SMARTChip biosensor undergoing clinical trials in England could pave way for clinical laboratories to provide additional diagnostic tests for monitoring patient progress
Emergency medical workers and mobile clinical laboratory technicians may soon have a point-of-care blood test that can identify patients having a stroke from its earliest moments. Currently being developed by Sarissa Biomedical at the University of Warwick in England, the SMARTChip is a finger-prick blood test that reportedly could cut diagnostic time to under five minutes.
Such a device could be a lifesaver for stroke victims. It would speed treatment decisions, ensure more patients receive treatment, and provide medical laboratories with an opportunity to play a crucial role in saving stroke victims’ lives and monitoring the progress of their recovery.
Development in Detecting Stroke Lags Behind Other Major Killers
Currently, there is no quick way to diagnose a stroke. Time-consuming CT and MRI scans and other tests must be used to evaluate the type of stroke a patient has had and to rule out other possible causes of symptoms that mimic a stroke. Every minute a major stroke is left treated, the brain loses an estimated 1.9 million neurons.
SMARTChip may change that. If the portable SMARTChip proves its diagnostic abilities in additional trials, it means stroke patients in the future may be able to begin receiving treatment sooner, perhaps while in an ambulance to the hospital.
The biosensor’s arrays measure compounds in blood called purines, which are produced within cells that are deprived of oxygen. During an ischemic stroke, purine levels surge when a blood clot blocks blood flow to the brain.
“Survival rates for heart attack victims have risen dramatically over the last 20 years,” noted Nicholas Dale, PhD, a neuroscientist and professor at the University of Warwick in Coventry, England. “In part, this has come from faster diagnostic tools such as ECG monitors, and rapid biochemical tests. By comparison, stroke patients have got a raw deal. No equally simple biochemical tests exist in stroke. For neuroscientists, this is depressing.”
Clinical trials at University Hospitals Coventry and Warwickshire (UHCW) NHS Trust followed 375 stroke patients who were administered the SMARTChip blood test when admitted to the hospital and again 24 hours later.
“SMARTChip has been developed to address the need for rapid diagnostic tests to inform clinical decision making in the early critical period following a stroke …,” Imray stated in a 2019 MidTECH case study.
“We were able to prove that on the onset of a stroke the brain releases a detectable quantity of purines into the blood,” he continued. “SMARTChip is able to measure these purines in the blood and help diagnose the symptoms of a stroke faster, which means that our patients get the care that they need as quickly as possible.”
Dale notes the next step for the SMARTChip device will be a “multicenter paramedic-led clinical trial in early 2019 for the evaluation of diagnostic accuracy.”
Identifying Type of Stroke Critical to Correct Treatment
Stroke is the fifth leading cause of death in the US, according to the US Centers for Disease Control and Prevention (CDC). Strokes are also one of the primary causes of serious disability among Americans.
“Use of rapid blood tests to identify patients with stroke is a very important and exciting area of research, and the results of this trial are awaited with keen interest by the stroke community,” Richard Perry, MD, a consultant neurologist at University College London Hospitals, told the Daily Mail.
However, Perry adds a word of caution regarding the SMARTChip’s potential, telling the Daily Mail it is unclear whether tracking purine-release levels will enable doctors to distinguish between an ischemic or hemorrhagic stroke. Most strokes (87%) are ischemic strokes, which occur when blood flow through an artery becomes blocked. This is typically caused by a blood clot in the brain. A hemorrhagic stroke happens when an artery in the brain leaks blood or ruptures.
“These two types of stroke require very different treatment strategies, so distinguishing them early is another important goal for blood biomarker studies,” Perry said.
According to ClinicalTrials.gov, the SMARTChip Stroke Study’s estimated completion date is June 2019. If this device ultimately makes it way to the commercial market, clinical laboratories will be looking for ways to build on its leading-edge technology with value-add testing for the monitoring of stroke patients.
—Andrea Downing Peck