FDA Clears First Rapid Traumatic Brain Injury Blood Test

Beth McQuinston, MD

The FDA has given 510 (k) clearance for the first rapid handheld traumatic brain injury (TBI) blood test, which will help clinicians assess patients with suspected mild TBIs, including concussions, and will be ran on Abbott’s handheld i-STAT Alinity platform.¹

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. Computed tomography (CT) scans, often used to diagnose concussion, can then be ruled out if a patient has a negative test result.

"Healthcare providers have been waiting for a blood test for the brain and now we have 1,” Beth McQuinston, MD, medical director, Abbott’s diagnostic business, said in a statement.¹ “You can’t treat what you don’t know and now physicians will be equipped with critical, objective information that will help them provide the best care possible, allowing patients to take steps to recover, prevent reinjury, and get back to doing the things they care about the most.”

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. A positive test result can complement CT scans and help clinicians evaluate whether a patient has TBI.

READ MORE: Biogen, Apple to Initiate Study to Develop Cognitive Health Digital Biomarkers

Abbott noted that the plasma test provides results with 95.8% sensitivity and 99% negative predictive value. It was originally developed in collaboration with the US Department of Defense (DOD), which have played a role in increasing detection and evaluation of TBI. The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team were the first to demonstrate how this TBI blood test can be used for the benefit of TBI patients in clinical care.

The i-STAT Alinity TBI plasma test simultaneously measures biomarkers glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in blood plasma. These 2 blood biomarkers have been correlated to brain injury when in elevated concentrations.

The 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.²

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 Scientist magazine cited the i-STAT Alinity system as 1 of the Top 10 Innovations of 2017, as independent judges ranked it among the most innovative products emphasizing the importance of technological development in the clinical diagnostic area. Additionally, the analyzer received the Silver A’Design Award in the Medical Devices category for its superior design.

"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.1 "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."

Blood test advancements have become a theme in recent months, as a growing amount of momentum was built in the Alzheimer disease (AD) community and for other cognitive disorders. Just recently, in November 2020, C2N Diagnostics announced the availability of its PrecivityAD blood test, the first widely accessible AD blood test in the clinic setting.³

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 510(k) clearance for the first rapid handheld blood test for concussions. News release. January 11, 2021. Accessed January 18, 2021. https://abbott.mediaroom.com/2021-01-11-Abbott-Receives-FDA-510-k-Clearance-for-the-First-Rapid-Handheld-Blood-Test-for-Concussions

2. i-Stat Alinity. Abbott. https://www.pointofcare.abbott/int/en/offerings/istat-alinity. Accessed January 18, 2021.

3. Alzheimer’s breakthrough: C2N first to offer a widely accessible blood test. News release. C2N Diagnostics. October 29, 2020. Accessed November 5, 2020. https://precivityad.com/news/alzheimers-breakthrough