Traditional challenges of Lp(a) measurement The widespread use of Lp(a) as an independent risk factor for cardiovascular disease (CVD) has until recently been impeded by the lack of internationally accepted standardization and the fact that many commercial Lp(a) methods suffer from apo(a) size related bias, potentially leading to patient misclassification.
The size heterogeneity of apo(a) affects, to varying degrees, the results of many commercially available Lp(a) kits. This may result in an underestimation of Lp(a) in samples containing apo(a) molecules, smaller than that used in the assay’s calibrator and conversely may overestimate the concentration in samples containing larger apo(a) particles.
Clinical significance of Lp(a)
The size of the apo(a) protein is genetically determined and varies widely. As such, the levels of Lp(a) can vary up to 1000-fold between individuals. Recent years have seen major scientific advances in the understanding of Lp(a) and its causal role in premature CVD.
IFCC guidelines
The International Federation of Clinical Chemistry (IFCC) Working Group on Lp(a) recommends that laboratories use assays which do not suffer from apo(a) size-related bias to minimize the potential misclassification of patients at risk of coronary heart disease.
The Randox Lp(a) assay
- The Randox Lp(a) assay is one of the only methodologies on the market that detects the non-variable part of the Lp(a) molecule reducing the risk of size-related bias providing more accurate and consistent results. The Randox Lp(a) kit is standardized to the WHO/IFCC reference material SRM 2B and is closest in terms of agreement to the ELISA reference method.
- Five calibrators with accuracy-based assigned target values are provided which accurately reflect the heterogeneity of isoforms present in the general population.
- Measuring units are available in nmol/L upon request
- Highly sensitive and specific method for Lp(a) detection in serum and plasma
- Liquid ready-to-use reagents for convenience and ease-of-use
- Applications are available detailing instrument-specific settings for the convenient use of the Randox Lp(a) assay on a wide range of clinical chemistry analyzers
