The Test

Further indications, advantages, reference concentration, specificity and sensitivity, method of detection, sample material, short protocol

• Diagnosis/exclusion of pancreatic involvement in abdominal pain
• Diagnosis/exclusion of exocrine pancreatic insufficiency caused by chronic pancreatitis, pancreatic cancer, papillary stenosis
• Control of the exocrine pancreatic capacity of patients with endocrine insufficiency (diabetes mellitus)
• Control of the pancreatic function in gallstone patients
• Early diagnosis of cystic fibrosis with pancreatic involvement (85% of CF patients have pancreatic involvement)
• Differential investigations of gastrointestinal allergies, lactose intolerance and coeliac disease
• Follow-up study of patients with mild or moderate pancreatic insufficiency

In contrast to other laboratory diagnostic parameters for the pancreas, such as amylase and lipase activity in serum for the diagnosis of acute pancreatitis and fecal chymotrypsin activity for the diagnosis of exocrine pancreatic insufficiency, the determination of pancreatic elastase 1 has the following advantages:

• Pancreatic elastase 1 is absolutely pancreas-specific.
• Since E1 is stable during intestinal transit, the faecal elastase 1 concentration reflects the secretory capacity of the pancreas (diagnosis or exclusion of pancreatic exocrine insufficiency).
• E1 determination correlates with the gold standard, the invasive secretin-pancreozymin test and the secretin-caerulein test.
• Intra-individual variation of pancreatic elastase 1 concentration is low.
• Digestive enzyme substitution therapy has no influence on the determination of E1. The monoclonal antibodies used in the test do not cross-react with elastases of animal origin, which are contained in enzyme substitution preparations.
• High stability of pancreatic elastase 1 allows time for convenient mailing of samples.

Adults and children after the first month of life:

• Values above 200 µg elastase/g stool indicate normal exocrine pancreatic function.
• Values below 200 µg elastase/g stool indicate exocrine pancreatic insufficiency.

Specificity: 93% Sensitivity: 93%

Sandwich ELISA with two monoclonal antibodies highly specific for human pancreatic elastase 1. The ELISA kit is based on a microtiter plate (96 well format) with 12 single strips x 8 wells suitable for up to 41 samples in duplicate.

• A single spot stool sample (about 100 mg) is sufficient (daily stool collections not required).
• Pancreatic elastase 1 determination is not influenced by pancreatic enzyme replacement therapy.
• Low intra-individual variability.
• Samples are stable for convenient mailing and may be stored in the laboratory for up to 3 days at 4 – 8°C or for up to 1 year at -20°C.
• Undiluted stool extracts are stable for 1 day at 4 – 8°C.

Important: The short protocol is not a substitute for the detailed protocol given in the instruction manual!

• Prepare the sample-/washing buffer and the extraction buffer
• Extract and homogenize stool
• Dilute stool extract in sample-/washing buffer
• Pipette 50 µl blank, standards, control and samples in duplicate into the ELISA-strips
• Incubate 30 minutes at room temperature
• Wash
• 50 µl anti E1-bio and POD-Streptavidin-Complex (ready-to-use)
• Incubate 15 minutes at room temperature (in the dark)
• Wash
• 100 µl substrate solution (ready-to-use)
• Incubate 15 minutes at room temperature (in the dark)
• Add 100 µl stop solution (ready-to-use)
• Read plate at OD 405 or OD 405 – OD 492
• Evaluate with standard curve using a log-log scal