Faecal elastase 1: a novel, highly sensitive, and specific tubeless pancreatic function test

Area of Science:

• Gastroenterology
• Pancreatic Physiology
• Diagnostic Testing

Background:

• Current indirect pancreatic function tests lack reliability for early chronic pancreatitis.
• Low sensitivity in mild/moderate exocrine pancreatic insufficiency limits clinical utility.

Purpose of the Study:

• Evaluate faecal elastase 1 test sensitivity, specificity, and practicality.
• Compare faecal elastase 1 to the secretin-caerulein test (gold standard).
• Assess performance across mild, moderate, and severe exocrine pancreatic insufficiency.

Main Methods:

• Faecal and duodenal elastase 1 measured by ELISA.
• Faecal chymotrypsin and fat analysis performed.
• Secretin-caerulein test used for categorization in 44 patients with insufficiency, 35 with GI disease, and 50 controls.

Main Results:

• Faecal elastase 1 sensitivity: 63% (mild), 100% (moderate), 100% (severe), 93% (overall).
• Specificity was 93%; chymotrypsin sensitivity was 64%.
• Faecal elastase 1 showed low day-to-day variation (15% CV) and stable storage.

Conclusions:

• Faecal elastase 1 determination is a highly sensitive and specific tubeless pancreatic function test.
• This method offers a practical and reliable diagnostic tool for exocrine pancreatic insufficiency.