Randox Release: Liquid Ready to Use LP(A) Kit from Randox With Minimal Size Related Bias

Crumlin, UK, 2010 -- The Randox liquid ready to use Lipoprotein (a) kit provides a highly sensitive and specific method for the detection of Lp(a) in serum and plasma, furthermore it is one of the only methods available on the market to exhibit minimum Apo (a) size related bias.

Lp(a) in combination with other lipid tests can provide clinicians with much needed additional information on an individual’s risk of developing cardiovascular disease. It is of particular use in assessing the risk of coronary heart disease in specific populations as Lp(a) concentrations have been shown to be genetically determined and to vary with ethnic populations.

Lp(a) is an LDL like particle with a molecule of Apolipoprotein B-100 (Apo B100) linked by a disulphide bridge to Apolipoprotein (a) (Apo(a)). Apo (a) is unique in that it is extremely heterogeneous in size. It is made up of a variable number of repeat structures known as kringles. The size heterogeneity of Apo (a) is due to the kringle 4 domain and the kringle 4 type 2 domain in particular which can be present in a variable number of repeat copies (3- 40).

The use of Lp(a) as an independent risk factor for cardiovascular disease risk has been impeded by the lack of internationally accepted standardisation and the fact that many commercial Lp(a) methods suffer from apolipoprotein (a) size related bias. The size heterogeneity of Apo (a) affects to varying degrees the outcome of many commercially available Lipoprotein (a) kits resulting in the underestimation of Apo (a) in samples containing an Apo (a) molecule smaller than that used in the assays calibrator and conversely to overestimate the concentration in samples containing larger Apo (a) particles. The antibody used in the Randox method detects the complete Lp(a) molecule providing accurate and consistent results.

Research has documented and shown the Randox method to be one of only few to exhibit minimum size related bias. The International Federation of Clinical Chemistry (IFCC) have conducted studies which clearly highlight the extent of the problem in other commercially available products and now recommend laboratories use tests from suppliers who do not suffer from Apo (a) size related bias.

Not only is the Randox Lp(a) kit robust against Apo (a) size heterogeneity it is also standardised to the WHO/IFCC reference material SRM 2B and is closest in terms of agreement to the ELISA reference method. Other benefits of the Randox Lp(a) kit include:

- Liquid ready to use reagents

- Excellent stability - open vial stability of 30 days on board the analyser at 10oC

- Dynamic assay range 3 – 90 mg/dl

- Excellent precision – within run CVs <3%

- No sample preparation required

- Limited interference from Intralipid®, Bilirubin, Haemoglobin, Ascorbic Acid, Triglycerides, Plasminogen and Apolipoprotein B

- Antigen excess effects are not noted up to 341 mg/dl

- Dedicated or multi-analyte controls and calibrators available

- Fully automated applications available for a wide range of clinical analysers

For further information contact Marketing on +44 (0) 28 9442 2413 or email marketing@randox.com

Randox Laboratories 55 Diamond Road Crumlin Co. Antrim BT29 4QY United Kingdom

Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 marketing@randox.com www.randox.com

About Randox:

- Randox is an international diagnostic solutions company, headquartered in the UK with 25 offices worldwide.

- Randox is a market leader in developing, manufacturing and marketing clinical diagnostic products including the revolutionary Biochip Array Technology, clinical chemistry analysers and reagents, quality controls and EQA as well as a complete life science range.

- Randox provides innovative products to over 30,000 customers worldwide ranging from hospitals and research laboratories to veterinary laboratories, pharmaceutical companies and crime labs.

- Re-invests significantly into Research and Development.

- 5 x Winners of the Queen’s Award for Enterprise.

- Invest NI Innovator of the Year 2009

- Manufacturing Excellence Award 2009 for Product Innovation

- Randox is revolutionising healthcare through continuously improving diagnostic solutions.

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