Abstract
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Polyclonal versus Monoclonal ELISA for the Determination of Fecal Elastase 1: Diagnostic Value in Cystic Fibrosis and Chronic Pancreatic Insufficiency
by Yvette Miendje, Diane Maisin, Marie J. Sipewa, Pierre Deprez, Jean P. Buts, Philippe De Nayer, Marianne Philippe
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Background – Several clinical studies have evaluated the diagnostic efficiency of fecal elastase 1 (FE1) determination using monoclonal antibodies (ScheBo-Tech, Wettenberg, Germany). We report the results of the comparison of this method with a polyclonal based assay (BioServ AG, Rostock, Germany).
Methods – We collected single spot samples from two groups of patients. The group of adults included 13 healthy subjects (HS), 12 patients with non-pancreatic gastrointestinal disease (NPGD), 26 with chronic pancreatitis with presence of calcification (CCP) and 14 without calcification (NCP). The group of children included 17 cases of cystic fibrosis (CF) and 21 controls (CO). After a common extraction, both assays were performed as recommended by the manufacturers.
Results – Both tests showed a statistically significant difference between patients with normal pancreatic function and patients with pancreatic disorders. Neither showed a significant difference between HS and NPGD.
Conclusions – Although a statistical difference was found between the two methods for the normal groups (HS and CO), both kits are suitable for the detection of severe pancreatic insufficiency either in adult patients or in children. However, caution should be taken in case of patients with liquid stool specimens.
DOI: Clin. Lab. 2004;50:419-424
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