Useful For/Utility

The Elastase-1 assay is an in vitro diagnostic chemiluminescent immunoassay intended for the quantitative determination of fecal pancreatic elastase in human stool specimens from adults and children. The test is an aid for diagnosis of exocrine pancreatic insufficiency. Chronic pancreatitis is a chronic inflammatory disease of the pancreas, typically causing pain and/or permanent loss of function of the pancreas. A major complication in chronic pancreatitis is a condition called exocrine pancreatic insufficiency which causes maldigestion. Exocrine pancreatic insufficiency occurs when the amount of enzymes released and transported to the small intestine is inadequate for proper food digestion and absorption of nutrients. Clinical symptoms of pancreatic insufficiency include: steatorrhea, weight loss, abdominal discomfort due to maldigestion, and malnutrition [2]. Any condition that blocks the pancreatic ducts or damages or destroy the cells that produce

elastase can cause pancreatic insufficiency. Pancreatic insufficiency can often be found in patients with chronic pancreatitis, some cases of pancreatic cancer, cystic fibrosis, Shwachman-Diamond syndrome, and celiac disease as well as others diseases that affect the pancreas.

Pancreatic elastase 1 or fecal elastase 1 (FE-1) is a human pancreas specific enzyme. It has a molecular weight of 28 kDa with high affinity to the carboxyl group of alanine, valine, and leucine, and is highly stable during passage through the gastrointestinal tract. FE-1 is enriched 5-6 fold in the feces compared with pancreatic juices and can be used as an indicator of pancreatic exocrine function. FE-1 levels are decreased in patients with pancreatic insufficiency, with concentrations less than 100 µg/g in stool considered severe pancreatic insufficiency and greater than 200 µg/g considered a normal level. FE-1 levels have been shown to correlate with other pancreatic function tests, such as the secretin-cholecystokinin or secretin-caerulein test. These tests are considered the “gold standard” test, however, they are invasive, time-consuming, and expensive [5]. An additional stool assay to diagnosis pancreatic insufficiency is Chymotrypsin, however, this assay requires three different stool samples from the patient, rather than the single stool sample required for detecting FE-1. The benefits of testing patients’ FE1 levels to diagnosis pancreatic insufficiency include better sensitivity and specificity than chymotrypsin testing, and unlike other tests it is non-invasive and does not require patients to consume a special diet or discontinue pancreatic enzyme replacement therapy.