SNAC Test for detecting Covid-19 [COVID-19]
Research type
Research Study
Full title
(SNAC Test): Evaluating a novel Saliva-based Nucleic ACid Test for infection by SARS-CoV-2
IRAS ID
285706
Contact name
Iain Hunter
Contact email
Sponsor organisation
University of Strathclyde
Duration of Study in the UK
0 years, 3 months, 2 days
Research summary
This project evaluates a novel methodology using a simple saliva-sample to test for the infective agent (SARS-CoV-2) in patients. The novel nucleic acid Test (‘SNAC Test’) is compared to the existing 'standard care' NHS Polymerase Chain Reaction test (‘NHS PCR Test’) used for diagnosis of Covid-19.
The NHS PCR Test uses cell samples obtained using nasopharyngeal (nose and throat) swabs. Many patients find the process uncomfortable - the methodology has been cited in Scottish Government press conferences as a barrier to getting samples from older people, particularly those with, for example, dementia. Even with younger patients, nose/throat swabbing is inconsistent and could lead to incorrect results (‘false negatives’) due to poor sampling technique.
Saliva as an alternative biological fluid circumvents many of these issues:
• Obtaining a sample is easy – simply providing saliva in a sterile container
• For people who have difficulty providing a ‘spit’ sample, saliva samples can be obtained via swabs or ‘saliva sponges’ dipped into saliva that pools in the mouth
• PPE is not needed if the patient provides the sample themselves – e.g., outwith the hospital setting
The novel test has two technical advantages:
(1) the inventive methodology makes it potentially more sensitive than the NHS PCR Test, hence saliva being an alternative sample source, and
(2) it contains an internal ‘positive’ control for saliva circumventing the ‘false negative’ issue that can occur due to poor nasopharyngeal sampling technique.
We will also assess patients’ views of two alternative methods for collecting the saliva. This is in support of the NHSScotland National Laboratories COVID-19 Saliva Testing Working Group, which is assessing how to integrate alternative testing approaches into NHS labs.
Such a disruptive change in methodology needs to be validated and compared against the current NHS PCR Test, which our study aims to do.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0080
Date of REC Opinion
23 Mar 2021
REC opinion
Favourable Opinion