The Presage^® ST2 Assay: analytical considerations and clinical applications for a high-sensitivity assay for measurement of soluble ST2

Abstract

The Presage^® ST2 Assay (Critical Diagnostics, CA, USA) is an in vitro diagnostic device that quantitatively measures soluble suppression of tumorigenicity 2 (sST2) in serum and plasma by ELISA. This assay is US FDA approved and is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. sST2 binds to IL-33 and functions as a ‘decoy’ receptor for IL-33, thereby attenuating the systemic effects of IL-33. Due to the role of IL-33/transmembrane isoform of suppression of tumorigenicity 2 signaling in cardiac remodeling, sST2 has emerged as a novel cardiovascular biomarker. In recent studies, it was shown that sST2 is a valuable predictor of several end points in heart failure, in acute coronary syndromes and in critically ill patients. In this review, analytical considerations and clinical applications of the Presage ST2 Assay will be discussed, as well as probable future concepts for adoption of sST2 measurements into clinical practice.

Keywords::

• acute coronary syndrome
• acute myocardial infarction
• asthma
• biomarker
• B-type natriuretic peptide
• cardiovascular disease
• chronic obstructive pulmonary disease
• emergency department
• heart disease
• heart failure
• IL-33
• ILRL1
• inflammation
• mortality
• natriuretic peptide
• outcome
• pneumonia
• prognosis
• sepsis
• ST2

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.