A breath test for COVID

For anyone who doesn’t enjoy being swabbed, news of a new COVID breath test may be welcome. Claimed as the first “ultra-rapid COVID-19 detection technology” a Finnish medical company has just received CE certification for their device, which means it can now be sold across Europe.

The device, called a BreathPass™ is portable and handheld. It analyses exhaled breath to detect COVID-19 infection. Simply blowing into the device once, like a breathalyser, can provide a positive or negative reading within 45 seconds.

If proven to be effective (sensitivity and specificity matter greatly) the devices may provide a welcome alternative to swabbing in asymptomatic screening. The speed at which the device may be able to work means it may have great benefit for workplaces, airports or sports events, where mass screening at speed may be very helpful.

How does the COVID breath test work?

The device contains a set nanosensors that record Volatile Organic Compounds (VOC) and other substances connected to biomarkers in exhaled breath gas. The device then communicates the results to an Artificial Intelligence cloud-based algorithm, which calculates how the VOC profile matches known COVID-19 features.

Similar approaches are used in the treatment of chronic obstructive pulmonary disease (COPD) and are also being developed to try and detect many illnesses at an early stage.

The device is described as a fast, easy and affordable testing method for detecting COVID-19 infection, that can be done anywhere with a reliable connection to the internet.

What evidence is there that it works?

Sadly, there is very little easily accessible evidence that the device has been through large scale trials, as yet. The data that has been published so far refers to very small trial sizes, some involving just ten people. The trials were not randomised or ‘blind’, which makes it very difficult to be certain that the device is accurate and reliable.

The data sheets provided by the manufacturer have very few references to trials or evaluations, other than previous evaluations of other devices tracking VOCs. Again, the trials were incredibly limited in scope and size, so it’s difficult to draw solid conclusions about the effectiveness of the approach.

Can a diagnosis really be made from a breath?

Although the evidence behind the Finnish COVID breath test is currently unclear, there is mounting evidence that VOC’s may offer a cost-effective and rapid route to diagnosis for many conditions. Companies all over the world are attempting similar approaches.

Owlstone Medical, another manufacturer of similar devices, has published many more research papers, several of which are larger and independent. Owlstone Medical first hit the headlines in 2017 and has extended their research and product base considerably since the business was founded.

The NHS Health Research Agency had considered trials with one device, although it is now being evaluated in South Carolina, USA, in a trial running until September this year. The results are likely to be published soon after the trial is completed.

When will the devices be available?

Although the devices need more trials to prove they are safe and effective, it’s likely that in coming years we may well see similar devices being used widely in healthcare settings.

Safety may not seem a big deal, because blowing in a tube isn’t very risky. However, the risk of being given an incorrect result, which could result in accidental infection of others (from a ‘false negative’) or unnecessary medical treatment (following a ‘false positive’) has to be excluded.

If they are proven to work well, they may be very well suited to health screening, so we expect to see them used widely in corporate health assessment programmes.

Whilst a COVID breath test may offer hope of a rapid alternative to swabbing, even the best machines do not match the performance standards of some of nature’s best sniff testers – dogs.

In a study we first covered in May 2021, dogs were shown to be highly effective at detecting COVID-19. They are excellent at finding drugs, explosives, bodies and even viruses. Their diagnostic skills are not to be sniffed at, but they may not be quite as well suited to being used in corporate health assessments.

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