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.

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

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

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

For more information

For additional information, please contact Customer Service at +1 858.270.2435 or by email at support@criticaldiagnostics.com.