CK-MB FS*

Order Information Reagents

Cat. No. Kit size Components and Concentrations
1 1641 99 10 021 R1 5 x 20 mL + R2 1 x 25 mL
1 1641 99 10 026 R1 5 x 80 mL + R2 1 x 100 mL
R1: Imidazole/Good’s buffer 120 mmol/L
1 1641 99 10 930 R1 4 x 20 mL + R2 2 x 10 mL Glucose 25 mmol/L
1 1641 99 10 951 600 (R1: 4 x 150, R2: 2 x 300) N-Acetylcysteine (NAC) 25 mmol/L
Tests on ADVIA 1200/1650/1800/2400 Magnesium acetate 12.5 mmol/L
EDTA-Na2 2 mmol/L
The following reagent is additionally required for determination with NADP 2.5 mmol/L
CK-MB DS: Hexokinase (HK) ≥ 5 kU/L
1 1690 99 10 065 3 x 3 mL Monoclonal antibodies against human
CK-M (mouse); inhibiting capacity ≥ 2500 U/L
Intended Use R2: Imidazole/Good’s buffer 90 mmol/L
ADP 10 mmol/L
Diagnostic reagent for quantitative in vitro determination of CK-MB
AMP 28 mmol/L
in human serum or lithium heparin plasma on automated
Glucose-6-phosphate dehydrogenase ≥ 15 kU/L
photometric systems.
(G6P-DH)
Diadenosine pentaphosphate 50 µmol/L
Summary Creatine phosphate 150 mmol/L
Creatine kinase (CK) is an enzyme, which consists of isoenzymes
mainly of the muscle (CK-M) and the brain (CK-B). CK exists in the Storage and Stability
human body in dimeric forms as CK-MM, CK-MB, CK-BB and as Reagents are stable up to the date of expiry indicated on the kit, if
macro-enzyme. Measurement of CK-MB is a specific test for the stored at 2 – 8°C and contamination is avoided. Protect from light.
detection of cardiac muscle damage and, therefore, is used for
diagnosis and monitoring of myocardial infarction. [1,2,3] Warnings and Precautions
1. Reagent 1 and 2: Danger. Contains: Imidazole. H360D
Method [4] May damage the unborn child. P201 Obtain special
Optimized UV test according to DGKC (German Society of Clinical instructions before use. P280 Wear protective
Chemistry) and IFCC (International Federation of Clinical gloves/protective clothing/eye protection. P308+P313 If
Chemistry and Laboratory Medicine) for CK with inhibition of CK-M exposed or concerned: Get medical advice/attention.
isoenzymes by monoclonal antibodies. 2. The reagents contain sodium azide (0.95 g/L) as preservative.
CK-MB consists of the subunits CK-M and CK-B. Specific Do not swallow! Avoid contact with skin and mucous
antibodies against CK-M inhibit the complete membranes.
CK-MM activity (main part of the total CK activity) and the CK-M- 3. The reagents contain animal and biological material. Handle
subunit of CK-MB. Only CK-B activity is measured, which is half of the product as potentially infectious according to universal
the CK-MB activity. precautions and good clinical laboratory practice.
4. In very rare cases, samples of patients with gammopathy
CK might give falsified results [5].
Creatine phosphate + ADP ◄───► Creatine + ATP 5. Sulfasalazine medication may cause false results in patient
samples. Blood collection must be performed prior to drug
HK administration.
Glucose + ATP ◄───► Glucose-6-phosphate + ADP 6. Heterophile antibodies in patient samples may cause falsified
results.
G6P-DH 7. Please refer to the safety data sheets and take the necessary
Glucose-6-phosphate ◄──────► 6-Phosphogluconolactone precautions for the use of laboratory reagents. For diagnostic
+ NADP+ + NADPH + H+ purposes, the results should always be assessed with the
patient’s medical history, clinical examinations and other
CK-MB DS
findings.
In samples with low CK-MB concentrations, the measuring signals 8. For professional use only.
are rather low. The supplementary reagent CK-MB DS produces
an additional reaction step which duplicates the measuring signal Waste Management
and, therefore, leads to an improvement of the precision and Refer to local legal requirements.
sensitivity:
PGL Reagent Preparation
6-Phosphoglucono- ──────► 6-Phosphogluconate The reagents are ready to use.
lactone
6-PGDH Materials Required
6-Phosphogluconate ──────► Ribulose-5-phosphate General laboratory equipment
+ NADP+ + CO2 + NADPH + H+

CK-MB FS – Page 1 844 1641 10 02 00 September 2021/1

Specimen Lipemia (triglycerides) 1000 mg/dL 33.0
Human serum or lithium heparin plasma 1700 mg/dL 85.9
Stability [6]: Sulfapyridin 30 mg/dL 24.2
2 days at 20 – 25°C
30 mg/dL 96.8
7 days at 4 – 8°C
4 weeks at –20°C Sulfasalazin 2.5 mg/dL 25.2
Only freeze once. Discard contaminated specimens. 9 mg/dL 98.8
For further information on interfering substances refer to Young DS [7,8].
Assay Procedure
Basic settings for BioMajesty® JCA-BM6010/C Precision
Within run (n=20) Sample 1 Sample 2 Sample 3
Wavelength 340/410 nm
Temperature 37°C Mean [U/L] 16.0 33.8 198
Measurement Kinetic CV [%] 2.57 3.47 2.36
Sample/Calibrator 4.0 µL Total (n=80) Sample 1 Sample 2 Sample 3
Reagent 1 80 µL
Reagent 2 20 µL Mean [U/L] 16.6 23.4 178
Addition reagent 2 Cycle 19 (286 s) CV [%] 2.90 2.03 1.00
Absorbance 1 –
Absorbance 2 Cycle 32/41 (464 s/586 s) Method comparison (n=162)
Calibration Linear Test x Competitor CK-MB FS
(cobas® c 501)
Calculation Test y DiaSys CK-MB FS
With calibrator (BioMajesty® JCA-BM6010/C)
ΔA/min. Sample Slope 0.966
CK-MB [U/L] = x Conc. Cal [U/L]
ΔA/min. Cal Intercept 2.31 U/L
Conversion Factor Coefficient of correlation 0.997
CK-MB [U/L] x 0.0167 = CK-MB [µkat/L]
** according to CLSI document EP17-A2, Vol. 32, No. 8
Calibrators and Controls Reference Range
DiaSys TruCal CK-MB is recommended for calibration. TruCal
Myocardial infarction: the risk of myocardial infarction is high if
CK-MB calibrator values have been made traceable to the molar
following three conditions are fulfilled [9]:
extinction coefficient. Control sera and calibrators containing non-
1. CK (Men) > 190 U/L (3.17 µkat/L)***
human CK-MB fractions are not suitable to be applied with this test
CK (Women) > 167 U/L (2.78 μkat/L)***
due to the monoclonal antibody used in the reagent. Only use
2. CK-MB > 24 U/L (0.40 μkat/L)***
controls and calibrators containing exclusively human CK-MB. Use
3. CK-MB activity is between 6 and 25% of total CK activity.
DiaSys TruLab N and P for internal quality control. Each laboratory ***calculated using temperature conversion factor 2.38 (25°C ─► 37°C)
should establish corrective action in case of deviations in control
recovery. If myocardial infarction is suspected and the conditions are not
Cat. No. Kit size fulfilled, the infarction may be fresh. In this case the measurements
TruCal CK-MB 5 9450 99 10 074 6 x 1 mL should be repeated after 4 hours with fresh samples.
TruLab N 5 9000 99 10 062 20 x 5 mL In healthy individuals different values are found depending on race
5 9000 99 10 061 6 x 5 mL and age [9,10].
TruLab P 5 9050 99 10 062 20 x 5 mL
5 9050 99 10 061 6 x 5 mL Each laboratory should check if the reference ranges are
transferable to its own patient population and determine own
Performance Characteristics reference ranges if necessary. For diagnostic purposes, CK values
Data evaluated on BioMajesty® JCA-BM6010/C should always be assessed in conjunction with the anamnesis, the
clinical examination and other findings.
Exemplary data mentioned below may slightly differ in case of
deviating measurement conditions. Literature
1. Stein W. Creatine kinase (total activity), creatine kinase
Measuring range from 9 up to 1900 U/L.
isoenzymes and variants. In: Thomas L, ed. Clinical
When values exceed this range samples should be diluted
laboratory diagnostics. Frankfurt: TH-Books
1 + 1 with NaCl solution (9 g/L) and the result multiplied by 2.
Verlagsgesellschaft;1998. p. 71-80.
Limit of detection** 8 U/L 2. Moss DW, Henderson AR. Clinical enzymology. In: Burtis CA,
Ashwood ER, editors. Tietz Textbook of Clinical Chemistry.
Interfering substance Interferences Analyte
3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 617-
≤ 10% up to concentration
721.
[U/L]
3. Würzburg U, Hennrich N, Orth HD, Lang H. Quantitative
Ascorbic acid 30 mg/dL 33.0 determination of creatine kinase isoenzyme catalytic
60 mg/dL 98.4 concentrations in serum using immunological methods. J Clin
Chem Clin Biochem 1977;15:131-7.
Bilirubin (conjugated) 36 mg/dL 33.0 4. Recommendations of the German Society for Clinical
32 mg/dL 91.6 Chemistry. Standardization of methods for the estimation of
enzyme activities in biological fluids: Standard method for the
Bilirubin (unconjugated) 36 mg/dL 33.0 determination of creatine kinase activity. J Clin Chem Clin
45 mg/dL 89.6 Biochem 1977;15:255-60.
5. Bakker AJ, Mücke M. Gammopathy interference in clinical
Hemoglobin 10 mg/dL 33.0 chemistry assays: mechanisms, detection and prevention.
ClinChemLabMed 2007;45(9):1240-1243.
45 mg/dL 104
6. Guder WG, Zawta B et al. The Quality of Diagnostic Samples.
1st ed. Darmstadt: GIT Verlag; 2001; p. 24-5.

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7. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th
ed. Volume 1 and 2. Washington, DC: The American
Association for Clinical Chemistry Press 2000.
8. Young DS. Effects on Clinical Laboratory Tests - Drugs
Disease, Herbs & Natural Products, https://clinfx.wiley.com/
aaccweb/aacc/, accessed in June 2021. Published by AACC
Press and John Wiley and Sons, Inc.
9. Stein W. Strategie der klinisch-chemischen Diagnostik des
frischen Myokardinfarkts. Med Welt 1985:36:572-7.
10. Myocardial infarction redefined – a consensus document of
the Joint European society of Cardiology/America College of
Cardiology Committee for the redefinition of myocardial
Infarction. Eur Heart J 2000;21:1502-13.
DiaSys Diagnostic Systems GmbH
Alte Strasse 9 65558 Holzheim
Germany
www.diasys-diagnostics.com

* Fluid Stable

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