Elevated levels of Lipoprotein(a), (Lp(a)), are considered to be both a causal risk factor and major independent genetic marker of atherosclerotic disorders. What differentiates Lipoprotein(a) testing is that the association between higher Lipoprotein(a) levels and increased CVD risk is continuous and does not depend on raised LDL levels or non-HDL cholesterol, or other CVD risk factors.

The major challenge with this test is the size variation of apo(a) within Lipoprotein(a). Dependent upon the size of apo(a) in the assay calibrator, many assays under or overestimate apo(a) size in the patient sample. Many Lipoprotein(a) measurement techniques therefore suffer size related bias problems resulting in an over estimation of Lipoprotein(a) in samples with large apo(a) molecules and an under estimation in samples with small apo(a) molecules. Randox Lipoprotein(a) offers an alternative to these techniques.

The Randox Lipoprotein(a) assay contains a very high density of isoform-insensitive antibodies and detection reagent which ensures more Lipoprotein(a) bound antibodies are detected. The antibody used in the Randox Lipoprotein(a) method detects the complete Lipoprotein(a) molecule therefore ensuring minimal bias effect and the production of more accurate and consistent results. Furthermore, Randox produces a 5-point calibrator which takes into account the heterogeneity of the Lipoprotein(a) molecule for each of the levels, resulting in excellent commutability of the calibrator with patient samples.

Additionally, a working collaboration with the renowned research centre responsible for the development of the gold standard for Lipoprotein(a) testing, has recently led to the 5-point Randox Lipoprotein(a) calibrator being fully traceable to this gold standard for a wide range of routinely used clinical chemistry systems. Randox understand the importance of standardization within Lipoprotein(a) measurement in order to deliver the ultimate in testing accuracy and quality of results.

Randox Lipoprotein(a) Key Assay Details

Liquid ready-to-use reagentsImmunoturbidimetric assayAssay range of 3-90 mg/dlNo sample preparation requiredInstrument Specific Applications available for a wide range of clinical chemistry analyzers