title: Fecal pancreatic elastase: a reproducible marker for severe exocrine pancreatic insufficiency.
abstract: BACKGROUND
  In order to apply fecal pancreatic elastase for follow-up of exocrine pancreatic function in chronic pancreatitis and cystic fibrosis, we examined the sensitivity, specificity, and long-term variability of a new polyclonal antibody-based enzyme-linked immunosorbent assay (ELISA).
  
  
  METHODS
  Patients with definite chronic pancreatitis (n = 23), probable or possible chronic pancreatitis (n = 14), autoimmune pancreatitis (n = 7), or acute pancreatitis (n = 11), and 51 healthy subjects and 11 healthy infants participated in this study. Pancreatic function was graded as normal (n = 3), mild (n = 18), moderate (n = 9), or severe (n = 18) exocrine insufficiency on the basis of secretin tests. Fecal pancreatic elastase was measured by a new ELISA.
  
  
  RESULTS
  Fecal pancreatic elastase concentration in control subjects varied widely, with a median of 478 microg/g. The specificity of this test was 90.2% with a cutoff value of >200 microg/g. The sensitivities were 60.9% for detecting definite chronic pancreatitis, 76.5% for calcifying pancreatitis, 71.4% for autoimmune pancreatitis, and 7.1% for probable or possible chronic pancreatitis. The sensitivities were 16.7% for mild, 12.5% for moderate, and 72.2% for severe exocrine pancreatic insufficiency. Forty patients were reexamined after a median interval of 347 days. The fecal pancreatic elastase levels between the first and second tests were not significantly different. Two infants, 4.5 and 5 months old, had abnormally low values, but after a median of 304 days all infants showed normal levels (median, 444 microg/g).
  
  
  CONCLUSIONS
  Fecal pancreatic elastase is a reproducible marker for severe exocrine pancreatic insufficiency. This test is valuable for longitudinal follow-up of exocrine pancreatic function.
authors.affiliation: Department of Gastroenterology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Naruse
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ishiguro
authors.forename: Shigeru B H
authors.initials: SB
authors.lastname: Ko
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Yoshikawa
authors.forename: Takeshi
authors.initials: T
authors.lastname: Yamamoto
authors.forename: Akiko
authors.initials: A
authors.lastname: Yamamoto
authors.forename: Sachiko
authors.initials: S
authors.lastname: Futakuchi
authors.forename: Hidemi
authors.initials: H
authors.lastname: Goto
authors.forename: Yukio
authors.initials: Y
authors.lastname: Saito
authors.forename: Susumu
authors.initials: S
authors.lastname: Takahashi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000378:metabolism; D002675:Child, Preschool; D002908:Chronic Disease; D004797:Enzyme-Linked Immunosorbent Assay; D010188:Exocrine Pancreatic Insufficiency / Q000201:enzymology*; D005243:Feces / Q000737:chemistry*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D010196:Pancreatic Elastase / Q000378:metabolism*; D011379:Prognosis; D015203:Reproducibility of Results; D012720:Severity of Illness Index
chemical_list: D015415:Biomarkers; D010196:Pancreatic Elastase