VIDAS® TBI (GFAP, UCH-L1)

VIDAS^® TBI (GFAP, UCH-L1)

RULES-OUT Intracranial Lesions in mild Traumatic Brain Injury

Fast all-in-one test kit based on blood-based brain biomarkers to predict absence of intracranial lesions in mild Traumatic Brain Injury patients and objectively assess the need for a head CT-scan.

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Overview
Assays
Resources

Overview

Standard patient assessment methods for mild Traumatic Brain Injury (mTBI) can be subjective and time-consuming. Head CT-scans are frequently performed to check for intracranial lesions (ICLs). ICLs are serious but rare, so a high number of head CT-scans prove to be unnecessary. VIDAS^® TBI (GFAP, UCH-L1) fills a gap in triage methods by safely ruling out ICLs and offering objective and accurate information to help determine if a head CT-scan is needed in adult patients.

Simultaneously tests for GFAP and UCH-L1, blood-based brain biomarkers released after brain injury
Safely rules out intracranial lesions and enables objective determination of need for head CT-scans
Broad eligible patient population and large testing window of up to 12 hours after injury

Safely RULES-OUT Intracranial Lesions (ICL)

VIDAS^® TBI (GFAP, UCH-L1) simultaneously tests glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1), blood-based brain biomarkers that are released from different cell types in the hours following a brain injury. Elevation of any of these biomarkers may indicate ICL while if both are low (below specific levels), ICL can be safely ruled out. Using VIDAS^® TBI (GFAP, UCH-L1) can shorten total workup time by avoiding unnecessary head CT-scans for mTBI patients while helping clinicians have confidence in their patient management decisions.

Objectively determine if a head CT-scan is necessary in mTBI patients

Wide adult patient population can benefit from this test
Large testing window of up to 12 hours after the injury
Easy to interpret:
- Both GFAP and UCH-L1 Negative - Can rule out the need for a head CT-scan by predicting the absence of intracranial lesions.
- GFAP and/or UCH-L1 Positive - The next step is often a head CT-scan
High sensitivity (96.7%); High NPV (99.5%); Good specificity (41.2%)
Avoiding unnecessary head CT-scans:
- Optimizes use of resources
- Helps reduce time spent in the ED
- Reduces patient work up time
- Reduce exposure to radiation
Results in less than 40 minutes
- Potentially discharge patients earlier and reduce patient anxiety

VIDAS^® Solutions

Reliable and easy-to-use instruments with random access and small footprint.
Well adapted to rapid response laboratories.
Factory-calibrated, single-dose tests which reduce the need for additional controls.
Short time to result.
Reagents can be used immediately after removal from the refrigerator.

REFERENCES

Peterson B, Zhou H, Thomas KE, Daugherty J. CDC Surveillance Report 2017: Traumatic Brain Injury-related Hospitalizations and Deaths by Age Group, Sex, and Mechanism of Injury. https://www.cdc.gov/traumaticbraininjury/pdf/TBI-surveillance-report-2016-2017-508.pdf

Levin H, Lancet Neurol 2015; https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(15)00002-2/fulltext

Source: https://www.center-tbi.eu/patients/facts

Gil-Jardiné C, et al. MANAGEMENT OF PATIENTS SUFFERING FROM MILD TRAUMATIC BRAIN INJURY 2023. Anaesth Crit Care Pain Med. 2023 Jun 5:101260.

Bazarian J, 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;17:782-789.

Papa L, Brophy GM, Welch RD, et al. Time Course and Diagnostic Accuracy of Glial and Neuronal Blood Biomarkers GFAP and UCH-L1 in a Large Cohort of Trauma Patients With and Without Mild Traumatic Brain Injury. JAMA Neurol. 2016 May 1;73(5):551-60

VIDAS^® TBI Package Insert (or IFU) last version as per IVDR approval.

Assays

Assays	Reference	Tests per Kit	Code	Time to Result	Decisional Cut-Offs
VIDAS^® TBI (GFAP, UCH-L1)	423615-30	30 tests	GFAP UCH 1 patient test = 1 GFAP + 1 UCH-L1	39 min	GFAP= 22pg/mL UCH-L1 = 327 pg/mL

Resources