Can be used for the diagnosis or the exclusion of exocrine pancreatic insufficiency, which may be associated with chronic pancreatitis, cystic fibrosis, carcinoma of the pancreas, diabetes mellitus type 1 (insulin-dependent diabetes mellitus), Shwachman-Diamond syndrome, and other etiologies of pancreatic insufficiency.

This assay does not measure the substituted enzyme (Pancreatin) and, therefore, is not necessary to stop medication before taking a sample.

Screw cap plastic container (sterile)

• Do not contaminate outside of container
• Do not overfill container
• Do not submit watery or unformed (loose) stool
• Do not use a preservative

Screw cap plastic container (sterile)

Frozen (preferred) – 12 months

Freeze/thawcycles: stable x2

Ambient – 8 hours

Refrigerated – 7 days

• Serum or plasma received
• Stool contaminated with urine
• Preserved stool received
• Outside of container contaminated
• Overfilled container

Chemiluminescent immunoassay (CLIA)

Normal:                      >200 μg elastase/g fecal material

Moderate insufficiency:   100−200 μg elastase/g fecal material

Severe insufficiency:    <100 μg elastase/g fecal material