AccuCardia ELISA Test System

Intended Use

The AccuCardia™ ELISA Test System is an enzyme assay for the in vitro quantitative determination of sPLA2-IIA protein levels in human EDTA plasma. sPLA2-IIA protein levels are to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.

Manage CVD patients via valuable novel cardiovascular risk assessment tools.

Significance and Background

Cardiovascular disease (CVD) accounts for nearly half of the noncommunicable diseases worldwide, and is a leading cause of global death. In 2008, the World Health Organization estimated that 17.3 million people died from CVD; the majority of these deaths being attributed to myocardial infarction (MI) and stroke. The severe clinical consequences of CVD, such as MI and stroke, are typically caused by atherosclerotic lesions; which ultimately disrupt the flow of blood to vital organs such as the heart and/or brain. Close examination of these lesions reveal complex arterial structures consisting of connective tissue elements, inflammatory cells, lipids, and debris. In recent years, research has shown that phosholipase A2 (PLA2) enzymes are key factors involved in atherosclerotic CVD; thus, they have emerged as promising biomarkers.

PLA2 enzymes are a family of proteins that catalyze the hydrolysis of phospholipids at the sn-2 position, yielding pro-inflammatory lysophospholipids and fatty acids. Secreted PLA2 (sPLA2) proteins make up a subgroup of this family, and consist of 10 calcium-dependent extracellular enzymes with relatively low molecular masses. A notable member of this subgroup, termed sPLA2-IIA, has been the focus of numerous basic research and clinical studies aimed at investigating its role in, and association with, cardiovascular conditions such as coronary artery disease (CAD) and atherosclerosis. For example, several reports have linked increased plasma levels of sPLA2-IIA with recurrent events and adverse outcomes in patients with stable CAD. Recently, additional studies have also shown that increased levels of sPLA2-IIA are predictive of recurrent cardiac events and death in patients presenting with acute coronary syndromes, such as MI and unstable angina.

Risk-stratify your patients & personalize patient care with appropriate therapeutic regimes.

Principle of the Assay

The AccuCardia test is a dual monoclonal antibody sandwich ELISA assay designed to quantitatively detect sPLA2-IIA protein in human plasma. A brief overview of the test procedure is as follows:

1. Test plasma, Calibrators, and Controls are diluted in Sample Diluent, then transferred to a microtiter plate containing immobilized anti-sPLA2-IIA antibody.
2. The diluted samples are incubated for one hour in the antibody-coated microwells. Sample-derived sPLA2-IIA is bound to the plate via interaction with the immobilized antibody. After incubation, the wells are washed to remove other plasma components.
3. A solution containing horse radish peroxidase (HRP)-conjugated anti-sPLA2-IIA antibody is then added to each well, and the plate is incubated again for one hour. After incubation, the plate is washed to remove unbound HRP conjugate.
4. The microwells containing immobilized sPLA2-IIA and HRP-conjugate are incubated for 10 minutes with peroxidase substrate solution, and hydrolysis of the substrate produces a color change.
5. After 10 minutes, the reaction is stopped and the color intensity of the solution is measured photometrically. The color intensity of the solution is proportional to the amount of sPLA2-IIA protein in the original test sample.

Benefits and Features

• System utilizes sPLA2-IIa biomarker
• Allows clinicians to risk stratify CAD/ACS patients and apply appropriate therapeutic regimes
• Independently associated with cardiovascular disease (CVD)
• Clinically validated with over 20 peer reviewed publications
• GRACE study showed patients with high sPLA2-IIa have over 3x odds of recurrent MI.
• Personalize patient care and provide better diagnostic and therapeutic treatment by better patient stratification

For more information visit accucardia.com.