The US Food and Drug Administration issued the first emergency use authorisation for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test. “The test we’re authorising today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by 30 March, which is an incredibly rapid timeline for such an effort. With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” said HHS Secretary Alex Azar. “With the development of point of care diagnostics, Americans who need tests will be able to get results faster than ever before. More and more options for reliable, convenient testing are becoming available at an incredibly rapid pace, thanks to the hard work of our FDA team and the ingenuity of American industry.”
“Our dedicated team at the FDA has been working nonstop to expedite the review and authorisation of novel diagnostics during the COVID-19 public health emergency,” said FDA commissioner Dr Stephen Hahn. “Today marks an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centres and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”
The FDA issued an emergency use authorization to Cepheid for the Xpert Xpress SARS-CoV-2 test for use in high- and moderate-complexity CLIA-certified laboratories as well as in certain patient care settings.
The authorisation was made Friday of last week and tests will begin shipping next week, CNN reports according to a statement from California-based Cepheid, the company manufacturing the tests. "During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities," said Dr David Persing, chief medical and technology officer at Cepheid.
"An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources," Persing added.
Scientists from the University of Oxford’s engineering science department and the Oxford Suzhou Centre for Advanced Research (OSCAR) have developed a rapid testing technology for the novel coronavirus SARS-CoV-2 (COVID-19). The team, led by Professor Zhanfeng Cui and Professor Wei Huang, have been working to improve test capabilities as the virus spreads internationally.
The new test is much faster and does not need a complicated instrument. Previous viral RNA tests took 1.5 to 2 hours to give a result. The research team has developed a new test, based on a technique which is capable of giving results in just half an hour – over three times faster than the current method.
Wei Huang says: ‘The beauty of this new test lies in the design of the viral detection that can specifically recognise SARS-CoV-2 (COVID-19) RNA and RNA fragments. The test has built-in checks to prevent false positives or negatives and the results have been highly accurate.’
Additionally, the technology is very sensitive. This means that patients in early stages of infection may be identified sooner, potentially helping to reduce the spread of the coronavirus SARS-CoV-2 (COVID-19). The technology only requires a simple heat-block which maintains a constant temperature for RNA reverse transcription and DNA amplification, and the results can be read by the naked eye. This makes it potentially useful in rural area or community healthcare centres.
The technology has been validated with real clinical samples at Shenzhen Luohou People’s Hospital in China. Shenzhen Luohu People’s Hospital has applied the rapid detection kits on 16 clinic samples, including 8 positives and 8 negatives, which have been confirmed by conventional RT-PCR methods and other clinical evidence. The test results using the rapid detection kits were all successful.
Zhanfeng Cui, the director of OSCAR, says: ‘I am proud of our team that have developed a useful technology and can make a contribution in combating COVID-19, and we are very grateful to the hospital’s medical team led by Dr Xizhou Sun, Dr Xiuming Zhang and Dr Dan Xiong for their part in testing this new technology.’
The Oxford scientists are now working to develop an integrated device so that the test can be used at clinics, airports, or even for home use. They are planning to run clinical validations within the UK and exploring options for production of the test kits.
The project was initiated by Oxford Suzhou Centre for Advanced Research (OSCAR), a University of Oxford centre in Suzhou Industrial Park.
Also, a team of medical research and bioethics experts at Oxford University are supporting several European governments to explore the feasibility of a coronavirus mobile app for instant contact tracing. If rapidly and widely deployed, the infectious disease experts believe such an app could significantly help to contain the spread of coronavirus.
The Oxford University team has provided European governments, including the UK, with evidence to support the feasibility of developing a contact tracing mobile app that is instant, could be widely deployed, and should be implemented with appropriate ethical considerations.
The Oxford University team recommends that the mobile application should form part of an integrated coronavirus control strategy that identifies infected people and their recent person-to-person contacts using digital technology.
Professor Christophe Fraser from the Oxford University Big Data Institute, Nuffield department of medicine, explains why a contact tracing app could be deployed with urgency: “Coronavirus is unlike previous epidemics and requires multiple inter-dependent containment strategies. Our analysis suggests that almost half of coronavirus transmissions occur in the very early phase of infection, before symptoms appear, so we need a fast and effective mobile app for alerting people who have been exposed. Our mathematical modelling suggests that traditional public health contact tracing methods are too slow to keep up with this virus.”
Fraser continues, “The instant mobile app concept is very simple. If you are diagnosed with coronavirus, the people you’ve recently come into contact with will be messaged advising them to isolate. If this mobile app is developed and deployed rapidly, and enough people opt-in to use such an approach, we can slow the spread of coronavirus and mitigate against devastating human, economic and social impacts.”
Dr David Bonsall, researcher at Oxford’s Nuffield department of medicine and clinician at Oxford’s John Radcliffe Hospital, says, “Our findings confirm that not everybody has to use the mobile app for it to work. If with the help of the app the majority of individuals self-isolate on showing symptoms, and the majority of their contacts can be traced, we stand a chance of stopping the epidemic. To work, this approach needs to be integrated into a national programme, not taken on by independent app developers. If we can securely deploy this technology, the more people that opt-in, the faster the epidemic will stop, and the more lives can be saved.”
Bonsall explains why the current contact tracing strategy is no longer viable: “At the current stage of the epidemic, contact tracing can no longer be performed effectively by public health officials in the UK, and many countries across Europe, as coronavirus is spreading too rapidly. Our research of early data from other countries shows that patient histories are incomplete – we don’t know the details of the person we sat next to on the bus. We need an instantaneous and anonymous digital solution to confirm our person-to-person contact history.'
Fraser highlights the urgency: “There are currently more daily cases in many small European countries than the whole of China. Our team is now preparing simulations for this mobile contact-tracing approach that could stop the epidemic with far less disruption than national or Europe-wide isolation. Our hope is to support communities with life-saving information as the pandemic worsens, or alternatively it could be used to release communities from large-scale isolation.”
Fraser’s team at Oxford University’s Big Data Institute are continuing to simulate performance of the application so it could be adjusted to include mobile app guided coronavirus testing, and / or provide targeted responses in areas with particularly high rates of transmission.
Professor Michael Parker, director of the Wellcome Centre for Ethics & Humanities and Ethox Centre, in Oxford’s Nuffield department of population health adds his recommendations on ethics: “The use of any coronavirus mobile application requires high ethical standards throughout the intervention, including: guaranteeing equal access and treatment; addressing privacy and data usage concerns; adopting a transparent and auditable algorithm; considering digital deployment strategies to support specific groups, such as health care workers, the elderly and the young; and, proceeding on the basis of individual consent.”
The Oxford University team suggest the mobile app should be combined with social distancing measures to reduce close contacts. Bonsall recommends: “We need a variety of measures to slow the spread of infection before vaccines and antiviral treatments become available. A significant number of infections are being transmitted before symptoms start, so we need a fast and efficient system for alerting people when they have been exposed. Regular handwashing and hygiene remain important; in addition, people should follow any recommendations to reduce close contact with others, especially in densely populated areas. Combining these measures will help to reduce onward transmissions, which in epidemiological terms, reduces the reproductive number R; the average number of transmissions from infected individuals. If a country reduces R to less than one, the epidemic will decline and eventually stop.”
Fraser concludes: “Current strategies are not working fast enough to intercept transmission of coronavirus. To effectively tackle this pandemic we need to harness 21st century technology. Our research makes the case for a mobile application that accelerates our ability to trace infected people and provides vital information that keeps communities safe from this pandemic.”
[link url="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-first-emergency-use-authorization-point-care-diagnostic"]FDA material[/link]
[link url="https://edition.cnn.com/2020/03/21/politics/fda-coronavirus-test/index.html?utm_term=1584926863712e5c58f1b535a&utm_source=Meanwhile+in+America+March+23&utm_medium=email&utm_campaign=192355_1584926863716&bt_ee=hR2IdYz%2FZ1cSfHWSzp09KTunmaOAAyO3DCEL3EAA9%2F0%3D&bt_ts=1584926863716"]Full CNN report[/link]
[link url="http://www.ox.ac.uk/news/2020-03-18-oxford-scientists-develop-rapid-testing-technology-covid-19"]University of Oxford material[/link]
[link url="http://www.ox.ac.uk/news/2020-03-17-infectious-disease-experts-provide-evidence-coronavirus-mobile-app-instant-contact"]University of Oxford material[/link]