Creatine Kinase in Human Serum with Roche c502

Detection of Creatine Kinase in Human Serum with Roche c502

Test Name: In vitro test for the quantitative determination of creatine kinase in human serum and plasma on Roche/Hitachi cobas c systems.
Method Name: UV-test that photometrically measures the rate of formation of NADPH, which is directly proportional to creatine kinase activity.
Results: Technical Range: 7-2000 U/L
Reportable Range: 9-420 U/L
Reference Ranges: Taken from Mayo Clinic.

≤3 months: not established
>3 months: 39-308 U/L

≤3 months: not established
>3 months: 26-192 U/L

Clinical Significance: Creatine kinase (CK) is a dimeric enzyme occurring in four different forms: a mitochondrial isoenzyme and the cytosolic isoenzymes CK-MM (skeletal muscle type), CK-BB (brain type) and CK-MB (myocardial type).

The determination of CK and CK-isoenzyme activities is utilized in the diagnosis and monitoring of myocardial infarction and myopathies such as the progressive Duchenne muscular dystrophy. Following injury to the myocardium, such as occurs with acute myocardial infarction1, CK is released from the damaged myocardial cells. In early cases, a rise in the CK-activity can be found just 4 hours after an infarction. The CK activity reaches a maximum after 12-24 hours and then falls back to the normal range after 3-4 days.

Submission Criteria: For specimen collection and preparation, only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Plasma: Li-heparin, K2-EDTA and K3-EDTA plasma.
Non-hemolyzed serum is the specimen of choice and is also recommended by IFCC.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, therefore not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases.  When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Storage and Stability:
2 days at 20 – 25 °C
7 days at 2 – 8 °C
4 weeks at -20 °C

Rejection Criteria: Rejection criteria include but are not limited to:
1. Specimens containing fibrin or clots.
2. Excessive platelet clumping
3. Leaking specimens
4. Substandard mixing or collection
5. Expired or improperly stored collection tubes.
6. Improperly filled tubes based on collection tube manufacturer’s guidelines.
7. Contaminated specimens (IV fluid, foreign particles, etc.)
8. Specimens not analyzed within the appropriate time frame.
9. Samples not shipped at appropriate temperature.
10. Samples without 2 proper identifiers or samples having identifiers that do not match the electronic or paper lab requisition.
Authorization: Diagnostic testing can only be performed with approval from an authorized provider/agency.
Turn Around Time: 1 day.