Pancreatic Elastase-1
Pancreatic Elastase-1
This test is used to detect exocrine pancreatic insufficency.
Test Summary
Pancreatic Elastase-1
Test code: 14693
Clinical use
- Diagnose exocrine pancreatic insufficiency (EPI)
Clinical background
EPI is a disorder in which the pancreas does not secrete enough enzymes for normal digestion, leading to malnutrition. It is a common complication of conditions that impair pancreatic function (Table 1) and affects an estimated 11% to 21% of the general population1 but is often underdiagnosed.2 Mild EPI may be asymptomatic, but more severe EPI can cause weight loss and gastrointestinal symptoms, such as abdominal pain, diarrhea, and fatty stool (steatorrhea).2 EPI is easily treated with pancreatic enzyme replacement therapy (PERT).2
Table 1. EPI in Conditions that Impair Pancreatic Function
Condition2,3,a |
Prevalence, % |
Cystic fibrosis |
80-90 |
Pancreatic ductal adenocarcinoma |
50-92 |
Chronic pancreatitis |
30-90 |
Previous pancreatic surgery |
20-90 |
Previous intestinal surgery |
16-80 |
Celiac disease |
5-80 |
Diabetes |
20-50 |
Acute pancreatitis |
15-40 |
Crohn disease |
4 |
| EPI, exocrine pancreatic insufficiency. | |
| a | Not a comprehensive list of all conditions associated with EPI. |
According to the American Gastroenterological Association (AGA), EPI should be suspected in patients with high-risk conditions (including chronic pancreatitis, relapsing acute pancreatitis, pancreatic ductal adenocarcinoma, cystic fibrosis, and previous pancreatic surgery) and considered in patients with moderate-risk conditions (including duodenal diseases such as celiac and Crohn disease, previous intestinal surgery, long-standing diabetes, and hypersecretory states such as Zollinger-Ellison syndrome).2 In patients with these conditions, symptoms consistent with EPI may be sufficient to clinically diagnose EPI.2 In other cases, pancreatic function testing, which measures exocrine pancreatic secretion, is used to help confirm EPI or differentiate it from other conditions with similar symptoms.2
Direct pancreatic function testing, which involves analyzing secretions from the pancreas, is considered the gold standard but is invasive and not well suited for routine use.2,4 Therefore, the AGA advises indirect testing by measuring levels of pancreatic elastase-1 in stool, which is easily performed and cost-effective.2,4 Another advantage of this test is that it can be used for patients already being treated with PERT because the porcine enzymes used in PERT do not interfere with the assay.4,5
Pancreatic elastase-1 tests measure the concentrations of several isoforms of pancreatic chymotrypsin-like elastase.3,6 Unlike other pancreatic enzymes, these enzymes do not degrade as they pass through the gastrointestinal tract, leaving them readily detectable in stool.6 Their concentration in stool correlates with their concentration in pancreatic secretions, making the test a useful, noninvasive, indirect marker of pancreatic function.3,6 Relative to fecal fat testing, elastase-1 testing is highly sensitive and moderately specific for EPI (Table 2).7
Table 2. Sensitivity and Specificity of Stool Elastase-1 Testing for EPI
Cutoff level |
Sensitivity (95% CI),7,a % |
Specificity (95% CI),7,a % |
<200 μg/g |
94 (82-98) |
69 (52-82) |
<100 μg/g |
88 (78-94) |
82 (58-94) |
<15 μg/g |
74 (62-83) |
83 (72-90) |
| CI, confidence interval; EPI, exocrine pancreatic insufficiency. | |
| a | Data from a meta-analysis, relative to fecal fat testing. |
Individuals suitable for testing
- Individuals with signs or symptoms suggestive of EPI (eg, gastrointestinal symptoms, malnutrition)
- Individuals with existing pancreatic disease or conditions associated with EPI (Table 1)
- Individuals being treated with PERT
Method
- Immunoassay
Interpretive information
Pancreatic elastase-1 levels >200 μg/g stool are consistent with normal pancreatic function, while levels ≤200 μg/g stool are considered abnormal.2 According to AGA guidance, levels <100 μg/g stool are consistent with EPI in the appropriate clinical context, and levels of 100 to 200 μg/g stool are considered indeterminate for EPI.2
Elastase-1 testing is less sensitive for mild EPI than for more severe EPI.2 Additionally, elastase-1 concentrations can be falsely decreased in liquid or semiliquid stool.2,6
References
- Lewis D. An updated review of exocrine pancreatic insufficiency prevalence finds EPI to be more common in general population than rates of co-conditions. J Gastrointest Liver Dis. 2024;33(1):123-130. doi:10.15403/jgld-5005
- Whitcomb DC, Buchner AM, Forsmark CE. AGA clinical practice update on the epidemiology, evaluation, and management of exocrine pancreatic insufficiency: expert review. Gastroenterology. 2023;165(5):1292-1301. doi:10.1053/j.gastro.2023.07.007
- Capurso G, Traini M, Piciucchi M, et al. Exocrine pancreatic insufficiency: prevalence, diagnosis, and management. Clin Exp Gastroenterol. 2019;12(0):129-139. doi:10.2147/ceg.s168266
- Ramsey ML, Galante GJ. Pancreas and pancreatitis: exocrine pancreatic insufficiency. Pediatr Pulmonol. 2024;59(S1):S44-S52. doi:10.1002/ppul.27013
- LIAISON® elastase-1. Package insert. DiaSorin Inc; 2023.
- Nelson HA. Preanalytical and analytical factors affecting elastase quantitation in stool. Clin Biochem. 2024;131:110811. doi:10.1016/j.clinbiochem.2024.110811
- de la Iglesia D, Agudo-Castillo B, Galego-Fernández M, et al. Diagnostic accuracy of fecal elastase-1 test for pancreatic exocrine insufficiency: a systematic review and meta-analysis. United Eur Gastroenterol J. 2025;13(8):1571-1582. doi:10.1002/ueg2.70061
Content reviewed 12/2025
This test is used to detect exocrine pancreatic insufficency.
Test Summary
Pancreatic Elastase-1
Test code: 14693
Clinical use
- Diagnose exocrine pancreatic insufficiency (EPI)
Clinical background
EPI is a disorder in which the pancreas does not secrete enough enzymes for normal digestion, leading to malnutrition. It is a common complication of conditions that impair pancreatic function (Table 1) and affects an estimated 11% to 21% of the general population1 but is often underdiagnosed.2 Mild EPI may be asymptomatic, but more severe EPI can cause weight loss and gastrointestinal symptoms, such as abdominal pain, diarrhea, and fatty stool (steatorrhea).2 EPI is easily treated with pancreatic enzyme replacement therapy (PERT).2
Table 1. EPI in Conditions that Impair Pancreatic Function
Condition2,3,a |
Prevalence, % |
Cystic fibrosis |
80-90 |
Pancreatic ductal adenocarcinoma |
50-92 |
Chronic pancreatitis |
30-90 |
Previous pancreatic surgery |
20-90 |
Previous intestinal surgery |
16-80 |
Celiac disease |
5-80 |
Diabetes |
20-50 |
Acute pancreatitis |
15-40 |
Crohn disease |
4 |
| EPI, exocrine pancreatic insufficiency. | |
| a | Not a comprehensive list of all conditions associated with EPI. |
According to the American Gastroenterological Association (AGA), EPI should be suspected in patients with high-risk conditions (including chronic pancreatitis, relapsing acute pancreatitis, pancreatic ductal adenocarcinoma, cystic fibrosis, and previous pancreatic surgery) and considered in patients with moderate-risk conditions (including duodenal diseases such as celiac and Crohn disease, previous intestinal surgery, long-standing diabetes, and hypersecretory states such as Zollinger-Ellison syndrome).2 In patients with these conditions, symptoms consistent with EPI may be sufficient to clinically diagnose EPI.2 In other cases, pancreatic function testing, which measures exocrine pancreatic secretion, is used to help confirm EPI or differentiate it from other conditions with similar symptoms.2
Direct pancreatic function testing, which involves analyzing secretions from the pancreas, is considered the gold standard but is invasive and not well suited for routine use.2,4 Therefore, the AGA advises indirect testing by measuring levels of pancreatic elastase-1 in stool, which is easily performed and cost-effective.2,4 Another advantage of this test is that it can be used for patients already being treated with PERT because the porcine enzymes used in PERT do not interfere with the assay.4,5
Pancreatic elastase-1 tests measure the concentrations of several isoforms of pancreatic chymotrypsin-like elastase.3,6 Unlike other pancreatic enzymes, these enzymes do not degrade as they pass through the gastrointestinal tract, leaving them readily detectable in stool.6 Their concentration in stool correlates with their concentration in pancreatic secretions, making the test a useful, noninvasive, indirect marker of pancreatic function.3,6 Relative to fecal fat testing, elastase-1 testing is highly sensitive and moderately specific for EPI (Table 2).7
Table 2. Sensitivity and Specificity of Stool Elastase-1 Testing for EPI
Cutoff level |
Sensitivity (95% CI),7,a % |
Specificity (95% CI),7,a % |
<200 μg/g |
94 (82-98) |
69 (52-82) |
<100 μg/g |
88 (78-94) |
82 (58-94) |
<15 μg/g |
74 (62-83) |
83 (72-90) |
| CI, confidence interval; EPI, exocrine pancreatic insufficiency. | |
| a | Data from a meta-analysis, relative to fecal fat testing. |
Individuals suitable for testing
- Individuals with signs or symptoms suggestive of EPI (eg, gastrointestinal symptoms, malnutrition)
- Individuals with existing pancreatic disease or conditions associated with EPI (Table 1)
- Individuals being treated with PERT
Method
- Immunoassay
Interpretive information
Pancreatic elastase-1 levels >200 μg/g stool are consistent with normal pancreatic function, while levels ≤200 μg/g stool are considered abnormal.2 According to AGA guidance, levels <100 μg/g stool are consistent with EPI in the appropriate clinical context, and levels of 100 to 200 μg/g stool are considered indeterminate for EPI.2
Elastase-1 testing is less sensitive for mild EPI than for more severe EPI.2 Additionally, elastase-1 concentrations can be falsely decreased in liquid or semiliquid stool.2,6
References
- Lewis D. An updated review of exocrine pancreatic insufficiency prevalence finds EPI to be more common in general population than rates of co-conditions. J Gastrointest Liver Dis. 2024;33(1):123-130. doi:10.15403/jgld-5005
- Whitcomb DC, Buchner AM, Forsmark CE. AGA clinical practice update on the epidemiology, evaluation, and management of exocrine pancreatic insufficiency: expert review. Gastroenterology. 2023;165(5):1292-1301. doi:10.1053/j.gastro.2023.07.007
- Capurso G, Traini M, Piciucchi M, et al. Exocrine pancreatic insufficiency: prevalence, diagnosis, and management. Clin Exp Gastroenterol. 2019;12(0):129-139. doi:10.2147/ceg.s168266
- Ramsey ML, Galante GJ. Pancreas and pancreatitis: exocrine pancreatic insufficiency. Pediatr Pulmonol. 2024;59(S1):S44-S52. doi:10.1002/ppul.27013
- LIAISON® elastase-1. Package insert. DiaSorin Inc; 2023.
- Nelson HA. Preanalytical and analytical factors affecting elastase quantitation in stool. Clin Biochem. 2024;131:110811. doi:10.1016/j.clinbiochem.2024.110811
- de la Iglesia D, Agudo-Castillo B, Galego-Fernández M, et al. Diagnostic accuracy of fecal elastase-1 test for pancreatic exocrine insufficiency: a systematic review and meta-analysis. United Eur Gastroenterol J. 2025;13(8):1571-1582. doi:10.1002/ueg2.70061
Content reviewed 12/2025