Lipoprotein(a) assay

Description

Intended Use

For the quantitative in vitro determination of Lp(a) in serum or plasma. This product is suitable for automated, semi-automated and manual use.

Clinical Significance

Lipoprotein (a) determination is intended for use in conjunction with clinical evaluation, patient risk assessment and other lipid tests to evaluate disorders of lipid metabolism and to assess coronary heart disease in specific populations.

WHO/IFCC Reference Material

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), through its Working Group on Lp(a) and together with research institutions and several diagnostic companies recommends that laboratories use assays which do not suffer from apo(a) size-related bias. The IFCC SRM 2B was accepted by the WHO Expert Committee on Biological Standardisation as the First WHO/IFCC International Reference Reagent for Lp(a) to ensure conformity by diagnostic companies to the European Union?s Directive on In vitro Diagnostic Medical Devices for the metrological traceability of calibrator materials.

Randox Lp(a) Assay

The Randox Lp(a) assay is standardised to the WHO/IFCC reference material (IFCC SRM 2B) and is closest in terms of agreement to the ELISA reference material. A dedicated five-point calibrator and control are available, accurately reflecting the heterogeneity of the apo(a) isoforms. Measuring units are in nmol/l which is more uniformed.