3 x 30/3 x 11 mL

LDL-C DIRECT 12023018

Intended Use *(when triglyceride in a sample exceeds 1000 mg/dL, dilute the sample 1+9 with
This reagent is intended for in vitro quantitative determination of LDL Cholesterol saline, repeat the assay and multiply result by 10)
in serum or plasma
-Selective solubilisation method Materials provided
-Linear up to 700 mg/dL LDL-C Direct R1 & R2 Reagents

Clinical Significance Reagents required but not provided

Blood total cholesterol levels have long been known to be related to coronary heart Multicalibrator (Product Code: 11610001), Qualicheck Norm (Product Code:
disease (CHD). In recent years, in addition to total cholesterol, low density 11601003), Qualicheck Path ( Product Code: 11601002)
lipoprotein cholesterol (LDL-C) has become an important tool used to assess an Unit Conversion
individual risk of developing CHD since a strong positive relationship between
Conversion from
LDL-Cholesterol concentration and the incidence of CHD was reported. LDL Trad itional Unit SI Unit
Cholestrol acts as a key factor in the pathogenesis of atherosclerosis and coronary Trad itional to SI
artery disease. mg/dL mmol/L x 0.026
Calibration
Principle Agappe Multicalibrator (Product Code: 11610001) is recommended for calibration
This assay method uses a surfactant for selectively solubilizing LDL alone in the of the assay.
cholesterol assay system that employs cholesterol esterase and cholesterol oxidase.
It passes the ester cholesterol and free cholesterol contained in the LDL to the Quality control
cholesterol reaction system to determine LDL cholesterol. The enzyme reactions It is recommended to use Qualicheck Norm (Product Code: 11601003) or Qualicheck
to other, non-LDL lipoproteins (HDL, VLDL, chilomicrons) are inhibited by the Path (Product Code: 11601002) to verify the performance of the measurement
surfactant and by the sugar compounds. These lipoproteins are therefore not passed procedure. Each Laboratory has to establish its own internal quality control scheme
to the cholesterol reaction system and consequently remain in the reaction liquid and procedures for corrective action if controls do not recover within the acceptable
as lipoproteins. Based on this principle it is thus possible to directly determine tolerance.
LDL-cholesterol on its own.
Reference Range
Kit Components It is recommended that each laboratory should establish its own reference values.
The following value may be used as guide line.
Reagent/ Product Code Description
Component 12023018 Desirable < 130 mg/dL
Borderline 130-159 mg/dL
LDL-C 3 x 30 mL HSDA 1 mmol/L
High Risk for CHD > 160 mg/dL
Direct R1 Good’s buffer pH 6.3
Results obtained for patient samples are to be correlated with clinical findings of
LDL-C 3 x 11 mL Cholesterol esterase 2.0 U/mL
patient for interpretation and diagnosis.
Direct R2 Cholesterol oxidase 1.0 mmol/L
4-Aminoantipyrin 2.5 mmol/L Performance
Good’s buffer pH 6.3 1. Linearity
The reagent is linear up to 700 mg/dL. If the concentration is greater than linearity
Risk & Safety (700 mg/dL), dilute the sample with normal saline and repeat the assay. Multiply
Material Safety data sheets (MSDS) will be provided on request the result with dilution factor.
Reagent Preparation 2. Comparison
LDL-C Direct R1 & R2 Reagents are ready to use. A comparison study has been performed between Agappe reagent and another
Reagent Storage and Stability internationally available reagent yielded a correlation coefficient of r2= 0.9922 and
The sealed reagents are stable upto the expiry date stated on the label, when stored a regression equation of y = 0.9592x.
at 2-8OC, protected from light. Do not freeze. 3. Precision

Open Vial Stability Intra Run Inter Run

Once opened the reagents are stable up to 90 days if contamination is avoided. Control Norm Path Norm Path
On-board Calibration Stability n 20 20 20 20
Calibration is stable for 20 days. Mean (mg/dL) 51.22 108.98 51.04 101.57
Reagent Deterioration SD 0.44 1.45 1.46 3.93
Turbidity or precipitation in any kit component indicates deterioration and the CV(%) 0.86 1.33 2.87 3.87
component must be discarded. Values outside the recommended acceptable range
for the Agappe Qualicheck Norm & Path control may also be an indication of
reagent instability and associated results are invalid. Sample should be retested Accuracy (mg/dL)
using fresh vial of reagent.
Control Expected Value Measured Value
Precaution Qualicheck Norm 49 ± 8.6 51.64
To avoid contamination, use clean laboratory wares. Close reagent bottles
Qualicheck Path 98 ± 18.6 109.58
immediately after use. Avoid direct exposure of reagent to light. Do not blow into
the reagent bottles. Control Level 1 130 ± 26 131.4
This reagent is only for IVD use and follow the normal precautions required for Control Level 2 56 ± 12.2 55.1
hand ling all laboratory reagents.
Waste Management 4. Sensitivity
Reagents must be disposed off in accordance with local regulations. Lower detection Limit is 1 mg/dL
Sample Bibliography
Fresh serum (Do not use lipemic or hemolysed sample) or EDTA Plasma
1. Crouse J.R et al., Studies of low density lipoprotein molecular weight in human
Interferences
beingd with coronary artery disease. J.Lipid Res 26:5666 (1985)
No interference for
Bilirubin up to 20 mg/dL 2. Gordon,T.Castelli, W.P.Hjortland, M.C. et al. AM.J.Med 62, 707-714 (1977) Rifai,
Haemoglobin up to 500 mg/dL N.and Warnick, G.R., Ed. Laboratory Measurement of Lipids, Lipoproteins and
Ascorbic acid up to 50 mg/dL Apolipoproteins AACC Press. Washington, DC,USA,1994
Triglyceride up to 3000 mg/dL

‘Agappe Hills’, Dist. Ernakulam, Kerala, India-683 562.

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