Development and validation of an improved test for the measurement of human faecal elastase-1

Ann Clin Biochem. 2009 Jan;46(Pt 1):33-7. doi: 10.1258/acb.2008.008123. Epub 2008 Nov 13.

Abstract

Background: Human faecal elastase-1 (FE-1) is an established biochemical test for the investigation of pancreatic exocrine insufficiency. Conventional extraction methods for FE-1 analysis can give false-positive results with watery stools. This is a major limitation as patients investigated for pancreatic disease commonly produce such stools. We have developed an improved FE-1 test that overcomes water interference by measuring the enzyme in dried faeces.

Methods: A novel collection device for FE-1 analysis that involves drying and weighing the stool sample was developed in our laboratory and compared with a conventional wet method, E1 Quick-Prep (Schebo, Biotech AG, Germany). The concentration of faecal FE-1 was determined using a commercially available enzyme-linked immunosorbent assay method (Schebo).

Results: FE-1 values obtained using the new dry extraction procedure (mean 1777 microg/g dry stool) were higher when compared with the conventional wet analysis (mean 402 microg/g stool). A 1:2 dilution in water, mimicking a loose stool, was found to affect FE-1 results obtained using the conventional wet extraction procedure. The new dry extraction method gave consistent results when water content was varied in the original stool sample.

Conclusion: We have demonstrated that our new device overcomes water interference, allowing results to be obtained from stool samples that would otherwise be unsuitable for FE-1 analysis.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Biological Assay / methods*
  • Child
  • Child, Preschool
  • Enzyme-Linked Immunosorbent Assay
  • Feces / enzymology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pancreatic Elastase / analysis*
  • Reproducibility of Results
  • Young Adult

Substances

  • Pancreatic Elastase