Amylase in Human Serum with Roche c502

Detection of Amylase in Human Serum with Roche c502

Test Name: In vitro test for the quantitative determination of amylase in human serum and plasma on Roche/Hitachi cobas c systems.
Method Name: Colorimetric assay that measures the catalytic activity of amylase on oligosaccharides. It measures the increase in absorbance.
Results: Technical Range: 3-1500 U/L
Reportable Range: 4-1412 U/L
Reference Ranges: 4-120 U/L
Clinical Significance: The α‑amylases (1,4‑α‑D‑glucanohydrolases, EC catalyze the hydrolytic degradation of polymeric carbohydrates such as amylose, amylopectin, and glycogen by cleaving 1,4‑α‑glucosidic bonds. In polysaccharides and oligosaccharides, several glycosidic bonds are hydrolyzed simultaneously. Maltotriose, the smallest such unit, is converted into maltose and glucose, albeit very slowly. Two types of α‑amylases can be distinguished, the pancreatic type (P‑type) and the salivary type (S‑type). Whereas the P‑type can be attributed almost exclusively to the pancreas and is therefore organ‑specific, the S‑type can originate from a number of sites. As well as appearing in the salivary glands it can also be found in tears, sweat, human milk, amniotic fluid, the lungs, testes, and the epithelium of the fallopian tube.

Because of the sparsity of specific clinical symptoms of pancreatic diseases, α amylase determinations are of considerable importance in pancreatic diagnostics. They are mainly used in the diagnosis and monitoring of acute pancreatitis. Hyperamylasemia does not, however, only occur with acute pancreatitis or in the inflammatory phase of chronic pancreatitis, but also in renal failure (reduced glomerular filtration), tumors of the lungs or ovaries, pulmonary inflammation, diseases of the salivary gland, diabetic ketoacidosis, cerebral trauma, surgical interventions or in the case of macroamylasemia. To confirm pancreatic specificity, it is recommended that an additional pancreas specific enzyme   lipase or pancreatic α amylase   also be determined.

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 and K2-EDTA plasma
Do not use fluoride 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:    7 days at 15-25°C
30 days at 2-8°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.