Further indications, advantages, reference concentration, specificity and sensitivity, method of detection, sample material, short protocol
Further indications
- 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
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.
Reference concentration
- Values above 200 µg elastase/g stool indicate normal exocrine pancreatic function.
- Values below 200 µg elastase/g stool indicate exocrine pancreatic insufficiency.
High specificity and sensitivity
Method of detection
Sample material
- 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.
Short protocol for the experienced user
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