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Comparison of Fecal Elastase-1 and Pancreatic Function Testing in Children

Objectives: The fecal pancreatic elastase-1 (FE-1) test is considered a simple, noninvasive, indirect measure of pancreatic function. We aimed to evaluate the performance of the FE-1 test compared with the direct pancreatic function test (PFT) with secretin stimulation in children. Methods: Data of 70 children (6 months–17 years of age) who had both FE-1 test and PFT were analyzed. Results: The average FE-1 concentration was 403 ± 142 &mgr;g/g. Eleven children had concentrations below 200 &mgr;g/g, 23 between 201 to 500 &mgr;g/g, and 36 were above 500 &mgr;g/g. The average pancreatic elastase activity measured on direct stimulation was 49.1 ± 38.6 &mgr;mol · min−1 · ml−1 and 11 children had activity below the established cutoff (10.5 &mgr;mol · min−1 · ml−1). Among the 11 children with pathologic PFT, 7 had normal FE-1, 4 were in the intermediate range (201–500 &mgr;g/g), and none were in the low range (<200 &mgr;g/g). Among the 59 children with normal direct PFT 11 (19%) had pathologic (<200 &mgr;g/g) and 19 (32%) had intermediate FE-1 tests. Twenty-nine children had both normal FE-1 concentration and normal PFT, giving a negative predictive value of 80%. The correlation between pancreatic elastase activity and FE-1 concentration was poor (r = 0.190). The sensitivity of the FE-1 test was found to be 41.7%, whereas the specificity was 49.2%. The positive predictive value of the FE-1 test was only 14%. Conclusions: The FE-1 test is a simple, noninvasive, indirect method; however, ordering physicians should be aware of its limitations. It can give false-positive results and has low sensitivity in children with mild pancreatic insufficiency without cystic fibrosis and in those with isolated pancreatic enzyme deficiencies.