Evaluation of a fecal pancreatic elastase-1 enzyme-linked immunosorbent assay: Assessment versus an established assay and implication in classifying pancreatic function.
BACKGROUND
Disagreement continues regarding 2 fecal pancreatic elastase-1 (PE-1) ELISAs and their respective capabilities to assess pancreatic function.


METHODS
The BioServ Diagnostics polyclonal PE-1 ELISA was validated and its performance characteristics compared to the previously validated ScheBo Biotech monoclonal PE-1 ELISA. Split sample study results were analyzed by Deming regression and Bland-Altman plot analysis. Data mining was utilized to explore PE-1 distribution and evaluate PE-1 and fecal fat correlation.


RESULTS
Analysis demonstrates limited quantitative agreement; slope=0.9640, intercept=10.787, R(2)=0.633. Means were 228.8 and 226.2 microg PE-1/g stool for the polyclonal and monoclonal assays respectively. Bland-Altman analysis showed 91% of paired values within 2 SD of their means. There was good qualitative agreement when interpreted against established intervals with 91% of results equivalent in pancreatic function classification. The remaining 9% varied by one classification level with no bias evident. The distribution of PE-1 concentrations (n=400, 0-25 years) classified 78% of subjects with normal pancreatic function, 7% with moderate pancreatic insufficiency and 15% with severe insufficiency. There was little agreement between PE-1 and fecal fat results.


CONCLUSIONS
The polyclonal PE-1 ELISA is an acceptable alternative to the monoclonal PE-1 ELISA. PE-1 is a potential substitute for fecal fat for evaluating pancreatic function.
Erickson
J Alan
JA
ARUP Laboratories, ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, Utah 84108, USA. ericksja@aruplab.com
Aldeen
William E
WE
Grenache
David G
DG
Ashwood
Edward R
ER
D000293:Adolescent; D000328:Adult; D000906:Antibodies / Q000276:immunology; D000911:Antibodies, Monoclonal / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D004797:Enzyme-Linked Immunosorbent Assay; D005243:Feces / Q000201:enzymology*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D010179:Pancreas / Q000201:enzymology / Q000502:physiology*; D010196:Pancreatic Elastase / Q000032:analysis* / Q000276:immunology; D010186:Pancreatic Function Tests
D000906:Antibodies; D000911:Antibodies, Monoclonal; D010196:Pancreatic Elastase