The versatile diagnostic platform that passes the test

People infected with both COVID-19 and flu are four times more likely to require ventilators than those with Covid alone, a recent Lancet study showed.

The authors concluded that hospitalised Covid patients should be tested for flu to identify those at risk as well as patients who may respond differently to immunomodulatory and antiviral therapy.

LumiraDx’s SARS-CoV-2 & Flu A/B Test is helping to inform treatment decisions as more than two years into the pandemic, the world moves towards the next phase.

Associate Director of Medical Affairs, Lucy Lehane, explains how it works.

Hi Lucy. The LumiraDx Instrument is more than just a Covid test. How does it work?

The LumiraDx Instrument is a state-of-the-art platform, that has been designed to go where the patient is. So it’s really driving testing in communities, testing in hubs, providing lab-comparable results, at point of care on a portable, easy to use platform.

There are currently twelve tests available on the platform, one of which is the LumiraDx SARS-CoV-2 and Flu A/B test. We have also just announced the launch of the LumiraDx SARS-CoV-2 & RSV test also.

The whole process from taking the nasal swab to delivering the result takes just 12 minutes.

Why did you decide to go down the dual Covid and flu route?

We launched Covid antigen and antibody tests during the height of the pandemic. They were very important in the management of patients during that period. But we’re now moving into the next phase of the pandemic era.

In the last two years, with people socially distancing, we saw a sharp decrease of prevalence of respiratory illnesses like Flu A and Flu B. However, as societies began to reopen once again these viruses are beginning to circulate

With that, Healthcare Professionals are now seeing patients with ambiguous respiratory symptoms. They’re asking, is it a Covid patient? Or could it be flu? Could it be both?

These respiratory conditions can present in a very similar way, but the action that the Healthcare professional needs to take is different and needs to be managed accordingly.

We launched the LumiraDx SARS-CoV-2 & Flu A/B Test during December 2021 taking into consideration that the 2022 respiratory season may have less COVID infections in circulation and possibly see the return of other respiratory viruses like Flu A and Flu B.

Is it pretty straightforward to identify and test for a new Covid variant?

Viruses constantly change through mutation, and new variants of a virus are expected to occur over time. Sometimes new variants emerge and disappear. Other times, new variants emerge and persist.

Many variants of the virus that cause COVID-19 have been detected globally during this pandemic and LumiraDx is actively monitoring for new mutations in the SARS-CoV-2 viral genome as they arise.

All testing to date has demonstrated that the LumiraDx SARS-CoV-2 Ag and the LumiraDx SARS-CoV-2 & Flu A/B tests can detect all the SARS-CoV-2 variants of concern with comparable sensitivity and, as we move into the future, we will closely monitor this.

How does the SARS-CoV-2 & Flu A/B Test differ from the other Covid tests?

The first difference is that, unlike a straightforward Covid test, this test measures three different things – SARS-CoV-2 Ag, Flu A and Flu B from one swab sample.  In terms of performance, we’ve compared our test to a gold standard, RT-PCR test.

Lucy Lehane

In clinical studies, the LumiraDx SARS-COV-2 & Flu A/B test demonstrated up to 95.5%, 83.3% and 80.0% positive percent agreement (PPA) versus RT-PCR for detection of SARS-COV-2, Flu A and Flu B respectively.

When we were developing and validating the flu test, there was obviously very little to no flu circulating in the population due to the pandemic so we are now running prospective clinical studies to be able to confirm performance with fresh Flu samples.

Flu B is difficult at the moment because there’s very little of circulating in the world. But for Flu A, we collected fresh samples between November last year and February this year. And in terms of performance of the Flu A portion of our test, we’re now seeing 100 per cent PPA against RT-PCR.

It’s great that we are able to do prospective testing and demonstrate the high performance and high accuracy of our tests in real time.

Where are your tests being used?

In the UK, the LumiraDx Platform is being used by GPs in primary care and also in the secondary care for example in Emergency Departments.

At the height of the pandemic, our Platform was being used to test patients for COVID Antigen before they went into Emergency departments to decide where to place patients so that they weren’t putting potentially infectious patients into a waiting room with other people.

Now, the LumiraDx Platform is the perfect point of care tool, allowing multi-analytes to be tested, in one place providing results quickly and importantly with lab-comparable accuracy beside the patient.

As well as tests for COVID (antigen and antibody) and COVID/Flu, the Lumira Dx platform currently supports D-Dimer, CRP, COVID/RSV, INR, HbA1c, and Nt-proBNP test capabilities.

There are over 30 tests in the pipeline across a range of assay technologies including enzyme, immunoassay, molecular and electrolyte assays.

Do you anticipate that mass testing will become a long term health strategy beyond Covid?

This next phase of the pandemic is still unfolding, so it is not clear yet what is the long term health strategy around the globe – what we do know is that at LumiraDx our focus is offering a point of care Platform that can accurately measure analytes from many different sample types – for example fingerprick blood samples, whole blood, plasma, serum and nasal swabs.

We have many more tests recently launched and in the pipeline to offer diagnostic testing for non-COVID infectious diseases, diabetes management, cardiovascular diseases, thrombosis and hemostasis as well as adding to our respiratory portfolio.

The most important thing is that the LumiraDx state-of-the-art Platform is able to deliver high accuracy diagnostics for community-based healthcare. Providing simple, accessible, and affordable point of care testing.