In an effort to better understand the new coronavirus, ongoing research and clinical trials for Covid-19 treatments and vaccines are happening globally. Among them, a non-invasive, highly accurate, disposable breath test that could hit the market before the end of 2020.
The trial is a collaboration between US-based Canary Health Technologies and South Africa based Ezintsha research group at the University of Witwatersrand (WITS). The test, which involves a handheld device with disposable sensors, is set to deliver results on-site in under five minutes. The human trial is due to start in South Africa by the end of June, and trials in the UK and US are also planned.
Test result backlog a major concern
Statistics from the Johns Hopkins Coronavirus Resource Centre show that as of 26 May, Covid-19 has infected more than 5.5 million people and killed over 346 000 worldwide. Major challenges in testing for Covid-19 remain, including a shortage of diagnostic tests and a backlog in test results. The Western Cape, for example, is battling with a huge 18 000-test backlog.
However, using exhaled Volatile Organic Compounds (VOC’s) found in human breath, which are biomarkers of the virus, this newly-developed diagnostic test, named Covid-19 RT BAP, could potentially identify those who are infected with the disease.
More than this, the test will greatly assist in identifying those who have not yet developed clinical symptoms, or are asymptomatic (infected but displaying no symptoms). Asymptomatic cases have been reported as part of contact tracing efforts, reports the World Health Organization (WHO). The test could therefore quickly detect those at risk and help reduce transmission.
How the trial will be done
The first phase of the trial will involve 150 people – both Covid-19 positive patients and those who do not have the virus, and will use nanosensors to collect patients’ breath samples. The participants will be asked to breathe into the device for three minutes.
The device will then translate their breath biomarkers into electronic signals which will be transmitted to a centralised “lab in the cloud” for analysis. This cloud-based pattern recognition technology will be used to determine if a Covid-19 breath pattern can accurately be established. Preliminary results are expected at the end of July.
Since these tests are analysed in a cloud-based system, they can detect the disease from the time of infection, in addition to providing real-time surveillance. This means that health professionals will be able to see disease hotspots in real-time, and respond accordingly.
More importantly, rapid diagnosis at high transmission areas, such as airports, will drastically reduce the potential for disease transmission, and also allow Covid-free people more freedom of movement.
‘We are thrilled to collaborate with Ezintsha’
Raj Reddy, CEO of Canary Health Technologies said: “We are 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 for a lab.
Reddy added that the device is ideal for use in doctors’ offices, nursing homes, and airports, and that it should be available before the end of 2020. “We aim to set the gold standard in Covid detection,” he said.
Professor Francois Venter, a world-renown infectious diseases expert, and Head of Ezintsha, also said: “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.
“This could revolutionise testing for Covid, to then build a base to detect many other diseases. A non-invasive and accurate test that healthcare workers can carry in their pockets is a win-win for all.”
If the initial phase of the trial is successful, Canary Health Technologies hopes to get it to the global market and will, therefore, move into another trial with a larger sample size for expedited regulatory approval with the US FDA and other markets.