An objective approach to aid in ruling out the presence of acute intracranial lesions is a test away.

Alinity i TBI helps accelerate triage for suspected mTBIs with an objective test to aid in ruling out the presence of acute intracranial lesions.

For In Vitro diagnostic use.

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Streamline mTBI assessment, reduce unnecessary CT scans, and send them on ^1,2

Life plays rough. When an mTBI is suspected, Alinity i TBI takes the guesswork out of mTBI assessments,—detecting blood-based biomarkers of mild brain injury within 12 hours of head trauma. When used in conjunction with other clinical information, this efficient blood test gives physicians the power to predict the absence of intracranial lesions in adult patients with suspected mTBI—accelerating triage, helping them confidently discharge patients faster and potentially improve emergency department (ED) care optimization and efficiency.^{1, 3-6}

Abbott’s Alinity i TBI test aids doctors in evaluating a suspected mild traumatic brain injury (such as a concussion) in people 18 and older within 12 hours of injury and specifically help rule out the need for a head CT scan.*

* Alinity i TBI IFU

See below for full intended use and important safety information.

Mild traumatic brain injury (mtbi) can affect anyone

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

The current mtbi evaluation pathways needs work

Subjective assessments

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

Lengthy ER visits, wait times

It can be three hours from ordering a CT scan to reading—about half the total time for evaluation of mTBI—slowing down patient throughput.³

Low diagnostic yield

Clinical decision rules have had limited impact on the number or diagnostic yield of CT, the primary diagnostic modality for mTBI, for the evaluation of mTBI.^10-12

Potentially unneeded radiation exposure

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

Alinity i TBI helps to accelerate mTBI Triage

Evaluation with Alinity i TBI has the potential to reduce unnecessary CT scans by up to 40%^1,2

The Alinity i TBI Difference

Send them on with an objective result

With high sensitivity to detect blood based biomarkers of mild brain injury within 12 hours of head trauma, clinicians have the power to predict the absence of intracranial lesions in adult patients with suspected mTBI.

Accelerate triage and optimize resources

Patients with a negative result, associated with the absence of intracranial lesions, can avoid an unnecessary CT scan and radiation equivalent to 100x that of a chest X-ray.¹³

Increase patient throughput

When physicians are empowered to accurately assess the absence of intracranial lesions without a CT scan, it may help them discharge patients faster from the emergency room—increasing patient throughput and reducing length of stay.^1,6

96.7%

Clinical sensitivity

Alinity i TBI has 96.7% clinical sensitivity to blood-based biomarkers indicative of the absence of acute traumatic intracranial lesions usually visible on a CT scan.¹

99.4%

Negative Predictive Value (NPV)

With a negative predictive value (NPV) of 99.4%, you can be confident that for patients with a negative test result, the probability of not having acute intracranial lesions is high.¹

Hear from the experts

Learn about the role of biomarker validation for mTBI assessment and opportunities for improvement in a recently published white paper. And watch the video to hear Dr. Martina Pavletic discuss the impact of using biomarkers to evaluate mild TBIs at her hospital.

Read the white paper

Core Laboratory Menus and Systems

View and download the Core Laboratory menus to see the complete list of available assays and in development assays, categorized by instrument.

Some assays may not be available on all platforms or in all regions.

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TRAUMATIC BRAIN INJURY

mTBI (UCH-L1 + GFAP)

Login or register for a new account on the Lab Central customer portal. Here you can view assay specific package inserts for intended use, important safety information and manage your personalized lab metrics.

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Alinity i Immunoassay system

Find out more

Reach out to a representative at Abbott to learn how our mTBI test can optimize the care you provide to patients.

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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 (UHC-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.

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

Alinity i TBI 802673R01. Instructions for use. Abbott Ireland Diagnostics Division. Sligo, Ireland; May 2023.
Data on file at Abbott.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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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