The i-STAT TBI Plasma test is not intended for use as a point-of-care-device
Millions of patients undergo emergency department (ED) evaluation for mTBI each year. But the Glasgow Coma Scale (GCS) score and clinical evaluation only provide subjective information, leading many to use CT.
The i-STAT TBI Plasma test may be the solution to time-consuming and often unnecessary head CTs for mTBI.1
Clinical decision rules (CDRs), such as the Canadian CT Head Rule have had limited impact on the number or diagnostic yield of CT for the evaluation of mTBI3-5
A systematic review of 14 studies found that among patients with minor head trauma, only 7% had severe intracranial injuries identified on a CT, while <1% had injuries that required neurosurgical intervention2
The interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients, 18 years or older, presenting with suspected mTBI (GCS score 13-15) within 12 hours of injury to assist in determining the need for head CT.*
*The i-STAT TBI Plasma test is to be used with plasma prepared from ethylenediaminetetraacetic acid (EDTA)–anticoagulated specimens in clinical laboratory settings by a healthcare professional. It is not intended for point-of-care use.
*The i-STAT TBI Plasma test is to be used with plasma prepared from EDTA-anticoagulated specimens in clinical laboratory settings by a healthcare professional. It is not intended for point-of-care use.
40.4% of negative results in the pivotal study had a true negative result on the i-STAT TBI Plasma test — suggesting a potential reduction in unnecessary CT of up to 40%11,12
1. Korley FK, Kelen GD, Jones CM, Diaz-Arrastia R. Emergency department evaluation of traumatic brain injury in the United States, 2009-2010. J Head Trauma Rehabil. 2016;31(6):379-387.
2. Easter JS, Haukoos JS, Meehan WP, Novack V, Edlow JA. Will neuroimaging reveal a severe intracranial injury in this adult with minor head trauma? The Rational Clinical Examination Systematic Review. JAMA. 2015;314(24):2672-2681.
3. Sharp AL, Nagaraj G, Rippberger EJ, et al. Computed tomography use for adults with head injury: describing likely avoidable emergency department imaging based on the Canadian CT Head Rule. Acad Emerg Med. 2017;24(1):22-30.
4. Sultan HY, Boyle A, Pereira M, Antoun N, Maimaris C. Application of the Canadian CT head rules in managing minor head injuries in a UK emergency department: implications for the implementation of the NICE guidelines. Emerg Med J. 2014;21(4):420-425.
5. Stiel IG, Clement CM, Grimshaw JM, et al. A prospective cluster-randomized trial to implement the Canadian CT Head Rule in emergency departments. CMAJ. 2010;182(14):1527-1532.
6. Michelson EA, Huff JS, Loparo M, et al. Emergency department time course for mild traumatic brain injury workup. West J Emerg Med. 2010;19(4):635-640.
7. US Food and Drug Administration. What are the radiation risks from CT? Updated December 5, 2017. Accessed November 20, 2020. https://www.fda.gov/radiation-emitting-products/medical-x-ray-imaging/what-are-radiation-risks-ct.
8. Zetterberg H, Blennow K. Fluid biomarkers for mild traumatic brain injury and related conditions. Nat Rev Neurol. 2016;12(10):563-574.
9. Chodobski A, Zink BJ, Symydynger-Chodobska J. Blood-brain barrier pathophysiology in traumatic brain injury. Transl Stroke Res. 2011;2(4):492-516.
10. Wang KK, Yang Z, Zhu T, et al. An update on diagnostic and prognostic biomarkers for traumatic brain injury. Expert Rev Mol Diagn. 2018;18(2):165-180.
11. i-STAT TBI Plasma Cartridge. Instructions for use. Abbott Point of Care Inc. Abbott Park, IL; 2020.
12. Data on file. Abbott Point of Care Inc.
13. Diaz-Arrastia R, Wang KKW, Papa L, et al; TRACK-TBI Investigators. Acute biomarkers of traumatic brain injury: relationship between plasma levels of ubiquitin C-terminal hydrolase-L1 and glial fibrillary acidic protein. J Neurotrauma. 2014;31(1):19-25.
14. Metting Z, Wilczak N, Rodiger LA, Schaaf JM, van der Naalt J. GFAP and S100B in the acute phase of mild traumatic brain injury. Neurology. 2012;78(18):1428-1433.
15. Papa L, Lewis LM, Silvestri S, Falk JL, Giordano P, Brophy GM. Serum levels of Ubiquitin C-terminal hydrolase (UCH-L1) distinguish mild traumatic brain injury (TBI) from trauma controls and are elevated in mild and moderate TBI patients with intracranial lesions and neurosurgical intervention. J Trauma Acute Care Surg. 2012;72(5):1335-1344.
16. Jones A, Jarvis P. Review of the potential use of blood neuro-biomarkers in the diagnosis of mild traumatic brain injury. Clin Exp Emerg Med. 2017;4(3):121-127.
17. Schulte S, Podlog LW, Hamson-Utley JJ, Strathmann FG, Strϋder HK. A systematic review of the biomarker S100B: implications for sport-related concussion management. J Athl Train. 2014;49(6):830-850.
18. Steiner J, Bernstein H-G, Bielau H, et al. Evidence for a wide extra-astrocytic distribution of S100B in human brain. BMC Neurosci. 2007;8:2.
19. Pelinka LE, Kroepfl A, Schmidhammer R, et al. Glial fibrillary acidic protein in serum after traumatic brain injury and multiple trauma. J Trauma. 2004;57(5):1006-1012.
20. Papa L, Lewis LM, Falk JL, et al. Elevated levels of serum glial fibrillary acidic protein breakdown products in mild and moderate traumatic brain injury are associated with intracranial lesions and neurosurgical intervention. Ann Emerg Med. 2012;59(6):471-483.
21. Papa L, Brophy GM, Welch RD, et al. Time course and diagnostic accuracy of glial and neuronal blood biomarkers GFAP and UCH-L1 in a large cohort of trauma patients with and without mild traumatic brain injury. JAMA Neurol. 2016;73(5):551-560.
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