Cholesterol SL Clinical Chemistry reagent, Elitech

Description

INTENDED USE

ELITech Clinical Systems CHOLESTEROL SL is an in vitro diagnostic reagent intended for the quantitative
determination of total cholesterol in human serum and plasma samples on analyzers or semi-automatic
analyzers.
The standard is intended for the calibration of reagent. These in vitro diagnostic devices are for professional
use only.

CLINICAL SIGNIFICANCE 
Total 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).

In practice, total cholesterol measurement is requested to assess predisposition of patients to cardiovascular
risk as part of a lipid profile and to monitor associated therapeutic strategies. Total Cholesterol measurement
is also important to help diagnose hyperlipoproteinaemias.

LIMITATION OF USE
The quantitative assay of total 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: R Good’s buffer, pH 6.7
Phenol 24 mmol/L
4-Aminoantipyrine 0.5 mmol/L
Cholesterol esterase ≥ 180 U/L
Cholesterol oxidase ≥ 200 U/L
Peroxidase ≥ 1 000 U/L
Sodium azide < 0.1 % (w/w)

Also contains surfactants and magnesium salts for optimal performance.

MATERIALS REQUIRED BUT NOT PROVIDED
– CALI-0550 ELICAL 2
– 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.

PRECAUTIONS FOR USE AND WARNINGS
– Consult Safety Data Sheet (SDS) for a proper handling.
– Reagent R contains sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides. When disposing of these reagents always flush with copious amounts of water to prevent
azide buildup.
– Take normal precautions and adhere to good laboratory practice.
– Use clean or single use laboratory equipment only to avoid contamination.