04524977190V4

CKL
Creatine Kinase
• Indicates cobas c systems on which reagents can be used
Order information Roche/Hitachi cobas c systems
Creatine Kinase cobas c 311 cobas c 501/502
200 tests Cat. No. 04524977 190 System-ID 07 5923 6 • •
Calibrator f.a.s. (12 x 3 mL) Cat. No. 10759350 190 Code 401
Calibrator f.a.s. (12 x 3 mL, for USA) Cat. No. 10759350 360 Code 401
Precinorm U plus (10 x 3 mL) Cat. No. 12149435 122 Code 300
Precinorm U plus (10 x 3 mL, for USA) Cat. No. 12149435 160 Code 300
Precipath U plus (10 x 3 mL) Cat. No. 12149443 122 Code 301
Precipath U plus (10 x 3 mL, for USA) Cat. No. 12149443 160 Code 301
Precinorm U (20 x 5 mL) Cat. No. 10171743 122 Code 300
Precipath U (20 x 5 mL) Cat. No. 10171778 122 Code 301
Precinorm CK-MB (4 x 3 mL) Cat. No. 11447378 122 Code 320
Precipath CK-MB (4 x 3 mL, not available in the USA) Cat. No. 04358210 190 Code 356
Diluent NaCl 9 % (50 mL) Cat. No. 04489357 190 System-ID 07 6869 3

English Reagents - working solutions

System information R1 Imidazole: 58.0 mmol/L, pH 6.00; N-acetylcysteine: 40.0 mmol/L;
For cobas c 311/501 analyzers: EDTA: 3.00 mmol/L; AMP: 10.0 mmol/L; diadenosine pentaphosphate:
CKL: ACN 057 24.0 µmol/L; NADP+: 9.5 mmol/L; Mg2+: 20.0 mmol/L; D-glucose:
For cobas c 502 analyzer: 40.0 mmol/L; preservative; stabilizer
CK: ACN 8057 R2 EDTA: 3.00 mmol/L, pH 9.1; HK (yeast): ≥ 600 µkat/L;
CK-RR: ACN 8071 (for USA) G6PDH (microbial): ≥ 600 µkat/L; ADP: 12.0 mmol/L; creatine phosphate:
180 mmol/L; N-methyldiethanolamine: 69.0 mmol/L; preservative;
Intended use stabilizer; detergent
In vitro test for the quantitative determination of creatine kinase (CK) in
human serum and plasma on Roche/Hitachi cobas c systems. Precautions and warnings
For in vitro diagnostic use.
Summary1,2,3,4,5,6 Exercise the normal precautions required for handling all laboratory reagents.
The CK enzyme is a dimer composed of subunits derived from either muscle Safety data sheet available for professional user on request.
(M) or brain (B). Three isoenzymes have been identified: MM, MB, and Disposal of all waste material should be in accordance with local guidelines.
BB. Normal serum CK is predominantly the CK-MM isoenzyme. Elevated
CK-serum levels are found in skeletal muscle disease, particularly muscular Reagent handling
dystrophy. The CK-MB fraction is found primarily in myocardial tissue and Ready for use.
its presence is generally detected within the 48-hour period following the Storage and stability
onset of a myocardial infarction. The use of total CK and CK-MB in the
CKL
diagnosis of myocardial infarction is the most important single application of
Shelf life at 2-8 °C: See expiration date on
CK measurement in clinical chemistry. Serum CK activity is also increased
cobas c pack label.
after cerebral ischemia, acute cerebrovascular disease, and head injury.
On-board in use and refrigerated on the analyzer: 8 weeks
Standardized methods for the determination of CK using the “reverse reaction”
and activation by NAC were recommended by the German Society for Clinical Diluent NaCl 9 %
Chemistry (DGKC) and the International Federation of Clinical Chemistry Shelf life at 2-8 °C: See expiration date on
(IFCC) in 1977 and 1989 respectively. This assay follows the recommendations cobas c pack label.
of the IFCC and DGKC, but was optimized for performance and stability. On-board in use and refrigerated on the analyzer: 12 weeks
Test principle Specimen collection and preparation
UV-test For specimen collection and preparation, only use suitable
CK
tubes or collection containers.
Creatine phosphate + ADP creatine + ATP Only the specimens listed below were tested and found acceptable.
Serum (free from hemolysis). Nonhemolyzed serum is the specimen
HK
ATP + D-glucose ADP + G6P of choice and also recommended by IFCC.
Plasma (free from hemolysis): Li-heparin plasma
G6PDH Please note: Differences in the degree of hemolysis resulting from the blood
G6P + NADP+ D-6-phosphogluconate + NADPH + H+
sampling procedure used can lead to deviating results in serum and plasma.
The rate of the NADPH formation is directly proportional to the catalytic CK The sample types listed were tested with a selection of sample collection tubes
activity. It is determined by measuring the increase in absorbance. that were commercially available at the time of testing, i.e. not all available
Equimolar quantities of NADPH and ATP are formed at the same tubes of all manufacturers were tested. Sample collection systems from
rate. The photometrically measured rate of formation of NADPH various manufacturers may contain differing materials which could affect
is directly proportional to the CK activity. the test results in some cases. When processing samples in primary tubes
(sample collection systems), follow the instructions of the tube manufacturer.
Centrifuge samples containing precipitates before performing the assay.
Stability:7 2 days at 15-25 °C
7 days at 2-8 °C
4 weeks at (-15)-(-25) °C
Materials provided
See “Reagents - working solutions” section for reagents.
2010-05, V 4 English 1/4 cobas c systems
CKL
Creatine Kinase
Materials required (but not provided) Calculation
See “Order information” section. Roche/Hitachi cobas c systems automatically calculate the
General laboratory equipment analyte activity of each sample.

Assay Conversion factor: U/L x 0.0167 = µkat/L

For optimum performance of the assay follow the directions given in
Limitations - interference8
this document for the analyzer concerned. Refer to the appropriate
Criterion: Recovery within ± 10 % of initial value at a creatine
operator manual for analyzer-specific assay instructions.
kinase activity of 140 U/L (2.34 µkat/L).
The performance of applications not validated by Roche is not
warranted and must be defined by the user. Icterus: No significant interference up to an I index of 60 (approximate
conjugated and unconjugated bilirubin concentration: 1026 µmol/L (60 mg/dL)).
Application for serum and plasma Hemolysis: No significant interference up to an H index of 200 (approximate
cobas c 311 test definition hemoglobin concentration: 124 µmol/L (200 mg/dL)). The level of interference
Assay type Rate A may be variable depending on the exact content of erythrocytes.
Reaction time / Assay points 10 / 14-28 Lipemia (Intralipid): No significant interference up to an L index of 1000. There is
Wavelength (sub/main) 546/340 nm poor correlation between the L index (corresponds to turbidity) and triglycerides
Reaction direction Increase concentration. Highly lipemic specimens (L index > 1000) may cause high
absorbance flagging. Choose diluted sample treatment for automatic rerun.
Units U/L (µkat/L)
Drugs: No interference was found at therapeutic concentrations
Reagent pipetting Diluent (H2O) using common drug panels.9,10
R1 61 µL 38 µL Cyanokit (Hydroxocobalamin) may cause interference with results.
R2 20 µL –
In very rare cases, gammopathy, in particular type IgM (Waldenström’s
Sample volumes Sample Sample dilution macroglobulinemia), may cause unreliable results.
Sample Diluent (NaCl) For diagnostic purposes, the results should always be assessed in conjunction
Normal 3 µL – – with the patient’s medical history, clinical examination and other findings.
Decreased 3 µL 15 µL 135 µL
ACTION REQUIRED
Increased 6 µL – –
Special Wash Programming: The use of special wash steps is mandatory
cobas c 501/502 test definition when certain test combinations are run together on Roche/Hitachi cobas c
Assay type Rate A systems. The latest version of the Carry over evasion list can be found with
the NaOHD/SMS/Multiclean/SCCS or the NaOHD/SMS/SmpCln1 + 2/SCCS
Reaction time / Assay points 10 / 21-42
Method Sheets. For further instructions refer to the operator manual.
Wavelength (sub/main) 546/340 nm cobas c 502 analyzer: All special wash programming necessary for avoiding
Reaction direction Increase carry over is available via the cobas link, manual input is not required.
Units U/L (µkat/L) Where required, special wash/carry over evasion programming must
Reagent pipetting Diluent (H2O) be implemented prior to reporting results with this test.
R1 61 µL 38 µL
Limits and ranges
R2 20 µL –
Measuring range
Sample volumes Sample Sample dilution 7-2000 U/L (0.12-33.4 µkat/L)
Sample Diluent (NaCl) Determine samples having higher activities via the rerun function. Dilution of
Normal 3 µL – – samples via the rerun function is a 1:10 dilution. Results from samples diluted
Decreased 3 µL 15 µL 135 µL by the rerun function are automatically multiplied by a factor of 10.
Increased 6 µL – – Lower limits of measurement
Lower detection limit of the test
Calibration 7 U/L (0.12 µkat/L)
Calibrators S1: H2O The lower detection limit represents the lowest measurable analyte
S2: C.f.a.s. level that can be distinguished from zero. It is calculated as the value
lying three standard deviations above that of the lowest standard
Calibration mode Linear
(standard 1 + 3 SD, repeatability, n = 21).
Calibration frequency 2-point calibration
- after reagent lot change Expected values
- and as required following quality control Reference intervals strongly depend on the patient group and
procedures the specific clinical situation.
For healthy people, according to Klein et al.:11
Traceability: This method has been standardized against the original IFCC
CK µkat/L U/L
formulation using calibrated pipettes together with a manual photometer
providing absolute values and the substrate-specific absorptivity, ε.3 Men 0.65–5.14 39–308
Women 0.43–3.21 26–192
Quality control
For quality control, use control materials as listed in the Consensus values:12
“Order information” section. CK µkat/L U/L
Other suitable control material can be used in addition. Men < 3.20 < 190
The control intervals and limits should be adapted to each laboratory’s Women < 2.85 < 170
individual requirements. Values obtained should fall within the defined
limits. Each laboratory should establish corrective measures to be
Consensus values:12
taken if values fall outside the limits.
Follow the applicable government regulations and local guidelines CK-MB µkat/L U/L
for quality control. Men/women < 0.42 < 25
cobas c systems 2/4 2010-05, V 4 English
04524977190V4

CKL
Creatine Kinase
Myocardial infarction: There is a high probability of myocardial damage when References
the following three conditions are fulfilled:13 1. Lott JA, Stang JM. Serum enzymes and isoenzymes in the
µkat/L U/L diagnosis and differential diagnosis of myocardial ischemia and
1 CKmen > 3.17 > 190 necrosis. Clin Chem 1980;26:1241-1250.
CKwomen > 2.78 > 167 2. Moss DW, Henderson AR, Kachmar JF. Enzymes. In: Tietz NW,
2 CK-MB > 0.40 > 24 ed. Fundamentals of Clinical Chemistry. 3rd ed. Philadelphia:
3 The CK-MB activity accounts for 6–25 % of the total CK-activity. WB Saunders 1987:346-421.
3. Schumann G et al. IFCC Primary Reference Procedures for the
According to Tietz:14 Measurement of Catalytic Activity Concentrations of Enzymes
CK µkat/L U/L at 37 °C - Part 2. Reference Procedure for the Measurement
Adult males > 19 years 0.33–3.34 20–200 of Catalytic Concentration of Creatine Kinase. Clin Chem
Adult females > 19 years Lab Med 2002; 40(6):635-642.
0.33–2.01 20–180
4. Mathieu M, Bretaudiere JP, Galteau MM, Giudollet J, Lalegerie P, Bailly M,
The reference values according to Klein et al. are based on the 95th et al. Recommendations for measuring the catalytic concentration of
percentile of a group of healthy persons (202 men and 217 women) creatine kinase in human serum at 30 °C. Ann Biol Clin 1982;40:87-164.
not involved in high-intensity athletic activities. 5. Hørder M, Magid E, Pitkänen E, Härkönen M, Strömme JH,
In order to ensure high sensitivity in the diagnosis of heart diseases the Theodorsen L, et al. Recommended method for the determination
values given by Tietz are recommended. The loss of diagnostic specificity of creatine kinase in blood modified by the inclusion of EDTA.
thereby incurred can be compensated for by additionally determining Scand J Clin Lab Invest 1979;39:1-5.
CK-MB and/or troponin T. When myocardial infarction is suspected the 6. Bergmeyer HU, Breuer H, Büttner H, Delbrück A, Laue D, Pilz W, et
diagnostic strategy proposals in the consensus document of European al. Empfehlungen der Deutschen Gesellschaft für Klinische Chemie.
and American cardiologists should in general be followed.15 Standard-Methode zur Bestimmung der Aktivität der Creatin-Kinase.
If despite the suspicion of myocardial infarction the values found remain J Clin Chem Clin Biochem 1977;15:249-254.
below the stated limits, a fresh infarction may be involved. In such cases, 7. Use of Anticoagulants in Diagnostic Laboratory Investigations. WHO
the determinations should be repeated after 4 hours. Publication WHO/DIL/LAB/99.1 Rev.2. Jan. 2002.
CK varies with physical activity level and race in healthy individuals.14,16 8. Glick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences
Each laboratory should investigate the transferability of the expected values to in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
its own patient population and if necessary determine its own reference ranges. 9. Breuer J. Report on the Symposium “Drug effects in Clinical Chemistry
Methods”. Eur J Clin Chem Clin Biochem 1996;34:385-386.
Specific performance data 10. Sonntag O, Scholer A. Drug interference in clinical chemistry:
Representative performance data on the analyzers are given below. recommendation of drugs and their concentrations to be used in drug
Results obtained in individual laboratories may differ. interference studies. Ann Clin Biochem 2001;38:376-385.
Precision 11. Klein G, Berger A, Bertholf R et al. Abstract: Multicenter Evaluation of
Precision was determined using human samples and controls in an internal Liquid Reagents for CK, CK-MB and LDH with Determination of Reference
protocol. Repeatability* (n = 21), intermediate precision** (3 aliquots per run, Intervals on Hitachi Systems. Clin Chem 2001;47:Suppl. A30.
1 run per day, 21 days). The following results were obtained: 12. Thomas L, Müller M, Schumann G, Weidemann G et al. Consensus
of DGKL and VDGH for interim reference intervals on enzymes
Repeatability* Mean SD CV in serum. J Lab Med 2005;29:301-308.
U/L (µkat/L) U/L (µkat/L) % 13. Stein W. Strategie der klinisch-chemischen Diagnostik des frischen
Precinorm U 174 (2.91) 1 (0.02) 0.5 Myokardinfarktes. Med Welt 1985;36:572-577.
Precipath U 390 (6.51) 2 (0.03) 0.5 14. Wu AHB, editor. Tietz Clinical Guide to Laboratory Tests, 4th edition.
Human serum 1 49.1 (0.820) 1.1 (0.018) 2.3 St. Louis (MO): Saunders Elsevier; 2006:306–307.
Human serum 2 702 (11.7) 5 (0.1) 0.7 15. Myocardial Infarction Redefined - A Consensus Document of
the Joint European Society of Cardiology/American College
Intermediate precision** Mean SD CV of Cardiology Committee for the Redefinition of Myocardial
U/L (µkat/L) U/L (µkat/L) % Infarction. Eur Heart J 2000;21:1502-1513.
Precinorm U 164 (2.74) 3 (0.05) 1.8 16. Black HR, Quallich H, Gareleck CB. Racial differences in serum
Precipath U 350 (5.85) 6 (0.10) 1.8 creatine kinase levels. Am J Med 1986;81:479-487.
Human serum 3 90.3 (1.51) 3.0 (0.05) 3.3 17. Passing H, Bablok W et al. A General Regression Procedure for Method
Human serum 4 309 (5.16) 8 (0.13) 2.5 Transformation. J Clin Chem Clin Biochem 1988;26:783-790.
* repeatability = within-run precision
** intermediate precision = total precision / between run precision / between day precision
Method comparison
Creatine kinase values for human serum and plasma samples obtained
on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those
determined using the same reagent on a Roche/Hitachi 917 analyzer (x).
Sample size (n) = 252
Passing/Bablok17 Linear regression
y = 1.000x + 7.618 U/L y = 0.998x + 6.272 U/L
τ = 0.957 r = 0.997
The sample activities were between 19.0 and 1817 U/L (0.317 and 30.3 µkat/L).

2010-05, V 4 English 3/4 cobas c systems

CKL
Creatine Kinase
FOR US CUSTOMERS ONLY: LIMITED WARRANTY
Roche Diagnostics warrants that this product will meet the specifications
stated in the labeling when used in accordance with such labeling and
will be free from defects in material and workmanship until the expiration
date printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE FOR
INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES.

COBAS, COBAS C, PRECINORM and PRECIPATH are trademarks of Roche.

Other brand or product names are trademarks of their respective holders.
Significant additions or changes are indicated by a change bar in the margin.
© 2010, Roche Diagnostics

Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim

www.roche.com
Distribution in USA by:
Roche Diagnostics, Indianapolis, IN
US Customer Technical Support 1-800-428-2336

cobas c systems 4/4 2010-05, V 4 English

 400/800

Creatine Kinase
Liquid Reagent

Order information

COBAS INTEGRA 200 Tests Cat. No. 04524977 190 Indicates analyzer(s) on which cobas c pack can be
used
Creatine Kinase System-ID 07 5923 6
Calibrator f.a.s. 12 × 3 mL Cat. No. 10759350 190
Calibrator f.a.s. (for USA) 12 × 3 mL Cat. No. 10759350 360
System-ID 07 3718 6
Precinorm U 20 × 5 mL Cat. No. 10171743 122
System-ID 07 7997 0
Precipath U 20 × 5 mL Cat. No. 10171778 122
System-ID 07 7998 9
Precinorm U plus 10 × 3 mL Cat. No. 12149435 122
Precinorm U plus (for USA) 10 × 3 mL Cat. No. 12149435 160
System-ID 07 7999 7
Precipath U plus 10 × 3 mL Cat. No. 12149443 122
Precipath U plus (for USA) 10 × 3 mL Cat. No. 12149443 160
System-ID 07 8000 6

System information The rate of the NADPH formation is directly proportional

COBAS INTEGRA Creatine Kinase (CKL) to the catalytic CK activity. It is determined by measuring
Test CKL, test ID 0-323 the increase in absorbance at 340 nm.

Intended use Reagents - working solutions

In vitro test for the quantitative determination of the Components Concentrations
catalytic activity of CK (EC 2.7.3.2; adenosine triphosphate: R1 R2=SR Test
creatine N-phosphotransferase) in human serum and Imidazole 58 29 mmol/L
plasma on COBAS INTEGRA systems. N-Acetylcysteine 40 20 mmol/L
EDTA 3 3 2 mmol/L
Summary1,2
AMP 10 5 mmol/L
The CK enzyme is a dimer composed of subunits derived from
either muscle (M) or brain (B). Three isoenzymes have been Diadenosine
identified: MM, MB, and BB. Normal serum CK is predominantly pentaphosphate 24 12 µmol/L
the CK-MM isoenzyme. Elevated CK-serum levels are found in NADP 9.5 4.8 mmol/L
skeletal muscle disease, particularly muscular dystrophy. The Mg++ 20 10 mmol/L
CK-MB fraction is found primarily in myocardial tissue and D-Glucose 40 20 mmol/L
its presence is generally detected within the 48-hour period Creatine phosphate 180 30 mmol/L
following the onset of a myocardial infarction. The use of total ≥600 98
HK (yeast) µkat/L (≥6 kU/L)
CK and CK-MB in the diagnosis of myocardial infarction is the
G6PDH (microbial) ≥600 98 µkat/L (≥6 kU/L)
most important single application of CK measurement in clinical
N-Methyldiethanolamine 69 11 mmol/L
chemistry. Serum CK activity is also increased after cerebral
ischemia, acute cerebrovascular disease, and head injury. ADP 12 2 mmol/L
Sodium azide 0.09 0.015 %
Test principle pH 6.0 9.1 6.6
Method according to the recommendations of the International
Federation of Clinical Chemistry (IFCC), the Société Française Both reagents contain nonreactive stabilizers. Reagent
de Biologie Clinique (SFBC), the Committee on Enzymes R2 (SR) contains nonreactive detergent.
of the Scandinavian Society for Clinical Chemistry and Precautions and warnings
Clinical Physiology (SCE), and the Deutsche Gesellschaft Pay attention to all precautions and warnings listed in this
für Klinische Chemie (DGKC).3-6 Method Manual, Chapter 1, Introduction.

CK Reagent handling
Creatine phosphate + ADP creatine + ATP
Ready for use.
HK
ATP + D-glucose ADP + G6P

G6PDH
G6P + NADP+ D-6-phosphogluconate
+ NADPH + H+

2008-08, V 2 EN 1/4 CKL

 Enzymes
4 0 0 /8 0 0

Storage and stability Pipetting parameters

Shelf life at 2 to 8°C See expiration date on Diluent (H2O)
R1 61 µL 9 µL
cobas c pack label
COBAS INTEGRA 400/400 plus systems Sample 3 µL 19 µL
On-board in use at 10 to 15°C 8 weeks SR 20 µL 10 µL
COBAS INTEGRA 800 systems Total volume 122 µL
On-board in use at 8°C 8 weeks Calibration
Specimen collection and preparation Calibrator Calibrator f.a.s.
For specimen collection and preparation, only use suitable Use deionized water as zero
tubes or collection containers. calibrator.
Only the specimens listed below were tested and found acceptable. Calibration mode Linear regression
Serum (free from hemolysis): Collect serum using Calibration replicate Duplicate recommended
standard sampling tubes. Calibration interval Each lot and as required following
Plasma (free from hemolysis): Li-heparin plasma. quality control procedures.
The sample types listed were tested with a selection of Traceability: This method has been standardized manually
sample collection tubes that were commercially available against the original IFCC formulation.
at the time of testing, i.e. not all available tubes of all Quality control
manufacturers were tested. Sample collection systems from
Reference range Precinorm U or Precinorm U plus
various manufacturers may contain differing materials which
could affect the test results in some cases. When processing Pathological range Precipath U or Precipath U plus
samples in primary tubes (sample collection systems), follow Control interval 24 hours recommended
the instructions of the tube manufacturer. Control sequence User defined
Stability:7 2 days at 15-25°C Control after calibration Recommended
7 days at 2-8°C For quality control, use control materials as listed in
the Order information section. Other suitable control
4 weeks at (-15)-(-25)°C
material can be used in addition.
Centrifuge samples containing precipitates before The control intervals and limits should be adapted to
performing the assay. each laboratory’s individual requirements. Values obtained
should fall within the defined limits.
Materials provided
Each laboratory should establish corrective measures to
See “Reagents - working solutions” section for reagents.
be taken if values fall outside the limits.
Assay Follow the applicable government regulations and local
For optimum performance of the assay follow the guidelines for quality control.
directions given in this document for the analyzer Calculation
concerned. Refer to the appropriate operator manual for COBAS INTEGRA analyzers automatically calculate
analyzer-specific assay instructions. the analyte concentration of each sample. For more
details, please refer to Data Analysis in the Online Help
Application for serum and plasma
(COBAS INTEGRA 400/400 plus/800 analyzers).
COBAS INTEGRA 400/400 plus test definition Conversion factor: U/L × 0.0167 = µkat/L

Measuring mode Absorbance Limitations - interference8

Abs. calculation mode Kinsearch Criterion: Recovery within ±10% of initial value.
Reaction mode R1-S-SR Serum, plasma
Reaction direction Increase Icterus No significant interference up to
an I index of 15 (approximate
Wavelength A/B 340/629 nm
conjugated/unconjugated bilirubin
Calc. first/last 43/60
concentration: 255 µmol/L or 15 mg/dL).
Unit U/L
Hemolysis No significant interference up to an
Pipetting parameters H index of 100 (approximate hemoglobin
concentration: 62 µmol/L or 100 mg/dL).
Diluent (H2O)
The level of interference may be variable
R1 61 µL 9 µL depending on the exact content of
Sample 3 µL 19 µL erythrocytes.
SR 20 µL 10 µL
Lipemia Highly lipemic specimens may cause high
Total volume 122 µL
absorbance flagging. Choose diluted sample
COBAS INTEGRA 800 test definition treatment for automatic rerun.
Drugs No interference was found at therapeutic
Measuring mode Absorbance
concentrations using common drug
Abs. calculation mode Kinsearch panels.9,10
Reaction mode R1-S-SR Exception: Calcium dobesilate causes
Reaction direction Increase artificially low CK values at the tested drug
Wavelength A/B 340/629 nm level.
Calc. first/last 61/91 Hydroxocobalamin (Cyanokit) may cause
Unit U/L false-low results.

CKL 2/4 2008-08, V 2 EN

Enzymes
4 0 0 /8 0 0
Other In very rare cases gammopathy, in
Each laboratory should investigate the transferability of
particular type IgM (Waldenström’s
the expected values to its own patient population and if
macroglobulinemia), may cause unreliable
necessary determine its own reference ranges.
results.
For diagnostic purposes, the results should always be Specific performance data
assessed in conjunction with the patient’s medical history, Representative performance data on the COBAS INTEGRA
clinical examination and other findings. analyzers are given below. Results obtained in individual
laboratories may differ.
ACTION REQUIRED
Special wash programming: The use of special wash steps is
Precision
mandatory when certain test combinations are run together
Reproducibility was determined using human samples and
on COBAS INTEGRA analyzers. Refer to the Method Manual,
controls in an internal protocol (within-run n = 20, between-run
Introduction, Extra Wash Cycles for further instructions.
n = 20). The following results were obtained:
Where required, special wash/carry-over evasion programming
must be implemented prior to reporting results with this test. Level 1 Level 2
Measuring range Mean 239 U/L 1641 U/L
7-2000 U/L (0.12-33.4 µkat/L) (3.97 µkat/L) (27.2 µkat/L)
Determine samples having higher concentrations via the rerun CV within-run 1.1% 1.2%
function. Dilution of samples via the rerun function is a 1:10 CV between-run 1.9% 2.0%
dilution. Results from samples diluted by the rerun function
Method comparison
are automatically multiplied by a factor of 10.
CK values for human serum and plasma samples obtained on
Lower detection limit a COBAS INTEGRA 700 analyzer with the COBAS INTEGRA
7 U/L (0.12 µkat/L) Creatine Kinase reagent were compared to those determined
The detection limit represents the lowest measurable analyte with commercially available reagents for CK on a COBAS
level that can be distinguished from zero. It is calculated as the INTEGRA analyzer and an alternative clinical chemistry
value lying three standard deviations above that of a zero sample system. Samples were measured in duplicate.
(zero sample + 3 SD, within-run precision, n = 30). Values ranged from 5 to 1330 U/L (0.09 to 22.6 µkat/L).
Expected values COBAS INTEGRA Alternative system
Reference values strongly depend on the patient group analyzer
and the specific clinical situation. Sample size (n) 252 250
For healthy people, according to Klein et al.:11
Corr. coefficient (r) 0.998 0.995
CK Men 39-308 U/L (0.65-5.14 µkat/L) (rs) 0.998 0.997
Women 26-192 U/L (0.43-3.21 µkat/L) Lin. regression y = 1.07x - 3 U/L y = 0.99x - 0 U/L
Consensus values 12 Passing/Bablok17 y = 1.07x - 2 U/L y = 0.99x + 2 U/L

CK Men <190 U/L (<3.20 µkat/L) References

Women <170 U/L (<2.85 µkat/L) 1. Lott JA, Stang JM. Serum enzymes and isoenzymes in the
CK-MB Men/women <28 U/L (<0.42 µkat/L) diagnosis and differential diagnosis of myocardial ischemia
and necrosis. Clin Chem 1980;26:1241-1250.
Myocardial infarction: There is a high probability of myocardial
2. Moss DW, Henderson AR, Kachmar JF. Enzymes. In:
damage when the following three conditions are fulfilled:13
Tietz NW, ed. Fundamentals of Clinical Chemistry. 3rd
1 CKmen >190 U/L (3.17 µkat/L) ed. Philadelphia: WB Saunders 1987:346-421.
CKwomen >167 U/L (2.79 µkat/L) 3. Hørder M, Elser RC, Gerhardt W, Mathieu M, Sampson
2 CK-MB >24 U/L (0.40 µkat/L) EJ. IFCC methods for the measurement of catalytic
3 The CK-MB activity accounts for 6-25% of the total CK concentration of enzymes. Part 7. IFCC method for creatine
activity. kinase (ATP: creatine N-phosphotransferase, EC 2.7.3.2).
J Int Fed Clin Chem 1989;1:130-139.
According to Tietz:14 4. Mathieu M, Bretaudiere JP, Galteau MM, Giudollet J,
CK Adult males >19 years 20-200 U/L (0.33-3.34 µkat/L) Lalegerie P, Bailly M, et al. Recommendations for measuring
Adult females >19 years 20-180 U/L (0.33-2.01 µkat/L) the catalytic concentration of creatine kinase in human
serum at 30°C. Ann Biol Clin 1982;40:87-164.
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217 women) not involved in high-intensity athletic activities. determination of creatine kinase in blood modified by the
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