新型心肌标志物生长刺激表达基因2蛋白st2 进口检测试剂盒说明书.pdfVIP

Presage® ST2 Assay - Instructions for Use ____________________________________________________________ Name and Ordering Information Presage® ST2 Assay Kit REF# BC-1065 Presage® ST2 Controls Kit REF# BC-1066 Indications for Use The Critical Diagnostics Presage® ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format. The Presage® ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. The Presage® ST2 Controls, Level 1 and Level 2, are designed to be used for monitoring the performance of test procedures on the Critical Diagnostics Presage® ST2 Assay kit. Summary and Explanation Heart failure is a chronic, progressive disease in which the ability of the heart to provide needed cardiac output weakens, thus impeding the heart’s ability to pump enough blood to support the body’s metabolic demands. The prevalence of heart failure is growing worldwide and is a major burden on hospital care costs. (AHA, 2011). A major component to this burden is the fact that patients afflicted with advanced heart failure have high rates of hospitalization and resource utilization, and similarly have a high risk for death (Schappert et al. 2008). Clinicians continue to seek improved methods to determine prognosis, and risk stratification in heart failure remain inadequate. One method now available to clinicians for such assessment is biomarker testing. ST2 (growth STimulation expressed gene 2; also known as IL1RL1, or Interleukin-1 Receptor- Like 1) is a member of the interleukin-1 receptor family. The ST2 protein has two isoforms directly