caa a22 4500 378898000 CHVBK 20180305123511.0 cr unu---uuuuu 161128e20040216xx s 000 0 eng 10.1515/CCLM.2004.012 doi (NATIONALLICENCE)gruyter-10.1515/CCLM.2004.012 Determination of lipase catalytic activity in two reference materials: BCR 693 and BCR 694 by titrimetry at constant pH [Elektronische Daten] [Jean-Marc Lessinger, Stella Parashou, Panteleimon Arzoglou, Paul Ramos, Catherine Chapus, Jeanine Dufaux, Wolfgang Junge, Christos Profilis, Georges Férard] Because routine assays for pancreatic lipase catalytic activity are not yet standardized, between-method comparability is very poor. This is mainly due to the lack of reference materials (RMs). The aim of this study was to assign values of catalytic concentration to two human pancreatic lipase RMs, one prepared from human pancreatic juice (BCR 693), the other obtained by recombinant technology (BCR 694). Lipase catalytic activity was assayed in five experienced laboratories, using aliquots from the same lot of triolein emulsion and a standardized titrimetric procedure, optimized with regard to substrate, cofactors and pH. The accepted sets of data (n=4) gave a mean ± the corresponding uncertainty expressed as the 0.95 confidence interval of 1732±72 U/l and 1043±60 U/l for BCR 693 and 694, respectively. Transferability of the whole operating procedure proved to be quite satisfactory. The authors conclude that both RMs can be used to verify the correct implementation of the standardized measurement procedure and to assign values to secondary lipase materials (commercial calibrators, control products) which, in turn, ensures traceability to the standardized procedure in this study, and contributes to the harmonization of laboratory results according to the Directive for in vitro Diagnostic Medical Devices. Copyright © 2004 by Walter de Gruyter GmbH & Co. KG Medical equipment & techniques nationallicence Medical diagnosis nationallicence Diseases & disorders nationallicence Lessinger Jean-Marc aut Parashou Stella aut Arzoglou Panteleimon aut Ramos Paul aut Chapus Catherine aut Dufaux Jeanine aut Junge Wolfgang aut Profilis Christos aut Férard Georges aut Clinical Chemistry and Laboratory Medicine Walter de Gruyter 42/1(2004-02-16), 62-66 1434-6621 42:1<62 2004 42 cclm https://doi.org/10.1515/CCLM.2004.012 text/html Onlinezugriff via DOI 1 research article jats NATIONALLICENCE 856 40 https://doi.org/10.1515/CCLM.2004.012 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Lessinger Jean-Marc aut NATIONALLICENCE 700 1- Parashou Stella aut NATIONALLICENCE 700 1- Arzoglou Panteleimon aut NATIONALLICENCE 700 1- Ramos Paul aut NATIONALLICENCE 700 1- Chapus Catherine aut NATIONALLICENCE 700 1- Dufaux Jeanine aut NATIONALLICENCE 700 1- Junge Wolfgang aut NATIONALLICENCE 700 1- Profilis Christos aut NATIONALLICENCE 700 1- Férard Georges aut NATIONALLICENCE 773 0- Clinical Chemistry and Laboratory Medicine Walter de Gruyter 42/1(2004-02-16), 62-66 1434-6621 42:1<62 2004 42 cclm CC0 http://creativecommons.org/publicdomain/zero/1.0 nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-gruyter