INSIGHT COVID-19 diagnosis
Research type
Research Study
Full title
INSIGHT: a scalable isothermal NASBA-based platform for COVID-19 diagnosis
IRAS ID
288161
Contact name
Sarah Teichmann
Contact email
Sponsor organisation
Genome Research Limited, operating as the Wellcome Sanger Institute
Duration of Study in the UK
1 years, 0 months, 6 days
Research summary
Research Summary
The coronavirus disease 2019 (COVID-19) pandemic is caused by the SARS-CoV-2 virus. Pandemic control has been challenging due to the long incubation period and high percentage of asymptomatic carriers of this disease. Nucleic acid testing is essential to identify and isolate infected individuals at an early stage to stop the spread of the virus. At the moment, the mainstream nucleic acid test relies on a reverse transcription polymerase chain reaction (RT-qPCR) assay, performed on nose or throat swabs. We have recently developed a two stage testing strategy named INSIGHT (Isothermal NASBA-Sequencing based hIGH-throughput Test). This test uses a combination of Nucleic Acid Sequence-Based Amplification (NASBA) and Next Generation Sequencing (NGS) technologies. We believe this INSIGHT test achieves the five desired features of an ideal test: It is accurate, cheap, scalable, portable and fast. This would allow for decentralised and frequent testing of a large proportion of the population, even in countries with limited medical resources, to monitor and manage the spread of the virus. We have developed the test in experimental settings using saliva from healthy volunteers spiked with synthetic viral RNA. This has allowed us to assess the detection limits of the assay. The aim of this study is to move from testing on synthetic virus to testing on real biological samples. This study will use residual material from unprocessed nose/throat swabs or saliva, or RNA extracted from nose/throat swabs or saliva, from both COVID-19 positive and negative individuals, that has been collected by other REC approved research studies. The results of the INSIGHT assay will be compared to the standard PCR tests used. This will enable the accuracy, test sensitivity and specificity of INSIGHT to be determined.
Summary of Results
INSIGHT (Isothermal NASBA-Sequencing based HIGH-throughput Test) is a two-stage testing strategy for viral pathogens, including COVID-19. It uses a combination of an isothermal NASBA reaction and next generation sequencing. The first stage involves isothermal amplification of viral RNA whilst simultaneously incorporating sample-specific barcodes into the amplification product. Fluorescent and dipstick-based viral RNA detection can be consistently achieved at 10-100 copies per 20 μl reaction. The second stage pools post-amplification barcoded products from multiple samples for scalable sequencing that could be centralised, to further improve the accuracy of the test in a massively parallel way. This two-stage testing strategy is suitable for further development into a home-based or point-of-care assay and can be scaled to the population level. We have tested Covid positive and negative patients saliva and swab using INSIGHT technology. In total, from 122 samples we found 29 positive cases detected by INSIGHT using fluoresce readout.
REC name
London - Queen Square Research Ethics Committee
REC reference
20/PR/0440
Date of REC Opinion
10 Sep 2020
REC opinion
Further Information Favourable Opinion