Correlation and Commutability Study between an LC-MS-Based Reference Measurement Procedure and Immunoassays Measuring Apolipoprotein A-I and Apolipoprotein B
Clinical Chemistry, vol. 72, pp. 960–972
Abstract
BACKGROUND: Serum concentrations of apolipoprotein A-I (ApoA-I) and apolipoprotein B (ApoB) can have a predictive value for cardiovascular events beyond the traditional lipid profile. The IFCC Working Group on Apolipoproteins by Mass Spectrometry is developing a novel reference measurement system for seven clinically relevant apolipoproteins, including ApoA-I and ApoB. The system will consist of a multiplex mass spectrometry-based reference measurement procedure (RMP) and commutable secondary reference materials (RMs). METHODS: Agreement between the RMP and 8 immunoassay-based measurement procedures (MPs) was investigated using 30 clinical samples. Furthermore, the commutability of 8 candidate RMs, consisting of frozen serum pools, and the existing WHO-IFCC standards SP1-01 and SP3-08 was assessed. RESULTS: The harmonization level among eight immunoassay-based MPs for ApoA-I and ApoB still needs improvement. The RMP results showed a good correlation with results of the immunoassay-based MPs for both ApoA-I and ApoB. For ApoA-I, 7 candidate RMs showed good commutability, while SP1-01 and one candidate RM showed potential noncommutability for one method comparison. For ApoB, the commutability profile of the candidate RMs was more variable, and SP3-08 showed noncommutability for several method comparisons. CONCLUSIONS: The RMP and the immunoassay-based MPs have comparable selectivity for ApoA-I and ApoB, and a well-established reference measurement system can lead to improved harmonization. Future commutable secondary RMs can be based on frozen human serum pools; however, for ApoB, preselection of single-donor samples might be needed to limit the impact of sample-specific effects.
Authors 34
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European Commission · Joint Research Center · Joint Research Centre · Joint Research Centre
Affiliation as printed
European Commission, Joint Research Centre (JRC) , Geel ,
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center , Leiden ,
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Laboratoire National de Métrologie et d'Essais
Affiliation as printed
Laboratoire National de Métrologie et d’Essais (LNE) , Paris ,
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Convent Hospital of the Brothers of Saint John of God
Affiliation as printed
Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz and Ordensklinikum Linz , Linz ,
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Convent Hospital of the Brothers of Saint John of God
Affiliation as printed
Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz and Ordensklinikum Linz , Linz ,
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Laboratoire National de Métrologie et d'Essais
Affiliation as printed
Laboratoire National de Métrologie et d’Essais (LNE) , Paris ,
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Affiliation as printed
Laboratorio LAMAT , Torino ,
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Exosome Diagnostics (United States)
Affiliation as printed
DiaSys Diagnostic Systems GmbH , Holzheim ,
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Affiliation as printed
In Vitro Diagnostic Traceability and Reference Research Department, Mindray Biomedical Electronics Co., Ltd. , Shenzhen ,
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Centers for Disease Control and Prevention
Affiliation as printed
Division of Laboratory Sciences, Centers for Disease Control and Prevention (CDC) , Atlanta ,
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Affiliation as printed
Beckman Coulter Ireland Inc., Clinical Chemistry R&D Laboratory , County Clare ,
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Siemens Healthineers (Germany)
Affiliation as printed
Siemens Healthcare Diagnostics Products GmbH , Marburg ,
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European Commission · Joint Research Center · Joint Research Centre · Joint Research Centre
Affiliation as printed
European Commission, Joint Research Centre (JRC) , Geel ,
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center , Leiden ,
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Affiliation as printed
Roche Diagnostics GmbH , Penzberg ,
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Centers for Disease Control and Prevention
Affiliation as printed
Division of Laboratory Sciences, Centers for Disease Control and Prevention (CDC) , Atlanta ,
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Affiliation as printed
Reference System Center of Maccura Biotechnology Co., Ltd. , Sichuan ,
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European Commission · Joint Research Center · Joint Research Centre · Joint Research Centre
Affiliation as printed
European Commission, Joint Research Centre (JRC) , Geel ,
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center , Leiden ,
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Laboratoire National de Métrologie et d'Essais
Affiliation as printed
Laboratoire National de Métrologie et d’Essais (LNE) , Paris ,
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Laboratoire National de Métrologie et d'Essais
Affiliation as printed
Laboratoire National de Métrologie et d’Essais (LNE) , Paris ,
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Centers for Disease Control and Prevention
Affiliation as printed
Division of Laboratory Sciences, Centers for Disease Control and Prevention (CDC) , Atlanta ,
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Centers for Disease Control and Prevention
Affiliation as printed
Division of Laboratory Sciences, Centers for Disease Control and Prevention (CDC) , Atlanta ,
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center , Leiden ,
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European Commission · Joint Research Center · Joint Research Centre · Joint Research Centre
Affiliation as printed
European Commission, Joint Research Centre (JRC) , Geel ,
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European Commission · Joint Research Center · Joint Research Centre · Joint Research Centre
Affiliation as printed
European Commission, Joint Research Centre (JRC) , Geel ,
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