The portable i-STAT TBI cartridge uses whole blood to screen for serum biomarkers to inform the need for conducting CT test in patients with suspected concussion. Image Credit: Ground Picture / Shutterstock.

The US Food and Drug Administration (FDA) has cleared Abbott’s i-STAT TBI cartridge for assessing patients with suspected concussion or mild traumatic brain injury (mTBI).

The current standard for assessing TBI is a subjective doctor assessment via a Glasgow Coma Scale and a computed tomography (CT) scan, which can be time-consuming and require specialised personnel.

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The portable i-STAT TBI cartridge uses whole blood to screen for two serum biomarkers, ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP). Elevation of these biomarkers indicates a severe injury, thereby, informing the need for conducting a CT scan. The test can used to objectively assess patients with suspected concussion.

The test can be performed in emergency settings and gives out results in approximately 15 minutes. The test is cleared for use in patients aged 18 years and older. Furthermore, it can used to evaluate patients for concussions up to 24 hours after injury.

Abbott plans to seek expanded clearance for the test that allows i-STAT TBI cartridge use in non-healthcare settings such as sporting events, and with a broader population, including teens and paediatrics.

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Abbott developed the i-STAT TBI blood test in partnership with the US Department of Defense (DoD). In 2014, Abbott received a $19.5m grant from the DoD to assess and verify mTBI biomarkers that can be used for rapid battlefield assessment of concussions.

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The development of rapid tests has increased in recent years, which was fuelled by the use of rapid testing during the Covid-19 pandemic. The market for point of care (POC) diagnostic tests was worth approximately $297.6bn last year, according to GlobalData analysis.

Another test for assessing concussion is Marker Diagnostics’ saliva-based test, MTx.100. The test measures the expression of small non-coding RNA (sncRNA) biomarkers found in saliva to diagnose concussion. It is being evaluated as a concussion diagnostic for sportspersons in a study with women rugby players.