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
For In Vitro Diagnostic Use.
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
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.
Number of people who sustain a TBI every year globally7
Most common injury in patients evaluated for TBI in the emergency room9
Defined as a score of 13 to 15 on the Glasgow Coma Scale (GCS)8
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
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
Patients are exposed to radiation equivalent to 100x that of a chest X-ray during potentially unnecessary head CT scans.13
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
Clinical performance parameters (N=1899)1
Learn how early adopters are using our test for the evaluation of traumatic brain injury.
| TRAUMATIC BRAIN INJURY |
| mTBI (UCH-L1 + GFAP) |
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