Amylase is a digestive enzyme secreted by salivary and pancreatic glands. Determinations of α-amylase activity in serum and urine are mainly used for the diagnosis and differentiation of pancreatic diseases. Increased levels of the enzyme are observed in acute pancreatitis and exacerbation of chronic pancreatitis. Elevated amylase activity may also be associated with conditions unrelated to the pancreatic diseases, such as renal failure, salivary gland inflammation, abdominal injuries, intestinal obstruction and gastrointestinal ulcer perforation. Increased amylase activity in the blood, with its low activity in the urine may indicate macroamylasemia (the presence of large amylase complexes formed as a result of the polymerization of enzyme particles or combining amylase with antibodies into immune complexes).
according to International Federation of Clinical Chemistry (IFCC), enzymatic, with EPS-G7 substrate, colorimetric
Specimen
serum, urine
On board stability
up to 12 weeks
Calibration stability
up to 12 weeks
Measuring range
linear up to 2000 U/l
Regulatory status
CE IVD
Storage temperature (1)
2-8°C
(1) For proper storage, follow the recommended temperature range available on the label. Full details are provided in the Instructions for Use/User Manual. Transport and store at a controlled temperature in accordance with the product labeling. Deviations from the required conditions may affect the quality of the reagent.
The specification was based on data determined on selected analyzers. We recommend that all users should refer to the instruction for use (IFU) and instruments’ user or service manuals before proceeding.
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