LIPOPROTEIN(A)-P ELISA

Research Use Only

The Lp(a)-P ELISA from Sun Diagnostics is for Research Use Only and is not for use in diagnostic testing

ASSURANCE™

Intro / Background

Lipoprotein (a) is an LDL-like particle with a unique glycoprotein, apo(a), covalently attached to apo B. Like LDL, Lp(a) is atherogenic and elevated Lp(a) concentrations are associated with increased risk for CHD and cerebrovascular disease (e.g. stroke).1 Since Lp (a) levels are highly heritable, Lp(a) may be an especially important marker for premature CHD.1 Because measured Lp (a) mass can vary substantially due to apo(a) size heterogeneity, expressing results as mg/dL is misleading, Lp(a) mass will vary because of differences in the sizes of apo(a) used to calibrate the assays2 and due to the fact that mass is the sum of protein, lipid, and carbohydrate components.3 A more accurate approach is taken by Sun Diagnostics by using the apo B moiety for detection, which reflects the number of Lp(a) particles. Because there is one molecule of apo B per particle, and because apo B is not subject to size isoform bias like apo (a), the Sun Diagnostics ELISA measures the number of Lp(a) particles in the circulation. Lp(a) particle number is better reflected by expressing concentrations in terms of nanomoles per liter (nmol/L). The SunDxLp(a)-P ELISA measure Lipoprotein(a) particle number.

The Sun DxLp(a)-P ELISA is sensitive, precise, and linear over a wider analytical range than most Lp(a) assays (13-400 nmol/L)

Level Mean Expected Bias nmol/L %Bias SD %CV
1 2 5 -3.2 0.37
2 136 126 9.8 7.84% 8.76 6.46%
3 248 246 1.1 0.47% 16.95 6.85%
4 348 367 -19.1 -5.19% 32.15 9.24%
5 499 488 11.3 2.31% 18.13 3.63%

SunDxLp(a)-P ELISA is strongly correlated to Reference Method (r= 0.971)

There is no statistically significant association between bias and the number of kringle 4 type 2 (k4t2) repeats (Sun Dx versus Northwest Lipid and Diabetes Research Laboratory).
References
  1. Kamstrup PR. Lipoprotein(a) and ischemic heart disease ˗ a causal association? Atherosclerosis 2010; 211:15-23.
  2. Marcovina SM, et al. Effect of the number of apolipoprotein(a) kringle 4 domains on immunochemical measurements of lipoprotein(a). Clin Chem 1995; 41:246-255.
  3. McConnell JP, et al. Lipoprotein(a) mass: a massively misunderstood metric. J Clin Lipidol 2014;

Carine Roitfeld

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