COVID-19 saliva test research study [COVID-19]
Research type
Research Study
Full title
COVID-19 saliva test research study - Evaluation of high throughput COVID-19 testing via saliva based sampling and alternative RNA extraction methods.
IRAS ID
283560
Contact name
Tom Stubbs
Contact email
Sponsor organisation
Chronomics Limited
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Gloucestershire Hospitals NHS Foundation Trust, 20/055/GHT
Duration of Study in the UK
0 years, 2 months, 6 days
Research summary
COVID-19 testing is critical to tracking the virus, managing cases and preventing further transmission and has been set as priority by the NHS and PHE. Some of the key challenges presented in the UK regarding the lack of COVID-19 testing are speed of mobilization, supply chain issues due to the international demand for crucial testing materials like kits, swabs and chemical reagents, and the quality and comfort of the nasopharyngeal (NSP) swabs commonly used.\n\nChronomics has developed novel methods to address these problems. Firstly, due to the shortage of the specific branded reagent products used in official CDC protocol for RNA extraction, Chronomics have sourced and compiled testing of components to create our own extraction kit with greater availability of supply for use within the protocol. Secondly, our methods are based on saliva collection which are pain-free and easy to collect. Thirdly, we have adapted the above mentioned protocol to serve high throughput processing through next generation sequencing methods as an alternative to RT-qPCR if required.\n\nThe objective of this study is to compare the Chronomics test against the NPS tests and protocol currently in use to demonstrate the efficacy of our approach. There are two components of our testing framework that we are looking to validate. Firstly, that our alternative RNA-extraction test does not impact sensitivity of detection and secondly, that our alternative sampling source of saliva also does not impact sensitivity of detection. To achieve validation of these two components, we would require access to the output for the NHS gold-standard test.\n\nPeople who are admitted to GHNHSFT with suspected COVID will be asked for two NPS samples and one saliva sample for this study; an NPS sample for NHS, an NPS sample for Chronomics and a saliva sample for Chronomics.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
20/HRA/2561
Date of REC Opinion
28 May 2020
REC opinion
Further Information Favourable Opinion