{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T17:09:48Z","timestamp":1792602588138,"version":"4.5.0"},"reference-count":19,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2024,5,31]],"date-time":"2024-05-31T00:00:00Z","timestamp":1717113600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background: Numerous immunoassays have been commercialized to determine pancreatic elastase (PE) in feces in screening for exocrine pancreatic insufficiency (EPI), but how the different assays compare to one another is controversial, especially in the context that all methods use the same cut-off values for interpreting the results obtained on the presence or absence of EPI or the degree of insufficiency if it is present. Our aim was to analytically verify a new method for determining PE, compare the results with a previous method, and verify the declared cut-off values for interpretation of the results. Methods: PE in the stool was assayed using a previous monoclonal enzyme-linked immunosorbent assay (\u201cScheBo ELISA\u201d) and a new polyclonal particle-enhanced turbidimetric immunoassay (\u201cB\u00fchlmann PETIA\u201d). The direct method comparison of two immunoassays was performed in 40 samples. Clinical comparisons were conducted against each other for the binary determination of \u201cabnormal\/normal\u201d elastase levels and the three-way determination of \u201csevere\/moderate\/no\u201d EPI in 56 samples. The indirect comparison method used external quality assessment (EQA) data to compare the monoclonal and polyclonal immunoassays for PE, and additionally compare the monoclonal ScheBo ELISA to a monoclonal chemiluminescence immunoassay (\u201cDiaSorin CLIA\u201d). Results: Precision in the series and intra-laboratory precision for B\u00fchlmann PETIA met the manufacturer\u2019s specifications for the concentration range of limit\/lower values and the range of normal values. The B\u00fchlmann PETIA immunoassay on different analytical platforms yielded comparable results and nearly perfect agreement in the case of three-way classification (kappa = 0.89 with 95%CI from 0.79 to 1.00. ScheBo ELISA tends to generate higher values of pancreatic elastase than the B\u00fchlmann PETIA; agreement between the methods was moderate in the case of binary classification (kappa = 0.43; 95% CI 0.25 to 0.62), and substantial in the case of three-way classification (kappa = 0.62; 95% CI 0.50 to 0.75). EQA data analysis showed a statistically significant difference between ScheBo ELISA and B\u00fchlmann PETIA peer groups (p = 0.031), as well as the DiaSorin CLIA and ScheBo ELISA peer groups (p = 0.010). Conclusion: The ScheBo ELISA and B\u00fchlmann PETIA do not appear to be commutable in the analytical and clinical context. Our data address a discordance between different mono- and polyclonal immunoassays for pancreatic elastase and the potential of misclassification using its universal cut-off values in screening suspected patients for exocrine pancreatic insufficiency.<\/jats:p>","DOI":"10.3390\/diagnostics14111166","type":"journal-article","created":{"date-parts":[[2024,5,31]],"date-time":"2024-05-31T11:43:48Z","timestamp":1717155828000},"page":"1166","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Clinical and Analytical Comparison of Monoclonal and Polyclonal Immunoassays for Fecal Pancreatic Elastase"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2554-4034","authenticated-orcid":false,"given":"Jasna","family":"Lenicek Krleza","sequence":"first","affiliation":[{"name":"Department of Laboratory Diagnostics, Children\u2019s Hospital Zagreb, 10000 Zagreb, Croatia"},{"name":"University Department of Nursing, Catholic University of Croatia, Ilica 244, 10000 Zagreb, Croatia"},{"name":"Department of Laboratory Medical Diagnostics, University of Applied Health Sciences Zagreb, 10000 Zagreb, Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4749-4760","authenticated-orcid":false,"given":"Merica","family":"Aralica","sequence":"additional","affiliation":[{"name":"Clinical Department for Laboratory Diagnostics, Clinical Hospital Centre Rijeka, 51000 Rijeka, Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lara","family":"Milevoj Kopcinovic","sequence":"additional","affiliation":[{"name":"Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, 10000 Zagreb, Croatia"},{"name":"School of Medicine, Catholic University of Croatia, 10000 Zagreb, Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renata","family":"Zrinski Topic","sequence":"additional","affiliation":[{"name":"Department of Laboratory Diagnostics, Children\u2019s Hospital Zagreb, 10000 Zagreb, Croatia"},{"name":"Department of Laboratory Medical Diagnostics, University of Applied Health Sciences Zagreb, 10000 Zagreb, Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,5,31]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1119","DOI":"10.1007\/s10620-017-4524-z","article-title":"Potential for Screening for Pancreatic Exocrine Insufficiency Using the Fecal Elastase-1 Test","volume":"62","author":"Hardt","year":"2017","journal-title":"Dig. Dis. Sci."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"67","DOI":"10.1136\/flgastro-2018-101171","article-title":"How to manage: Patient with a low faecal elastase","volume":"12","author":"Lam","year":"2019","journal-title":"Front. Gastroenterol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"908542","DOI":"10.3389\/fped.2022.908542","article-title":"Assessment of exocrine pancreatic unction in children and adolescents with direct and indirect testing","volume":"10","author":"Hopson","year":"2022","journal-title":"Front. Pediatr."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1177\/2050640616684695","article-title":"HaPanEU\/UEG Working Group, United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis (HaPanEU)","volume":"5","author":"Rosendahl","year":"2017","journal-title":"United Eur. Gastroenterol. J."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"768","DOI":"10.1016\/0016-5085(91)80024-4","article-title":"Studies on the sterol-binding capacity of human pancreatic elastase 1","volume":"100","author":"Sziegoleit","year":"1991","journal-title":"Gastroenterology"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"222","DOI":"10.1093\/clinchem\/42.2.222","article-title":"Immunoreactive elastase I: Clinical evaluation of a new noninvasive test of pancreatic function","volume":"42","author":"Stein","year":"1996","journal-title":"Clin. Chem."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"189","DOI":"10.1097\/01.mpa.0000153617.40513.34","article-title":"A new fecal elastase 1 test using polyclonal antibodies for the detection of exocrine pancreatic insufficiency","volume":"30","author":"Hahn","year":"2005","journal-title":"Pancreas"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"87","DOI":"10.1016\/j.cca.2008.07.022","article-title":"Evaluation of a fecal pancreatic elastase-1 enzyme-linked immunosorbent assay: Assessment versus an established assay and implication in classifying pancreatic function","volume":"397","author":"Erickson","year":"2008","journal-title":"Clin. Chim. Acta"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"219","DOI":"10.1097\/MPG.0b013e31802c41de","article-title":"Comparison of monoclonal and polyclonal ELISAs for fecal elastase in patients with cystic fibrosis and pancreatic insufficiency","volume":"44","author":"Borowitz","year":"2007","journal-title":"J. Pediatr. Gastroenterol. Nutr."},{"key":"ref_10","unstructured":"(2024, January 11). Buhlmann Laboratories AG. Buhlmann fPELA\u00ae Turbo. Product Information. Available online: https:\/\/www.buhlmannlabs.ch\/products-solutions\/clinical-chemistry\/pancreatic-elastase\/."},{"key":"ref_11","unstructured":"(2024, February 16). ScheBo Biotech AG. ScheBo Pancreatic Elastase-1. Tests for the Quantification of Human Pancreatic Elastase 1. Available online: https:\/\/www.schebo.com\/products\/pancreatic-elastase-1\/."},{"key":"ref_12","doi-asserted-by":"crossref","unstructured":"\u0106elap, I., Vukasovi\u0107, I., Juri\u010di\u0107, G., and \u0160imundi\u0107, A.M. (2017). Minimum requirements for the estimation of measurement uncertainty: Recommendations of the joint Working group for uncertainty of measurement of the CSMBLM and CCMB. Biochem. Med. (Zagreb), 27.","DOI":"10.11613\/BM.2017.030502"},{"key":"ref_13","unstructured":"(2024, January 11). Buhlmann Laboratories AG. Buhlmann CALEX Cap. Available online: https:\/\/www.buhlmannlabs.ch\/wp-content\/uploads\/2023\/06\/CALEX-Cap-Flyer_MF002-07E.pdf."},{"key":"ref_14","unstructured":"(2024, January 11). ScheBo Biotech AG. ScheBo Master Quick-Prep. Stool-Extraction System. Available online: https:\/\/www.schebo.com\/products\/schebo-quick-prep\/."},{"key":"ref_15","unstructured":"CLSI (2014). Approved Guideline, Clinical and Laboratory Standards Institute. [3rd ed.]. Available online: https:\/\/clsi.org\/standards\/products\/method-evaluation\/documents\/ep15\/."},{"key":"ref_16","unstructured":"(2024, January 11). Reference Institute for Bioanalytics, Surveys Fecal Diagnostics. Available online: https:\/\/www.rfb.bio\/cgi\/surveys?searchType=rv_type&rv_type=FD&analyte=all&year=2024."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"243","DOI":"10.1097\/MPA.0000000000002006","article-title":"Clinical and Analytical Characterization of the DiaSorin and ScheBo Fecal Pancreatic Elastase 1 Assays","volume":"3","author":"Wyness","year":"2022","journal-title":"Pancreas"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1016\/j.clinbiochem.2022.05.002","article-title":"Comparison of fecal calprotectin and pancreatic elastase assays based on proficiency testing results","volume":"107","author":"Johnson","year":"2022","journal-title":"Clin. Biochem."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"771","DOI":"10.1080\/003655201300192058","article-title":"Faecal elastase-1: Lyophilization of stool samples prevents false low results in diarrhoea","volume":"36","author":"Fischer","year":"2001","journal-title":"Scand. J. Gastroenterol."}],"container-title":["Diagnostics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2075-4418\/14\/11\/1166\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T14:51:53Z","timestamp":1760107913000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2075-4418\/14\/11\/1166"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5,31]]},"references-count":19,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2024,6]]}},"alternative-id":["diagnostics14111166"],"URL":"https:\/\/doi.org\/10.3390\/diagnostics14111166","relation":{},"ISSN":["2075-4418"],"issn-type":[{"value":"2075-4418","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5,31]]}}}