A technical and clinical evaluation has confirmed OptiGene RT-LAMP tests to be accurate and sensitive enough to be used for COVID-19 testing, including for patients without symptoms.
An evaluation carried out by NHS trusts and universities in the UK found the test to be highly effective in identifying infectious cases.
The OptiGene RT-LAMP (loop-mediated isothermal amplification) test was found to have a sensitivity of 79% and specificity of 100%, meaning it is effective in identifying the patients who are infectious and are most likely to transmit the disease.
And, in samples with a higher viral load, the sensitivity of the test increased to 94% for saliva and 100% for swabs.
Unlike traditional PCR tests, LAMP tests do not require sequential changes of temperature and so can turnaround test results more rapidly.
As part of the strategy to deliver asymptomatic testing to identify those who might otherwise unknowingly spread the virus, OptiGene RT-LAMP tests have been used to test some NHS staff and in asymptomatic testing pilots in Southampton, including at the University of Southampton which has seen 55,000 people tested.
With up to a third of individuals with COVID-19 not displaying symptoms, we are rolling out asymptomatic testing to protect those at highest risk; most importantly NHS staff who are at the forefront of fighting this virus
Initial results from these pilots show the test as effective in identifying positive cases and breaking chains of transmission.
Commenting on the findings, Health Minister, Lord Bethell, said: “With up to a third of individuals with COVID-19 not displaying symptoms, we are rolling out asymptomatic testing to protect those at highest risk; most importantly NHS staff who are at the forefront of fighting this virus.
“By broadening testing to identify those showing no symptoms and who can infect people unknowingly, we can find positive cases more quickly and break chains of transmission.
“We are using the latest technology to do this, and the country’s leading scientists have rigorously evaluated the Optigene LAMP test in the lab and in the field and confirmed its sensitivity for asymptomatic testing.”
Professor Dame Sue Hill, chief scientific officer for England in NHS Test and Trace, who led the evaluation, added: “We’ve shown through carefully-conducted studies that the OptiGene LAMP test is fast, reliable, and easy to use and, dependent on testing format, can work directly with saliva samples as well as with swabs.
“It has been effective in the pilot study sites and can make a valuable contribution to our overall COVID-19 testing capability.”And Professor Keith Godfrey of the University of Southampton’s MRC Lifecourse Epidemiology Unit, who led the first phase of the Southampton saliva testing pilot, said: “The saliva LAMP project in Southampton has proved to be very easy for students to use and is extremely popular with parents and staff.
By broadening testing to identify those showing no symptoms and who can infect people unknowingly, we can find positive cases more quickly and break chains of transmission
“Participation among University of Southampton students has been very encouraging, with 80% of students in halls of residence, and over two thirds of those in private accommodation, registered for regular saliva LAMP testing.
“Targeted educational materials and effective continued engagement with the students and school staff have been an essential part of the programme’s success, supported by well-developed laboratory, IT, enquiries and case contacting systems.
“During the pilot, with regular testing and participation rates exceeding 80% among the school staff and students, there has been no evidence of any transmission of infection within the schools involved.”