R2 ADP 15,2 mmol /L WR (mL) 1,0

AMP 25mmol /L Sample (µl) 40

di -Adenosine-5-pentaphosphate 103mmol /L
CREATINE KINASE – MB 4. Mix and incubate 10 minutes.
Gl ucos e-6-phos pha tedehydrogena s e ≥8800U/L
5. Read initial absorbance (A1) of the sample, start the
CK-MB LQ Crea ti ne phosphate 250 mmol /L
stopwatch and read again after 5 minutes (A2).
For in -vitro diagnostic and professional use only CK-NAC/CK-MB CONTROL (optional): l yophi l i zed huma n 6. Calculate the difference between absorbance:
s erum. A= A2 – A1
Store at 2°‐8°C
INTENDED USE MATERIALS REQUIRED BUT NOT PROVIDED CALCULATIONS
For the Quantitative determination of creatine kinase MB  Spectrophotometer or colorimeter measuring at A x 825 = U/L of CK-B
(CK-MB) concentration in human serum. 340 nm. A x 1651 = U/L of CK-MB
 Thermostatic bath at 25°C, 30°C ó 37° C (± 0,1°C). Calculating factor in automatic analyzers by kinetic
INTRODUCTION
 Matched cuvettes 1,0 cm light path. method (A/min.) is 8255.
Creatine kinase is present in significant concentrations in  General laboratory equipment. Units: One international unit (IU) is the amount of
skeletal muscle and cardiac muscle and to a lesser extent
enzyme that transforms 1 mol of substrate per minute,
in gastrointestinal tract and brain tissue.
STORAGE AND STABILITY in standard conditions. The concentration is expressed in
Creatine kinase activity in serum rises rapidly in
 All the components of the kit are stable until the units per litre of sample (U/L).
conditions such as acute myocardial infarction and
expiration date on the label when stored tightly
trauma to skeletal muscle.
closed at 2-8°C, protected from light and Temperature conversion factors
Creatine kinase-MB is considered one of the best
contaminations prevented. To correct results to other temperatures multiply by:
laboratory indicators of AMI. CK-MB determination
 Do not use reagents over the expiration date. Assay Conversion factor to
within the proper time frame after infarction is most
 Signs of reagent deterioration: Temperature 25°C 30°C 37°C
critical being the useful interval ("window") from about
- Presence of particles and turbidity.
10 to 24 hour after the infarction. Its detection is of
- Blank absorbance (A) at 340 nm ≥ 1,2. 25°C 1,00 1,53 2,38
importance in determining the degree of the injury and
the efficacy of the treatment. REAGENT PREPARATION 30°C 0,65 1,00 1,56
Working reagent (WR): Mix 4 volumes of reagent 1 + 1 37°C 0,42 0 ,64 1,00
PRINCIPLE
volume of reagent 2.
The procedure involves measurement of CK activity in the QUALITY CONTROL
Stability: 7 days at 2-8°C or 12 hours at room
presence of an antibody to CK-M monomer. This
temperature (20-25°C).  If control values are found outside the defined
antibody completely inhibits the activity of CK-MM and range, check the instrument, reagents and
half of the activity of CK-MB while not affecting the B SAMPLES technique for problems.
subunit activity of CK-MB and CK-BB. Then it’s used the Serum free of hemolysis or heparin plasma: Stability 7  Each laboratory should establish its own Quality
CK method to quantitatively determine CK-B activity. The days at 2-8°C, protected from light. Control scheme and corrective actions if controls
CK-MB activity is obtained by multiplying the CK-B activity CK-MB activity decreases a 10% after 24 hours at 4°C or 1 do not meet the acceptable tolerances.
by two. hour at 25°C.

REAGENT COMPOSITION REFERENCE VALUES

PROCEDURE The normal range of CK-MB activity in the serum of adults
RI Imi dazol, pH 6.7 125 mmol /L
1. Assay conditions: is considered to be 2.0 U/L to 19.5 U/L at 37°C.
D-Gl ucos e 25 mmol /L
N-Acetyl -L-Cys tei ne 25 mmol /L Wavelength:………………………………………………………340nm Newborns, infants, and children have higher serum CK-
Ma gnesium a cetate 12,5 mmol /L Cuvette:……………………………………………….1 cm light path MB values than adults.
NADP 2,52 mmol /L Constant temperature………………….....25ºC/30ºC/ 37ºC A ratio between CK-MB and-total CK activities above 4%
EDTA 2,02 mmol /L 2. Adjust the instrument to zero with distilled water or should be considered suspicious, and above 10%
Hexoki na s e ≥6 800 U/L air. consistent with acute myocardial infarction.
3. Pipette into a cuvette: When the three conditions stated below are met the
probability of myocardial injury is very high. commercial reagents (x). Atlas Medical
2 Ludwig-Erhard Ring 3
It is recommended that each laboratory establishes its Correlation coefficient (r) : 0,999.
15827 Blankenfelde-Mahlow
own reference range. Regression equation: y = 0,976 x - 0,269.
Germany
The results of the performance characteristics depend on
Tel: +49 - 33708 – 3550 30
25°C 30°C 37°C the analyzer used. Email: Info@atlas-medical.com
CK-MB > 10 U/L > 15 U/L > 24 U/L
TOTAL CK 25°C 30°C 37°C REFERENCES PPI1629A01
MEN Up to 80 U/L 130 U/L 195 U/L 1. Abbot B et al. Creatinine kinase. Kaplan A et al. Clin Rev A (02.09.2019)
WOMEN Up to 70 U/L 110 U/L 170 U/L Chem The C.V. Mosby Co. St Louis. Toronto. Temperature
Ca ta l ogue Number
Princeton 1984: 1112-116. l i mit
2. Gerhardt W et al. Creatine kinase B-Subunit activity In Vitro di a gnos ti c
CK- MB Activity Ca uti on
in serum after immunohinhibition of M-Subunit medi ca l devi ce
CK-TOTAL Activity X 100 = 6 - 25 % CK - MB Activity in the
activity. Clin Chem 1979;(25/7): 1274-1280. Conta i ns s uffi ci ent Cons ul t
sample for <n> tes ts a nd i ns tructi ons for
These values are for orientation purpose. Each laboratory 3. Young DS. Effects of drugs on Clinical Lab. Tests, 4th
Rel a ti ve s i ze us e (IFU)
should establish its own reference range. ed AACC Press, 1995.
4. Young DS. Effects of disease on Clinical Lab. Tests, Ba tch code Ma nufacturer
INTERFERENCES 4th ed AACC 2001. Fra gi le,
5. Burtis A et al. Tietz Textbook of Clinical Chemistry, Us e-by da te
Bilirubin (mixed isomers): Less than 10% interference up ha ndle with care
to 600 μmol/L Bilirubin. 3rd ed AACC 1999. Do not us e if
6. Tietz N W et al. Clinical Guide to Laboratory Tests, Ma nufa cturer fa x
Hemolysis: Less than 10% interference up to 1,25 g/L pa ckage is
number
Hemoglobin. 3rd ed AACC 1995. da maged
Lipemia: Les than 10% interference up to 2,5 g/L 7. Mathieu M. et coll. Recommandation pour la Ma nufa cturer Da te of
Intralipid. mesure de la concentration catalytique de la tel ephone number Ma nufacture
A list of drugs and other interfering substances with CK créatinine kinase dans la sérum humain. Ann. Biol.
Clin.,40, (1482), 87. Keep a wa y from
determination has been reported3 Keep dry
8. Neumeier, D., Prellwitz, W., Würzburg, U. et coll. s unl i ght
PERFORMANCE CHARACTERESTICS Determination of creatine kinase
1. Measuring range: isoenzyme MB activity in serum using
From detection limit of 1,9 U/L to linearity limit of 318 immunological inhibition of creatine kinase M
U/L. If the results obtained were greater than linearity subunit acitivity. Activity kinetics and diagnostic
limit, dilute the sample 1/1 with NaCl 9 g/L and multiply significance in myocardial infarcton, Clin. Chim.
the result by 2. Acta, 73, (1976), 445.

2. Precision:
Intra-Assay Inter-Assay

Mean(U/L) 33.7 166.5 31.3 161.0

SD 1.00 3.76 1.19 3.47
CV% 2.96 2.26 3.81 2.15

3. Sensitivity: 1 U/L = 0,000134 (A).

4. Accuracy:
Results obtained using Atlas reagents (y) did not show
systematic differences when compared with other