Details on the determination of human fecal pancreatic Elastase with the BIOSERV ELISA
FDA-registered
The fecal Elastase ELISA from BIOSERV Diagnostics is used for the diagnosis of a pancreatic insufficiency, which may be caused by
Chronic Pancreatitis, Cystic Fibrosis, Diabetes mellitus, Shwachman Syndrome and other ailments
EU registration number
DE/CA80/7.001
FDA registration: owner/operator number 9056861, registration number 3003594692
For further information please send us an e-mail: info@bioserv-diagnostics.com
BIOSERV Diagnostics also offers facultative sample preparation systems for use with the pancreatic Elastase ELISA
Advantages of the BIOSERV ELISA kit for the detection of fecal pancreatic elastase in stool
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polyclonal antibodies raised against synthetized specific sequences of the human pancreatic Elastase
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high sensitivity and specificity
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minimum of strain for patients due to non-invasive diagnosis
Principle of the test: Sandwich-ELISA with polyclonal antibodies directed against defined sequences of human pancreatic elastase.
Sample material: stool
Medical indications for the application of the test
Exocrine pancreatic insufficiency, caused by
Chronic pancreatitis is a progressing disease causing the original and functional pancreatic parenchyma to degenerate in a gradual sclerotic process. Characteristic features are its symptoms (abdominal pain, steatorrhea, loss of weight), typical morphological changes of the pancreas (calcification, a dilated and irregularly demarcated Ductus pancreaticus) as well as a continuous loss of the exocrine and endocrine function (maldigestion, Diabetes mellitus). Clinical prevalence of chronic pancreatitis is 6 to 8 cases per 100,000 inhabitants each year.
Hereditary pancreatitis is associated with mutations in the genes coding for trypsinogen and a proteinase inhibitor. The patients show a high incidence for pancreatic cancer.
Autoimmunologically caused pancreatitis clinically manifest pancreatitis without fibrosis and calcifications. Mainly destruction of the pancreatic ducts.
Pancreatic cancer, mostly adenocarcinoma of the head of the pancreas, leading to an obstructive pancreatitis.
Cystic fibrosis, caused by mutations of the gene coding for the protein CFTR (cystic fibrosis transmembrane conductance regulator). The incidence rate is dependent on the ethnic group:
: :
|
Afrika |
1/17.000 births |
|
Asia |
1/100.000 births |
|
Europe, North America |
1/1.600 - 1/2500 births |
The most common mutation is the in-frame deletion ΔF 508, entailing the loss of a phenylalanine at position 508. 900 more mutations have been described.
Only heterozygous carriers of these mutations manifest the disease. The clinical picture is determined by metabolic disorders, obstructive disorders (e.g., pancreatic insufficiency) and chronic infections of the respiratory tract. The disease can be symptomatically treated by enzyme substitution, antibiosis and training of the respiratory musculature.
Cholelithiasis (Gallstones) may cause an obstructive pancreatitis
Diabetes mellitus very probably correlates with an enhanced risk for an exocrine pancreatic insufficiency for both type 1 (IDDM = insulin dependent diabetes mellitus=juvenile diabetes mellitus) and for type 2 (NIDDM=non insulin dependent diabetes mellitus mostly of adults).
Autoimmunopathies and connectivitides can be accompanied by exocrine pancreatic insufficiency. Examples are Wegener's Granulomatosis, sclerodermia and others.
Chronic inflammatory bowel diseases like, e.g., Morbus Crohn, may cause an exocrine pancreatic insufficiency.
Pancreatic resection may, depending on the extent of the resection, lead to an exocrine pancreatic insufficiency. The organ reserve of the exocrine pancreas is about 90%, so there is much room for compensation.
Shwachman-Diamond-syndrome is a very rare autosomal recessive hereditary disease characterized by exocrine pancreatic insufficiency in combination with neutropenia, thrombocytopenia, anemia and, in about half of the cases, metaphysary dysostoses leading to stunted growth.
Literature
Qualia CM, Villalona JF, Ren C, Rossi TM (2007): Specificity of the Polyclonal Antibody Test System For Human Elastase in Stool. Journal of Pediatric Gastroenterology and Nutrition, Vol 45:E26 # 66, 2007
Weiss U, Ruthenbuerger M, Hammer E, Voelker U, Lerch MM (2006): Assessment of Isoform Specificity of a Polyclonal Elastase ELISA. Journal of Pediatric Gastroenterology and Nutrition 43:E32 # 58, 2006. Hahn JU, Bochnig S, Kerner W, Koenig H, Sporleder B, Lankisch PG, Maisonneuve P, Lowenfels AB (2005): A New Fecal Elastase 1 Test Using Polyclonal Antibodies for the Detection of Exocrine Pancreatic Insufficiency. Pancreas Vol 30, No 2, pages 189 – 190. Miendje Y, Maisin D, Sipewa MJ, Deprez P, Buts JP, De Nayer P, and Philippe M (2004): Polyclonal versus monoclonal ELISA for the determination of faecal elastase-1: Diagnostic Value in Cystic Fibrosis and Chronic Pancreatic Insufficiency. Clinical Laboratory, Vol. 50, Nr. 7+8, pages 419 – 414 Keim, Volker; Teich, Niels; and Moessner, Joachim (2003): Clinical Value of a New Fecal Elastase Test for Detection of Chronic Pancreatitis. Clinical Laboratory Vol. 5 +6, page 209 -215.Garcia-Bueno, Carlos A; Rossi, Thomas M (Michael); Lee, Kusuma W, Yuwono, Melawati T; Robinson, Amy; Tjota, Amin (2002): Quantification of fecal elastase-1 using either polyclonal or monoclonal antibodies. Gastroenterology Vol. 122 (4), page A-510.
Keim, Volker; Teich, Niels; and Moessner, Joachim (2000): Value of polyclonal elastase ELISA for diagnosis of chronic pancreatitis. Pancreas, Vol. 21, Number 4, November 2000.
For further literature please contact us: info@bioserv-diagnostics.com
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For further information please send us an e-mail: info@bioserv-diagnostics.com