CK NAC (IFCC)

Optimized Kinetic UV (5 + 1 Reagent)

Cat.No
120 000
120 016
120 001
120 002 (Hit I)
120 003 (Hit II)
120 008 (Hit II)
120 006 (AU)
120 025 (LW)

Package Size
5 x 20 mL
7 x 10 mL
2 x 100 mL
4 x 50 mL
4 x 100 mL
2 x 80 mL
4 x 70 mL
7 x 10 mL

2 x 10 mL
2 x 7 mL
2 x 20 mL
2 x 20 mL
4 x 20 mL
2 x 16 mL
3 x 20 mL
2 x 7 mL

PREPARATION AND STABILITY

OF WORKING REAGENTS
One-reagent procedure
Mix 5 volumes of R1 with 1 volume of R2.
Stability :
2 days at 20-25C
2 weeks at 2-8C
Two-reagent procedure
The reagents are ready to use.
SAMPLES

METHOD
Enzymatic UV, Kinetic.

Serum free of hemolysis. heparinized or EDTA plasma.

REFERENCE VALUES (U/L)

PRINCIPLE
Kinetic determination of the creatine kinase based
upon IFCC and DGKC recommendations:
CK
Creatine phosphate + ADP
Creatine + ATP
HK
ATP + D-Glucose
G-6-P + ADP
G-6-PDH
G-6-P + NADP+
D-Gluconate-6-phosphate + NADPH +
H+
CK = Creatine kinase
HK = Hexokinase
G-6-P =
D-Glucose-6-phosphate
G-6-PDH = Glucose-6-phosphate dehydrogenase

REAGENT COMPOSITION
(Concentrations in the working reagent ; pH 6.7)
Imidazole
100 mmol/L
N-Acetyl-L-Cysteine
20 mmol/L
Magnesium acetate
10 mmol/L
D-Glucose
20 mmol/L
EDTA
2 mmol/L
NADP
2 mmol/L
Hexokinase
> 2500
U/L
Creatine phosphate
30 mmol/L
ADP
2 mmol/L
G-6-PDH
> 1500
U/L
Diadenosine pentaphosphate
10 mol/L
AMP
5 mmol/L

PRECAUTIONS
-

For in vitro diagnostic use only.

Carefully read instructions.
Avoid contamination by using clean laboratory
material(pipette, plastic vial for analyzers,...).
Use reagents only until the expiration date as printed
on each vial label. Do not use expired reagents.
Close each vial with its cap after use. Do not mix the
vial caps with different caps.
These reagents contain sodium azide (0,95 g/L).

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

25 C
30 C
37 C
Adult
Women
10 - 70
115 - 110
24 - 170
Men
10 - 80
15 - 125
24 - 195
Children
Umilical cord
72 - 165
112 - 258
175 - 402
Newborn
192 494
300 770
468 - 1200
80 - 288
125 - 450
195 - 700
5 Days
< 6 Months
17 - 136
27 - 212
41 330
> 6 Months
10 - 94
15 - 147
24 229
Note: It is recommended for each laboratory to establish
and maintain its own reference values. The given data are only
an indication.

ASSAY PROCEDURE
The reagent can be used manually (see method below)
and on most analyzers. Applications are available on
request.
Wavelength :
340 nm/Hg334,Hg365 nm
Temperature :
37C
Cuvette
:
1 cm light path
Read against reagent blanc (RB).

One-reagent procedure
Working reagent:
Sample
:

1 mL
50 L

Mix and after a 3 minute incubation, measure the

change of absorbance per minute (A) during
3 minutes, calculate average value
Two-reagent procedure
R1
Sample

:
:

1 mL
50 L

Mix and wait 3 minutes

R2

200 L

Mix and after a 2 minutes incubation, measure the

change of absorbance per minute (A) during
3 minutes, calculate average value
Page 1/2

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

www.greiner-diagnostic.com

CALCULATION

INTERFERENCES

A = ASample A RB

A x Factor = CK-Activity [U/l]

Wavelength
340 nm
334 nm
365 nm

PROCEDURE
2-Reagent
3968
4045
7143

1-Reagent
3333
3398
6000

CALIBRATION & QUALITY CONTROL

For the calibration of automated analyzers Greiner
Multicalibrator Unical-M is recommended, for
quality control use Greiner normal and abnormal
Controlsera Unitrol-I and Unitrol-II .
PERFORMANCE DATA (37C)
- Analytical range
The reagent is linear up to CK activities
corresponding to a A/min of 0,50 at 340 nm and
334 nm, corresponding to 2000 U/L
If A/min exceeds 0.50 at 340 nm, repeat the test
using serum diluted 1/10 with sodium chloride
solution (9 g/L). Multiply result by 10.
- Sensitivity
The sensitivity is equal to 1,6 U/L
- Precision
Within-run reproducibility
n = 11
Mean
value[U/L]
Sample 1
162
Sample 2
468
Sample 3
152

Ascorbic acid: no interference until 100 mgd/L

Bilirubin: no interference until 40 mg/dL
Hemoglobin: no interference until 200 mg/dL
Triglycerides: no interference until 1000 mg/dL

BIBLIOGRAPHY
1.

2.

3.

4.

Stein W. Creatine kinase (total activity), creatine

kinase isoenzymes and variants. in: Thomas L, ed.
Clinical laboratory diagnostics. Frankfurt: TH-Books
Verlagsgesellschaft;1998.p.71-80.
Moss DW, Henderson AR. Clinical enzymology. In:
Burtis CA, Ashwood ER, editors. Tietz Textbook of
Clinical Chemistry. 3rd ed. Philadelphia: W.B
Saunders Company; 1999. p. 617-721.
Recommendations of the German Society for
Clinical Chemistry. Standardization of methods for
the estimation of enzyme activities in biological
fluids: Standard method for the determination of
creatine kinase activity. J Clin Chem Clin Biochem
1977;15:255-60.
Lorentz K, Rhle G, Siekmann L. Introduction of new
standard methods 1994 for the determination of
catalytic enzyme concentrations at 37 C. DG
Klinische Chemie Mitteilungen 1995;26:290-3.

SYMBOLS USED
Standarddeviation[U/L]
1,21
1,19
1,41

CV
[%]
0,75
0,25
0,93

For in vitro diagnostic medical use

Batch Code
Between-run reproducibility
n = 11
Mean
Standardvalue[U/L]
deviation[U/L]
Sample 1
162
1,79
Sample 2
467
3,56
Sample 3
151
1,99

CV
[%]
1,11
0,76
1,32

Use by
Temperature limitation

-Correlation
A comparative study has been performed between
the Greiner method and another commercial
reagent on 32 human serum samples. The
parameters of linear regression are as follows:
Linear regression:
Correlation coefficient

y = 0,980 x + 1,34 U/l

r = 1,000

06/2013//rev07/2014

Page 2/2

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

www.greiner-diagnostic.com