Elecsys® GDF-15

Personalized bleeding-risk prediction for AF patients

Elecsys Reagent Pack

Personalized bleeding-risk prediction for your AF patients1

 

Atrial Fibrillation is the most common rhythm disorder (arrhythmia) of the heart.2,3 Roche GDF-15 is the strongest predictor in the ABC bleeding risk score, providing you with an improved understanding of each patient’s bleeding-risk profile which may help to inform treatment decisions.

How can GDF-15 help?

A general marker of disease severity and mortality4

 

Baseline GDF-15 levels were independently associated with estimated 12-month rates of major bleeding, cardiovascular mortality and stroke or systemic embolic events in RE-LY study.

Predicting bleeding risk in atrial fibrillation patients with more confidence

Bleeding risk is a leading concern when selecting oral anticoagulation (OAC) therapy for stroke prevention in patients with atrial fibrillation (AF).6,7

GDF-15 is the strongest predictor in the ABC bleeding risk score.1 It provides physicians with an improved understanding of each patient’s bleeding risk profile and can inform treatment decisions.1

Enabling a more personalized selection of treatment

Intended use

Immunoassay for the in vitro quantitative determination of Growth Differentiation Factor‑15 (GDF‑15) in human serum and plasma. The Elecsys GDF‑15 assay is intended as an aid in risk stratification of patients with Acute Coronary Syndrome (ACS) or Chronic Heart Failure (CHF). The Elecsys GDF‑15 assay is intended as an aid in risk prediction of major bleeding events of patients with Atrial Fibrillation (AF). 

The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.

Assay analytical performance

  • Assay Time

    18 min

  • Sample material

    Serum and Li 
    heparin, K2 EDTA and K3
    EDTA plasma

  • Measuring range

    400-20,000 pg/mL

* RE-LY study: Biomarker sub study in patients with AF who had at least one stroke risk factor***, the ABC-bleeding risk score was validated (validation cohort)

***previous stroke or TIA, congestive heart failure or reduced left ventricular ejection fraction (<40%), ≥75 years of age, or ≥65 years of age with diabetes mellitus, hypertension or coronary artery disease.

 

References

 

  1. Hijazi Z, et al. Lancet 2016; 387, 2302–2311
  2. Kirchof P, et al. Eur Heart J 2016;37:2893–62
  3. January CT, et al. Circulation 2014;130:e199–e267
  4. Wollert, et al. Clin Chem 2017; 63:140–5
  5. Hijazi, et al. Am Heart J 2017; 190:94–103
  6. Wallentin L, et al. Circulation 2014; 130, 1847–1858
  7. O’Brien E.C, et al. Eur Heart J 2015; 36, 3258–3264