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.
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.
Authors: James D Otvos; John R Guyton; Margery A Connelly; Sydney Akapame; Vera Bittner; Steven L Kopecky; Megan Lacy; Santica M Marcovina; Joseph B Muhlestein; William E Boden Journal: J Clin Lipidol Date: 2018-01-12 Impact factor: 4.766
Authors: Peter R van Dijk; Joëlle C Schutten; Elias J Jeyarajah; Jenny E Kootstra-Ros; Margery A Connelly; Stephan J L Bakker; Robin P F Dullaart Journal: Diabetologia Date: 2019-06-27 Impact factor: 10.122
Authors: Andrew P Demidowich; Anna Wolska; Sierra R Wilson; Jordan A Levine; Alexander V Sorokin; Sheila M Brady; Alan T Remaley; Jack A Yanovski Journal: J Clin Lipidol Date: 2019-10-22 Impact factor: 4.766
Authors: Laura A McGuinn; Alexandra Schneider; Robert W McGarrah; Cavin Ward-Caviness; Lucas M Neas; Qian Di; Joel Schwartz; Elizabeth R Hauser; William E Kraus; Wayne E Cascio; David Diaz-Sanchez; Robert B Devlin Journal: Environ Int Date: 2018-11-13 Impact factor: 9.621
Authors: Mohammad Shadab Siddiqui; Mark L Van Natta; Margery A Connelly; Raj Vuppalanchi; Brent A Neuschwander-Tetri; James Tonascia; Cynthia Guy; Rohit Loomba; Srinivasan Dasarathy; Julia Wattacheril; Naga Chalasani; Arun J Sanyal Journal: J Hepatol Date: 2019-10-18 Impact factor: 25.083
Authors: Micah L Olson; Ana Rentería-Mexía; Margery A Connelly; Sonia Vega-López; Erica G Soltero; Yolanda P Konopken; Allison N Williams; Felipe G Castro; Colleen S Keller; Hongwei P Yang; Michael W Todd; Gabriel Q Shaibi Journal: J Clin Lipidol Date: 2018-09-22 Impact factor: 4.766
Authors: Laura Durcan; Deborah A Winegar; Margery A Connelly; James D Otvos; Laurence S Magder; Michelle Petri Journal: J Rheumatol Date: 2016-02-01 Impact factor: 4.666
Authors: Stephanie T Chung; Celeste K L Cravalho; Abby G Meyers; Amber B Courville; Shanna Yang; Nirupa Rachel Matthan; Lilian Mabundo; Maureen Sampson; Ronald Ouwerkerk; Ahmed M Gharib; Alice H Lichtenstein; Alan T Remaley; Anne E Sumner Journal: Circ Res Date: 2019-10-18 Impact factor: 17.367
Authors: Erwin Garcia; Justyna Wolak-Dinsmore; Zeneng Wang; Xinmin S Li; Dennis W Bennett; Margery A Connelly; James D Otvos; Stanley L Hazen; Elias J Jeyarajah Journal: Clin Biochem Date: 2017-06-15 Impact factor: 3.281