̽��ֱ�� of Cambridge - Helen Lee

Rapid coronavirus test speeds up access to urgent care and will free up beds ahead of winter

fpjl2 — Wed, 03 Jun 2020 10:43:55 +0000

̽��ֱ��first analysis of a new point-of-care 'nucleic acid test' for SARS-CoV-2 in a UK hospital setting shows these machines dramatically reduce time spent on COVID-19 ‘holding’ wards – allowing patients to be treated or discharged far quicker than with current lab testing set-ups.

̽��ֱ��rapid diagnostic capability of SAMBA II devices – an average of 2.6 hours compared with 26.4 hours for standard lab tests – led to an increased availability of ‘isolation rooms’ needed for infected patients, as well as fewer hospital bay closures.

̽��ֱ�� of Cambridge researchers behind the new study, currently a pre-print and awaiting peer-review, say that the time and hospital capacity spared by these devices will be “critical as we move towards autumn and winter”.

̽��ֱ��SAMBA II machine was developed by a ̽��ֱ�� spinout company, Diagnostics in the Real World, and deployed for trials in Addenbrooke’s Hospital, part of Cambridge ̽��ֱ�� Hospitals NHS Foundation Trust (CUH).

“ ̽��ֱ��backlog of routine operations and screenings as a result of the pandemic is a huge issue, and must be resolved ahead of winter, when the NHS will face even more pressure from other infections like norovirus and influenza,” said study lead author Professor Ravi Gupta.

“Rapidly testing admissions for SARS-CoV-2 at the point of care is essential for reducing COVID-19 transmission in hospitals, speeding up access to urgent care and allowing safe discharge to care homes. It could make all the difference in a few months’ time.”

“Use of point-of-care testing would speed up the identification of patients for COVID-19 clinical trials, and receiving an experimental treatment a day earlier could make a clinical difference.”

“Hospitals across the UK, as well as care homes and prisons, could benefit from SAMBA II devices,” said Gupta, from the Cambridge Institute of Therapeutic Immunology & Infectious Diseases (CITIID). “Given the technological capital of the UK we should not be falling so short on rapid point-of-care testing.”

Standard tests are sent for analysis in central laboratories, where backlogs can see delays of two days or more. SAMBA machines can produce a diagnosis in as little as 90 minutes.

Dr Helen Lee, CEO of Diagnostics in the Real World, developed the SAMBA II technology while at Cambridge’s Department of Haematology. ̽��ֱ��chemistry behind the machines has been used for on-the-spot HIV diagnostics across Africa.

̽��ֱ��devices search for tiny traces of virus genetic code, and are extremely sensitive in the detection of active infections. Once nose and throat swabs have been loaded into a SAMBA machine, the process is fully automated, making them easy to use.

̽��ֱ��initial ‘COVIDx’ clinical study led by Gupta at Addenbrooke’s with 149 participants found SAMBA II had 96.9% sensitivity (accurate identification of positive cases) and 99.1% specificity (accurate identification of negative cases) compared to the standard lab test. It was also around 24 hours faster.

̽��ֱ��success of the COVIDx study saw the hospital switch nearly all of its SARS-CoV-2 testing from the standard lab ‘RT-PCR’ tests over to the use of SAMBA II during May: an opportunity for a “real-world” comparison and its effect on hospital functioning.

Gupta and colleagues compared data from the electronic patient records of all those who had in-hospital tests done in the ten days before and then after the switch to SAMBA devices at CUH.

̽��ֱ��researchers found that the average length of time patients had to spend on a COVID019 ‘holding’ ward before they could be discharged or progress with treatment almost halved: dropping from 58.5 hours to just 30 hours.

They also saw a fall in use of the single-occupancy ‘isolation’ rooms in which COVID-19 patients are ideally treated – from 30.8% to 21.2% after SAMBA’s introduction, as patients with symptoms were shown to be COVID-19 negative.

In fact, the researchers say the testing devices prevented 11 ward closures in the ten days after implementation. “Keeping surgical bays open means fewer cancelled operations, speeding up access to life-saving clinical intervention,” said Gupta.

̽��ֱ��majority of those tested using SAMBA II during the first ten days of hospital-wide use were admissions to the Emergency Department (ED). ̽��ֱ��remainder included pre-op screenings and discharges to nursing homes.

̽��ֱ��SAMBA II tests were “beneficial” for 76% of ED patients: expediting treatment or discharge, and allowing the release of examination rooms. ̽��ֱ��24% without benefit was mainly due to triage or discharge before results were returned.

Some 96% of the SAMBA testing on pre-operative patients increased speed of “surgical intervention”, including kidney and liver transplants. ̽��ֱ��tests also allowed earlier discharge to nursing homes or into supported living in 79% of those cases, with the remainder delayed by “systematic issues” not tests themselves.

Dr Dami Collier, who coordinated and analysed COVIDx, said: “Our research demonstrates that point-of-care testing with SAMBA II machines is not only reliable, accurate and much faster, but that the diagnostic speed leads to significant real-world improvements for patient care and safety.”

CUH Medical Director, Dr Ashley Shaw, said: “Point of care testing has been hugely beneficial in enabling our clinical teams to make well-informed and timely decisions, keeping patients and staff as safe as possible throughout this difficult period.”

This work was supported by Wellcome, the Addenbrooke’s Charitable Trust, and the National Institute of Health Research (NIHR) Cambridge Biomedical Research Centre.

How you can support Cambridge's COVID-19 research effort

Donate to support COVID-19 research at Cambridge

Researchers say faster tests helped expedite access to life-saving treatments such as organ transplants – and might make all the difference later this year.

Rapidly testing admissions for SARS-CoV-2 at the point of care is essential for reducing COVID-19 transmission in hospitals, speeding up access to urgent care and allowing safe discharge to care homes

Ravi Gupta

Cambridge ̽��ֱ�� Hospitals

Research nurse from the NIHR Clinical Research Facility processing patient samples using SAMBA machines at Adden brooke’s Hospital in Cambridge

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Rapid COVID-19 diagnostic test developed by Cambridge team to be deployed in hospitals

cjb250 — Thu, 02 Apr 2020 08:13:15 +0000

̽��ֱ��SAMBA II machines, developed by Diagnostics for the Real World, provide a simple and accurate system for the diagnosis of infection with SARS-CoV-2, the virus that causes the disease COVID-19. They will be used by healthcare workers at point-of-care in order to rapidly diagnose patients, directing those who test positive for the infection to dedicated wards. They can also help identify which healthcare workers are infected, enabling those who test negative to return to the front line.

̽��ֱ��machines will be made available to a number of hospitals across the country thanks to a US$3million (about £2.4 million) donation from the businessman and philanthropist Sir Chris Hohn, which will enable the purchase of 100 machines. ̽��ֱ��donation has enabled Addenbrooke’s Hospital, part of Cambridge ̽��ֱ�� Hospitals NHS Foundation Trust, to obtain the first 10 SAMBA II machines this week for use in wards where suspected COVID-19 patients are brought in. ̽��ֱ��donation will be matched by the purchase of 10 additional machines by the Cambridge Trust.

SAMBA II looks for tiny traces of genetic material belonging to the virus, amplifies it billions of times chemically and is therefore extremely sensitive in the detection of active infections. Dr Helen Lee, CEO of Diagnostics for the Real World said: “Our goal has always been to make cutting-edge technology so simple and robust that the SAMBA machine can be placed literally anywhere and operated by anyone with minimum training.”

Patients will provide a nasal and throat swab. Once these have been loaded into the SAMBA machine, the remainder of the process is fully automated. At the moment, tests are sent for analysis in centralised laboratories and this, compounded by the sheer number of samples that are having to be analysed, means that diagnosis can take one to two days. SAMBA II is able to deliver results while the patient waits, helping healthcare workers ensure that those infected can be quickly directed to specialised wards. Whereas current tests can take over 24 hours or longer to deliver their results, SAMBA is able to deliver a diagnosis in less than 90 minutes.

̽��ֱ��tests have been validated by Public Health England, Cambridge, in 102 patient samples and shown to have 98.7% sensitivity (ability to correctly identify positive cases) and 100% specificity (the ability to correctly identify negative cases) compared to the currently used NHS/Public Health England test. This has enabled the team to obtain a CE mark.

Dr Martin Curran who conducted the evaluation said: “I am extremely happy with the performance of the SAMBA test because it matched the routine centralised laboratory results.”

Professor Ravi Gupta from the Cambridge Institute for Therapeutic Immunology and Infectious Disease, who is leading the ‘COVIDx’ clinical study to evaluate the impact of the test, said: “Testing healthcare workers could help reduce the risk of infection in healthcare facilities themselves, which might in turn assist national control efforts. It will also reduce the number of staff self-isolating for symptoms as we could use the test to determine who is actually infected. At present the lack of testing is resulting in severe staff shortages nationally.”

Research nurses to support COVIDx will be provided by the NIHR Cambridge Biomedical Research Centre.

Researchers at Cambridge will also be using SAMBA II to test healthcare workers in high-risk areas such as intensive care units or COVID-19 wards. Their aim is to see whether the tests can identify asymptomatic individuals – those who are infected but do not realise it – so that they can self-isolate and prevent inadvertent transmission.

̽��ֱ��technology behind SAMBA II was developed while Dr Lee was at Cambridge’s Department of Haematology. ̽��ֱ��development of the technology has been supported by Wellcome, the Children’s Investment Fund Foundation, the US National Institutes of Health and Cambridge Enterprise, among others.

“We urgently need rapid diagnostic tests to help the NHS and Public Health England manage the coronavirus outbreak and identify those patients at risk to themselves and to others,” says Sir Chris Hohn. “I’m delighted to have supported Dr Lee’s important research and now help begin the rollout of this cutting-edge technology across the NHS. This is a game changer.”

How you can support Cambridge's COVID-19 research effort

Donate to support COVID-19 research at Cambridge

A new rapid diagnostic test for COVID-19, developed by a ̽��ֱ�� of Cambridge spinout company and capable of diagnosing the infection in under 90 minutes, is being deployed at Cambridge hospitals, ahead of being launched in hospitals nationwide.

This is a game changer

Sir Chris Hohn

Cambridge ̽��ֱ�� Hospital

Research nurse from the NIHR Clinical Research Facility processing patient samples using SAMBA machines at Addenbrooke’s Hospital in Cambridge

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Researcher gets green light for new Hep B test

bjb42 — Fri, 21 May 2010 00:00:00 +0000

Developed by Cambridge researcher Dr Helen Lee, the inexpensive test delivers accurate while-you-wait results and allows doctors to take immediate action - circumventing the need to send samples away for laboratory analysis.

With around 400 million people worldwide estimated to carry the disease, the Hepatitis B Rapid Test could revolutionise detection of the condition in poorer countries.

Dr Helen Lee from Diagnostics for the Real World (DRW), who led the development of the test said: "Our test is simple, quick, inexpensive and can survive very hot conditions for many months - all vital factors when you are working in poorer parts of the world".

Dr Lee, who works at the ̽��ֱ��'s Diagnostics Development Unit, set up DRW in 2002. ̽��ֱ��group has already launched a rapid test for Chlamydia that is currently sold within the EU and many other countries around the world. Other tests in the pipeline include rapid tests for the detection of HIV and influenza.

Hepatitis B virus (HBV) is highly infectious and is endemic in many parts of the world. In the UK alone, one in 1,000 people are infected and in China and Africa as many as one in six people carry the virus.

Spread through contact with infected blood or other body fluids, including sexual contact, infection rarely kills but can cause serious health problems and places enormous strain on healthcare resources.

Compared with existing diagnostics, which involve sending patient samples away to laboratories for analysis by skilled technicians using expensive machinery, the new Hepatitis B Rapid Test, developed with funding from the Wellcome Trust, uses a dipstick technology to deliver an accurate diagnosis on-site within half an hour and can be used with minimal training.

According to Professor Baruch S. Blumberg, who was awarded the Nobel Prize for Medicine in 1976 for the discovery of the Hepatitis B virus and the invention of the HBV vaccine said: "Approval of the new Hepatitis B Rapid Test is positive news for the estimated 400 million HBV carriers worldwide."

"HBV infection and the diseases related to it are solvable problems. ̽��ֱ��Hepatitis B Rapid Test developed by Diagnostics for the Real World can make a significant contribution to the solution."

̽��ֱ�� ̽��ֱ�� of Cambridge's Diagnostics Development Unit (DDU) was established a decade ago by a group of industry scientists who worked at a multinational diagnostic company. Its aim is to develop innovative tests that are rapid, simple, cost-effective and more sensitive than currently available rapid tests.

This new generation of point-of-care tests is intended to detect infectious agents that cause serious health problems in resource-limited settings, particularly in developing countries.

A ‘dipstick’ test that detects Hepatitis B within 30 minutes – and could be used in some of the world’s poorest countries – has been given the green light for use in the European Union.

Our test is simple, quick, inexpensive and can survive very hot conditions for many months - all vital factors when you are working in poorer parts of the world.

Dr Helen Lee

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U.S. Army medical researchers take part in World Malaria Day 2010, Kisumu, Kenya, April 25, 2010

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