Vincent Delatour1, Noemie Clouet-Foraison2, François Gaie-Levrel2, Santica M Marcovina3, Andrew N Hoofnagle4, Zsuzsanna Kuklenyik5, Michael P Caulfield6, James D Otvos7, Ronald M Krauss8, Krishnaji R Kulkarni9, John H Contois10, Alan T Remaley11, Hubert W Vesper5, Christa M Cobbaert12, Philippe Gillery13. 1. Laboratoire National de Métrologie et d'Essais (LNE), Paris, France; vincent.delatour@lne.fr. 2. Laboratoire National de Métrologie et d'Essais (LNE), Paris, France. 3. Northwest Lipid Metabolism and Diabetes Research Laboratories, University of Washington, Seattle, WA. 4. Department of Laboratory Medicine, University of Washington, Seattle, WA. 5. Centers for Disease Control and Prevention, Division of Laboratory Sciences, Atlanta, GA. 6. Quest Diagnostics Nichols Institute, San Juan Capistrano, CA. 7. Laboratory Corporation of America® Holdings, Morrisville, NC. 8. Children Hospital Oakland Research Institute, Oakland, CA. 9. VAP Diagnostics Laboratory Inc., Birmingham, AL. 10. Sun Diagnostics, LLC, New Gloucester, ME. 11. Lipoprotein Metabolism Section, National Heart, Lung, and Blood Institute, Bethesda, MD. 12. Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, the Netherlands. 13. University Hospital of Reims, Laboratory of Pediatric Biology and Research, Reims, France.
Abstract
BACKGROUND: Despite the usefulness of standard lipid parameters for cardiovascular disease risk assessment, undiagnosed residual risk remains high. Advanced lipoprotein testing (ALT) was developed to provide physicians with more predictive diagnostic tools. ALT methods separate and/or measure lipoproteins according to different parameters such as size, density, charge, or content, and equivalence of results across methods has not been demonstrated. METHODS: Through a split-sample study, 25 clinical specimens (CSs) were assayed in 10 laboratories before and after freezing using the major ALT methods for non-HDL particles (non-HDL-P) or apolipoprotein B-100 (apoB-100) measurements with the intent to assess their comparability in the current state of the art. RESULTS: The overall relative standard deviation (CV) of non-HDL-P and apoB-100 concentrations measured by electrospray differential mobility analysis, nuclear magnetic resonance, immunonephelometry, LC-MS/MS, and vertical autoprofile in the 25 frozen CSs was 14.1%. Within-method comparability was heterogeneous, and CV among 4 different LC-MS/MS methods was 11.4% for apoB-100. No significant effect of freezing and thawing was observed. CONCLUSIONS: This study demonstrates that ALT methods do not yet provide equivalent results for the measurement of non-HDL-P and apoB-100. The better agreement between methods harmonized to the WHO/IFCC reference material suggests that standardizing ALT methods by use of a common commutable calibrator will improve cross-platform comparability. This study provides further evidence that LC-MS/MS is the most suitable candidate reference measurement procedure to standardize apoB-100 measurement, as it would provide results with SI traceability. The absence of freezing and thawing effect suggests that frozen serum pools could be used as secondary reference materials.
BACKGROUND: Despite the usefulness of standard lipid parameters for cardiovascular disease risk assessment, undiagnosed residual risk remains high. Advanced lipoprotein testing (ALT) was developed to provide physicians with more predictive diagnostic tools. ALT methods separate and/or measure lipoproteins according to different parameters such as size, density, charge, or content, and equivalence of results across methods has not been demonstrated. METHODS: Through a split-sample study, 25 clinical specimens (CSs) were assayed in 10 laboratories before and after freezing using the major ALT methods for non-HDL particles (non-HDL-P) or apolipoprotein B-100 (apoB-100) measurements with the intent to assess their comparability in the current state of the art. RESULTS: The overall relative standard deviation (CV) of non-HDL-P and apoB-100 concentrations measured by electrospray differential mobility analysis, nuclear magnetic resonance, immunonephelometry, LC-MS/MS, and vertical autoprofile in the 25 frozen CSs was 14.1%. Within-method comparability was heterogeneous, and CV among 4 different LC-MS/MS methods was 11.4% for apoB-100. No significant effect of freezing and thawing was observed. CONCLUSIONS: This study demonstrates that ALT methods do not yet provide equivalent results for the measurement of non-HDL-P and apoB-100. The better agreement between methods harmonized to the WHO/IFCC reference material suggests that standardizing ALT methods by use of a common commutable calibrator will improve cross-platform comparability. This study provides further evidence that LC-MS/MS is the most suitable candidate reference measurement procedure to standardize apoB-100 measurement, as it would provide results with SI traceability. The absence of freezing and thawing effect suggests that frozen serum pools could be used as secondary reference materials.
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