Tests for the quantification of human pancreatic elastase 1

Two ELISA test kits (based on monoclonal antibodies) are available for the determination of pancreatic elastase 1.
The stool test quantifies E1 in stool, allowing the diagnosis or exclusion of pancreatic exocrine insufficiency, which can be caused by chronic pancreatitis, cystic fibrosis, pancreatic tumor, cholelithiasis or diabetes mellitus for example.
The serum test quantifies E1 in serum, allowing the diagnosis or exclusion of an acute pancreatitis or an inflammatory episode of chronic pancreatitis or ERCP- or gallstone-induced pancreatitis.
Stool Test
Human pancreatic elastase 1 (E1) remains undegraded during intestinal transit. Therefore its concentration in faeces reflects pancreatic exocrine function. The diagnostic efficiency of pancreatic elastase 1 determination in stool has been evaluated in several clinical studies. Stein et al. (1993 & 1996, 1997) and Löser et al. (1995 & 1996) compared the E1 determination with invasive intubation tests, the secretin-pancreozymin test and the secretin-caerulein test, respectively. Both authors report a sensitivity and specificity greater than 90% for the diagnosis of exocrine pancreatic insufficiency. In contrast to the fecal chymotrypsin assay, even a moderate pancreatic insufficiency can be detected by E1 determination (Löser et al., 1995 & 1996, Gullo et al., 1999).
Serum Test
Human pancreatic elastase 1 is synthesized from the acinar cells of the pancreas. During an inflammatory episode of the pancreas, E1 is released into the blood circulation. Thus the quantification of pancreatic elastase 1 in the serum allows diagnosis or exclusion of acute pancreatitis.