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CHOLESTEROL

CHOD-PAP (Monoreagent)
Cat.No

Package Sizes

118 016
118 000
118 001
118 002
118 003
118 004
118 009
118 007
118 025
118 026

R = 9 x 10 ml + Standard
R = 2 x 50 ml + Standard
R = 4 x 100 ml + Standard
R = 2 x500 ml + Standard
R = 4 x 50 ml
R = 4 x 100 ml
R = 6 x 100 ml
R = 8 x 70 ml
R = 9 x 20 ml
R = 2 x 50 ml

(Hit I)
(Hit II)
(Hit II)
(AU)
(LW)
(LW)

Enzymatic colorimetric Trinder type endpoint test


according to the following reactions:

Cholesterol +

O2

H2O

CHE > Cholesterol + Fatty acid

CHO > Cholesterol-3-on + H2O2


POD > Chinonimine + 4 H2O

2 H2O2 + 4-Aminoantipyrine + Phenol

REAGENT COMPOSITION
Reagent (R)
Good's Buffer (pH 6,7)
Phenol
4-Aminoantipyrine
Cholesterinesterase
Cholesterinoxidase
Peroxidase

Normal
< 200 mg/dL (5.18 mmol/L)
Borderline high 200-239 mg/dL (5.18 - 6.19 mmol/L)
High
240 mg/dL (6.22 mmol/L)
Note: It is recommended for each laboratory to establish and
maintain its own reference values. The data given here are only an
indication.

METHOD / PRINCIPLE

Cholesterol ester+

REFERENCE VALUES
The NCEP (American National Cholesterol Education
Program) has established the following classification for
serum cholesterol levels according to the risk of developing
coronary heart diseases:

(CHE)
(CHO)
(POD)

PROCEDURE
This reagent can be used manually (see method
below) and on most analyzers. The applications are
available on request.
Wavelength :
500 nm (492-550)
Temperature :
37C
Cuvette :
1 cm light path
Read against reagent blank (R-Blank)

50 mmol/l
5 mmol/l
0,3 mmol/l
200 U/l
100 U/l
3 kU/l

R
Std
Sample

Standard:
Cholesterol

R-BLANK

STANDARD

SAMPLE

1 mL
-

1 mL
10 L
-

1 mL
10 L

200 mg/dl (5,17 mmol/l)

PRECAUTIONS
-For in vitro diagnostic use only.
-The reagent contains < 0,95 g/L sodium azide.
Avoid contact with skin and/or mucous membranes.
-Use clean or single use glass material to avoid any
contaminations.

Mix and read the absorbance (A) after a 5 minute


incubation.
The final color is stable for at least 1 hour.
CALCULATION
A sample
A standard

x C

mg/dL
g/L
mmol/L

C
C
C

= 200
=
2
= 5.17

STABILITY OF REAGENTS
When stored at 2-8 C and protected from light,
the unopened reagent is stable until the expiry
date stated on the label.

C = standard concentration.

PREPARATION AND STABILITY


OF WORKING REAGENT
Reagent and standard are ready for use.

CALIBRATION & QUALITY CONTROL


For the calibration of automated analyzers Greiner
Multicalibrator is recommended, for quality control
use Greiner normal and abnormal control, Unitrol I
and Unitrol II, or for lipids the special lipid control.

Stability after opening the bottles :


At least 3 months at 2 8 C
(contamination has to be avoided !)

.
SAMPLES
Serum, Plasma(EDTA/Heparin)

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Greiner Diagnostic GmbH - Unter Gereuth 10 D-79353 Bahlingen Germany


www.greiner-diagnostic.com

PERFORMANCE DATA

BIBLIOGRAPHY

- Analytical range
The test is linear up to a cholesterol
concentration of 1200 mg/dl or 30.0 mmol/l.
Samples with a higher concentration have to be
diluted 1+2 with phys. saline (0.9 %), repeat the
determination, multiply result by 3.
- Detection limit
The detection limit is 5 mg / dL
- Precision
Within-run reproducibility
N = 11
Mean
Control 1
99,6
Control 2
196,5
Patient
150,7

SD
1,75
2,77
1,68

CV
1,76%
1,41%
1,11%

Unit
mg/dL
mg/dL
mg/dL

Between-run reproducibility
N = 11
Mean
SD
Control 1
100,3
1,30
Control 2
195,9
3,55
Patient
147,9
1,99

CV
1,30%
1,81%
1,35%

Unit
mg/dL
mg/dL
mg/dL

1. Rifai N, Bachorik PS, Albers JJ. Lipids, lipoproteins


and apolipoproteins. In: Burtis CA, Ashwood ER,
editors. Tietz Textbook of Clinical Chemistry. 3rd ed.
Philadelphia: W.B Saunders Company; 1999. p. 80961.
2. Recommendation of the Second Joint Task Force
of European and other Societies on Coronary
Prevention. Prevention of coronary heart disease in
clinical practice. Eur Heart J 1998;19: 1434-503.
3 Artiss JD, Zak B. Measurement of cholesterol
concentration. In: Rifai N, Warnick GR, Dominiczak
MH, eds. Handbook of lipoprotein testing. Washington:
AACC Press, 1997:99-114.
4 Deeg R, Ziegenhorn J. Kinetic enzymatic method
for automated determination of total cholesterol in
serum. Clin Chem 1983;29:1798-802.
5 Schaefer EJ, McNamara J. Overview of the
diagnosis and treatment of lipid disorders. In: Rifai N,
Warnick GR, Dominiczak MH, eds. Handbook of
lipoprotein testing. Washington: AACC press, 1997:2548.

SYMBOLS USED

- Correlation
A comparative study has been performed
between the Greiner method and another
commercial reagent on 30 human serum
samples. The parameters of linear regression
are as follows:
y = 1.032 x + 1.939 mg/dl

For in vitro diagnostic medical use

Batch Code

r = 1.000
Use by

INTERFERENCES

Temperature limitation

Ascorbic Acid: no interference until 5 mg/dL


Bilirubin: no interference until 20 mg/dL
Hemoglobin: no interference until 200 mg/dL
Triglycerides: no interference until 2000 g/dL

06/2013//rev07/2014

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Greiner Diagnostic GmbH - Unter Gereuth 10 D-79353 Bahlingen Germany


www.greiner-diagnostic.com

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