CHOLESTEROL

COD 21505 10 x 60 mL COD 23505 4 x 60 mL

CHOLESTEROL
Only for in vitro use in the clinical laboratory
CHOLESTEROL OXIDASE/PEROXIDASE

INTENDED USE METROLOGICAL CHARACTERISTICS

Reagent for the measurement of cholesterol concentration in human serum or plasma. The The metrological characteristics described below have been obtained using a BA400 analyzer
obtained values are useful as an aid in the risk of suffering clinical manifestations of and following the guidelines of the Clinical & Laboratory Standards Institute (CLSI).
atherosclerosis.  Detection limit: 4.2 mg/dL = 0.109 mmol/L.
This reagent is for use in the BioSystems BA analyzers or in other analyzer with similar
performance characteristics.  Linearity limit: 1000 mg/dL = 26 mmol/L.
 Precision:
CLINICAL SIGNIFICANCE
Mean concentration Repeatability (CV) Within-laboratory (CV)
Cholesterol is a steroid of high molecular weight and possesses the cyclopentanophenanthrene
skeleton. Dietary cholesterol is partially absorbed and it is also synthesized by the liver and other 153 mg/dL = 3.97 mmol/L 0.7 % 1.4 %
tissues. Cholesterol is transported in plasma by lipoproteins. It is excreted unchanged into bile or 220 mg/dL = 5.7 mmol/L 0.6 % 1.0 %
after transformation to bile acids.
 Trueness: Results obtained with this reagent did not show systematic differences when
Increased total cholesterol values are associated with a progressively escalating risk of
compared with reference reagents. Details of the comparison experiments are available on
atherosclerosis and coronary artery disease1,2.
request.
Clinical diagnosis should not be made on the findings of a single test result, but should integrate
both clinical and laboratory data. LIMITATIONS OF THE PROCEDURE
 Interferences: bilirubin (up to 10 mg/dL), hemolysis (hemoglobin up to 500 mg/dL) and lipemia
PRINCIPLE OF THE METHOD
(triglycerides up to 1000 mg/dL) do not interfere. Other drugs and substances may interfere6.
Free and esterified cholesterol in the sample originates, by means of the coupled reactions
described below, a coloured complex that can be measured by spectrophotometry 3,4. BIBLIOGRAPHY
chol. esterase 1. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th ed. Burtis CA, Ashwood
Cholesterol ester + H2O Cholesterol + Fatty acid
ER, Bruns DE. WB Saunders Co, 2005.
chol. oxidase
Cholesterol + ½ O2 + H2O Cholestenone + H2O2 2. Friedman and Young. Effects of disease on clinical laboratory tests, 4th ed. AACC Press,
2001.
peroxidase
2 H2O2 + 4 – Aminoantipyrine + Phenol Quinoneimine + 4 H2O 3. Allain CC, Poon LS, Chan CSG, Richmond W and Fu PC. Enzymatic determination of total
serum cholesterol. Clin Chem 1974; 20: 470-475.
CONTENTS
4. Meiattini F, Prencipe L, Bardelli F, Giannini G and Tarli P. The 4-hydroxybenzoate/4-
COD 21505 COD 23505 aminophenazone chromogenic system used in the enzymic determination of serum
A. Reagent 10 x 60 mL 4 x 60 mL cholesterol. Clin Chem 1978; 24: 2161-2165.
5. National Cholesterol Educarion Program Expert Panel. Third report of the National Cholesterol
COMPOSITION Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High
A. Reagent: Pipes 35 mmol/L, sodium cholate 0.5 mmol/L, phenol 28 mmol/L, cholesterol Blood Cholesterol in Adults (ATP III). NIH Publication. Bethesda: National Heart, Lung, and
esterase  0.2 U/mL, cholesterol oxidase 0.1 U/mL, peroxidase  0.8 U/mL, Blood Institute; 2001.
4-aminoantipyrine 0.5 mmol/L, pH 7.0. 6. Young DS. Effects of drugs on clinical laboratory tests, 5th ed. AACC Press, 2000.
STORAGE AND STABILITY TEST PARAMETERS
Store at 2-8 ºC. These reagents may be used in several automatic analyzers. Specific instructions for application
Components are stable once opened until the expiry date marked in the label if they are stored in many of them are available on request.
well closed and care is taken to prevent contamination during their use. R1: use Reagent A.
On board stability: Reagents open and kept in the refrigerated compartment of the analyzer are BA200 BA400
stable 2 months.
Indications of deterioration: Absorbance of the blank over the limit indicated in “Test Parameters”. GENERAL
Name CHOLESTEROL CHOLESTEROL
ADDITIONAL MATERIALS REQUIRED (NOT PROVIDED) Short name CHOL CHOL
Biochemistry Calibrator (BioSystems cod. 18011) or Biochemistry Calibrator Human (BioSystems Sample type serum / plasma serum / plasma
cod. 18044). Analysis mode endpoint monoreagent endpoint monoreagent
Unit mg/dL mg/dL
REAGENT PREPARATION Decimals 0 0
Reagents are provided ready to use. Reaction type increasing increasing

SAMPLES PROCEDURE
Reading mode bichromatic bichromatic
Serum or plasma collected by standard procedures.
Main filter 505 505
Cholesterol is stable for 7 days at 2-8ºC. Heparin, EDTA, oxalate and fluoride may be used as Reference filter 670 670
anticoagulants. Sample 3 3
Vol. R1 300 300
CALIBRATION
Vol. R2 - -
A reagent blank should be done every day and a calibration at least every 2 months, after reagent Reading 1 (cycle) 18 36
lot change or as required by quality control procedures. Reading 2 (cycle) - -
QUALITY CONTROL Predilution factor - -
It is recommended to use the Biochemistry Control Serum level I (cod. 18005, 18009 and 18042) CALIBRATION AND BLANK
and II (cod. 18007. 18010 and 18043) to verify the accuracy of the measurement procedure. Blank type distilled water distilled water
Each laboratory should establish its own internal Quality Control scheme and procedures for Calibration mode experimental calibrator experimental calibrator
corrective action if control results are not within the acceptable limits. Number of calibrators 1 1
Calibration curve - -
REFERENCE VALUES
OPTIONS
The following uniform cut-off points have been established by the US National Cholesterol Blank absorbance limit 0.200 0.200
Education Program and have also been adopted in many other countries for the evaluation of Kinetic blank limit - -
coronary artery disease risk5.
Linearity limit 1000 1000
Up to 200 mg/dL = 5.2 mmol/L Desirable Substrate depletion - -
200-239 mg/dL = 5.2-6.21 mmol/L Borderline High
> 240 mg/dL = > 6.24 mmol/L High

M21505i-04 12/2016
BioSystems S.A. Costa Brava, 30. 08030 Barcelona (Spain)
Quality System certified according to
EN ISO 13485 and EN ISO 9001 standards