HDL- C Direct

Direct Method
Cat.No
150116
150100
150101
150104
150102
150103
150105

Package Size
6 x 10 mL
2 x 10mL
4 x 25 mL
2 x 17 mL
3 x 100 mL
1 x100 mL
Hit I 3 x 20 mL
1 x 20 mL
Hit I 3 x 50 mL
1 x 50 mL
Hit II 3 x 100 mL
5 x 50 mL
AU 3 x 50 mL
3 x 17 mL

ANALYTICAL PROCEDURE
This is the standard procedure, Instrument
Applications are available upon request.
Wavelength
Temperature
Cuvette

600 nm (sub 700)

37C
1 cm light path

Read against reagent blank

METHOD
Enzymatic-colorimetric. End point.

REAGENTS
R1:

Goods buffer, pH 7.0

H-DAOS
Goods buffer, pH 7.0
CE*
COD
POD
4-AA**

R2:

20 mmol/L
0.8 mmol/L
20 mmol/L
> 250 U/L
> 5000 U/L
> 11000 U/L
2.6 mmol/L

(RBL)

RBL
CALIBRATOR SAMPLE
Reagent R1
240 L
240 L
240 L
Calibrator
2,5 L
Sample
2,5 L
Mix well, incubate for 5 min, read A1 and then add
Reagent R2
80 L
80 L
80 L
Mix well, incubate for 5 min,then read A2

A = (A2 A1) Sample or Calibrator - (A2 A1) RBLl

* Cholesterinesterase
** 4-Aminoantipyrin

CALCULATION

STABILITY
The sealed reagents are stable up to the indicated
expiry date if stored at 2 to 8C.

with calibrator

PREPARATION
R1 and R2 are ready for use. Store at 2-8C.
Do not freeze !

HDL - C [mg / dl ] =

A sample
Conc. Cal. [mg / dl ]
A calibrator

Stability after opening :

At least 3 months
at 2 to 8 C, if contamination is avoided
On board stability is at least 4 weeks at 2 8C

CALIBRATION & QUALITY CONTROL

WARNINGS AND PRECAUTIONS
1.When discarding the reagents, dispose them
according to local or federal regulations.
2.Avoid contact with eyes and skin. If contacted,
flush eyes or rinse skin with a large amount of
water. If irritation persists, consult a physician.

For the calibration of automated analyzers Greiner

special calibrator or the Multicalibrator is recommended,
for quality control use Greiner Unitrol-I and -II ,
respectively the special Greiner lipid control.

NOTES
HDL-C Calibrator is not provided with the kit. Refer
to the instruction sheet in the Calibrator kit.

10.2006

Page 1/2

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

www.greiner-diagnostic.com

PERFORMANCE

BIBLIOGRAPHY

- Analytical range
The measurable range is 1-200 mg/dL HDL-cholesterol.
If the obtained value exceeds 200 mg/dL, repeat the test
using serum diluted 1/10 with 0.9% sodium chloride.
Multiply result by 10.

1.

2.
- Sensitivity
The lowest detectable value is 1 mg/dL
3.

- Precision
Within series
n = 30

Mean value
[mg/dL]

CV
[%]

32.6
47.3
68.5

0,65
0,78
0,65

Sample 1
Sample 2
Sample 3

4.

- Correlation
A comparative study has been performed between the
Greiner method and another commercial reagent on 100
human serum samples. The parameters of linear
regression are as follows:

5.

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.
809-61.
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.
Wiebe DA, Warnick GR. Measurement of highdensity lipoprotein cholesterol. In: Rifai N, Warnick
GR, Dominiczak MH, eds. Handbook of lipoprotein
testing. Washington: AACC Press, 1997:p.127-44.
Nauck M, Maerz W, Wieland H. New
immunoseparation-based homogenous assay for
HDL-cholesterol compared with three homogenous
and two heterogeneous methods for HDLcholesterol. Clin Chem 1998;44:1443-51.
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.p.25-48.

Correlation coefficient
r = 0.996
Linear regression
y = 1.000 x + 2.0 mg/dL

SYMBOLS USED

INTERFERENCES
- Ascorbic Acid: no interference up to 100 mg/dL
- Bilirubin: no interference up tol 40 mg/dL
- Triglycerides: no interference up to 1000 mg/dL
- Hemoglobin: no interference up to 500 mg/dL

For in vitro diagnostic medical use

Batch Code

EXPECTED VALUES
Normal values are > 35 mg/dl (0.9 mmol/l)
Clinical Interpretation:
Epidemiological studies have shown that for men values
< 35 mg/dl (< 0.9 mmol/l), and for women
values < 43 mg/dl (< 1.0 mmol/l) stand for increased
coronary risk factors, especially if triglyrerides
are > 180 mg/dl (> 2 mmol/l).

Use by
Temperature limitation

10.2006

Page 2/2

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

www.greiner-diagnostic.com