NMR measurement of LDL particle number using the Vantera Clinical Analyzer

Autor: Elias J. Jeyarajah, Yuan Xu, Paul J. Braun, Thomas S. Clement, Margery A. Connelly, Irina Shalaurova, Justyna Wolak-Dinsmore, Suzette M. Warner, Steven P. Matyus, Timothy J. Fischer
Rok vydání: 2014
Předmět:
Zdroj: Clinical biochemistry. 47(16-17)
ISSN: 1873-2933
Popis: Background The Vantera Clinical Analyzer was developed to enable fully-automated, high-throughput nuclear magnetic resonance (NMR) spectroscopy measurements in a clinical laboratory setting. NMR-measured low-density lipoprotein particle number (LDL-P) has been shown to be more strongly associated with cardiovascular disease outcomes than LDL cholesterol (LDL-C) in individuals for whom these alternate measures of LDL are discordant. Objective The aim of this study was to assess the analytical performance of the LDL-P assay on the Vantera Clinical Analyzer as per Clinical Laboratory Standards Institute (CLSI) guidelines. Results Sensitivity and linearity were established within the range of 300–3500 nmol/L. For serum pools containing low, medium and high levels of LDL-P, the inter-assay, intra-assay precision and repeatability gave coefficients of variation (CVs) between 2.6 and 5.8%. The reference interval was determined to be 457–2282 nmol/L and the assay was compatible with multiple specimen collection tubes. Of 30 substances tested, only 2 exhibited the potential for assay interference. Moreover, the LDL-P results from samples run on two NMR platforms, Vantera Clinical Analyzer and NMR Profiler, showed excellent correlation (R 2 = 0.96). Conclusions The performance characteristics suggest that the LDL-P assay is suitable for routine testing in the clinical laboratory on the Vantera Clinical Analyzer, the first automated NMR platform that supports NMR-based clinical assays.
Databáze: OpenAIRE