SARS-CoV-2 LAMP saliva v.1 [COVID-19]
Research type
Research Study
Full title
Evaluation of reverse-transcription loop-mediated amplification (RT-LAMP) for the rapid detection of SARS-CoV-2 in saliva samples - a pilot study.
IRAS ID
287983
Contact name
Christopher W Holmes
Contact email
Sponsor organisation
University Hospitals of Leicester NHS Trust
Duration of Study in the UK
0 years, 1 months, 19 days
Research summary
Research Summary:The COVID-19 pandemic has enforced radical change in individual and collective behaviours throughout the world, with significant health, wellbeing and financial impacts. Evidence suggests that people can transmit SARS-CoV-2 (the virus which causes COVID-19) before or without developing symptoms. This means that the infection can spread undetected, necessitating the implementation of social distancing policies which have a negative impact on economic activity and the delivery of education.
Screening for SARS-CoV-2 is a key component in reducing transmission, however, many of the tests currently available are either slow, time-consuming or insufficiently accurate. Supply issues for reagents and equipment to carry out tests and materials to collect samples (swabs and transport media) has also hampered the ability to undertake large-scale screening. There is therefore a requirement for alternative rapid and simple diagnostic tests to complement the pathways already available (referred to in the UK as Pillar 1 and Pillar 2 testing).
A method for detection of the SARS-CoV-2 virus using reverse-transcription loop-mediated amplification (RT-LAMP) has been developed by the study team at the University of Leicester and shown to be sensitive, rapid, cost-effective and scalable.
The aim of this study is to evaluate the performance of the RT-LAMP test in detecting the SARS-CoV-2 virus in saliva compared to the standard approach of testing an oropharyngeal/nasopharyngeal (throat/nose) swab tested by reverse-transcription polymerase chain reaction (RT-PCR). Saliva is a readily-obtainable specimen which can be provided by most patients without discomfort. We will compare the proportion of cases of SARS-CoV-2 infection detected by the two methods and their relative speed and cost. The results of this study will inform further work on the application of RT-LAMP to population-level SARS-CoV-2 screening.Summary of Results:This study looked at how useful it would be to use a test called LAMP to look for the virus that causes COVID-19 (SARS-CoV-2) in saliva samples. This was to investigate whether this could be used as an alternative to PCR tests using swab samples because these are uncomfortable to collect, more expensive to perform, and during pandemic peaks, there is often a shortage of PCR tests.
The study showed that testing saliva with LAMP detected approximately four in five cases of COVID-19 compared to PCR, and would most often give a positive result when the patient had a high concentration of SARS-CoV-2 virus in their samples. People with a high concentration of virus in their nose and throat are thought to be more likely to spread the virus to others. This saliva LAMP test would therefore be useful for identifying the most infectious people so that they could self-isolate and reduce transmission to others.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
20/EE/0212
Date of REC Opinion
25 Aug 2020
REC opinion
Further Information Favourable Opinion