The Randox Lp(a) assay is calibrated in nmol/l and traceable to the WHO/IFCC reference material (IFCC SRM 2B) and provides an acceptable bias compared with the Northwest Lipid Metabolism Diabetes Research Laboratory (NLMDRKL) gold standard method.
Dedicated five-point calibrator available
Five-point calibrator with accuracy-based assigned target values (in nmol/l) is available, accurately reflecting the heterogeneity of the apo(a) isoforms. Dedicated Lp(a) control is available offering a complete testing package.
Excellent correlation
A correlation coefficient of r=0.995 was displayed when the Randox method was compared against other commercially available methods.
Precision
Excellent precision
The Randox Lp(a) assay displayed a within run precision of <2.54%.
Liquid ready-to-use
The Randox Lp(a) assay is available in a liquid ready-to-use format for convenience and ease-of-use.
Applications available
Applications are available detailing instrument-specific settings for the convenient use of the Randox Lp(a) assay on a wide range of clinical chemistry analysers.
The main challenge in Lp(a) measurement lies in the heterogeneity of apo(a) isoforms, leading to under- or overestimation of concentrations. In immunoassays, variable KIV-2 repeats in Lp(a) act as multiple epitopes, making standardisation of calibrators crucial. Without a matching range of isoforms in calibrants and test samples, higher KIV-2 repeats result in overestimation of Lp(a) levels.
* FDA 510(k) cleared for mg/dL units only, measuring Lp(a) in nmol/L is not FDA approved for the USA market.