The South Africa-based Ezintsha research group at the University of Witwatersrand in Johannesburg and U.S.-based Canary Health Technologies will collaborate on the trial, the researchers said in a statement emailed to Xinhua.
The trial will determine whether a highly accurate, non-invasive, disposable breath test that could detect virus before symptom onset could be on global market before the end of 2020.
The rapid breath test, if successful, can deliver results on site in less than five minutes, thus quickly detecting persons at risk to reduce transmission.
Using exhaled Volatile Organic Compounds (VOC’s) found in human breath as biomarkers of the virus, this diagnostic test (COVID-19 RT BAP) could potentially identify those who are acutely infected with COVID-19 as well as those who have not yet developed clinical symptoms, according to the statement.
The initial phase of the trial will see the collection of breath samples from 150 people – both COVID-19 positive patients and those who do not have the virus. They will be asked to breathe for three minutes into the device. The device will then translate their breath biomarkers into electronic signals which will be transmitted to a centralized “lab in the cloud” for analysis.
The human trial is due to start in South Africa by the end of June, with preliminary results expected by the end of July. Similar trials are also planned in the UK and the U.S.
“We are very excited to partner with Canary on this game-changing technology. The holy grail is a real time, point of care device which can capture Volatile Organic Compounds or VOC as biomarkers,” said Prof. Francois Venter, an infectious diseases expert and Head of Ezintsha.
This could revolutionize testing for COVID-19, to then build a base to detect many other diseases, he said, adding that a non-invasive and accurate test that healthcare workers can carry in their pockets is a win-win for all.
Raj Reddy, CEO of Canary Health Technologies, said his institution is thrilled to collaborate with Ezintsha which is a world-class research unit focused on health innovations.
“We are confident that our highly responsive sensors and proprietary software can detect COVID-19 in less than five minutes without the need of a lab,” he said.
This handheld device with disposable sensors is ideal for use in doctors’ offices, nursing homes, airports and should be available before the end of the year, according to Reddy.
“We aim to set the gold standard in COVID-19 detection,” he said.
If this initial phase of the human trial is successful, Canary Health Technologies will seek to move quickly into a pivotal trial with a larger sample size for expedited regulatory approval with the U.S. Food and Drug Administration and other markets, for global use, the statement said.