Abbott Receives FDA Approval for i-STAT TBI Cartridge Whole Blood Rapid Test

Abbott has received the US FDA clearance for the i-STAT TBI cartridge to be used with whole blood, enabling doctors to assess patients with suspected concussion at the patient’s bedside and obtain lab-quality results in 15 minutes. Previously, the tests to help with the assessment of TBI were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing.

This new clearance will enable testing to be performed in an array of new healthcare settings beyond hospital emergency departments including urgent care clinics with a certificate to perform moderate complexity tests. This is an important step toward a future where testing could be done outside traditional healthcare settings, such as on the sidelines of sporting events.

The whole blood test on a portable instrument helps clinicians evaluate patients 18 years of age and older who present with suspected mild traumatic brain injury or mTBI, commonly known as concussion. Test results can help rule out the need for a CT scan of the head and assist in determining the best next steps for patient care. The ability to perform the test with a whole blood sample means testing can take place at healthcare settings without a lab which helps to accelerate the evaluation of head traumas.

With this clearance, the i-STAT TBI test can be used to help evaluate patients up to 24 hours after injury, an important advancement since those injured often wait before seeking care.

With the help of this whole blood test, we can quickly and objectively determine whether or not a patient needs a CT scan or additional evaluation, right at the point of care. It’s an incredibly helpful tool that advances the treatment of traumatic brain injury,” said Geoffrey Manley, M.D., PhD, Chief of Neurosurgery at Zuckerberg San Francisco General Hospital, Professor of Neurosurgery at the University of California San Francisco and contact principal investigator for the TRACK-TBI Network.

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