BIOMARKERS OF HEAD INJURY
Traumatic brain injury test: clinical performance summary of a pivotal study
Introducing a new, high-sensitivity test to detect blood- based biomarkers of mild traumatic brain injury within 12 hours of head trauma, which gives clinicians the power to predict the absence of intracranial lesions in adult patients with suspected mild traumatic brain injury.
A major focus of recent studies into the assessment of traumatic brain injury (TBI) has been the application of biomarkers in identification and clinical management. Evidence suggests that
biomarkers can have applications far beyond detecting brain injuries, including: i) determining whether a mild TBI patient presenting in accident and emergency (A&E) requires a computed tomography (CT) scan for identification of intracranial pathology; ii) guiding personalised management and helping direct resources for optimising care; and iii) guiding clinical research of targeted therapies for TBI by providing information about the underlying pathologies of the condition.
Biomarker panel A new TBI test from Abbott is an immunoassay panel using glial fibrillary acidic protein (GFAP)
and ubiquitin C-terminal hydrolase L1 (UCH-L1) measurements in the serum or plasma collected within the first 12 hours after injury in mild TBI (ie Glasgow Coma Score [GCS] 13–15) patients aged 18 or older. Quantitative values are provided for both biomarkers alongside a semi-quantitative interpretation of test results. The interpretation of the test considers both biomarker measurements in relation to their respective cut-offs set at 35 pg/ mL for GFAP and 400 pg/mL for UCH-L1. The test is interpreted to be positive if at least one of the biomarkers is at or above the cut-off. If both biomarkers are below the cut-off, the test is interpreted as negative.
A negative test result is associated with the absence of intracranial lesions visible on a CT scan of the head. When used in conjunction with other clinical information, a negative test result can be used to aid in ruling out the need for a CT scan.
Pivotal study details Clinical performance of the TBI test was demonstrated in a pivotal study,1
where
analysis of archived (frozen) plasma specimens for GFAP and UCH-L1 levels was performed using the Alinity i TBI test (Abbott). The specimens were originally collected in a prospective, multicentre clinical study that enrolled patients at 22 clinical sites across the United States, Germany and Hungary. This study enrolled subjects 18 years of age
Computed tomography scan of the brain showing a subdural haematoma.
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The TBI test is interpreted to be positive if at least one of the biomarkers is at or above the cut-off
SEPTEMBER 2022
WWW.PATHOLOGYINPRACTICE.COM
Lucien Monfils CC BY-SA 3.0 Wikimedia Commons
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