Mild traumatic brain injury

It's more than a test. 
It's real life. Theirs.

An objective approach to aid in ruling out the presence of acute intracranial lesions

 

For In Vitro Diagnostic Use.

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Alinity i tbi is the first ce-marked lab-based blood test that aids in ruling out intracranial lesions when mild traumatic brain injury (mtbi) is suspected, reducing unnecessary ct scans 1,2

When used in conjunction with other clinical information, Alinity i TBI offers physicians peace of mind that may help them confidently discharge patients faster—potentially improving emergency room (ER) care optimization and efficiency.1, 3-6

Suspected mild traumatic brain injury (mtbi) sends millions of people to emergency rooms for evaluation each year

69 million

Number of people who sustain a TBI every year globally7

#1 cause: falls

Most common injury in patients evaluated for TBI in the emergency room8

94.5% have mtbi

Defined as a score of 13 to 15 on the Glasgow Coma Scale (GCS) 8

Current tools for evaluating mtbi Have significant drawbacks

Subjective, influenced by patient factors

Neurocognitive assessments, such as the Glasgow Coma Scale (GCS), are subjective, and can also be difficult to perform for patients who have a change in mental status, experience language barriers or are intoxicated.9

Primary test, but low diagnostic yield

Head computed tomography (CT) scan—the primary diagnostic modality for mTBI—has a low diagnostic yield. Clinical decision rules have had limited impact on the number or diagnostic yield of CT for the evaluation of mTBI.10-12

Maybe unneeded tests, radiation exposure

Patients are exposed to radiation equivalent to 100x that of a chest X-ray during potentially unnecessary head CT scans.13

Lengthy er visits and patient wait times

The time from ordering to reading CT can be up to 3 hours—about half the total time for evaluation of mTBI—so patients with suspected mTBI have lengthy ER visits.3

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Semi-quantitative, objective assessment to inform mtbi evaluation1

The TBI test is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays (CMIA) used for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in human plasma and serum and provides a semi-quantitative interpretation of test results derived from these measurements using the Alinity i system.

The interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head. A negative test result is associated with the absence of acute intracranial lesions visualized on a head CT scan. The TBI test is intended for use in clinical laboratory settings by healthcare professionals.

Find out more

 Learn about the role of biomarker validation for a common neurological disorder in a recently published white paper:

Exploring future possibilities to improve evaluation and management of traumatic brain injury.

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TRAUMATIC BRAIN INJURY
mTBI (UCH-L1 + GFAP)

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References
  1. Alinity i TBI H22974R01. Instructions for use. Abbott Ireland Diagnostics Division. Sligo, Ireland; October 2021.
  2. Data on file at Abbott.
  3. Michelson EA, Huff JS, Loparo M, et al. Emergency department time course for mild traumatic brain injury workup. West J Emerg Med. 2018;19(4):635-640. doi:10.5811/ westjem.2018.5.37293
  4. Bazarian JJ, Biberthaler P, Welch RD, et al. Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): a multicentre observational study. Lancet Neurol. 2018;17(9):782-789. doi:10.1016/S1474-4422(18)30231-X
  5. Wang KKW, Kobeissy FH, Shakkour Z, Tyndall JA. Thorough overview of ubiquitin C-terminal hydrolase-L1 and glial fibrillary acidic protein as tandem biomarkers recently cleared by US Food and Drug Administration for the evaluation of intracranial injuries among patients with traumatic brain injury. Acute Med Surg. 2021;8(1):e622. doi:10.1002/ams2.622
  6. Bazarian JJ, Welch RD, Caudle K, et al. Accuracy of a rapid GFAP/UCH-L1 test for the prediction of intracranial injuries on head CT after mild traumatic brain injury [published online ahead of print, 2021 Aug 6]. Acad Emerg Med. 2021;10.1111/acem.14366. doi:10.1111/ acem.14366
  7. Dewan MC, Rattani A, Gupta S, et al. Estimating the global incidence of traumatic brain injury. J Neurosurg. 2018;1-18. doi:10.3171/2017.10.JNS17352
  8. 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. doi:10.1097/HTR.0000000000000187
  9. Centers for Disease Control and Prevention. Get the facts about TBI. May 12, 2021. Accessed December 3, 2021. https://www.cdc.gov/traumaticbraininjury/get_the_facts.html
  10. Stiell IG, Clement CM, Rowe BH, et al. Comparison of the Canadian CT Head Rule and the New Orleans Criteria in patients with minor head injury. JAMA. 2005;294(12):1511-1518.doi:10.1001/jama.294.12.1511
  11. 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. doi:10.1111/acem.13061
  12. 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. doi:10.1136/ emj.2003.011353
  13. US Food and Drug Administration. What are the radiation risks from CT? Updated December 5, 2017. Accessed December 3, 2021. https://www.fda.gov/radiation-emitting-products/medical-x-ray-imaging/what-are-radiation-risks-ct