Critical Diagnostics Soluble ST2 Biomarker Assays
Soluble ST2 (sST2) is a biomarker specific to myocardial remodelling and cardiac fibrosis. Unlike traditional natriuretic peptides that indicate cardiac stretch, sST2 provides insight into the active tissue remodelling process, aiding in long-term risk assessment and treatment monitoring for heart failure. Critical Diagnostics offers validated testing solutions tailored to diverse laboratory workflows.
| Parameter | Presage® ST2 Assay | SEQUENT-IAT™ ST2 Assay | ASPECT-PLUS™ Rapid Test |
| Assay Format | Quantitative 96-well Sandwich ELISA | Automated Turbidimetric Immunoassay | Lateral Flow Immunoassay Cassette |
| Sample Type | Serum & Plasma | Plasma | EDTA Plasma (30 µL) |
| Time to Result | Standard ELISA incubation [UNCONFIRMED] | Rapid automated clinical chemistry run | 20 minutes |
| Readout / Instrument | Microplate Reader [UNCONFIRMED] | Automated Analysers (cobas®, AU) | Dedicated Aspect-PLUS Reader[cite: 5, 6] |
| Regulatory Status | CE-IVD & US FDA 510(k) Cleared | CE-IVD | CE-IVD |
| Item Code | Description | Pack Size / Details |
| BC-1065E | Presage® ST2 Assay Kit | 96-well ELISA Kit |
| BC-1066E | Presage® ST2 Control Kit | Control Kit for Presage® Assay |
| PLUS0001 | Aspect-Plus ST2 Kit | 20 test cassettes, 1 buffer bottle |
| LQC1111 | Aspect Plus ST2 Liquid Quality Control | Liquid Quality Control Kit |
| READ0001 | Aspect Reader | Includes 1 EQC-cartridge & 1 roll paper |
| SEQUENT-IAT | SEQUENT-IAT™ ST2 Assay | Automated Turbidimetric Immunoassay Reagent |
Contact Philippe Loir your Diagnostics expert
Resources
Have product questions?
- Independent Marker of Cardiac Fibrosis & Ventricular Remodelling
- Low Biological Variation
- Rapid Response to Clinical Status
- Unaffected by Age, BMI, or Impaired Renal Function
- Independent Marker of Cardiac Fibrosis & Ventricular Remodelling
- Low Biological Variation
- Rapid Response to Clinical Status
- Unaffected by Age, BMI, or Impaired Renal Function
Testing Solutions
Available ST2 Assay Formats
Presage® ST2 Assay (ELISA)
A quantitative 96-well sandwich ELISA for microplate workflows. Serves as the established reference methodology utilized across landmark clinical trial literature.
SEQUENT-IAT™ ST2 Assay (Automated)
An automated turbidimetric immunoassay designed for high-throughput clinical chemistry platforms, including selected Roche cobas® and Beckman Coulter AU systems.
ASPECT-PLUS™ Rapid ST2 Test
A quantitative point-of-care lateral flow test paired with a dedicated reader, delivering precise sST2 results in 20 minutes from a 30 µL EDTA plasma sample. (Note: Check regional availability).
Clinical Utility & Assessment
Using ST2 in Heart Failure Patient Management
Soluble ST2 is a cardiac biomarker that provides actionable prognostic insight for managing patients with heart failure. Integrating sST2 testing into routine clinical care supports precise risk stratification, therapeutic decision-making, and patient monitoring.
Cardiac biomarkers are systemic substances released into the circulation following myocardial strain or tissue injury. In chronic heart failure management, measuring these biomarkers helps clinicians:
- Support patient risk stratification
- Evaluate potential therapeutic options
- Monitor disease progression
- Inform in-hospital and post-discharge care protocols
ST2 is a soluble cardiac protein expressed in response to myocardial disease or stress. Circulating sST2 levels change dynamically alongside changes in patient status. When interpreted alongside established clinical parameters, sST2 measurements assist physicians in determining appropriate interventions.
Clinical studies demonstrate that blood concentrations of sST2 predict patient outcomes. Measuring sST2 via a non-invasive blood test facilitates the early identification of chronic heart failure patients facing higher risks of readmission and mortality.
Measuring soluble ST2 offers several key analytical and clinical benefits:
- Established Clinical Cutpoint:
A single threshold of 35 ng/mL streamlines clinical decision-making. - Minimal Confounding:
Circulating levels are not adversely affected by age, sex, BMI, history of heart failure, anaemia, or impaired renal function. - Rapid Kinetics:
sST2 levels adjust dynamically to changes in a patient's underlying condition. - Complementary Value:
Provides independent, additive prognostic data when used alongside other cardiac biomarkers.
Support & Implementation
Integrate Soluble ST2 Testing in Your Laboratory
Contact our Diagnostics product specialists to evaluate analyzer compatibility, review clinical data, or request trial kits.
Frequently Asked Questions About Soluble ST2
Essential information regarding biological characteristics, clinical utility, and laboratory implementation.
Natriuretic peptides (BNP/NT-proBNP) are released in response to myocardial wall stretch and haemodynamic stress. In contrast, soluble ST2 is a marker of cardiac fibrosis and ventricular remodelling. It acts as a decoy receptor for IL-33, reflecting active structural tissue changes rather than fluid overload alone.
Unlike natriuretic peptides, circulating sST2 levels are not significantly altered by confounders such as advanced age, elevated body mass index (BMI), or impaired renal function (eGFR). This minimizes "gray zones" and simplifies result interpretation in heterogeneous patient populations.
Clinical studies establish a standard cutpoint of 35 ng/mL for risk stratification. Patients with sST2 levels exceeding 35 ng/mL exhibit significantly higher risk for 30-day rehospitalization, disease progression, and long-term mortality.
Yes. Soluble ST2 exhibits rapid kinetic response and low intra-individual biological variation. Serial measurements enable clinicians to track treatment efficacy; falling sST2 levels indicate positive response to medical therapy (e.g., beta-blockers or aldosterone antagonists), whereas persistently elevated levels signal high residual risk.
Critical Diagnostics offers the Presage® ST2 Assay (a quantitative 96-well ELISA for microplate workflows), the SEQUENT-IAT™ ST2 Assay (an automated turbidimetric immunoassay for clinical chemistry analyzers), and the ASPECT-PLUS™ Rapid ST2 Test (a point-of-care lateral flow system).
No. Soluble ST2 is designed to complement existing markers within a multi-biomarker strategy. Combining sST2 (fibrosis/remodelling) with natriuretic peptides (haemodynamic stretch) and troponins (myocardial necrosis) provides a comprehensive risk profile for clinical decision-making.