Lipase in Human Serum with Roche c502

Detection of Lipase in Human Serum with Roche c502

Test Name: In vitro test for the quantitative determination of lipase in human serum and plasma on Roche/Hitachi cobas c systems.
Method Name: Enzymatic colorimetric assay with 1,2‑O‑dilauryl-rac-glycero-3-glutaric-acid-(6‑methylresorufin) ester as substrate. The color intensity of the red dye formed is directly proportional to the lipase activity and can be determined photometrically.
Results: Technical Range: 3-300 U/L Reportable Range: 3-274.2 U/L
Reference Ranges: 13-60 U/L
Clinical Significance: Lipases are glycoproteins with a molecular weight of 47000 daltons. They are defined as triglyceride hydrolases which catalyze the cleavage of triglycerides to diglycerides with subsequent formation of monoglycerides and fatty acids. In addition to α amylase, pancreatic lipases have for many years been undeniably the most important clinical chemistry parameters for the differential diagnosis of diseases of the pancreas. The lipase activity determination has gained increasing international recognition because of its high specificity and rapid response. After acute pancreatitis, the lipase activity increases within 4 8 hours, reaches a peak after 24 hours and decreases after 8 to 14 days. However, there is no correlation between the lipase activity determined in serum and the extent of damage to the pancreas.
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 plasma

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:    365 days at -20°C
7 days at 4-8°C
7 days at 20-25 °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.