A study of more than 23,000 samples carried out by teams across the UK shows Oxford Nanopore’s COVID-19 test, LamPORE, is highly accurate for the detection of SARS-CoV-2, in both symptomatic and asymptomatic population settings.
The study was performed on both swab and saliva samples across four NHS sites, showing very high LamPORE test accuracy, as follows:
|LamPORE assay on swabs from asymptomatic patients||34 positive
|100% (95 CI 85.2-100%)||99.72% (95% CI 99.5-99.7%)|
|LamPORE assay on saliva from asymptomatic patients|| 299 positive
(95% CI 96.2-99.9%)
(95% CI 99.26-99.49%)
|LamPORE assay on swabs from patients with respiratory symptoms|| 745 negative
(95% CI 85.18-100%)
These data support the use of LamPORE for testing of both symptomatic people, and those without symptoms. It also provides positive data on the use of LamPORE to detect SARS-CoV-2 from saliva samples, providing the potential to further streamline the testing workflow following relevant regulatory approvals.
Professor Andrew Beggs, of the Institute of Cancer & Genomic Sciences at the University of Birmingham said: “We were very pleased to be able to assess the LamPORE assay on real-world patient samples. The test represents a real leap forward in the ability to produce a new type of quick, highly accurate test. This type of technology can also be used to test for other respiratory illness and so will have great utility within healthcare”
This publication comes in addition to a study published in September 2020 of over 500 samples from Oxford, PHE Porton Down, and Sheffield, that found 99.1% sensitivity and 99.6% specificity, where the authors noted that “This indicates that LamPORE has a similar performance to RT-PCR for the diagnosis of SARS-CoV-2 infection in symptomatic patients, and offers a promising approach to high-throughput testing.”
LamPORE is CE marked for in vitro diagnostic use and LamPORE devices are currently being piloted in a number of NHS labs, to support expanded high-accuracy testing for the UK. Oxford Nanopore is intending to submit an Emergency Use Authorisation application to the US FDA for LamPORE Covid-19 in the coming weeks.
Dr Gordon Sanghera, CEO of Oxford Nanopore, said: “This remarkable study is a testament to the scientific teams who worked so hard over the summer to validate a new generation of diagnostic test.
“We believe there are phenomenal opportunities here: not only to deliver high quality, rapid COVID testing, but to catalyse the development and delivery of real-time, data-rich clinical testing using nanopore sequencing. This has the potential to tackle infectious disease and to reach into cancer, rare disease, and tissue typing/immunology.”
Source – University of Birmingham