Description
INTENDED USE
ELITech Clinical Systems HDL CHOLESTEROL is an in vitro diagnostic reagent intended for the quantitative
determination of HDL 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).
HDL transports cholesterol from the cells into the liver where it can be catabolized and eliminated. Low HDL
levels have thus been shown to be a risk factor for coronary heart diseases in otherwise healthy people.
In practice, HDL cholesterol measurement is requested to assess predisposition of patients to cardiovascular
risk as part of a lipid profile. HDL Cholesterol measurement is also important to help diagnose hyperlipoproteinaemias.
LIMITATION OF USE
In patients where abnormal lipoprotein is observed, the HDL cholesterol results may be discrepant between
homogeneous measurement methods.
The quantitative assay of HDL 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 ≥ 8 000 U/L
Inorganic and organic phosphorous compounds
Reagent 2 : R2
Buffer, pH 8.15
Cholesterol Oxidase ≥ 2 000 U/L
Cholesterol Esterase ≥ 180 U/L
Peroxidase ≥ 15 000 U/L
4-aminoantipyrine ≥ 2 mmol/L
Surfactant 0.6 %
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
– Analyzers or semi-automatic analyzers.
– General Laboratory equipment (e.g. pipette).
– Do not use materials that are not required as indicated above.
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