CHOLESTEROL BLOSR6x16 EN
CHOLESTEROL BLOSR6x16 EN
CHOLESTEROL BLOSR6x16 EN
OSR6116 4 x 22.5 mL R1
OSR6216 4x 45 mL R1
*OSR6516 4 x 107 mL R1
Intended Use
Enzymatic colour test for the quantitative determination of cholesterol in human serum and plasma on Beckman Coulter AU analysers. For in vitro
diagnostic use only.
*Cholesterol reagent OSR6516 for use on the AU2700 and AU5400 systems only.
Summary1
Cholesterol is synthesised ubiquitously throughout the body and is an essential component of cell membranes and lipoproteins as well as being a
precursor for the synthesis of steroid hormones and bile acids.
The individual predictive value of total cholesterol concentration with regard to coronary risk is low. Cholesterol is mainly transported in two lipoprotein
classes (LDL and HDL), both of which play a contradictory role in the pathogenesis of lipid disorders. The total cholesterol concentration therefore provides
only a baseline value that indicates whether further laboratory investigations of lipoprotein metabolism should be carried out (HDL, LDL, and triglycerides).
Test Principle2
The Cholesterol reagent utilises an enzymatic method to measure cholesterol in human serum and plasma. In this procedure cholesterol esters in a
sample are hydrolysed by cholesterol esterase (CHE). The free cholesterol produced is oxidised by cholesterol oxidase (CHO) to cholestene-3-one with
the simultaneous production of hydrogen peroxide (H2O2), which oxidatively couples with 4-aminoantipyrine and phenol in the presence of peroxidase
(POD) to yield a chromophore.
The red quinoneimine dye formed can be measured spectrophotometrically at 540/600 nm as an increase in absorbance.
Reaction Principle
CHE
2 Cholesterol esters + 2 H2O 2 Cholesterol + 2 Fatty acids
CHO
2 Cholesterol + 2 O2 2 Cholestene-3-one + 2 H2O2
POD
2 H2O2 + 4-Aminoantipyrine + Phenol Quinoneimine + 4 H2O
Reagent Preparation
The reagent is ready for use and can be placed directly on board the instrument.
Specimen3
Serum and EDTA or heparinised plasma. Icteric samples should be avoided.
Plasma is not recommended using anticoagulants such as oxalate, citrate or fluoride.
Stable in serum and plasma for 7 days when stored at 2...8 °C.
Test Procedure
Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.
Calibration
System Calibrator Cat. No. 66300.
The calibrator cholesterol value is traceable to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 909b
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Level 1 (Isotope Dilution Mass Spectrometry). This method is also certified against the Centers of Disease Control Reference Method (Abell-Kendall).
Recalibrate the assay when the following occur:
Change in reagent lot number or significant shift in control values;
Major preventative maintenance was performed on the analyser or a critical part was replaced.
Calculation
The Beckman Coulter analysers automatically compute the cholesterol concentration of each sample.
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Total cholesterol levels in plasma should be corrected by multiplying the result obtained by 1.03 to be equivalent to serum levels of total cholesterol.
Reference Intervals
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National Cholesterol Education Program Adult Treatment Panel III recommendations:
< 5.2 mmol/L (200 mg/dL) Desirable
5.2 – 6.2 mmol/L (200 – 239 mg/dL) Borderline High
≥ 6.2 mmol/L (240 mg/dL) High
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European Atherosclerosis Society recommendations:
Cholesterol < 5.2 mmol/L (< 200 mg/dL) No Lipid metabolism disorder
Triglyceride < 2.3 mmol/L (< 200 mg/dL)
Cholesterol 5.2 – 7.8 mmol/L (200 – 300 mg/dL) Lipid metabolism disorder if HDL-Cholesterol is < 0.9 mmol/L (< 35 mg/dL)
Cholesterol > 7.8 mmol/L (> 300 mg/dL) Lipid metabolism disorder.
Triglyceride > 2.3 mmol/L (> 200mg/dL)
National and regional guidelines for interpretation and treatment may differ from the above recommendations. Please follow the guidelines which are
applicable to your population.
Expected values may vary with age, sex, sample type, diet and geographical location. Each laboratory should verify the transferability of the expected
values to its own population, and if necessary determine its own reference interval according to good laboratory practice. For diagnostic purposes, results
should always be assessed in conjunction with the patient's medical history, clinical examinations and other findings.
Interfering Substances
Results of studies conducted to evaluate the susceptibility of the method to interference were as follows:
Ascorbate: Interference less than 10% up to 3 mg/dL ascorbate
Icterus: Interference less than 10% up to 8 mg/dL or 137 µmol/L bilirubin
Haemolysis: Interference less than 10% up to 5 g/L haemoglobin
®
Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid
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Refer to Young for further information on interfering substances.