1001 NW Technology Drive, Lee's Summit, MO 64086 // (800) 305-5198 // (816) 347-0143 Fax // info@viracor-eurofins.com 30148 - ST2 Plasma - 3/29/2024 11:03:36 AM Page of ST2 Plasma Test Code: 30148 Clinical and Procedure Clinical Utility For the quantitative measurement of Suppression of Tumorigenicity 2 (ST2). ST2 is member of the Toll-interleukin 1 receptor family, and functions as a down-regulator of the pro-inflammatory cytokines IL-1, IL-6 and TNF-α. ST2 has been shown to be elevated in inflammatory conditions. ST2 activation enhances inflammation-associated hypersensitivity to pain and protects from atherosclerosis and has been reported as a monitoring tool of cardiac myocyte hypertrophy. The soluble ST2 isoform is elevated in the serum under inflammatory conditions including allergic asthma, sepsis, trauma, dengue fever, and pulmonary disease. Serum ST2 elevation is also associated with multiple aspects of heart failure including aortic stenosis, congestive cardiomyopathy, and risk of cardiovascular heart failure and death.  High levels of serum ST2 are a biomarker of poor prognosis in cardiovascular diseas. Additionally, ST2 testing has been reported as useful as a surrogate biomarker of Ulcerative colitis activity and therapeutic response.  This assay is recommended for the quantitative determination of human Suppression of Tumorigenicity 2 (ST2) concentrations in cell culture supernates, serum, and plasma. This individual assay has not been optimized for use in calculating the MAGIC Algorithm Probability (MAP) for aGVHD and will provide inaccurate values if used in calculating the MAGIC Algorithm Probability (MAP) for Hematopoietic Cell Transplant (HCT) patients. See the Pre-Symptomatic, Symptomatic Onset, or Post-Treatment aGVHD assays here. Procedure The assay for quantification of ST2 is a sandwich ELISA performed in a microtiter plate format. Conversion of a chromogenic substrate produces a color, the intensity of which is proportional to the concentration of ST2 in the sample material. A standard curve is used to calculate the concentration of ST2 in each of the test samples. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. Specificity Specific to human ST2. Turnaround Time 3 business days from receipt of specimen Specimen Information Specimen Type Order Code CPT Code NY Approved Volume Assay Range plasma 30148 83006 Yes 1 mL 1.6-100.0 ng/mL Special Instructions - Whole blood should be collected in sodium heparin tube. - Plasma separated by centrifugation within 30 minutes of the draw time. - 1 mL of plasma sample should be removed to a sterile tube and frozen immediately (-70°C). The reference range for a healthy population is less than 30.0 ng/mL. However it should be noted that these ranges are obtained from a limited population of apparently healthy adults and are not diagnostic thresholds. 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: Eurofins Viracor, 18000 W 99th St. Ste, #10, Ste.#10, Lenexa, KS 66219. Causes for Rejection Invalid specimen type, inadequate volume, gross hemolysis or gross lipemia, sample not frozen upon receipt. Disclaimer 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. References Magro F, Lopes S, Silva M, et al. Soluble human Suppression of Tumorigenicity 2 is associated with endoscopic activity in patients with moderate-to-severe ulcerative colitis treated with golimumab. Therapeutic Advances in Gastroenterology. 2019;12. doi:10.1177/1756284819869141 Sanada, S. et al. (2007) J. Clin. Invest. 117:1538. Verri Jr., W.A. et al. (2008) Proc. Natl. Acad. Sci. USA 105:2723. Miller, A.M. et al. (2008) J. Exp. Med. 205:339. Hayakawa, H. et al. (2007) J. Biol. Chem. 282:26369. Martinez-Rumayor, A. et al. (2008) Am. J. Clin. Pathol. 130:578. Becerra, A. et al. (2008) Cytokine 41:114. Brunner, M. et al. (2004) Intensive Care Med. 30:1468. Tajima, S. et al. (2003) Chest 124:1206. Bartunek, J. et al. (2008) J. Am. Coll. Cardiol. 52:2166. Szerafin, T. et al. (2009) Thorac. Cardiovasc. Surg. 57:25. Sabatine, M.S. et al. (2008) Circulation 117:1936. Mueller, T. et al. (2008) Clin. Chem. 54:752. Shimpo, M. et al. (2004) Circulation 109:2186. Weinberg, E.O. et al. (2003) Circulation 107:721. Scott IC, Houslay KF, Cohen ES. Prospects to translate the biology of IL-33 and ST2 during organ transplantation into therapeutics to treat graft-versus-host disease. Ann Transl Med 2016;4(24):500. doi: 10.21037/atm.2016.11.74. Salvagno GL, Pavan C. Prognostic biomarkers in acute coronary syndrome. Ann Transl Med 2016;4:258. Vander Lugt MT, Braun TM, Hanash S, et al. ST2 as a marker for risk of therapy-resistant graft-versus-host disease and death. N Engl J Med 2013;369:529-39. Solán L, Kwon M, Carbonell D, Dorado N, Balsalobre P, Serrano D, Chicano-Lavilla M, Anguita J, Gayoso J, Díez-Martín JL, Martínez-Laperche C and Buño I (2019) ST2 and REG3_ as Predictive Biomarkers After Haploidentical Stem Cell Transplantation Using Post-transplantation High-Dose Cyclophosphamide. Front. Immunol. 10:2338. doi: 10.3389/fimmu.2019.02338 Ball LM, Egeler RM, EBMT Paediatric Working Party. Acute GvHD: pathogenesis and classification. Bone Marrow Transplant. 2008 Jun;41 Suppl 2:S58-64. Deeg HJ, Henslee-Downey PJ. Management of acute graft-versus-host disease. Bone Marrow Transplant. 1990 Jul;6(1):1-8. Atkinson K. Chronic graft-versus-host disease. Bone Marrow Transplant. 1990 Feb;5(2):69-82. Paczesny S, Krijanovski OI, Bruan TM, et al. A biomarker panel for acute graft-versus-host disease. Blood. 2009 Jan 8;113(2):273-8. Vander Lugt MT, Braun TM, Ferrara JLM, et al. Plasma Concentration of Suppressor of Tumorigenicity 2 (ST2), the IL33 Receptor, at lnitiation of Graft Versus Host Disease Therapy Predicts Day 28 Response and Day 180 Survival Post-Treatment.  Biol Blood Marrow Transpl . 2012 February; 18 (2):S201-S202. Vander Lugt MT, Braun TM, Ferrara JLM, et al. Plasma Concentration of ST2, the IL33 Receptor, AIInitiation of Graft Versus Host Disease Therapy Predicts Day 28 Response and Day 180 Survival Post-Treatment.  Blood.  2011 118(21). Paczesny S, Braun TM, Levine JE, et al. Elafin is a biomarker of graft-versus-host disease of the skin. Sci Transl Med 2010;2: 13ra2. Error page

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