COVID-19 testing and the need for regulation – 6 May 2021

The COVID-19 pandemic presented huge challenges worldwide. In response to the unprecedented need for COVID-19 PCR testing, the UK government set up a new network of Lighthouse laboratories across the country to provide the required capacity for testing thousands of samples each day. These laboratories proved a vital part of the test and trace strategy but were also under immense pressure to meet their targets and, following an investigation by Panorama, it was found that the expected high standards, were not always met. 

Alongside the NHS testing laboratories (Lighthouse laboratories), a range of private laboratories also stepped up to offer COVID-19 testing services to meet the needs of the public such as workplace and school testing, fit-to-fly PCR certificates, test-to-release and more recently the day 2 and day 8 PCR testing and associated sequencing of positive samples to identify and track new variants within the country. These laboratories offer PCR tests manufactured by a variety of different companies. Yourgene is uniquely placed to offer COVID-19 testing as it developed, manufactures and processes the Clarigene™ SARS-CoV-2 test in its own laboratory, based at Citylabs 1.0 in Manchester.

Following the introduction of the privately available COVID-19 PCR tests, the UK government made the decision to regulate the testing services that are available to the public to ensure the tests and testing practices meet an acceptable standard. To be able to continue providing a COVID-19 testing service, all laboratories had to submit a range of evidence to show that they meet the minimum standards set-out1. Yourgene is an approved provider for general COVID-19 testing2, test-to-release for international travel (TTR)3 and day 2 and day 8 coronavirus testing for international arrivals4. To aid the tracking of new variants of concern and variants under consideration, positive test results from the day 2 testing that meet certain criteria, such as a certain viral load, will have the genetic code of the virus sequenced. Yourgene Genomic Services are able to offer this service both for samples processed using the Clarigene™ SARS-CoV-2 assay in our laboratory and also as a service for samples that were tested in other laboratories.

The Clarigene™ SARS-CoV-2 assay is a CE-marked PCR test which identifies current COVID-19 infections with >99.9% specificity. The Yourgene Genomic Services COVID-19 service has scored 100% in all 3 rounds of External Quality Assessment (EQA) that has been performed so far demonstrating the reliability of the service. Yourgene is really proud of its COVID-19 testing service which offers same-day, 24 and 48hr turnaround time options to fit individual sample testing requirements. 78% of our tests results are provided in under 24 hours. The Yourgene Genomic Services COVID-19 testing workflow and processes conform to the highest quality standards. The assay is CE-marked and Yourgene Health is ISO13485 certified.

To find out more about the Yourgene Genomic Services COVID-19 testing service, please email us at covid@yourgene-health.com.

  1. https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/for-testing-service-providers-covid-19-tests-and-testing-kits
  2. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/973998/covid-private-testing-providers-general-testing-290321.csv/preview
  3. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/973999/covid-private-testing-providers-test-to-release-290321.csv/preview
  4. https://www.gov.uk/guidance/providers-of-day-2-and-day-8-coronavirus-testing-for-international-arrivals