For In-vitro diagnostic use. Enzyme linked immunosorbent assay (ELISA) for the quantitative determination of pancreatic elastase and other pancreatic enzymes for the diagnosis of acute pancreatitis in human serum.
An acute pancreatitis, the acute inflammation of the pancreas, is mostly caused by the dystopic protease activation in the azinus cells, the obstruction of the luminal secretion and the formation of intracellular vacuoles (Schneider 1999). The yearly incidence rate is 50 to 100 cases per 100.000 persons. The clinical picture is determined by pronounced abdominal pain and general symptoms like nausea, vomiting and circulatory collapse (Selberg et al. 1995). The mild form of an acute pancreatitis, the endematous pancreatitis (ca. 80% of all cases of an acute pancreatitis) progresses without complications and under adequate therapy patients normally recover within 72 hours. The severe form of an acute pancreatitis, the hemorrhagic narcotising pancreatitis is characterized by necrosis and by a protracted course with frequent failure of organs or organ systems (Asanuma at. al. 1999, Singer et al. 1988). Morphologically a thickening and irregular delimitation of the pancreas can be observed as well as an accumulation of liquid in the peritoneal space. The main cause of an acute pancreatitis are an increased alcohol consumption (Blank et al. 1999, Lankisch 2000) and trapped gallstones which possibly get into the pancreatic duct via a reflux (Niederau et al. 1997, UHL et al. 1999, Sharma et al. 1999).
|Test format||Microtiter plate with 96 wells (12 strips with 8 breakable strips each)|
|Standard range||4 Standards (100 - 200 - 400 - 800 µg elastase/g stool)|
|Cut-off||- Normal: <160 Pankrin® Units/ml serum |
- Questionable: 160 - 190 Pankrin®-Units/ml serum
- Pathological: >190 Pankrin