To determine the average concentration and its ranges of fecal elastase-1 (FE1) in healthy controls; to calculate the sensitivity and specificity of FE1 in the assay of pancreatic insufficiency; and to evaluate the diagnosing and differentiating value of FE1 in pancreatic diseases.Used the FE1 ELISA kit to quantitate the concentrations of FE1 in 73 healthy controls with different age groups, and 30 patients with chronic pancreatitis, 17 patients with pancreatic cancer and 24 patients with non-pancreatic digestive diseases. Urine N-benzoyl-tyrosyl-para-aminobenzoic acid (BT-PABA) was measured in those patients as a comparison simultaneously.(1) FE1 concentration in healthy controls ranged from 136 to 1380 (966.93 +/- 256.17) microg/g. There were no statistical significances between the different age groups (P > 0.05). (2) The FE1 of both groups of chronic pancreatitis [(208.80 +/- 197.72) microg/g, ranged from 15 to 900 microg/g] and pancreatic cancer [(175.00 +/- 172.25) microg/g, ranged from 15 to 460 microg/g] compare to that in non-pancreatic digestive diseases [(502.63 +/- 210.28) microg/g] were significantly low (P < 0.05). (3) FE1 concentration of pancreatic diarrhea [(166.11 +/- 192.35) microg/g] was significant lower than that of non-pancreatic diarrhea [(444.50 +/- 212.91) microg/g] (P < 0.01). The sensitivity and specificity of FE1 for diagnosing pancreatic diarrhea were 77.8% and 89.5% as well as 50.0% and 42.9% of urine BT-PABA. (4) The sensitivity and specificity of FE1 for diagnosing chronic pancreatitis were 63.3% and 97.3% respectively, the sensitivity of urine BT-PABA was 83.3%.FE1 concentration is (966.93 +/- 256.17) microg/g in healthy controls. Our study clearly showed that there are no changes of FE1 concentration in different age groups. FE1 showed the higher specificity for chronic pancreatitis than urine BT-PABA. The test is noninvasive and can assist in diagnosing exocrine pancreatic insufficiency, and is better than the BT-PABA in differentiating pancreatic and non-pancreatic diarrhea.