Abbott’s Whole Blood Rapid Test Gains the US FDA’s Clearance to Evaluate Concussion

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The US FDA has cleared the company’s i-STAT TBI cartridge for its use with whole blood enabling evaluation of patients with suspected concussion to obtain outcomes within 15mins.
The test can assess patients aged 18yrs. and above with suspected concussion up to 24 hours after injury at the patient’s bedside, extending availability to urgent care and other healthcare settings
The i-STAT TBI cartridge, used with the i-STAT Alinity System, requires a small venous blood sample to measure two brain biomarkers, ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), enabling the assessment of potential brain injury for treatment decisions

Ref: Abbott | Image: Abbott

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