of vari- tightly closed.
Sample 1 47.00 0.885 1.91
ous lipolytic enzymes on triglyceride-rich Very Low Density Lipoproteins (VLDLs).
Specific LDL receptors exist to facilitate the elimination of LDL from plasma by SPECIMEN COLLECTION AND HANDLING Sample 2 92.69 1.500 1.61
liver parenchymal cells. It has been shown that most of the cholesterol stored in Use serum or heparin plasma.
atherosclerotic plaques originates from LDL. For this reason the LDLCholesterol It is recommended to follow NCCLS procedures (or similar standardized conditions). COMPARISON
concentration is considered to be the most important clinical predictor, of all single
Stability in serum/plasma: 12 hours at 20–25°C A comparison between XL-Systems LDL DIRECT (y) and a commercially available
parameters, with respect to coronary atherosclerosis. 2-8
10 days at 4–8°C test (x) using 40 samples gave following results:
Accurate measurement of LDL Cholesterol is of vital importance in therapies
12 weeks at -20°C y = 0.964x -1.615 mg/dl
which focus on lipid reduction to prevent atherosclerosis or reduce its progress
Discard contaminated specimens. r = 0.995
and to avoid plaque rupture. Can be applied on automated analyzers.

PRINCIPLE CALIBRATION INTERFERENCES

The assay is based on a modified polyvinyl sulfonic acid (PVS) and polyethylene- Calibration with HDL/LDL CAL, Cat. No. XSYS0061 is recommended. Following substances do not interfere:
glycol methyl ether (PEGME) coupled classic precipitation method with the impro- Calibration frequency: it is recommended to do a calibration haemoglobin up to 10 g/l, bilirubin up to 40 mg/dl, triglycerides up to 2000 mg/dl.
vements in using optimized quantities of PVS/PEGME and selected detergents. • after reagent lot change
LDL, VLDL, and chylomicron (CM) react with PVS and PEGME and the reaction • as required by internal quality control procedures WARNING AND PRECAUTIONS
results in inaccessibility of LDL, VLDL and CM by cholesterol oxidase (CHOD) and Traceability: For in vitro diagnostic use. To be handled by entitled and professionally educated
cholesterol esterase (CHER), whereas HDL reacts with the enzymes. Addition of This calibrator has been standardized using the NIST SRM 1951b reference person. Reagents of the kit are not classified like dangerous.
R2 containing a specific detergent releases LDL from the PVS/PEGME complex. material.
The released LDL reacts with the enzymes to produce H2O2 which is quantified
by the Trinder reaction. WASTE MANAGEMENT
QUALITY CONTROL Please refer to local legal requirements.
PVS
PEGME For quality control ERBA NORM, Cat. No. BLT00080 and ERBA PATH, Cat. No.
HDL + LDL + VLDL + CM HDL + (LDL + VLDL + CM) • PVS / PEGME BLT00081 are recommended.
CHOD, CHER
HDL Fatty Acid + H2O2 CALCULATION
Detergent Results are calculated automatically by the instrument.
(LDL + VLDL + CM) • PVS / PEGME LDL + (VLDL + CM) • PVS / PEGME
CHOD, CHER UNIT CONVERSION
LDL Fatty Acid + H2O2 mg/dl = 0.026 mmol/l
Peroxidase
2H2O2 +4-AA+TODB Quinone + 5 H2O EXPECTED VALUES 11
Less than 100 mg/dl – optimal
REAGENT COMPOSITION 100 – 129 mg/dl – near/above optimal
R1 130 – 159 mg/dl – borderline high
MES buffer (pH 6.5) 50 mmol/l 160 – 189 mg/dl – high
Polyvinylsulfonic acid 50 mg/l ≥190 mg/dl – very high
Polyethyleneglycolmethylester 30 ml/l It is recommended that each laboratory verify this range or derives reference
4-aminoantipyrine 0.9 g/l interval for the population it serves.
Cholesterol esterase 5 kU/l
Cholesterol oxidase 20 kU/l
PERFORMANCE DATA
Peroxidase 5 kU/l
Data contained within this section is representative of performance on ERBA
Detergent
XL systems. Data obtained in your laboratory may differ from these values.
R2 QUALITY SYSTEM CERTIFIED
MES buffer (pH 6.5) 50 mmol/l Limit of quantification: 2.60 mg/dl ISO 9001 ISO 13485
Detergent Linearity: 263 mg/dl
TODB N,N-Bis(4-sulfobutyl)-3-methylaniline 3 mmol/l Measuring range: 2.60 – 263 mg/dl
Erba Lachema s.r.o., Karásek 1d, 621 00 Brno, CZ
e-mail: diagnostics@erbalachema.com, www.erbamannheim.com
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N/21/13/C/INT Date of revision: 25. 3. 2014

 ASSAY PARAMETERS (conventional units) ASSAY PARAMETERS (SI units)
XL-100 XL-200 XL-300/600 XL-100 XL-200 XL-300/600
Instrument XL-640 XL-1000 XL-180 Instrument XL-640 XL-1000 XL-180
EM-100 EM-200 EM-360 EM-100 EM-200 EM-360
Test Details Test Details
Test LDL LDL LDL LDL LDL LDL Test LDL LDL LDL LDL LDL LDL
Test Code 50 50 50 50 50 50 Test Code 50 50 50 50 50 50
Report Name LDL Direct LDL Direct LDL Direct LDL Direct LDL Direct LDL Direct Report Name LDL Direct LDL Direct LDL Direct LDL Direct LDL Direct LDL Direct
Unit mg/dl mg/dl mg/dl mg/dl mg/dl mg/dl Unit mmol/l mmol/l mmol/l mmol/l mmol/l mmol/l
Decimal Places 1 1 1 1 1 1 Decimal Places 2 2 2 2 2 2
Wavelength-Primary 600 600 600 600 600 600 Wavelength-Primary 600 600 600 600 600 600
Wavelength-Secondary 700 700 700 700 700 700 Wavelength-Secondary 700 700 700 700 700 700
Assay type 2-Point 2-Point 2-Point 2-Point 2-Point 2-Point Assay type 2-Point 2-Point 2-Point 2-Point 2-Point 2-Point
Curve type Linear Linear Linear Linear Linear Linear Curve type Linear Linear Linear Linear Linear Linear
M1 Start 16 16 12 24 14 16 M1 Start 16 16 12 24 14 16
M1 End 16 16 12 24 14 16 M1 End 16 16 12 24 14 16
M2 Start 34 34 48 61 29 34 M2 Start 34 34 48 61 29 34
M2 End 34 36 51 63 31 34 M2 End 34 36 51 63 31 34
Sample replicates 1 1 1 1 1 1 Sample replicates 1 1 1 1 1 1
Standard replicates 3 3 3 3 3 3 Standard replicates 3 3 3 3 3 3
Control replicates 1 1 1 1 1 1 Control replicates 1 1 1 1 1 1
Control interval 0 0 0 0 0 0 Control interval 0 0 0 0 0 0
Reaction Direction Increasing Increasing Increasing Increasing Increasing Increasing Reaction Direction Increasing Increasing Increasing Increasing Increasing Increasing
React. Abs. Limit 0.8 0.8 0.9 0.9 0.9 0.9 React. Abs. Limit 0.8 0.8 0.9 0.9 0.9 0.9
Prozone Limit % 0 0 0 0 0 0 Prozone Limit % 0 0 0 0 0 0
Prozone Check Lower Lower Lower Lower Lower Lower Prozone Check Lower Lower Lower Lower Lower Lower
Linearity Limit % 0 0 0 0 0 0 Linearity Limit % 0 0 0 0 0 0
Delta Abs/Min 0 0 0 0 0 0 Delta Abs/Min 0 0 0 0 0 0
Technical Minimum 2.60 2.60 2.60 2.60 2.60 2.60 Technical Minimum 0.07 0.07 0.07 0.07 0.07 0.07
Technical Maximum 263 263 263 263 263 263 Technical Maximum 6.84 6.84 6.84 6.84 6.84 6.84
Y=aX+b Y=aX+b
a= 1 1 1 1 1 1 a= 1 1 1 1 1 1
b= 0 0 0 0 0 0 b= 0 0 0 0 0 0
Reagent Abs Min 0 0 0 0 0 0 Reagent Abs Min 0 0 0 0 0 0
Reagent Abs Max 0.3 0.3 0.3 0.3 0.3 0.3 Reagent Abs Max 0.3 0.3 0.3 0.3 0.3 0.3
Auto Rerun No No No No No No Auto Rerun No No No No No No
Total Reagents 2 2 2 2 2 2 Total Reagents 2 2 2 2 2 2
Reagent R1 LDL R1 LDL R1 LDL R1 LDL R1 LDL R1 LDL R1 Reagent R1 LDL R1 LDL R1 LDL R1 LDL R1 LDL R1 LDL R1
Reagent R2 LDL R2 LDL R2 LDL R2 LDL R2 LDL R2 LDL R2 Reagent R2 LDL R2 LDL R2 LDL R2 LDL R2 LDL R2 LDL R2
Reagent R3 NA NA NA NA NA NA Reagent R3 NA NA NA NA NA NA
Test Volumes Test Volumes
Test LDL LDL LDL LDL LDL LDL Test LDL LDL LDL LDL LDL LDL
Sample Type SERUM SERUM SERUM SERUM SERUM SERUM Sample Type SERUM SERUM SERUM SERUM SERUM SERUM
Sample Volumes Sample Volumes
Normal 2 2 3 2 2 2 Normal 2 2 3 2 2 2
Dilution Ratio 1 1 1 1 1 1 Dilution Ratio 1 1 1 1 1 1
Increase 4 4 4 4 4 4 Increase 4 4 4 4 4 4
Dilution Ratio 1 1 1 1 1 1 Dilution Ratio 1 1 1 1 1 1
Decrease 2 2 2 2 2 2 Decrease 2 2 2 2 2 2
Dilution Ratio 5 5 1 5 5 5 Dilution Ratio 5 5 1 5 5 5
Standard volume 2 2 3 2 2 2 Standard volume 2 2 3 2 2 2
Reagent Volumes and Stirrer speed Reagent Volumes and Stirrer speed
RGT-1 Volume 180 180 210 180 180 180 RGT-1 Volume 180 180 210 180 180 180
R1 Stirrer Speed High High NA High High High R1 Stirrer Speed High High NA High High High
RGT-2 Volume 60 60 70 60 0 60 RGT-2 Volume 60 60 70 60 0 60
R2 Stirrer Speed High High NA High NA High R2 Stirrer Speed High High NA High NA High
RGT-3 Volume 0 0 0 0 60 0 RGT-3 Volume 0 0 0 0 60 0
R3 Stirrer Speed NA NA NA NA High NA R3 Stirrer Speed NA NA NA NA High NA
Reference Ranges Reference Ranges
Test LDL LDL LDL LDL LDL LDL Test LDL LDL LDL LDL LDL LDL
Sample Type SERUM SERUM SERUM SERUM SERUM SERUM Sample Type SERUM SERUM SERUM SERUM SERUM SERUM
Reference Range Default Default Default Default Default Default Reference Range Default Default Default Default Default Default
Category Male Category Male
Normal-Lower Limit 0 0 0 0 0 0 Normal-Lower Limit 0 0 0 0 0 0
Normal-Upper Limit 130 130 130 130 130 130 Normal-Upper Limit 3.38 3.38 3.38 3.38 3.38 3.38
Panic-Lower Limit NA NA NA NA NA NA Panic-Lower Limit NA NA NA NA NA NA
Panic-Upper Limit NA NA NA NA NA NA Panic-Upper Limit NA NA NA NA NA NA
Category Female Category Female
Normal-Lower Limit 0 0 0 0 0 0 Normal-Lower Limit 0 0 0 0 0 0
Normal-Upper Limit 130 130 130 130 130 130 Normal-Upper Limit 3.38 3.38 3.38 3.38 3.38 3.38
Panic-Lower Limit NA NA NA NA NA NA Panic-Lower Limit NA NA NA NA NA NA
Panic-Upper Limit NA NA NA NA NA NA Panic-Upper Limit NA NA NA NA NA NA
Revision Number Revision Number
<A-100- <A-200- <A-300/600- <A-640- <A-1000- <A-180- <ASI-100- <ASI-200- <ASI-300/600- <ASI-640- <ASI-1000- <ASI-180-
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Revision LDL-2 LDL-2 LDL-2 LDL-2 LDL-2 LDL-1 Revision LDL-2 LDL-2 LDL-2 LDL-2 LDL-2 LDL-1
26.09.2013> 26.09.2013> 26.09.2013> 26.09.2013> 26.09.2013> 12.12.2013> 26.09.2013> 26.09.2013> 26.09.2013> 26.09.2013> 26.09.2013> 12.12.2013>