Clarigene Test-Saliva [COVID-19]

• Research type

  Research Study

• Full title

  Validation of the Clarigene® test using Saliva as an alternative specimen type

• IRAS ID

  289610

• Contact name

  Joanne Mason

• Contact email

  Jo.Mason@yourgene-health.com

• Sponsor organisation

  Yourgene Health

• Duration of Study in the UK

  0 years, 3 months, 4 days

• Research summary

  To verify the performance of the Clarigene assay using saliva, the Calrigene test has received CE marking for use with Nasophyrengeal sample specimens. This study will aim to demonstrate equivalence between matched Nasophyrangeal and Saliva samples.
  
  Also, establish the screening performance of the Clarigene® test limit of detection in saliva samples (Accuracy, sensitivity, specificity, reproducibility, and repeatability).

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  20/NE/0273

• Date of REC Opinion

  10 Dec 2020

• REC opinion

  Further Information Favourable Opinion