A new lateral flow test that can detect monkeypox infections in humans in just 10 minutes is being trialled in London as part of a research partnership between UK life science firm SureScreen Diagnostics, medical technology provider TestCard and Guy’s and St Thomas’ NHS Foundation Trust.
The antibody test, which is run by using a small drop of finger-prick blood, is believed to be the first of its kind in Europe and has been developed to help contain the spread of the virus and trace its progress across the country more effectively.
So far 846 cases of monkeypox have been confirmed in the UK and it has now been declared as a notifiable disease by the UK Health Security Agency, which places the onus on medical and health professionals to alert local health authorities to suspected cases.
Monkeypox, which spreads through close contact, is currently diagnosed by a PCR test with a viral swab taken from one or more vesicle or ulcers that appear on patients’ skin by a clinician, which must then be sent to the laboratory for testing.
It can take time for results to come back from laboratory testing, so having a rapid diagnostic device with a digital reader app that can be used next to the patient, and even away from the hospital via community screening, could help inform clinicians much quicker about the spread of the disease.
Building on the back of SureScreen’s 25-year history of expertise in lateral flow testing, the company has been able to develop this latest test in record time to react quickly to the need of clinicians and if clinical trials at Guy’s and St Thomas’ are successful, the tests could be ready for deployment within a couple of months.
SureScreen and Guy’s and St Thomas’ will work together with digital partner TestCard to incorporate the monkeypox lateral flow device into TestCard’s ClearScreen app, which will enable the results to be transferred rapidly directly onto the patient’s medical record and making it easier to track the spread of the disease and notify health bodies.
The monkeypox trials are the latest project in an ongoing partnership between the three organisations, who previously worked together on developing lateral flow tests and digital reading applications for COVID-19.
SureScreen’s COVID-19 antigen LFTs were the first European tests to pass the validation process in the laboratory by Public Health England last year and, as well being used as part of the UK Government’s rapid testing programme, they are currently being exported to around 60 countries worldwide.
David Campbell, a director at SureScreen Diagnostics, said: “We’re extremely grateful to be working with such a great team at Guy’s and St Thomas’ on this ground-breaking work in developing a rapid lateral flow antibody test that can be used to help monitor and understand the spread of monkeypox throughout the UK and further afield.
“We don’t expect monkeypox to be an issue anything like what COVID-19 has been, but as we learnt during the early stages of COVID-19 it is critical that quality testing is put in place quickly so we can better understand the nature and spread of the disease.
“This work also demonstrates yet another example of how lateral flow technology can play such a critical part in healthcare across the world outside of COVID-19 and it will help us to improve healthcare in the future.”
Dr Rahul Batra MD, technologies and innovations lead at the Centre for Clinical Infection and Diagnostics Research at Guy’s and St Thomas’ NHS Foundation Trust, said: “While monkeypox does not spread easily and there is currently not a need for mass community testing, the COVID-19 pandemic has shown us that emerging infectious diseases require rapid diagnostics development, effective surveillance and health information systems capable of using point of care diagnostic data for rapid and effective interventions.
“Building on the previous successful collaboration with our diagnostics and digital technologies partners SureScreen and TestCard we have been able to quickly develop and begin trialling a new point-of-care test for monkeypox antibodies.
“Our hope is that this test and others like it that we have in development will provide a mechanism to assist clinicians with rapid identification of cases, clusters, and the sources of infection sooner than previously possible, in order to provide optimal clinical care to patients and prevent further transmissions.”