Cholesterol LDL Clinical Chemistry reagent, Elitech

Description

INTENDED USE
ELITech Clinical Systems LDL CHOLESTEROL is an in vitro diagnostic reagent intended for the quantitative
determination of LDL cholesterol in human serum and plasma samples on analyzers or semi-automatic
analyzers.
This in vitro diagnostic device is for professional use only.

CLINICAL SIGNIFICANCE 
Cholesterol in the serum is derived from dietary sources or is synthesized endogenously, mainly in
hepatic and intestinal cells. Cholesterol is an important structural component of cell and organelle membranes.
It is a precursor of bile acids, vitamin D and steroid hormones. Cholesterol, being insoluble in water, circulates
in association with lipoproteins (HDL, LDL, VLDL and chylomicrons).
LDL cholesterol contributes to the formation of atherosclerosis plaques in arteries and it has been shown that
a high concentration of LDL cholesterol is a very significant risk factor for coronary heart disease. Reducing
LDL cholesterol has thus become a priority target in the prevention of these pathologies.
In practice, LDL cholesterol measurement is requested to assess predisposition of patients to cardiovascular
risk as part of a lipid profile and to monitor associated therapeutic strategies. LDL Cholesterol measurement
is also important to help diagnose hyperlipoproteinaemias.

LIMITATION OF USE
In patients where abnormal lipoprotein is observed, the LDL cholesterol results may be discrepant between
homogeneous measurement methods. The quantitative assay of LDL cholesterol alone cannot be used to diagnose a disease or a specific pathology.
The results must be interpreted in conjunction with other diagnostic test results, clinical findings and the
patient’s medical history.

COMPOSITION
Reagent 1: R1
Buffer, pH 6.85
N-(2-Hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline sodium salt (HDAOS)) ≥ 0.5 mmol/L
Peroxidase ≥ 5 000 U/L
Inorganic and organic phosphorous compounds Surfactant 1 %

Reagent 2: R2
Buffer, pH 8.15
Cholesterol oxidase ≥ 2 000 U/L
Cholesterol esterase ≥ 2 000 U/L
Peroxidase ≥ 20 000 U/L
4-aminoantipyrine (4-AA) ≥ 2 mmol/L
Surfactant 0.025 %
Sodium azide < 0.1 % (p/p)
Also contains ascorbate oxidase for optimal performance.

MATERIALS REQUIRED BUT NOT PROVIDED
– HLCA-0041 HDL LDL CALIBRATOR
– CONT-0060 ELITROL I
– CONT-0160 ELITROL II
– Normal saline solution (NaCl 9 g/L).
– Analyzers or semi-automatic analyzers.
– General Laboratory equipment (e.g. pipette).
– Do not use materials that are not required as indicated above.