Cambridge Consultants develops core technology for Ellume’s world-first fully-at-home over-the-counter Covid-19 test
Cambridge Consultants developed key technology behind the world’s first over-the-counter fully-at-home Covid-19 test, which has been granted approval in the United States.
Combining optics, electronics and software, the test gives results in 20 minutes and is suitable for use for those aged two and up.
It worked on the product for Australian digital diagnostics company Ellume, which struck a $231.8million deal with the US government to deliver 8.5 million of the devices and establish its first US manufacturing facility.
Dr Sean Parsons, CEO and founder of Ellume, said: “The Cambridge Consultants team’s dedicated work and novel approach helped us to create a highly accurate and quantitative digital immunoassay that is also affordable, robust and simple to use – the crucial elements at the heart of successful at-home testing.
“At-home, rapid testing is key to slowing the spread of Covid-19 in the coming months. Without Cambridge Consultants and their continued partnership over the years, we wouldn’t have been able to achieve technical success.”
In clinical trials, the Ellume Covid-19 Home Test correctly identified 96 per cent of positive samples and 100 per cent of negative samples in individuals with symptoms.
For those without symptoms, it correctly identified 91 per cent of positive samples and 96 per cent of negative samples.
This places its sensitivity above that of the lateral-flow devices currently used in the UK, although slightly below the gold-standard PCR tests carried out in the lab.
Its technology relies on several years of work by a multidisciplinary team at Cambridge Consultants to create an optoelectronic detection system for all of Ellume’s diagnostics products.
Mike Hazell, senior consultant at Cambridge Consultants, said: “We began working with Ellume back in 2015 to support its ambition to develop an over-the-counter rapid flu test. Together we cracked some key challenges.”
A sensitive, but inexpensive reader is used to detect and interpret the near-infrared photons emitted from a quantum dot captured at the test zones of a lateral flow test strip.
Combined with Ellume’s supercharged fluorescent immunochromatography, this delivers what is described as “world-leading specificity and sensitivity” for such a test.
“We also worked on the design for ease of use and high volume, low-cost manufacture,” added Mike. “The core technology represents a versatile, highly capable platform.”
The test requires users to take a mid-turbinate nasal swab to detect antigens - meaning it is collected further back than the usual nasal swab, but not as far back as nasopharyngeal swabs, which are only suitable for trained health care providers.
The analyser connects to an app on users’ smartphones to help them perform the test and interpret the results.
Users enter their date of birth and postcode, and optionally their name and email address, and the results are reported back to public health authorities to help monitor the prevalence of the virus.
Symon Cotton, head of life sciences at Cambridge Consultants, said: “The kit provides huge benefits - not least, screening frontline workers who are constantly coming into contact with Covid.”
Nick Hawson, senior vice president for medtech (US West) at Cambridge Consultants, said: “Dr Parsons came to us with a big challenge and a strong vision that together, we faced head on. At the time, we never knew the impact it would have on the Covid-19 epidemic.
“We’ve created a strong, long-lasting partnership with Ellume rooted in collaboration and innovation, and we hope we continue to find ways to use this technology in digital diagnostics and continue our impact on global health.”
When the US Food and Drug Administration announced approval for the test, FDA commissioner Stephen Hahn said: “By authorising a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.
Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, added: “This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”
As yet, there are no plans for the test to be released in the UK.
Here, the government’s approach has been to make rapid home-testing kits - using lateral flow tests - freely available to parents of school-age children, school workers and their families, while also encouraging workplace testing regime and community-based asymptomatic testing for key workers.
The specificity of these tests has been put at least 99.9 per cent - meaning that there is fewer than one false positive in every 1,000 lateral flow tests carried out. Their sensitivity - meaning the proportion of positive cases detected - has been variously placed by studies at between 58 and 79 per cent in studies, depending on who conducts the test, meaning they should be seen as ‘red light’ tests that help to pick up additional cases, rather than ‘green light’ tests, as those who test negative could still have the virus.
Meanwhile, Ellume has used the same technology that Cambridge Consultants helped to develop for two other diagnostic tests in the past year – its QIAREACH Covid-19 antigen and antibody tests are aimed at the laboratory market, while the ellume·lab Covid-19 serology and antigen tests are due to be launched for healthcare professionals later in 2021.
Beyond the coronavirus, the core sensing breakthrough is being used for Ellume’s rapid home flu test and diagnostic assay for tuberculosis
Cambridge Consultants said: “Not only are rapid tests like Ellume’s integral to stopping the spread of the Covid-19 virus, but they could also play a critical role in tackling future pandemics and other infectious diseases across the globe.”
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