Fecal pancreatic Elastase


For the in-vitro diagnosis of a pancreatic insufficiency, which may be caused by

Chronic Pancreatitis, Cystic Fibrosis, Diabetes mellitus, Shwachman Syndrome and other ailments. Test kit for the quantitative detection of human fecal pancreatic elastase in stool in order to diagnose and quantify pancreatic insufficiency. The fecal pancreatic Elastase ELISA from BIOSERV Diagnostics has been registered with the FDA


In Germany this parametre is exclusively sold and marketed by R-Biopharm AG, Darmstadt


  EU registration number

FDA registration: owner/operator number 9056861, registration number 3003594692

Order Code No.:

Shelf Life:
18 months after date of manufacture


  • exclusively produced in the pancreas and therefore excellently suitable to diagnose pancreatic malfunctions like pancreatic insufficiency
  • extraordinary stable when passing through the bowels
  • enriched 5-6 fold in feces in comparison to the concentration in the duodenal juice
  • small intra-personal variation in regarding the concentration
  • direct correlation of fecal pancreatic Elastase concentration and pancreatic function
  • no age-dependency of the fecal pancreatic elastase secretion from
    infancy (first year) on
  • the fecal pancreatic elastase molecule is stable for at least 6 days at refrigeration and for at least 3 days at room temperature
  • polyclonal antibodies raised against synthetized specific sequences of the human pancreatic Elastase
  • high sensitivity and specificity
  • minimum of strain for patients due to non-invasive diagnosis
  • FDA-registered

The Bioserv Elastase ELISA for the detection of fecal pancreatic Elastase allows a highly sensitive and specific determination of fecal pancreatic Elastase, enabling the clinician to establish a prompt and reliable diagnosis of suspected cases of pancreatic insufficiency.

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 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.


  • Erickson JA, Aldeen WE, Grenache DG, Ashwood ER (2008): Evaluation of a fecal pancreatic elastase-1 enzyme-linked immunosorbent assay: Assessment versus an established assay and implication in classifying pancreatic function. Clinica Chimica Acta, Volume 397, Issues 1-2, November 2008, pages 87-91.
  • 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.
  • Abdel Rahman H, Abdul Wahab A, Abdel Rahman MO, Abdel Rahman M (2006): Fecal elastase-1concentration in cystic fibrosis patients with CFTR I1234V mutation. Acta Paediatrica, 2006; 95:1066-1069.
  • 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 inquiries please contact us: info@bioserv-diagnostics.com