FDA Clears Abbott’s Alinity i Lab-Based Blood Test for Traumatic Brain Injury

Beth McQuinston, MD

According to news from Abbott, the FDA cleared its Alinity i laboratory traumatic brain injury (TBI) blood test, the first commercially available test of its kind.¹

The test will be available in hospitals to quickly assist clinicians in assessing patients with mild TBIs, known as concussions, in an objective way and help develop the next steps of care for patients. 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 96.7% sensitivity and 99.4% negative predictive value.

Beth McQuiston, MD, medical director in Abbott's diagnostics business, told NeurologyLive^®, “We are seeing the beginning of the future in how concussions are evaluated. This lab test for concussion will be a game changer for concussion assessment in hospitals, giving clinicians an objective tool to quickly assess a possible brain injury, triage patients, and reduce the number of unnecessary CT scans—giving people who test negative peace of mind. This is only the beginning of advancements in concussion testing as we continue to research future indications for both adults and children.”

In a statement,¹ McQuiston noted that hits to the head are often minimized or ignored and that some "wonder if a visit to the doctor or emergency room for a possible concussion will provide them with meaningful answers or care."

Abbott's Alinity i TBI lab test evaluates patients who are 18 years of age or older that present suspected mild TBI within 12 hours of injury (scoring between 13 and 15 on the Glasgow Coma Scale), determining whether they are candidates for a CT scan. A blood sample is drawn from the arm and then sent to the lab for preperation to be run on the Alinity i instrument. Results are complete in as little as 18 minutes, and are then shared with the provider for further evaluation.

In January 2021, the FDA cleared Abbott'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.² 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.³ 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.

"Evaluating brain injuries is complex—and research shows that we only catch about half of those who show up to the hospital with a suspected TBI," Geoffrey Manley, MD, PhD, vice chair, neurological surgery, University of California, San Francisco, said in a statement at the time.² "And beyond those who go to the hospital for a suspected TBI, many more never do. A test like this could encourage more people to get tested after a head trauma, which is important, because not receiving a diagnosis can be dangerous and may prevent people from taking the necessary steps to recover safely."

In recent years, blood test advancements have become a common theme in the Alzheimer disease (AD) community and for other brain disorders. In November 2020, C2N Diagnostics announced the availability of its PrecivityAD blood test, the first widely accessible AD blood test in a clinical setting.⁴ The PrecivityAD test identifies whether a patient is likely to have amyloid plaques in the brain. It relies on precise and robust quantitation of the amyloid-beta 42/40 ratio (Aß 42/40) and detection of the Apoliproprotein E proteotype (equivalent to APOE genotype) in blood samples, using C2N’s proprietary mass spectrometry platform.

REFERENCES
1. Abbott Receives FDA Clearance for First Commercially Available Lab-Based Blood Test to Help Evaluate Concussion. News Release. Abbott. Published March 7, 2023. Accessed March 7, 2023. https://abbott.mediaroom.com/2023-03-07-Abbott-Receives-FDA-Clearance-for-First-Commercially-Available-Lab-based-Blood-Test-to-Help-Evaluate-Concussion
2. Abbott receives FDA 510(k) clearance for the first rapid handheld blood test for concussions. News release. January 11, 2021. Accessed March 7, 2023. https://abbott.mediaroom.com/2021-01-11-Abbott-Receives-FDA-510-k-Clearance-for-the-First-Rapid-Handheld-Blood-Test-for-Concussions
3. i-Stat Alinity. Abbott. Accessed March 7, 2023.https://www.pointofcare.abbott/int/en/offerings/istat-alinity
4. Alzheimer’s breakthrough: C2N first to offer a widely accessible blood test. News release. C2N Diagnostics. October 29, 2020. Accessed March 7, 2023. https://precivityad.com/news/alzheimers-breakthrough