Oxford University & US firm Cepheid fast track COVID-19 tests

Oxford University and US firm Cepheid are fast tracking new rapid testing for COVID-19.

The Old Schools Quadrangle of the Bodleian Library, University of Oxford.

The UK and US both hope to deploy rapid coronavirus testing that will help authorities detect cases sooner.

The California-based Cepheid in a media statement says it has received emergency use authorisation from the US Food and Drug Administration (FDA) for its “Xpert Xpress SARS-CoV-2” test.

“The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide, with a detection time of approximately 45 minutes,” it says in a statement.

“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," says David Persing, the company’s chief medical and technology officer.

Cepheid president Warren Kocmond says its automated systems do not require users to have specialty training to perform testing. “They are capable of running 24/7, with many systems already doing so today." However it’s available for authorised emergency use only and Cepheid says the test is “pending submission and review by international regulatory agencies”.

The FDA says while there are no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19, there are several approved treatments that may help ease the symptoms from a supportive care perspective. The FDA says it is working with Gilead Sciences in the US which is sponsoring a randomised controlled trial of COVID-19 patients being treated with the investigational antiviral drug remdesivir.

Oxford University meanwhile says its fast test for COVID-19 that detects the virus earlier could be available in weeks. However it depends on clinical validation and regulatory approval in each country.

Professor Zhanfeng Cui

The Australian reported last week that scientists at the university had claimed a breakthrough in coronavirus testing.

The Oxford team, led by Professor Zhanfeng Cui and Professor Wei Huang, from the university’s Engineering Science department and the Oxford Suzhou Centre for Advanced Research, say the new test for COVID-19 can give an accurate result as to whether a person is infected in half an hour.

They say they are developing “an integrated device” so that the tests can be used at clinics, airports, or even at home.

Detecting coronavirus in a person earlier would give health workers and government medical officers more up-to-date information on the virus’s spread. Current coronavirus tests offer a snapshot of the spread of the virus a week ago, and leave open the chance that many people in the community are undiagnosed carriers.

Professor Cui told The Australian that the test kits can easily be scaled-up in production. “We need to do more clinical validation to get regulatory approval,” he says. “Depending on access to clinical samples, the test kits for professionals could be available in the matter of weeks. For home use, it would take longer.”

Asked whether the tests can be quickly made available across the world, Professor Cui says the research team “will need to work with manufacturing companies for large scale production, and there is a regulatory requirements to each country, and that may be different.

The coronavirus rapid testing device. Picture: Oxford University.

“We aim at combating this pandemic globally and (are) happy to be able to contribute.”

He says the Oxford team is in discussion with local (British) companies to get production going “but happy to explore with others, particularly in different regions”.

He says he can’t exactly say how quickly the new test can detect the virus, but he says: “If the virus is present in the swab, we can detect it. It should be ‘earlier’ than (an) antibody test, as it needs more time to get the body response.” He says the test will be “relatively inexpensive, as we aim at providing this products to general public”.

The researchers say the test is more than a three-fold time improvement on what was possible before. Previous viral RNA tests took 1.5 to 2 hours to give a result. The university says the technology has been validated with real clinical samples at Shenzhen Luohu People’s Hospital in China.

Earlier story: Oxford University scientists say they can fast-track coronavirus testing.