Abstract
Although being the recommended laboratory test to diagnose acute pancreatitis, serum pancreatic lipase (LIP) is among the poorly standardized laboratory tests, and laboratory stakeholders often appear to not take enough care of the quality of its measurements. Here we discuss some important issues that, if not correctly managed and solved, make misdiagnosis of acute pancreatitis by using serum LIP a real possibility. First, the current unavailability of a suitable higher-order reference material to be used as common calibrator should be filled up to definitively improve the inter-method bias. Second, knowledge of the analytical characteristics that may explain the defective performance of LIP assays should be deepened. IVD manufacturers should be more explicit in providing this information, including description of their internal protocol for transferring LIP values from internal references to commercial calibrators. Third, recommended models for accurately estimating measurement uncertainty and reliably defining analytical performance specifications for LIP measurements should be applied. Finally, investments considering alternative options for measuring LIP (e.g., targeted to the development of automated LIP immunoassays) should be warranted. All involved stakeholders (standardization bodies, higher-order reference providers, in vitro diagnostics manufacturers, and laboratory professionals) should contribute to fill the existing gap.
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Research funding: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Not applicable.
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Ethical approval: Not applicable.
References
1. Panteghini, M, Bais, R. Serum enzymes. In: Rifai, N, Horvath, AR, Wittwer, CT, editors. Tietz textbook of clinical chemistry and molecular diagnostics, 6th ed. St. Louis: Elsevier Saunders; 2018:404–34 pp.10.1016/B978-1-4160-6164-9.00022-6Search in Google Scholar
2. Panteghini, M. Electrophoretic fractionation of pancreatic lipase. Clin Chem 1992;38:1712–6.10.1093/clinchem/38.9.1712Search in Google Scholar
3. Panteghini, M. Laboratory evaluation of the pancreas. In: Clarke, W, editor. Contemporary practice in clinical chemistry, 2nd ed. Washington DC: AACC Press; 2011:333–41 pp.Search in Google Scholar
4. Lippi, G, Panteghini, M, Bernardini, S, Bonfanti, L, Carraro, P, Casagranda, I, et al.. Laboratory testing in the emergency department: an Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) and Academy of Emergency Medicine and Care (AcEMC) consensus report. Clin Chem Lab Med 2018;56:1655–9. https://doi.org/10.1515/cclm-2017-0077.Search in Google Scholar
5. Gomez, D, Addison, A, De Rosa, A, Brooks, A, Cameron, IC. Retrospective study of patients with acute pancreatitis: is serum amylase still required? BMJ Open 2012;2:e001471. https://doi.org/10.1136/bmjopen-2012-001471.Search in Google Scholar
6. Tenner, S, Baillie, J, DeWitt, J, Vege, SS, American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol 2013;108:1400–15. https://doi.org/10.1038/ajg.2013.218.Search in Google Scholar
7. Lessinger, JM, Férard, G. Plasma pancreatic lipase activity: from analytical specificity to clinical efficiency for the diagnosis of acute pancreatitis. Eur J Clin Chem Clin Biochem 1994;32:377–81. https://doi.org/10.1515/cclm.1994.32.5.377.Search in Google Scholar
8. Infusino, I, Frusciante, E, Braga, F, Panteghini, M. Progress and impact of enzyme measurement standardization. Clin Chem Lab Med 2017;55:334–40. https://doi.org/10.1515/cclm-2016-0661.Search in Google Scholar
9. Panteghini, M. The never-ending search of an acceptable compromise for pancreatic lipase standardisation. Clin Chem Lab Med 2012;50:419–21. https://doi.org/10.1515/cclm-2012-0035.Search in Google Scholar
10. Schimmel, H, Zegers, I, Emons, H. Standardization of protein biomarker measurements: is it feasible? Scand J Clin Lab Invest Suppl 2010;242:27–33. https://doi.org/10.3109/00365513.2010.493362.Search in Google Scholar
11. ISO 21151:2020. In vitro diagnostic medical devices — requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples. Geneva, Switzerland: ISO; 2020.Search in Google Scholar
12. Panteghini, M, Bonora, R, Pagani, F. Measurement of pancreatic lipase activity in serum by a kinetic colorimetric assay using a new chromogenic substrate. Ann Clin Biochem 2001;38:365–70. https://doi.org/10.1258/0004563011900876.Search in Google Scholar
13. Cattozzo, G, Franzini, C, Melzi d’Eril, GM. Commutability of calibration and control materials for serum lipase. Clin Chem 2001;47:2108–13. https://doi.org/10.1093/clinchem/47.12.2108.Search in Google Scholar
14. Lessinger, JM, Arzoglou, P, Ramos, P, Visvikis, A, Parashou, S, Calam, D, et al.. Preparation and characterization of reference materials for human pancreatic lipase: BCR 693 (from human pancreatic juice) and BCR 694 (recombinant). Clin Chem Lab Med 2003;41:169–76. https://doi.org/10.1515/CCLM.2003.028.Search in Google Scholar
15. Moerman, A, Stove, V, Oyaert, M. Evaluation of three different lipase reagents on the Abbott Alinity C chemistry analyzer. Clin Chim Acta 2019;493:S44. https://doi.org/10.1016/j.cca.2019.03.100.Search in Google Scholar
16. Clinical and Laboratory Standards Institute (CLSI). EP09-A3—measurement procedure comparison and bias estimation using patient samples; approved guideline, 3rd ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2013.Search in Google Scholar
17. ISO/TS 20914:2019. Medical laboratories – practical guidance for the estimation of measurement uncertainty, 1st ed. Geneva, Switzerland: ISO; 2019.Search in Google Scholar
18. Braga, F, Panteghini, M. The utility of measurement uncertainty in medical laboratories. Clin Chem Lab Med 2020;58:1407–13. https://doi.org/10.1515/cclm-2019-1336.Search in Google Scholar
19. Braga, F, Pasqualetti, S, Aloisio, E, Panteghini, M. The internal quality control in the traceability era. Clin Chem Lab Med 2021;59:291–300.10.1515/cclm-2020-0371Search in Google Scholar PubMed
20. Braga, F, Infusino, I, Panteghini, M. Performance criteria for combined uncertainty budget in the implementation of metrological traceability. Clin Chem Lab Med 2015;53:905–12. https://doi.org/10.1515/cclm-2014-1240.Search in Google Scholar
21. European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Biological Variation Database. Available from: https://biologicalvariation.eu/meta_calculations [Accessed Jul 2021].Search in Google Scholar
22. Braga, F, Panteghini, M. Performance specifications for measurement uncertainty of common biochemical measurands according to Milan models. Clin Chem Lab Med 2021;59:1362–8.10.1515/cclm-2021-0170Search in Google Scholar PubMed
23. Pasqualetti, S, Infusino, I, Carnevale, A, Szőke, D, Panteghini, M. The calibrator value assignment protocol of the Abbott enzymatic creatinine assay is inadequate for ensuring suitable quality of serum measurements. Clin Chim Acta 2015;450:125–6. https://doi.org/10.1016/j.cca.2015.08.007.Search in Google Scholar
24. Braga, F, Infusino, I, Frusciante, E, Ceriotti, F, Panteghini, M. Trueness evaluation and verification of interassay agreement of 11 serum IgA measuring systems: implications for medical decisions. Clin Chem 2019;65:473–83. https://doi.org/10.1373/clinchem.2018.297655.Search in Google Scholar
25. Braga, F, Frusciante, E, Ferraro, S, Panteghini, M. Trueness evaluation and verification of inter-assay agreement of serum folate measuring systems. Clin Chem Lab Med 2020;58:1697–705. https://doi.org/10.1515/cclm-2019-0928.Search in Google Scholar
26. Ceriotti, F, Fernandez-Calle, P, Klee, GG, Nordin, G, Sandberg, S, Streichert, T, et al.. Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference. Clin Chem Lab Med 2017;55:189–94. https://doi.org/10.1515/cclm-2016-0091.Search in Google Scholar
27. Rizzotti, P, Dechecchi, C, Zanchetta, M, Zaninotto, M, Plebani, M, Burlina, A. Enzyme immunoassay for pancreatic lipase: comparison with turbidimetric method in pancreatic diseases. Clin Biochem 1985;18:230–2. https://doi.org/10.1016/s0009-9120(85)80045-x.Search in Google Scholar
28. Carrère, J, Galabert, C, Thouvenot, JP, Figarella, C. Assay of human pancreatic lipase in biological fluids using a non-competitive enzyme immunoassay. Clin Chim Acta 1986;161:209–19. https://doi.org/10.1016/0009-8981(86)90214-7.Search in Google Scholar
29. Ohkaru, Y, Kurooka, S, Kitamura, T. Application of two monoclonal antibodies to either an immunosorbent enzyme assay or a competitive binding enzyme immunoassay for human serum pancreatic lipase. Clin Chim Acta 1989;182:295–300. https://doi.org/10.1016/0009-8981(89)90107-1.Search in Google Scholar
30. Panteghini, M, Pagani, F, Bonora, R, Alebardi, O, Ceriotti, F. Diagnostic value of four assays for lipase determination in serum: a comparative re-evaluation. Clin Biochem 1991;24:497–503. https://doi.org/10.1016/s0009-9120(05)80009-8.Search in Google Scholar
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