FDA Clears Abbott’s i-STAT Traumatic Brain Injury Whole Blood Test as Bedside Assessment


The newly cleared i-STAT TBI test can be used to help assess patients up to 24 hours after injury at patient bedside, with lab-quality results produced in 15 minutes.

Beth McQuiston, MD, RD, neurologist and medical director at Abbott

Beth McQuiston, MD, RD

Credit: Medical Laboratory Observer

According to a recent announcement, the FDA has granted clearance for Abbott's i-STAT traumatic brain injury (TBI) cartridge test to be used to assess patients with suspected mild TBIs, known as concussions, at their bedside. This decision by the agency will enable testing to be performed in many new healthcare settings beyond hospital emergency departments, thus advancing the potential of testing for TBI outside traditional healthcare settings.1

The whole blood test, a portable instrument, evaluates patients aged 18 years and older who report a suspected mild TBI. Results from the test can assist in ruling out the need for a CT scan of the head and help with determining the next steps of care for the patient. The testing, which is done with whole blood samples, can take place at healthcare settings without a lab, accelerating the evaluation of head traumas. Abbott’s previous TBI tests were cleared only for use with plasma or serum which required samples to be sent to a lab for processing and testing.

Top Clinical Takeaways

  • FDA clearance for Abbott's i-STAT TBI cartridge with whole blood marks a significant advancement in TBI assessment, especially for mild cases.
  • Portable testing capabilities with whole blood allow for quicker evaluation and decision-making in healthcare settings beyond traditional hospitals.
  • The clearance underscores the potential for future medical testing to move outside conventional healthcare settings, improving accessibility and efficiency.

“Clinicians should be aware that this blood test, performed on Abbott's portable i-STAT Alinity device, uses whole blood to assess patients suspected of having a TBI, or concussion. The fact that it delivers lab-quality results in just 15 minutes is critical,” Beth McQuiston, MD, RD, neurologist and medical director at Abbott, told NeurologyLive®. “This means that clinicians can have access to test results right at the patient's bedside, which is significant for urgent care clinics and other healthcare settings beyond the hospital ER. Importantly, the test is applicable for evaluating patients up to 24 hours after an injury.”

READ MORE: Phase 2 Study Highlights Therapeutic Potential of Nexalin's Transcranial Electrical Stimulation Device in TBI

In March 2023, the FDA cleared the company's Alinity i laboratory TBI blood test to quickly assist clinicians in hospitals with assessing patients with mild TBIs in an objective way.2 The test measures 2 biomarkers in the blood plasma and serum, ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), both of which are tightly correlated to brain injury. Notably, clinicians can receive a reliable result from the test in 18 minutes, with a reported 96.7% sensitivity and 99.4% negative predictive value.

Using the i-STAT Alinity device, clinicians could evaluate patients who are 18 years of age or older that present with suspected mild TBI within 12 hours of injury (scoring between 13 and 15 on the Glasgow Coma Scale) and determine whether they are candidates for a CT scan. With the device, a sample of blood is drawn from the arm and then sent to the lab for preparation to be run on the Alinity i instrument. Results are complete in as little as 18 minutes, and then shared with the provider for further evaluation.

“This is a game-changer in enhancing how we approach concussions. With the FDA approval, healthcare providers can now use a rapid blood test to gather crucial information quickly. It’s a tremendous advance for the efficiency of emergency room operations and overall patient care and safety. It’s a significant advancement in our standard of care for traumatic brain injuries,” McQuiston added when asked how the new FDA clearance for the whole blood test impacts the field in TBI.

In January 2021, the FDA cleared the company’s rapid i-STAT TBI Plasma test, the first rapid handheld TBI blood test, to assist clinicians in assessing patients with suspected mild TBIs, including concussions.3 The test measures specific proteins present in the blood after a TBI and provides results in as little as 15 minutes after plasma is placed in the test cartridge. CT scans, often used to diagnose concussion, can then be ruled out if a patient has a negative test result. Following a blood sample drawn from a patient’s arm, plasma is extracted with a centrifuge and applied to the test’s cartridge. The cartridge is then inserted into the handheld instrument.

Abbott's rapid i-STAT TBI Plasma test includes a high-resolution color touchscreen, enabling simple and intuitive navigation, an easy-to-replace rechargeable battery, a high-resolution camera that captures 2D barcodes with picture ID, and an easy-grip ergonomic designed that makes use balanced, comfortable, and secure.4 Its durable construction allows for fast-paced environments and is built with materials that can resist damage. The user-friendly design has audio, color, and light cues that can signal the operator to critical results. The test was originally developed in collaboration with the US Department of Defense (DOD), which have played a role in increasing detection and evaluation of TBI.

“Hearing the news filled me with immense joy. Being deeply involved in developing this test for more than 10 years, along with more than 300 Abbott scientists, seeing the partnership between the Department of Defense and Abbott come to fruition was incredibly rewarding. It's often said that concussions are invisible injuries, but our test makes the invisible visible. While blood tests have been developed for numerous conditions, pioneering one for the brain is a significant leap forward,” McQuiston said when asked about her reaction to the recent news of the clearance for the TBI test at patient bedside.

1. Abbott Receives FDA Clearance for Whole Blood Rapid Test to Help with Assessment of Concussion at the Patient's Bedside. News Release. Abbott. Published April 1, 2024. Accessed April 8, 2024. https://abbott.mediaroom.com/2024-04-01-Abbott-Receives-FDA-Clearance-for-Whole-Blood-Rapid-Test-to-Help-with-Assessment-of-Concussion-at-the-Patients-Bedside
2. Abbott Receives FDA Clearance for First Commercially Available Lab-Based Blood Test to Help Evaluate Concussion. News Release. Abbott. Published March 7, 2023. Accessed April 8, 2024. https://abbott.mediaroom.com/2023-03-07-Abbott-Receives-FDA-Clearance-for-First-Commercially-Available-Lab-based-Blood-Test-to-Help-Evaluate-Concussion
3. Abbott receives FDA 510(k) clearance for the first rapid handheld blood test for concussions. News release. January 11, 2021. Accessed April 8, 2024. https://abbott.mediaroom.com/2021-01-11-Abbott-Receives-FDA-510-k-Clearance-for-the-First-Rapid-Handheld-Blood-Test-for-Concussions
4. i-Stat Alinity. Abbott. Accessed April 8, 2024. https://www.pointofcare.abbott/int/en/offerings/istat-alinity
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