The Presage® Assay

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 heart failure.

The Presage® ST2 Controls, Level 1 and Level 2, are designed to be used for verifying the performance of the Critical Diagnostics Presage® ST2 Assay kit.

The assay is calibrated with seven standards spanning the range of 3.1 to 200.0 ng/ml. The standard ST2 analysis cutpoint is 35 ng/ml.

Use of ST2 in Conjunction with Natriuretic Peptides.

ST2 and natriuretic peptides, such as NT-proBNP, are measures of separate and distinct biological processes. ST2 and natriuretic peptides provide independent and complementary prognostic information. Consult the Instructions For Use manual for more information.

Click here for a pdf copy of the CE-Marked version of the Instructions For Use manual for the Presage ELISA Assay.

Click here for a pdf copy of the CE-Marked version of the Instructions For Use manual for the Presage ELISA Assay Control Kit.