Randox Unveils an Assay for the Rapid Measurement of Small Dense LDL Cholesterol (sdLDL-C)

Results of these assays only detect about 20% of all atherosclerotic cardiovascular disease patients. However, studies have shown that sdLDL-C could predict risk of coronary heart disease in individuals considered being at low cardiovascular risk based on their LDL-C levels. These studies found that patients with a predominance of sdLDL-C had a three-fold increased risk of myocardial infarction (MI), while the relative risk was 4.5 for coronary artery disease and 7.0 for MI when sdLDL-C levels were greater than 100 milligrams per deciliter.

Until recently, the primary methods for determining a patient's sdLDL-C levels were based on laborious and time-consuming ultracentrifugation and electrophoresis. Then, in November 2017, the [U.S.] Food and Drug Administration granted 510(k) marketing clearance to Denka Seiken (Tokyo, Japan) for a small dense low-density lipoprotein cholesterol (sdLDL-C) assay designed for use on any standard clinical chemistry analyzer. The assay quantified sdLDL-C in serum and plasma samples in 10 minutes using a two-step process. The first step removed chylomicrons, very low LDL, intermediate-density lipoprotein, large LDL, and high-density lipoprotein using a surfactant and sphingomyelinase. In the second step, a specific surfactant released cholesterol only from the sdLDL-C particles for measurement by standard methods.

The Randox (Crumlin, United Kingdom) sdLDL-C assay utilizes the Denka Seiken method, providing accurate patient results. It was designed for use on automated biochemistry analyzers for efficiency and convenience. Applications are available detailing instrument-specific settings for the convenient use of the Randox sdLDL-C assay on a wide range of biochemistry analyzers. Dedicated sdLDL-C controls and calibrator are available providing a complete testing package. The Randox sdLDL-C assay is a niche product, and Randox is one of the only manufacturers of this test in an automated format.