Yourgene are uniquely placed to offer COVID-19 testing as we developed, manufacture and run the Clarigene® SARS-CoV-2 test in our own laboratory.
Yourgene Genomic Services based at Citylabs 1.0 in Manchester, UK provides a high quality HSE cleared COVID-19 testing service. The service uses Yourgene Health’s Clarigene® SARS-CoV-2 test which is a PCR-based assay to detect SARS-CoV-2 virus RNA targets to confirm the presence of the virus. Results are available with a rapid turnaround time from sample receipt.
Following wet lab testing, it is confirmed that the performance of the Clarigene® SARS-CoV-2 assay is not impacted by any currently known mutations in the VUI-202012/01 strain. Click here for more details.
The testing service is available through our network of partners to provide workplace and private testing to enable people to get back to work, school and to travel.
Please note: Yourgene Health are not able to discuss individual patient queries regarding samples. These queries MUST be directed to the service/kit provider where the test was ordered.
What accreditation does your test and laboratory have? +The Clarigene® SARS-CoV-2 test is CE-IVD so complies with European in-vitro Diagnostic Devices Directive (98/79/EC). Our laboratory is ISO 13485 accredited, ANIVISA and CQC registered. Our laboratory works to good clinical practice (GCP) requirements.
We are not currently ISO 15189 accredited but are in the process of becoming ISO 15189 accredited.
What assay do you use to perform the test and what is the performance data? +The service uses Yourgene Health’s Clarigene® SARS-CoV-2 assay which is a real time RT-PCR-based assay used to detect SARS-CoV-2 viral RNA targets to confirm the presence of the virus. Clarigene® has high accuracy with >99.9% specificity*. Clinical sample testing presented 100% concordance when compared to gold standard reference** The test has excellent sensitivity and precision; results are in concordance with an international external quality assessment panel.
*In silico analysis did not identify any potentially amplifiable targets in other respiratory pathogens.
** 48/48 positive and 24/24 negative
What is the turnaround time for the test? +Yourgene Health’s COVID-19 testing service offers a 24-48hr turnaround time from sample receipt. We are able to receive samples between 9am-5pm Monday to Friday. Please note, our turnaround time is non-inclusive of weekends therefore if samples are received on a Thursday or Friday, reports may not be issued until the following week.
How do I obtain my results? +Results are obtained in a Covid-19 Genetic Analysis Report which is sent via email to the address provided on your account form. Reports may differ if you are using one of partners that integrate our results into their reporting systems.
I haven’t received the result from my PCR test? +Please contact your testing provider, we are unable to disclose any confidential information.
Yourgene Health is unable to issue fit to fly certificates or supplementary information in addition to the PCR certificate, these may be issued by our partners upon request.
All enquiries about the services offered by our partners must be addressed directly with them. We are unable to communicate directly with individuals. Each country and airline have different polices regarding COVID-19 testing for travel, please see the relevant websites for guidance. Due to the varying and evolving nature of these guidelines, it is the responsibility of the client to determine the suitability of this assay for travel purposes, and Yourgene Health accepts no responsibility for travel disruptions caused as a result of using this test for travel purposes.
In the event of a positive result, who is responsible for informing Public Health England? +It is the client's responsibility to inform Public Health England of any positive results.