In efforts to contain the spread of COVID-19, various methods such as social distancing and mandatory wearing of masks have been implemented. However, caution must be employed to ensure complete control of the transmission of droplets and aerosols which carry the virus. Respiratory aerosols are produced while breathing and may carry respiratory viruses and spread them onto surfaces and people. Researchers at Mayo Clinic discovered during an exercise stress test for heart patients that a high level of exertion results in an increased concentration of aerosol in the surrounding room. Another finding prompted a solution of using a high-efficiency particulate air filter (HEPA) to effectively screen out aerosols and decrease the time required between patients to clear the air.

Thomas Allison, Director of Cardiopulmonary Exercise Testing at Mayo Clinic in Rochester, Minnesota, and senior author of both studies which are published in the journal CHEST spoke about how during the early onset of the pandemic, the necessity of adopting new measures was paramount in protecting patients and staff from the virus while continuing to provide quality cardiovascular care. “We quickly realised that there might be a risk of conducting exercise tests on patients with asymptomatic COVID-19. Cardiovascular Medicine leadership at Mayo asked me to first review existing published material to see if aerosol generation by exercise was documented and, if so, how the lab might mitigate these aerosols. My review showed that the subject of aerosols and exercise was not previously addressed, therefore, we put a research team together to find answers through scientific testing and data,” he says.

The genesis of the study

Related: Birmingham researchers confirm speed, simplicity and sensitivity for new COVID-19 test

In the first study, a dedicated aerosol laboratory was set up in a plastic tent with controlled airflow to identify the aerosols generated during various intensities of exercise. Equipment that measured oxygen consumption, ventilation, and heart rate was worn by eight exercise volunteers and two types of laser beam particle counters were used to measure aerosol concentration at the front, back and sides of a person riding an exercise bike.

With intervals of five minutes, followed by four rounds of three-minute exercises staged with monitoring and coaching at 25, 50, 75, and 100 per cent of the age-predicted heart rate of the volunteer, there was a surge in aerosol concentrations throughout, especially during exercise at or above 50 per cent of resting heart rate.

Related: Why PCRs remain the gold standard of COVID-19 testing

"In a real sense, I think we have proven dramatically what many suspected ― that is why gyms were shut down and most exercise testing laboratories closed their practices. Exercise testing was not listed as an aerosol-generating procedure prior to our studies because no one had specifically studied it before,” Dr Allison says. “Exercise generates millions of respiratory aerosols during a test, many of size reported having virus-carrying potential. The higher the exercise intensity, the more aerosols are produced.”

HEPA’s effectiveness

Dr Allison's follow-up study looked at how to reduce the number of aerosols produced during exercise testing by filtering them out of the air directly after exiting the subject’s oral cavity. The controlled airflow exercise tent, particle counter, and stationary cycle were repeated with the inclusion of a portable HEPA filter with a flume hood. The 20-minute exercise test was completed by six volunteers, without the mitigation, followed by the portable HEPA filter running.

“We performed experimental studies in a tightly controlled environment where we could accurately measure aerosol production and mitigation.  The research allowed us to quickly return to full capacity in the exercise labs. Stress testing is a necessary (Class I) indication for diagnosis and management of many cardiovascular conditions, so it was necessary to bring this service back online while eliminating risk for patients and staff.”

A separate experiment at the clinical exercise testing laboratories tested aerosol clearance time by using artificially generated aerosols to assess the duration for 99.9 per cent of the aerosols to be cleared. The test was conducted initially with only existing heating, ventilation, air conditioning, and then with the portable HEPA filter operating.

"Studying clearance time informed us of how soon we could safely bring a new patient into the laboratory after finishing the test on the previous patient. HEPA filters cut this time by 50 per cent, allowing the higher volume of testing necessary to meet the clinical demands of our Cardiovascular Medicine practice," Dr Allison says.

The researchers translated U.S. Centers for Disease Control and Prevention guidelines for aerosol mitigation with enhanced airflow through HEPA filters and demonstrated that it worked well for exercise testing: the HEPA filter removed 96 per cent (plus or minus 2 per cent) of all aerosols of all sizes generated during heavy exercise.

In the hospital setting, isolation rooms employ air recirculators with HEPA filters. “The U.S. Center for Disease Control and Prevention recommended HEPA filters to help control exposure to SARS-COV-1, so we thought that this might be a good strategy for mitigating SARS-CoV-2. We figured out the easiest way to use HEPA filters in the exercise lab. Our research then confirmed the benefit. As a result, we have been able to return to our practice of performing up to 100 stress tests per day without any recorded transmission of COVID in our exercise testing laboratories," he concludes.

A further look on precautions exercise facilities should consider:

Dr Allison comments on how controlling the risk of spread of COVID-19 in gyms where multiple people are exercising is difficult, but shares strategies on how to overcome the challenge:

• Check temperatures of people as they enter the gym
• Vaccination required to use the facility
• Enhance airflow as much as possible
• Maintain as much distance as possible between stations, such as a treadmill, where vigorous exercise is being performed
• Limit the number of people who can be using the facility at any one time, perhaps through an appointment system
• Clean surfaces regularly.

Researchers from the University of Birmingham have confirmed the speed, accuracy and simplicity of a novel, a highly sensitive testing method for COVID-19 that can be used at entertainment venues, airport arrival terminals, and in remote settings where clinical testing laboratories are not available.

A study published today in PNAS journal confirmed that the Exponential Amplification Reaction (EXPAR) method is just as sensitive, but faster, than both PCR and LAMP tests, which are currently used in hospital settings. Currently, the RT-PCR (Reverse Transcription Polymerase Chain Reaction) test is considered a standard for diagnosing COVID-19 in the UAE.

Two-step process

Related: A short guide on treating COVID-19 at home

The Birmingham COVID-19 test, called RTF-EXPAR, gives a sample-to-signal time of under 10 minutes, even for low viral levels where current lateral flow tests are less effective.

Professors Tim Dafforn from the School of Biosciences, and Jim Tucker from the School of Chemistry, worked with graduate student Jake Carter, and Professor Andrew Beggs from the Institute of Cancer and Genomic Sciences on the study.

Related: Why PCRs remain the gold standard of COVID-19 testing

Both PCR and LAMP tests detect viral RNA, which can be present in extremely low levels in swabs taken from the mouth and nose. These tests use a two-step process that involves first converting to RNA to DNA and then ‘amplifying’ the material many times over so it can be detected in the sample.

Professor Tim Dafforn said: “Both these steps slow down existing COVID assays and are based on nucleic acid detection, compared to antigen tests, such as lateral flow, which do not have these steps. However, while this makes lateral flow tests faster than those based on PCR and LAMP, in return they are typically less sensitive. An ideal test would be one that is both sufficiently sensitive and speedy – our test, called RTF-EXPAR, achieves this goal.”

RTF-EXPAR achieves this feat in two ways – firstly the assay team designed a new RNA-to-DNA conversion step that avoids reverse transcription, making it reverse transcription-free (RTF). Secondly, their amplification step to generate the read-out signal uses Exponential Amplification Reaction (EXPAR), an alternative DNA amplification process to PCR and LAMP.

The study revealed that the RTF-EXPAR method converts under 10 strands of RNA into billions of copies of DNA in under 10 minutes, using a one-pot assay that is compatible with more basic, benchtop equipment than that used with current testing methods.

The assay has been tested at the Surgical Research Laboratory at the University of Birmingham. Professor Andrew Beggs, whose team conducted the testing, commented: “The testing used swabs containing a typical range of viral loads seen during the pandemic, had a six-minute cut-off time. The analysis showed RTF-EXPAR’s sensitivity is equivalent to quantitative PCR testing. We expect to publish the full results of this testing in the near future.”

The team is now seeking commercial partners for rapid licensing, to make the RTF-EXPAR test as available as widely as possible.

References available on request

Since the onset of the pandemic, one of the key mandates by healthcare organistions and governing bodies has been social distancing and quarantining if individuals are experiencing any symptoms of COVID-19.

It is highly important for those who have been in contact with those who tested positive to self-isolate and undergo PCR testing. In instances where they are awaiting their results, or during the isolation period, there are at-home treatment options they can consider to recuperate from the infection.

To learn more, watch the video below:

Tips from the video:

• Stay Home – one of the major reasons for the spread of the infection is due to transmission. Patients who have tested positive, or those who may feel they have been exposed, can place those who are more susceptible to contracting the infection at risk. As recovery for all is not the same, especially for those who have preexisting health conditions, the outcome can be fatal.
• Stay hydrated – drink plenty of fluids
• Stay isolated – avoid contact
• Wear a mask – In instances of interaction with healthcare providers or caretakers, always ensure you are wearing your mask.
• If you have a fever, take anti-fever medicines such as paracetamol.
• Monitor symptoms, such as shortness of breath
• If symptoms start progressing, seek medical care

Remember, no oral medications you can take at home have been proven in clinical trials to improve health outcomes.

In January 2020, genome of the severe acute respiratory syndrome coronavirus 2, known as SARS-CoV-2, was assembled and published, prompting the rapid development of testing methods to detect the new virus. This launched the world’s largest testing program ever, with millions of individuals tested to date. The enormous volume of testing has driven advancements in public health testing techniques, technology, and concepts.

Over the course of the pandemic, access to testing and accuracy of results has been increasingly important to ensure the containment of the infection and the safety of the population. Various forms of tests have been developed including antigen, and saliva testing to detect hallmarks of the virus, however, PCR testing has remained the most preferred and accurate testing method to date.

Rapid Results

Innovation in the COVID era has been tremendous. Since the start of the pandemic, the exploration of new kits and methodology has been in high drive, with positive outcomes. Every day, there is a new solution to accelerate rapid testing. Presently, numerous kits give individuals results within 20 minutes, which is real-time testing of very sensitive and specific samples.

During the onset of the pandemic, healthcare faced challenging limitations. There was a lack of supplies of PCR kits and machines, however, recognising this demand there has been a surge in producing more kits and diversifying testing methods. Biogenix Labs developed the saliva test last October followed by conducting a pilot study that performed positively. Young children under the age of 12 might experience sensitivity to the nasal pharyngeal swab PCR, therefore the Saliva Polymerase-Chain-Reaction (SPCR) is a promising alternative. The rollout of saliva testing in Abu Dhabi schools has been successful with over 50,000 tests executed in schools in Abu Dhabi.

 

Harnessing Innovation

Lab technology has evolved, and the method of detection is rapid with high throughput. Biogenix Labs has deployed reverse transcription loop-mediated isothermal amplification or RT-LAMP, a highly sensitive technology that sequences the virus, to generate a result within a few hours. “Presently, we are sequencing the virus with full genome sequencing as well and NGS technology. The idea behind using multiple methodologies, such as Oxford nanopore, and Illumina technology is to give us access to the detection of variants and mutations. This is currently taking place on a real-time basis to detect new variants and mutations, which we are reporting back to the Department of Health.”

The ultimate test

In the last year, many alternatives to PCR testing were developed, including the antigen test which produces rapid results within 15 to 30 minutes. Antigen testing has paved way for rapid mass testing solutions in other countries. “In the UAE, it has not been well adopted, since we have a huge capacity for PCRs.” Therefore, PCR is still regarded as the gold standard of testing due to its high accuracy rate, especially in the UAE.

Future of labs

The pandemic has affected the lab business, with escalated daily testing numbers changing the workflow of pathologists. “Methodologies and techniques have evolved in R&D, and overall pathologists, lab technicians, biomedical engineers have expanded their knowledge to adapt to the new normal. It has been a learning curve that has paved the way for developments in improving our processes and progressing in automation.” Fully automated solutions can further expand the capacity of PCR testing, in addition AI solutions work in tandem by linking reports from the lab to results to the patients. “The innovation we are witnessing presently is unparalleled, and it will continue to evolve,” concludes Dr. Mahmoud.    

 

 

Researchers at Cleveland Clinic in Cleveland, Ohio, are enrolling patients in a clinical trial that aims to work toward a cure for sickle cell disease by changing the patient’s genetics. Sickle cell disease, a genetic blood disorder, is a painful and debilitating condition for which there are few approved therapies.

The multicenter study will evaluate the safety and effectiveness of a single dose of EDIT-301, an experimental one-time gene editing cell therapy that modifies a patient’s own blood-forming stem cells to correct the mutation responsible for sickle cell disease.

Related: Hemophilia gene therapy: Where do we stand?

During the study, patients’ stem cells are collected for gene editing in a laboratory. Patients then are treated with chemotherapy to destroy the remaining bone marrow to make room for the repaired cells, which are infused back into the body. The study will initially enrol 40 adult patients ages 18 to 50 with severe sickle cell disease, with the possibility of expansion to include adolescents. Patients will be monitored closely after treatment for up to two years.

“Gene therapy is an incredible technology that works by replacing or inactivating disease-causing genes,” said Rabi Hanna, M.D., director of the paediatric blood and bone marrow transplant program at Cleveland Clinic and principal investigator of the trial. “In this study, the gene therapy will introduce healthy genes into the body with the goal of correcting genetic abnormalities of red blood cells. By enabling the cells to produce more fetal haemoglobin, this treatment has the potential to cure sickle cell disease in a precise way.”

Related: Stem cells and gene therapy come under the spotlight in sickle cell disease awareness month

This technology is a highly precise tool to modify blood stem cells genomes to enable robust, healthy blood cell production.

Dr Hanna explains: “CRISPR/Casp12 is a tool that enables gene correction. Gene correction is done on the hematopoietic stem cells in ex-vivo (outside the body). We collect the stem cells through the peripheral vein after we stimulate the marrow to release the blood stem.”

Genetic scissors

CRISPR/Cas12 is a system that will help to identify and modify the abnormal gene. It works like a pair of “genetic scissors”: the Cas12 nuclease opens both strands of the targeted sequence of DNA to introduce the modification. By delivering the Cas12 nuclease complexed with a synthetic guide RNA (gRNA) into a cell, the cell's genome can be cut at the desired location, allowing existing genes to be removed and/or new ones added.

“The technique is considered highly significant in biotechnology and medicine as it allows for the genomes to be edited in vivo with extremely high precision with ease,” Dr Hanna adds. “The development of the CRISPR technique earned Jennifer Doudna and Emmanuelle Charpentier the Nobel Prize in Chemistry in 2020.”

After the cells are modified, the patient is prepared to receive the modified hematopoietic stem cells by giving him or her chemotherapy to get rid of the abnormal cells in the bone marrow and to create enough space for the new cells. When the patient is ready, the modified cells are infused, similar to how blood is infused in the vein. These cells - given their capacity to replicate and differentiate into normal cells in few weeks - will make new red blood cells that will work normally and hopefully prevent any future sickle cell disease pain crisis or other complications

“The risks are mostly related to the chemotherapy we use to prepare patent, but there is also a potential risk that patient's modified cells do not engraft and, lastly, there is always the risk of “off-target” activity. We only use this now in ex-vivo “hematopoietic cells” and not in any embryo because these changes could be irreversible,” Dr Hanna concludes.

Traditional methods are being replaced across healthcare pillars, patients are more aware of treatment options, and physicians and healthcare facilities are focused on ensuring positive patient outcomes are met. Inclusive of treatment and care, medical furniture plays a pivotal role in establishing comfort, safety, and convenience. Hospital facility managers have various factors to consider such as ergonomics, bariatric patients, cleanability and aesthetics to ensure patient experience meets expectations.

It is necessary for furniture in the hospital to be ergonomically correct, for patients and specialists in the hospital. Caregivers can experience serious strain while supporting patient transfers, walking, or standing for extensive periods of time during their shifts, or by being seated for long durations while entering patient information on systems.

According to a study published in the International Journal of Industrial Ergonomics, hospital beds designs can effectively minimise physical strain for healthcare workers and patients. A steering lock and adjustable push height were assessed during patient transportation using perceptual responses and measures of performance and physical demands. The bed contour feature was established based on patient sliding distance during bed raising/lowering being repeated.

Results showed reduced number of adjustments required during bed movements by using the steering lock by 28 percent and reduced ratings of physical challenges. The adjustable push height minimised shoulder moments by 30 percent and the bed contour feature reduced patient sliding distance by 40 percent, over 12 raise/lower cycles. These findings display that steering lock and adjustable push height features can reduce the strain placed on healthcare workers efficiently.

Smart technologies

Designs that support smart technology devices are also becoming popular, furniture with smart features such as beds connected to EMR networks to send patient data and help nurses monitor patient statistics such as movement and weight changes, are proving to revolutionise patient care environments. Efficient, they surpass the conventional medical furniture features, with innovative integrations enabling physicians to oversee any changes even remotely.

Smart beds are also enabled to detect patient movement and alert a caretaker if the patient is struggling to move or if beds are occupied. It can also make adjustments to ensure the patient is positioned correctly and supported. Sensors under the mattresses of the bed, as well as other wireless equipment like wearable heart monitors, can monitor the health of the patients. In addition, another feature of many smart beds is placing a pressure cushion on the arms of the bed to alert the caretaker when the patient gets out of bed, therefore current hospital beds can distinguish the patient leave from the bed alarm. After the alarm from the bed goes off, the nursing staff quickly notices this movement. 

Enchaining patient comfort and safety during their hospital stay, especially extended periods is a focal point in “smart bed” advancements. Patient safety also remains paramount; however, the Affordable Care Act (ACA) representing the US healthcare system, has prioritised patient satisfaction and comfort.

The escalation in innovation and patient preference has given rise to the ‘smart bed’ with the segment expected to increase at a rate of 4.2 percent in the next years. According to IBISWorld's market research report, the industry was valued $2.5 billion in 2012.

During the COVID-19 outbreak, French healthcare facilities were entirely focused on containing the pandemic and providing care for French residents. Currently, the number of French COVID-19 patients in intensive care is low, and healthcare facilities are well organised to cope with the pandemic. In an interview with Omnia Health Magazine, Jean-François Gendron, president of the French Healthcare Association, shared that travel to France for medical reasons will again be widely possible, and the country expects to receive more and more medical travellers in the coming months. Excerpts:

Is France considering vaccine tourism?

There are no plans to bring foreign patients to be vaccinated in France. But since the beginning, France has been committed to ensuring access to vaccines for all through active support for the WHO’s COVAX programme, a system for pooling vaccine purchases for the most disadvantaged countries. Recently, President Macron announced that France would provide at least 30 million vaccines to the COVAX programme to ensure that people in all corners of the world get access to COVID-19 vaccines.

For what treatment do patients usually travel to France?

Related: Vaccine tourism and passports: a shot in the arm for the industry

French medicine combines therapeutic and technological innovations and a strong network of specialists in every field of medicine. This is especially true for cancer treatment, which is the first reason for medical travel in France because we have leading cancer centres. Patients also travel to France to consult experts in cardiology, urology, proctology, internal medicine, diabetology and vascular surgery. The French offer is very large.

Beyond the excellence of medical treatment, French healthcare facilities are also fully organised and dedicated to answering to international patient needs. To guarantee high-quality services, such as bespoke reception, catering to special demands and efficient communication, the French Hospital Quality label was designed. It identifies institutions that meet the highest quality standards. French Healthcare Association has also launched a dedicated website: https://myfrenchhospital.com, a search engine intended for foreign patients seeking a hospital in France.

Related: Medical Travel Special 2021

Jean-François Gendron

Has France responded positively to telemedicine?

Telemedicine acts have been clearly defined in France since 2010. Moreover, the French Health Insurance covers teleconsultation acts since 2018. Access to teleconsultation has been further facilitated in the context of the pandemic and has proven its usefulness, with more than four million virtual consultations in France in April 2020!

This boom was enabled by favourable public policies and a rich ecosystem, including innovative companies such as H4D and Doctolib. French hospitals are also developing tele-expertise on an international scale.

What, according to you, are the healthcare trends to watch out for in 2021?

In France, the release of the Sanofi vaccine will allow to boost the French global response to COVID-19 and accelerate the already fast-paced vaccination campaign. In addition, it will contribute to speeding up medical tourism in France.

Furthermore, many countries must fight against cancer, cardiovascular diseases and complications linked to diabetes. They also express needs around emergency care, remote care and mobile health. France can offer them equipment and expertise in all these areas.

French Healthcare is an innovative public-private initiative aimed at bringing together under a single banner all the players in the French healthcare ecosystem (businesses, researchers, healthcare professionals, key public stakeholders, etc.) to jointly promote their activities, expertise, technologies and innovations internationally. French Healthcare is supported by the Ministry for Europe and Foreign Affairs, The French Healthcare Association and Business France.