Intended use

This device is intended to be used for the in vitro quantitative determination of soluble growth stimulation gene-2 (sST2) in human whole blood, serum or plasma. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.

Summary

Soluble ST2 (sST2) is a member of the interleukin-1 (IL-1) receptor family and it can be found in a transmembrane form (ST2 ligand or ST2L) and a soluble, circulating form (sST2) When soluble ST2 levels are low, ST2’s ligand, IL-33, is available to bind to ST2L and has a cardioprotective effect resulting in preserved cardiac function. However, when soluble ST2 levels are high, soluble ST2 competitively binds to IL-33, making IL-33 less likely to bind to ST2L and thereby making IL-33 unavailable for cardioprotective signaling.

This higher concentration of soluble ST2 is associated with increased myocardial fibrosis, adverse cardiac remodeling, worse cardiovascular outcomes and an increase in the rate of disease progression.

Studies shows that the changes in sST2 level during follow up patients admitted with acute HF represent a strong, independent predictor of the composite endpoint of all-cause mortality or readmission for HF over at least 1 year follow-up.

The current clinical methods for detecting sST2 include chemiluminescence, immunochromatography and so on.

PRODUCT PARAMETER

TEST INFORMATION
Method	Microfluidic Fluorescent Immunoassay	Test	LYOFIA® sST2
Format	Cassette	Reaction Time	10min
Linearity	3.1～200ng/mL	Reference Interval	＜35ng/mL
Sample	WB / S / P	Certificate	CE

ORDERING
Cat. No.	LMCMSS25	Applicable analyzer	LYOFIA-I, LYOFIA 8,	Kit Size	25T
Cat. No.	LACMSS25	Applicable analyzer	LYOFIA 100 (Full-Automatic)	Kit Size	25T