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FDA clears first handheld blood test to evaluate mild concussions

The U.S. Food and Drug Administration (FDA) has cleared a new rapid, handheld blood test that could detect whether or not patients have mild concussions.

The test, known as iSTAT and manufactured by Abbott Laboratories, looks for specific proteins present in the blood after head trauma.

What’s more, results are returned within 15 minutes.

Researchers say this could eliminate long wait times in emergency rooms as well as potentially costly and unnecessary CT scans.

The test is currently only available in healthcare settings. However, in the future, it could be used at sporting events, such as NFL games, so players can receive a quick evaluation.

The FDA has cleared a new test developed by Abbott Laboratories to detect mild concussions in patients, which requires drawing a blood sample and looking for two blood biomarkers

Researchers say they hope the test could be used in the future outside of healthcare settings, such as at sporting events. Pictured: Baltimore Ravens running back Gus Edwards (35) avoids the tackle of New York Giants cornerback Isaac Yiadom (27) during the game at M&T Bank Stadium in Baltimore, December 2020

Researchers say they hope the test could be used in the future outside of healthcare settings, such as at sporting events. Pictured: Baltimore Ravens running back Gus Edwards (35) avoids the tackle of New York Giants cornerback Isaac Yiadom (27) during the game at M&T Bank Stadium in Baltimore, December 2020

Dr Beth McQuiston, medical director for Abbott’s diagnostics business, told DailyMail.com that the U.S. Department of Defense started working on this project 20 years ago.

In 2014, the agency asked Abbott if the company wanted to collaborate and began running studies.

‘This test is a game changer,’ McQuiston said. 

‘This is the first available rapid handheld blood test to evaluate concussions in minutes. It’s a huge leap forward in the assessment of traumatic brain injuries (TBIs).’

Currently, concussions are diagnosed by a physician observing for signs such as  headache, fatigue, dizziness, blurry vision, nausea, vomiting and ringing in the ears.

In addition to a neurological exam or cognitive testing, patients may have to undergo MRIs or CT scans.

According to the University of Pittsburgh Medical Center, between 1.7 and three million sports- and recreation-related concussions occur each year. 

However, as many as half go unreported or undetected. 

Untreated concussions can lead to severe neurological damage in the future, especially if a second injury occurs before the first injury is completely healed.

‘It is an invisible injury so we want to make the invisible visible,’ McQuiston said.

The test measures two biomarkers in the blood: glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L)

Both appear in greater concentrations in blood plasma after brain trauma, but in mild injuries may not appear on scans

Patients have a small blood sample drawn from the arm, and researchers then separate plasma, the liquid portion of blood, from the rest of the sample.

The plasma is then applied to the test’s cartridge, which is inserted into the handheld instrument.  

Abbott says the test is 95.8% at identifying patients with concussions and produce results within 15 minutes

Abbott says the test is 95.8% at identifying patients with concussions and produce results within 15 minutes

Results of a study that showed the test was 95.8 percent accurate at identifying patients with concussions and 99 percent accurate at identifying those without were published in The Lancet in August 2019. 

No cost has been set yet, but McQuiston says ‘it will be many times lower than the cost’ of a CT scan.

Researchers say a negative result could rule out the need for a CT scan while a positive test could complicate a CT scan. 

‘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,’ said Dr Geoffrey Manley, vice chair of neurological surgery at the University of California, San Francisco, in a statement.

‘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.’ 

McQuiston said the largest share of concussions occur from slip and falls and then motor vehicle accidents, which means the test has implications for everyday Americans, but the test could be helpful among professional sports leagues. 

This includes being a game changer for the NFL, which has been struggling to deal with a growing number of retired players diagnosed with CTE.  

CTE, or chronic traumatic encephalopathy, is a neurodegenerative  condition associated with repeated head trauma. 

Football players who receive a positive test that may otherwise go undetected could rest up before charging back onto the field.  

McQuiston says Abbott is currently working on a test that doesn’t involve separating plasma from the blood sample and hopes the test can be used outside of healthcare settings, such as at schools and sporting events. 

‘We are very hopeful that we continue to work on our TBI test because we want to take it where folks need it,’ she said.

Read more at DailyMail.co.uk