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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 Abbott's game changing biomarker combination 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 department (ED) care optimization and efficiency.1, 3-6

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Semi-quantitative, objective assessment to inform mtbi evaluation1

Intended Use

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.

Click here to view important safety information.

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 room9

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 approximately 3 hrs—about half the total time for evaluation of mTBI—so patients with suspected mTBI have lengthy ER visits.3

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It's optimizing care and resources with the potential to reduce unnecessary CT scans by up to 40%1,2

 

 

 

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It is the power to predict the absence
of intracranial lesions  

Negative Predictive Value (NPV)
Clinical Sensitivity

Clinical performance parameters (N=1899)1

  • A highly negative predictive value (NPV) means that you can be confident that for patients with a negative test result, the probability of not having acute intercranial lesions is high
  • High clinical sensitivity to detect blood-based biomarkers indicative of the absence of acute traumatic intercranial lesions usually visible on a CT scan

 

View the Infographic to learn more

Find out more

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

 

 

Read the white paper
Learn more from Early Adopters
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Some assays may not be available on all platforms.

 

View the core laboratory menu to see the complete list of available assays and in development assays, categorized by instrument and segment.

 

TRAUMATIC BRAIN INJURY
mTBI (UCH-L1 + GFAP)

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IMPORTANT SAFETY INFORMATION

Rx ONLY (For use by or on the order of a physician only)

CAUTION: This product requires the handling of human specimens. It is recommended that all human-sourced materials and all consumables contaminated with potentially infectious materials be considered potentially infectious and handled in accordance with the OSHA Standard on Bloodborne Pathogens. This product contains sodium azide. Contact with acids liberates very toxic gas. Dispose of contents/container in accordance with local regulations.

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References
  1. Alinity i TBI 802673R01. Instructions for use. Abbott Ireland Diagnostics Division. Sligo, Ireland; May 2023.
  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.

 

 

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