Excalibur rapid SARS-COV-2 antigen screening test, validated by LSTM, granted MHRA approval

News article 13 Jan 2021
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Excalibur Healthcare Services Ltd, a UK-based provider of high-quality medical products and services, has announced that its Rapid SARS COV-2 Antigen Screening test is the first ever lateral flow antigen test to receive regulatory approval for use in mass screening for COVID-19 in asymptomatic, pre-symptomatic and symptomatic populations.

To date, COVID-19 tests in the UK have been approved for use only on people displaying COVID-19 symptoms. Now, following approval from the Medicines & Healthcare Products Regulatory Agency (MHRA), the Excalibur Rapid SARS COV-2 Antigen Screening test can be deployed for widespread mass screening of populations to rapidly track down infectious individuals capable of spreading the disease.

The CE-marked Excalibur test is one of the world’s most accurate and fastest SARS-COV-2 Antigen lateral flow testing kits ever developed. It has already been extensively trialled and shown to deliver trustworthy results within minutes.

It is designed to be deployed at scale across large numbers of people in a wide range of environments – including hospitals, clinics, care homes, educational establishments, businesses, offices, construction, transport, entertainment and sporting venues.

The Excalibur Rapid SARS COV-2 Antigen Screening test has equivalent or better sensitivity than any of its competitors, as shown by very extensive studies and expert third party testing. The test demonstrated consistently excellent results when tested independently by LSTM; Imperial College, London; a world leading pharmaceutical company and by Boson Diagnostics, China, in collaboration with the renowned National Pathogen Culture Library of Korean Pathogen Resources (NCCP).

A further independent clinical trial at the Catholic University of Korea Incheon St Mary’s Hospital, in a sample size of 659 patients presenting for care, recorded an overall sensitivity of 96%, accurately corresponding to RT-qPCR-confirmed COVID-19 cases. The test has a specificity of 100%.

Limit of detection studies show a 50% Tissue Culture Infectious Dose (TCID50/ml) of 93-142 (<5×10^2 pfu/ml), a key tool for estimating the infectious titre of a virus.

LSTM's Dr Emily Adams said: We have analysed the Excalibur test in our laboratories on isolates of SARS-CoV-2, and found the test to have high analytical sensitivity and specificity. Deploying tests, such as this one developed by Excalibur, in populations to screen for asymptomatic infections could produce significant amounts of clinical data which will help in the continuing fight against the virus. We look forward to evaluating that data.”

Professor Sir Chris Evans, Chairman of Excalibur Healthcare Services Ltd, commented: “This test can be used with complete confidence in a wide range of everyday settings and will help organisations and businesses operate with the knowledge that their personnel are not infectious at the time of testing. It is fast, accurate, dependable and affordable and will screen out any highly infectious people quickly and reliably. Our test can now play a key role in helping us all combat the spread of coronavirus.”

The Excalibur Healthcare SARS CoV-2 Rapid Antigen Screening test has successfully been used in screening trials in hospitals, healthcare environments, offices, retail chains, workplaces, care homes, a retirement village, several businesses and professional sports clubs.

Theo Paphitis, owner of Ryman and hardware retailer, Robert Dyas, and former star of Dragon’s Den said: “We have bought thousands of Excalibur Rapid Antigen Screening tests and are extremely impressed. We have applied these tests in our administrative central offices and in our Rymans and Robert Dyas stores to great effect. We found individuals with no symptoms who showed up as highly infectious and been able to retire these people from mixing with other team members within a matter of minutes of showing positive. These are excellent and invaluable screening tools developed by Excalibur – use them and stay safe.’

Jason Davies, acting managing director of Royal Buckinghamshire Hospital, said: “Our hospital has purchased thousands of tests from Excalibur to test staff and visitors across the site. We are using them as the first line of defence as per government guidelines. They have already proved their worth in picking out a number of asymptomatic positive Covid visitors. The tests are very reliable, easy to use and robust. I would highly recommend them in any setting where safety is a concern.”

Dr Conal Perrett, a leading UK dermatologist & founder of 18 Week Support, which provides clinicians to support the NHS, said: “We apply this test every day to every visitor, patient, and staff member without fail. It is very easy to use, produces positive results sometimes within 2-3 minutes and is always extremely reliable and accurate. We have a great confidence in this excellent test and it is relatively inexpensive for what it does.”

Andrea Ponti, Founder GHO Capital, a leading specialist healthcare PE, said: “We have been using the rapid Covid-19 test in our office settings to make sure those who are there can feel safe. They have run lots of expert independent validations with excellent results and the tests can be used every day to check for the presence of any Covid-19 infection among the GHO professionals or visitors.” 

Excalibur recently set up laboratories in the Accelerator within the Knowledge Quarter in Liverpool and accessed dedicated support from LSTM's diagnostics team. The activity was part funded by the European Regional Development Fund (ERDF) program Formulated Materials for Infectious Disease Prevention. It is a great example of how LSTM's academic support can make a difference in helping companies get their products to market.