The UK Medicines & Healthcare Products Regulatory Agency (MHRA) has approved Excalibur Healthcare Services’ lateral flow antigen test for mass screening for Covid-19 in asymptomatic, pre-symptomatic, and symptomatic people.
The widely trialled Rapid SARS COV-2 Antigen Screening Test can potentially provide reliable results within minutes.
So far, Covid-19 tests approved in the UK are for testing individuals showing Covid-19 symptoms. The test can be used at scale in various environments such as hospitals, clinics, care homes, educational institutions, and businesses.
Excalibur Healthcare Services chairman professor Chris Evans said: “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.”
The CE-marked Excalibur test showed consistently outstanding results in independent testing.
The independent test was carried out by Liverpool School of Tropical Medicine, Imperial College, London, a pharmaceutical firm, and by Boson Diagnostics, China, in partnership with the National Pathogen Culture Library of Korean Pathogen Resources (NCCP).
Liverpool School of Tropical Medicine senior lecturer 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.”
Furthermore, in an independent clinical trial on 659 patients at the Catholic University of Korea Incheon St Mary’s Hospital, the overall sensitivity of 96% was observed, which is consistent with RT-qPCR-verified Covid-19 cases.
Excalibur noted that the test has 100% specificity.