Gastrointestinal Health Marker Guide

Pancreatic elastase

What this marker measures

Pancreatic elastase is a stool marker of pancreatic exocrine function. It is used to help diagnose or exclude pancreatic exocrine insufficiency (PEI) and to monitor pancreatic function in conditions such as cystic fibrosis, diabetes, and chronic pancreatitis^1–5.

This assay is issued under the European IVDR framework (the assay is classified IVDR Class C) with ARTG listing for use in Australian markets
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Assay indications

Adapted from the instructions for use

Pancreas elastase ismainly boundto bile salts during intestinal passage and is not degraded. The stool concentration reflects the secretory capacity of the pancreas.

Diagnosis or exclusion of exocrine pancreas insufficiency in case of unexplained diarrhoea, constipation,steatorrhoea, flatulence, weight loss, upper abdominal pain, and food intolerances

Monitoringof exocrine pancreas function in cystic fibrosis, diabetes mellitus, or chronic pancreatitis

Clinical associations*

Consider this marker when your patient presents with:

Pancreatic function

Low faecal elastase-1 may indicate reduced pancreatic exocrine function and can support detection of moderate-to-severe PEI.

Malabsorption symptoms

Consider when patients present with steatorrhoea, oily or floating stools, unexplained weight loss, bloating, diarrhoea, or fat-soluble vitamin deficiency

High-risk conditions

Consider in chronic pancreatitis, relapsing acute pancreatitis, cystic fibrosis, pancreatic cancer, previous pancreatic surgery, or other contexts where PEI is suspected.

*In addition to the assay’s intended use, all clinical associations have been reviewed by the Microba science team to ensure clinical validity supported by Microba’s cited literature.

Interpreting the result

OUT OF RANGE LOW

Below 100 mcg/mL. Low pancreatic elastase

May indicate severe PEI. Further investigation is warranted if clinically indicated. Interpret alongside symptoms, nutritional markers and other diagnostic tests; watery or liquid stools may yield falsely low results.

BORDERLINE

100 – 200ug/ml Borderline/indeterminate pancreatic elastase

May indicate reduced exocrine pancreatic function or mild-to-moderate PEI, but results should be interpreted with symptoms, risk factors and other diagnostic tests. Watery or liquid stools may yield falsely low results.

WITHIN RANGE

≥ 200ug/ml within the expected range

PEI is less likely, particularly moderate-to-severe PEI. No intervention is typically needed unless symptoms or risk factors remain clinically concerning.

Treatment guidance

Consider the cause of low pancreatic elastase.

Clinical management - OUT-OF-range

Out-of-range result: referral to a medical specialist is warranted if cause unknown.

Clinical management - borderline

Borderline result: Repeat testing or further assessment may be appropriate, particularly if the sample was watery/liquid or symptoms of malabsorption are present.

Clinical management - medication

Pancreatic enzyme replacement therapy (PERT) may improve diarrhoea or malabsorption symptoms when borderline pancreatic elastase is accompanied by clinical features suggestive of pancreatic exocrine insufficiency^6–8.
GRADE D

Tips for discussing out-of-range results

Your pancreatic elastase result gives us insight into whether your pancreas is releasing enough enzymes to digest food properly. A low result may mean you are not getting enough digestive enzymes into the gut, which can affect nutrient absorption. We’ll investigate the cause and determine the right next steps

Evidence grading for patient management insights

The letter grades shown next to each patient management insight show the quality of the research behind it. Every insight provided has been through a rigorous review of the scientific literature and graded using the NHMRC Levels of Evidence, so you can see exactly how strong the evidence is before applying it in practice.

Pancreatic elastase_ Reference sourcesSource references for all clinical associations, interpretation definitions, and patient management insights on this card.

1. Sankararaman, S., Hendrix, S., Neudecker, M. & Borowitz, D. Utility of Fecal Elastase‐1 in Estimating Exocrine Pancreatic Function in Cystic Fibrosis: A Scoping Review. Pediatr Pulmonol 61, e71649 (2026).
2. Jalal, M. et al. Are we missing pancreatic exocrine insufficiency in ‘at-risk’ groups? Prospective assessment of the current practice and yield of faecal elastase testing in patients with diabetes mellitus, HIV and/or high alcohol intake. Clin Med (Lond) 23, 588–593 (2024).
3. Whitcomb, D. C., Buchner, A. M. & Forsmark, C. E. AGA Clinical Practice Update on the Epidemiology, Evaluation, and Management of Exocrine Pancreatic Insufficiency: Expert Review. Gastroenterology 165, 1292–1301 (2023).
4. Vanga, R. R., Tansel, A., Sidiq, S., El-Serag, H. B. & Othman, M. Diagnostic Performance of Measurement of Fecal Elastase-1 in Detection of Exocrine Pancreatic Insufficiency – Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol 16, 1220-1228.e4 (2018).
5. Campbell, J. A. et al. Should we Investigate Gastroenterology Patients for Pancreatic Exocrine Insufficiency? A Dual Centre UK Study. J Gastrointestin Liver Dis 25, 303–309 (2016).
6. Mathew, A., Fernandes, D. & Andreyev, H. J. N. What is the significance of a faecal elastase-1 level between 200 and 500μg/g? Frontline Gastroenterology 14, 371–376 (2023).
7. Phillips, M. E. et al. Consensus for the management of pancreatic exocrine insufficiency: UK practical guidelines. BMJ Open Gastroenterol 8, e000643 (2021).
8. Evans, K. E., Leeds, J. S., Morley, S. & Sanders, D. S. Pancreatic insufficiency in adult celiac disease: do patients require long-term enzyme supplementation? Dig Dis Sci55, 2999–3004 (2010).