Validation of COVID19 diagnostic testing by LCMSMS [COVID-19]
Research type
Research Study
Full title
Validation of COVID19 diagnostic testing by liquid chromatography mass spectrometry
IRAS ID
296024
Contact name
Holly Gettings
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust
Duration of Study in the UK
0 years, 2 months, 10 days
Research summary
COVID testing by LC-MS/MS is part of the DHSC ‘Operation Moonshot’ programme which is a collaboration between industry, academia and the NHS. A novel method to detect COVID-19 has been developed using liquid chromatography mass spectrometry (LC-MS/MS). The initial validation indicates that this method compares well to existing PCR based methods. The next stage is validation of the method in a clinical laboratory and UKAS accreditation. The LCMSMS test offers a number of advantages; it relies upon a different supply chain to the existing COVID tests; it will be provided by a different group of scientists (biochemists) thus relieving pressure on Virology staff; it has high throughout with a single instrument being able to analyse approx. 1000 samples each day.
To translate the LC-MS/MS test from the academic laboratory and into a NHS clinical laboratory, we urgently need access to additional samples to validate the new method and gain UKAS accreditation.
This application is a request to collect an additional combined nose and throat swab and a saliva sample from patients presenting to the Emergency Department who are already having a routine nose and throat swab collected for SARSCoV-2 PCR testing. The research swab and saliva samples will be collected into an ethanol buffer which deactivates the virus at the point of collection, thus simplifying the logistics of sample handling and processing. The samples will be pseudoanonymised and there will be no impact on the clinical care of the patient, nor will the research results be returned to the participant. There will be no impact on standard of care for the participants as a result of this study.REC name
Wales REC 3
REC reference
21/WA/0101
Date of REC Opinion
18 Mar 2021
REC opinion
Favourable Opinion