Goobi - d01b7 - 2026-04-23T13:10:32Zautvan NeerNicolaas J.M.van Neer, Nicolaas J.M.autRuhaakL. ReneeRuhaak, L. ReneeautDiederiksNina M.Diederiks, Nina M.autRomijnFred P.H.T.M.Romijn, Fred P.H.T.M.autPieterseMervin M.Pieterse, Mervin M.autCobbaertChrista M.Cobbaert, Christa M.Analytical validation of an IFCC-endorsed mass spectrometry-based semi-automated reference measurement procedure for global standardization of serum apolipoprotein (a)textbookBerlin [u.a.]De Gruyter20262026engOnline-Ressourceborn digitalObjectives: An LC-MRM-MS-based Reference Measurement Procedure (RMP) with manual sample preparation for standardization of commercial Lp (a)/apo (a) test kits in molar units was previously developed by three calibration laboratories of the IFCC Working Group on Apolipoprotein Standardization. Semi-automation of the sample preparation was introduced in the Leiden Apolipoprotein Reference Laboratory to improve the precision of the RMP. Methods: The RMP was adapted for semi-automation on an Agilent BRAVO Automated Liquid Handling Platform using VWorks software. Measurement of apo (a) is based on three proteotypic peptides and five serum calibrators traceable to the former WHO-IFCC reference material SRM2B, and is independent of the apo (a) size polymorphism. Concentration-dependent performance criteria were established according to the EFLM Biological Variation Database, and precision was assessed per CLSI EP05-A3. Results: Compared to manual sample preparation, semi-automation improved analytical precision, resulting in within-run imprecision estimates for quantifying peptide LFLEPTQADIALLK of 5.0, 4.7, and 4.5 % at 146.8, 197.4 and 238.7 nmol/L, respectively. Furthermore, compared to the concentration-dependent maximum allowable uncertainty, and following correction for repeated measurements, the measurement uncertainty of the RMP was deemed acceptable over the entire measurement range of apo (a) (3.8–456.0 nmol/L). Conclusions: Semi-automation improved the analytical precision of the RMP for the quantitation of apo (a), meeting concentration-dependent analytical performance criteria and facilitating longitudinal accuracy of Lp (a)/apo (a) test results produced by CE-IVD Lp (a)/apo (a) kits. With semi-automation of the sample preparation, a more precise RMP has been developed, making it easier to meet the maximum allowable measurement uncertainty in the Lp (a)/apo (a) calibration hierarchy.Open AccessArchivierung/Langzeitarchivierung gewährleistetcardiovascular risk assessmentanalytical validationapolipoproteinreference measurement procedureautomationNaturwissenschaftenMedizinMedizinepflicht#naturwissenschaftenepflicht#medizinepflicht#medizin019854943141515009510.1515/cclm-2026-0130urn:nbn:de:101:1-2608010344508.215016896240141515009564, Heft 9 (2026), 1947-1956 (gesamt 10)Freier ZugangCC BY1415150095digital.zlb.de