New 5-minute Covid-19 test based on breath now in clinical trials

Exhalation Technology Ltd (ETL) in Cambridge has announced a large clinical study for its CoronaCheck breath test for Covid-19.

The rapid antigen test offers “a sub-five minute test of high specificity and sensitivity” based on exhaled breath condensate (EBC).

The Newmarket Road-based diagnostics company has developed the game changing point-of-care screening device from an existing technology, the Inflammacheck. The Inflammacheck is a handheld, non-invasive, point-of-care diagnostic device – the only device on the market designed to collect EBC and tests for compounds directly at the location of the test.

In its original form the Inflammacheck detects hydrogen peroxide, H2O2, in EBC. H2O2 is a well-documented biomarker for inflammatory conditions in the airways system. The full test cycle, including sample collection and test assay, typically takes place in five minutes, following a fully automated procedure.

The Inflammacheck is CE marked for the EU and UKCA (UK confirmatory authorisation) by the MHRA for sales and use in the UK.

“Building on an existing CE marked IVD medical device platform is expected to enable a short time to market while at the same time de-risking the project significantly,” noted Stig Lytke Brejl, director of ETL.

The ETL clinical trial program for CoronaCheck will take place at the Clinic for Respiratory Medicine based in The Queen Alexandra Hospital, Portsmouth, and is headed by Professor Anoop Chauhan for a cohort of up to 150 patients to be tested in an ethics-approved clinical trial on infected and normal patients.

Of 62 patients tested so far, CoronaCheck has detected with 100 per cent specificity and 100 per cent sensitivity those patients who are either positive or negative for Covid-19. Some of those who tested positive for Covid-19 were asymptomatic.

Helle Funch Nielsen, CEO of ETL, said: “Initial results from patients recruited into our clinical study are very promising.

“Our CoronaCheck test is set to provide novel technology for high volume screening of individuals in a range of environments including schools, airports, shopping centers and sporting events, to name but a few.

“The technology is entirely innovative and our initial test is based on rapid testing in exhaled breath, a simple and convenient means of sample collection.

“Our collaboration with Imperial College in London and clinical centres in the UK – such as the Clinic for Respiratory Medicine based in The Queen Alexandra Hospital – is providing rapid proving and validation of this novel approach to Covid-19 testing.”

CoronaCheck has been tested on the laboratory bench with live virus as well as in inactivated virus, and in controlled solutions as well as in “virus-spiked” EBC.

The bench tests with UV-inactivated influenza virus also show that CoronaCheck can distinguish between Covid-19 and other viruses such as seasonal flu.

CoronaCheck includes embedded Bluetooth functionality, which enables the rapid reporting of results to healthcare authorities and other interested bodies.

ETL is now seeking a global strategic partner with which it can collaborate to exploit its new Covid-19 test.