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ST2 Presage® ELISA Serum

Test Code: 30151
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Clinical Utility

The ST2 Presage® assay kit is an in vitro diagnostic device that quantitatively measures ST2 (growth stimulation expressed gene 2) in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format. ST2 Presage® ELISA is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.

Procedure

The ST2 Presage® ELISA assay is a quantitative sandwich monoclonal ELISA in a 96-well microtiter plate format for measurement of soluble ST2 in serum, EDTA plasma, or heparin plasma. This test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

Specific to human ST2.

1-4 business days from receipt of specimen

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
serum 30151 83006 Yes 3.1-200.0 ng/mL 3.1-200.0 ng/mL
  • Collect 3-5 mL whole blood in a gel separator tube (SST).
  • Centrifuge specimen within 2 hours of draw to pellet cells below the gel. Minimum volume is 0.2 mL serum following centrifugation.
  • Specimen can be stored ambient for up to 48 hours, refrigerated at 2 to 8°C for up to 7 days, or preferably stored frozen.
  • Specimen should be shipped on dry ice for overnight delivery.

The ST2 analysis cutpoint of 35 ng/mL was selected by choosing a Presage® ST2 Assay concentration value above the 90th and below the 95th percentile of the Reference Group.

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 1001 NW Technology Dr, Lee's Summit, MO 64086.

Causes for Rejection

Specimens beyond their acceptable length of time from collection as indicated in the specimen handling, or specimen types other than those listed.

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Viracor Eurofins' interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for general informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

Information derived from the Presage® ST2 Assay package insert (Critical Diagnostics). Presage® ST2 is a product and registered trademark of Critical Diagnostics®.

 

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