An immunoassay for canine pancreatic elastase 1 as an indicator for exocrine pancreatic insufficiency in dogs

The detection of pancreatic elastase I in stool samples has become the noni nvasive gold standard for the diagnosis of pancreatic insufficiency in huma ns. Accordingly, the development of a sandwich-ELISA specific for canine pa ncreatic elastase 1, based on monoclonal antibodies, is presented here. The test has a detection range of 4-240 mug canine pancreatic elastase 1/g fec es. The intraassay coefficient of variation is 7.4%, and the interassay coe fficient of variation is 7.7%. Spiking experiments show that canine elastas e 1 is quantitatively detectable in fecal samples. Interestingly, the range of the elastase 1 concentration in canine feces within several days is hig her as compared with humans. As the proposed cutoff of 10 mug/g is below th is variation range in 96.1% of the tested samples, the effect on the test s pecificity is negligible. Because the test detects neither human nor bovine and porcine elastase 1, pancreatic function can be monitored without inter rupting an enzyme replacement therapy.