Abbott Receives Health Canada Authorization for Whole Blood Rapid Test to Help Assess Suspected Concussions

Original from: PR Newswire

· The test, run on Abbott's portable i-STAT® Alinity® instrument, uses whole blood to help evaluate patients with a suspected mild traumatic brain injury (mTBI), otherwise known as concussion

· The test produces lab-quality results in 15 minutes

· Clinicians can get a result at the patient's bedside, making the test accessible at urgent care clinics and healthcare settings outside of the hospital emergency room

· The test can be used to help evaluate patients up to 24 hours after injury

Abbott (NYSE: ABT) announced today that Health Canada has approved the company's i-STAT TBI test cartridge for use with whole blood, helping clinicians to assess suspected concussion at the patient's bedside and obtain lab-quality results in 15 minutes. Previously, the tests used to help assess mild traumatic brain injury (mTBI) were only authorized for use with plasma or serum, requiring samples to be sent to a lab for processing.

This new authorization will enable testing to be performed in an array of new healthcare settings beyond hospital emergency departments, including urgent care clinics. This is an important step toward a future where testing could be done in settings such as in pharmacies, clinics without radiology or even in locations such as the sidelines of a sporting event.

"Particularly in the emergency setting, we have long needed a reliable and expedient way to assess and triage patients for urgent computed tomography (CT) imaging of the brain after head trauma," said Andrew Beckett, M.D., a trauma surgeon and medical director of the Trauma Program at St. Michael's Hospital, Unity Health Toronto, and an associate professor at the University of Toronto. "The availability of a rapid point of care and objective test for traumatic brain injury will be a major advancement in emergency care as it can help facilitate immediate and precise diagnosis, ensuring prompt, appropriate treatment." 

The whole blood test on a portable instrument helps clinicians evaluate patients 18 years of age and older who present with suspected mTBI, commonly known as a 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 in conjunction with other clinical information. The ability to perform the test with a whole blood sample means testing can take place in healthcare settings without a lab, which helps to accelerate head trauma evaluation.

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

It is estimated that 165,000 Canadians will experience a TBI this year. Likewise, each year in Canada, more than 20,000 people are hospitalized for TBI, which can range from mild to severe and include concussions.

Among all types of TBIs, concussions are the most common, accounting for approximately 80 to 95 percent of such injuries. Even a mild form of TBI can have long-term consequences.

For decades, standard TBI assessment has remained the same, with doctors leveraging tools such as the Canadian CT Head Rule which uses the Glasgow Coma Scale, a subjective assessment as well as CT scans, to detect brain tissue damage or lesions. A blood test provides objective information and helps remove the ambiguity of a standard concussion assessment.

"Abbott has pioneered breakthroughs in TBI testing technology for more than a decade," said Beth McQuiston, M.D., senior medical director in Abbott's diagnostics business. "We're proud of this important step forward in advancing the standard of care for concussions. With this approval, right from the patient's bedside, clinicians are now able to order a rapid blood test that can provide powerful objective information, quickly. This dramatically changes the efficiency in the emergency room and helps optimize patient care."

This approval expands Abbott's TBI test on market offerings, which already includes the i-STAT TBI Plasma test and the ARCHITECT®and Alinity i lab test (serum and plasma).

Source: Abbott Receives Health Canada Authorization for Whole Blood Rapid Test to Help Assess Suspected Concussions