Human fecal pancreatic elastase in children

A new test is presented for the evaluation of pancreas function in children by determining fecal pancreatic elastase (elastase). Methods: Elastase was measured by an ELISA based on two monoclonal antibodies of IgG2b class which specifically recognize two different epitopes of Fl. A stool sample of about 0.5 g is sufficient for the test. Stool analysis was performed in 376 hospitalized infants and children, aged from 1 day to 14 years, without pancreas insufficiency, and 112 patients with cystic fibrosis (CF), 7 days to 35 years of age. In 10 children elastase was measured in ten consecutively assembled stool samples to determine intraindividual variability of elastase. In addition to descriptive analysis, Mann Whitney rank sum test was applied to compare elastase values of various age groups. Results: Fecal elastase values in the meconium of healthy newborn infants were between 5 and 195 ((x) over bar = 64) mu g/g, independently of gestational age or physical development. In older infants and children values ranged between 168-4420 ((x) over bar = 763) mu g/g, showing no statistical differences between age groups, meconium values excepted, although there was a slight tendency of elastase concentrations increasing with age. Mean intraindividual coefficient of variation was 15 (3 to 28) %. Of 112 CF-patients 95 had pathologically low values (< 150 mu g/g). In one CF-patient the pancreas function worsened within a few months as documented by decreasing fecal elastase concentrations. Conclusions: Determination of fecal pancreatic elastase in a tiny sample is an additional tool to confirm maturation or decrease of pancreatic function. The test impresses by its simplicity, stability, and low variability.