We are pleased to confirm that Everything Genetic’s COVID-19 (SARS-Cov-2) Antigen Test has been approved in the UK under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) Regulations 2021 (CTDA) for continued sale.
It is the company’s first test to be added to the CTDA register and we are already seeing significant demand from our clinical partners and resellers for this product. We anticipate similar from the general public following the Government’s recent announcement to end access to free testing from 1 April 2022.
Everything Genetic’s COVID-19 (SARS-Cov-2) Antigen Test, which is also CE marked, is intended for in vitro qualitative detection of the nucleocapsid protein antigen from SARS-Cov-2 in nasal swabs from individuals. It is suitable for use by individuals who are symptomatic or asymptomatic.
The assay boasts a clinical performance of 96.1% sensitivity and 100% specificity with results provided at point of care within 15 minutes.
Low-cost lateral flow test kits
The test kit is purposely priced at a low price per unit in line with our continued commitment to democratise testing for all with single test kits selling for £2 and packs of 10’s and 20’s starting at £20.00 and £40.00 respectively.
In addition to this test being available for general at-home use, we are also seeing demand from large corporates who wish to regularly test their workforce, and when combined with our photo verification service it is also suitable for fit to travel testing.
James Price, CEO and Founder of Everything Genetic said:
“I am delighted to announce that Everything Genetic’s COVID-19 (SARS-Cov-2) Antigen Test has been approved and added to the CTDA register. This is a significant milestone in our Covid testing service; a service which we have been providing since the start of the pandemic.
“With the Government announcing the end of access to free lateral flow tests, we look forward to ensuring that our customers continue to have access to this market-leading test at affordable prices coupled with a reliable delivery service and excellent customer care.”
For general at-home, non-travel testing, click here.
For employers who require bulk purchase options, enquire now.