Laboratory validation of a low density lipoprotein apolipoprotein-B assay |
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| Institution: | 1. Maine Standards Company, Windham, ME, USA;2. Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA;3. Geisel School of Medicine at Dartmouth, Hanover, NH, USA;1. Department of Epidemiology, Erasmus MC, 3015 GE Rotterdam, The Netherlands;2. Department of Epidemiology, Harvard T.H Chan School of Public Health, 02115 Boston, USA;3. Department of Global Public Health, Leiden University College, 2595 DG The Hague, The Netherlands;1. Pediatric Endocrine Unit, Massachusetts General Hospital for Children and Harvard Medical School, 175 Cambridge Street, Boston, MA 02114, USA;2. Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA;3. Division of Sports Medicine, Boston Children''s Hospital, 319 Longwood Avenue, Boston, MA 02115, USA;4. Department of Medicine, Massachusetts General Hospital and Harvard Medical School, USA;5. Department of Adolescent Medicine, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA;6. Department of Radiology, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA |
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| Abstract: | ObjectivesNumerous publications have shown strong association between CHD risk and either apolipoprotein B (Apo-B) or low density lipoprotein (LDL) particle number (LDL-P). It is however unknown if Apo-B or LDL-P has a stronger predictive ability for future CHD. This uncertainty may be due to the inability of current Apo-B assays to separate the contribution of very low-density lipoprotein particles from the total Apo-B concentration. As such we have performed a laboratory validation of the Maine Standards® LDL Apo-B assay on the Roche Cobas 6000 analyzer.Design and methodsImprecision, linear range, and limit of quantitation studies were performed using quality control materials. Plasma samples collected for lipid profile analysis were analyzed via the LDL Apo-B assay and compared to the LDL cholesterol (LDL-C) concentration determined via direct LDL assay and Friedewald equation.ResultsThe LDL Apo-B within-run imprecision was 2.3% at 62 mg/dL and 2.2% at 109 mg/dL. The within-laboratory imprecision was 9.7% at 57 mg/dl and 6.1% at 104 mg/dL. Linear regression analysis of LDL Apo-B versus calculated and measured LDL-c resulted in equations of LDL Apo-B = 0.620 1 (LDL) + 45.4, R = 0.9063 and LDL-Apo-B = 0.607 1 (LDL) + 38.8, R = 0.9393, respectively. Bias plot analyses revealed that at low LDL-C concentration, there was a tendency for a higher than anticipated LDL Apo-B concentration.ConclusionsThe Maine Standards LDL Apo-B assay is a precise automated assay and comparison of LDL Apo-B to LDL-c concentration demonstrates that low LDL-C concentrations may still carry residual risk of CHD due to increased concentration of small dense LDL particles. |
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