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Articles from 2020 In April


Cleveland Clinic Journal of Medicine Middle East – April 2020

White-paper-Cleveland Clinic Journal of Medicine Middle East – April 2020

In this issue of the Journal, Hockings et al (page 08) discuss aspects of the growing field of pharmacogenomics, and Hoogwerf (page 18) describes clinical subsets of diabetes mellitus. Both approaches, one molecular and one clinical (supported by biochemical testing), can help predict successful initial therapeutic interventions. These molecular and clinical approaches (supported by specific testing) represent nascent examples of how precision medicine is evolving. But the clinical, genomic, and molecular approaches still have a way to go before they are uniformly accepted and widely applicable.

Click below to download this edition - and for future issues, sign up here to receive the Journal in its new online-only format.

Predicting the peak of COVID-19 in selected MENA countries

White-paper- Predicting the peak of COVID-19 in selected MENA countries

COVID-19 represents one of the greatest challenges that the global healthcare system has faced in the last few centuries. The current pandemic started with a cluster of cases of unknown pneumonia in Wuhan, Hubei Province in China in December, 2019.

It wasn't until the end of January when the World Health Organization (WHO) declared it a public health emergency of international concern (PHEIC). With more spread in different countries, the WHO declared it a pandemic on 11th of March 2020.

Currently, there are more than 2,300,000 confirmed COVID-19 cases worldwide, with the US, China, Iran, and many European countries as highly impacted countries. In the Middle Eastern countries, the COVID-19 impact has been slower with the peak of the curve still yet to come for many countries except for Iran which has more than 80,000 confirmed cases with a peak that was reached in the 1st week of April 2020.

Till the time of writing this study, Saudi Arabia (9,362), United Arab Emirates (6,781), Qatar (5,448), Egypt (3,144), Morocco (2,855), and Algeria (2,629) are having the highest confirmed COVID-19 cases.

An epidemiological curve (epidemic curve) is a statistical chart to visualise the frequency of new cases compared to the date of disease onset which eventually showcase the disease's magnitude. The curve would typically have a steep upslope, a peak, and a more gradual downslope.

One of the most important components to understand in the epidemic curve is the peak, in which the healthcare systems is overwhelmed by the impact of the disease while the healthcare resources are facing the highest demand. Understanding the likely timing of the peak will help in the planning of the healthcare resources to meeting the patients’ need while minimising the morbidity and associated mortality.

When is COVID-19 peaking in your MENA country?

Article-When is COVID-19 peaking in your MENA country?

It seems that everyone is an epidemiologist on social media these days, to the extent that "flattening the curve" has entered the popular lexicon. Predicting when the curve will begin coming down in any country is no easy task, however. 

A team of experts in the UAE from TachyHealth, the deep technology R&D company, has turned to a rigorous methodology - a "time-dependent compartmental model" - to understand where the curve is headed in the UAE, Saudi Arabia, Egypt and Algeria.

According to TachyHealth, the peak is the point at which the healthcare system is overwhelmed by COVID-19. Understanding the likely timing of the peak in these Middle Eastern countries will help in the planning of healthcare resources to meet patients' needs, while minimising the number of deaths.

Their results presented the scenarios below, with the epidemic in the UAE peaking sooner than in other countries, and Egypt projected to peak later:

UAE

  • Scenario 1: Peak date is expected at 29/April/2020 
  • Scenario 2: Peak date is expected at 16/May/2020 
  • Scenario 3: Peak date is expected at 28/May/2020 

Egypt

  • Scenario 1: Peak date is expected at 06/June/2020 
  • Scenario 2: Peak date is expected at 18/June/2020 
  • Scenario 3: Peak date is expected at 16/July/2020 

Saudi Arabia

  • Scenario 1: Peak date is expected at 20/May/2020 
  • Scenario 2: Peak date is expected at 11/June/2020 
  • Scenario 3: Peak date is expected at 25/June/2020 

Algeria

  • Scenario 1: Peak date is expected at 29/May/2020 
  • Scenario 2: Peak date is expected at 11/June/2020 
  • Scenario 3: Peak date is expected at 06/July/2020

TachyHealth caveated that the real representation of the epidemiological curve depends on many factors, including the availability and access to the COVID-19 testing, the population response to the public health interventions, and the magnitude and strength of mitigation actions.

Other factors relate to the virus itself; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) including the response of the immune system, the mutations of the virus, and the seasonality of the spread of the infection.

What next

Mobile hearing centre launched to provide care during COVID-19 lockdown

Article-Mobile hearing centre launched to provide care during COVID-19 lockdown

Star Key Hearing Centers, a leading UAE based hearing care solutions provider has launched the first mobile hearing centre in the region in line with the ‘National Home Screening Program for People of Determination”. This home screening initiative was launched by HH Sheikh Mohammad Bin Zayed, Abu Dhabi Crown Prince and Deputy Supreme Commander of the UAE Armed Forces earlier this month. The core aim of this program is to provide health care services to people of determination who cannot physically visit health facilities during the current COVID-19 lockdown situation.

‘Star Key Mobile Center’ is a unique mobile hearing centre dedicated to serve hearing impaired especially for people of determination. This also enables Star Key Hearing Center to play its vital role in the society in realizing the plans and programs of the UAE government focusing in providing healthcare services for people.

Mr. Mohammad Kettaneh, Chief Executive Officer of Star Key Hearing Centers, said: “One of the core responsibilities at Star Key Hearing Centers is our commitment to enabling better hearing care solutions and increasing the accessibility of hearing health by bringing the hearing services closer to the community, especially for those who cannot easily access traditional medical care, yet are in urgent need. The vehicle is fitted with high-end advanced medical equipment by ASTEMED Medical Supplies and staffed by skilled hearing professionals who are passionate to assist in any circumstance and anywhere in the UAE”.

“Consequently, Star Key Hearing is also committed to help develop and boost the healthcare services and finding solutions to the challenges faced by the people who have hearing concerns. The launch of the mobile hearing care vehicle comes in line with supporting the national efforts and initiatives of the UAE government. In light of the exceptional circumstances that the whole world is going through, Star Key Hearing LLC is extending its way in seeking to provide all possible protection and safety for citizens while continuously providing better healthcare services and easy access right at their doorsteps with a reachable and realistic approach of hearing services,” added Mr Kettaneh.

The mobile hearing care centre, the first of its kind in the region is fully equipped with the latest technologies and wireless equipment that enable the capability of providing comprehensive and immediate mobile hearing care services. Various tests can be performed inside the vehicle including adult hearing tests, pediatric hearing tests (without sedation), middle ear measurements, and wireless video otoscopy.

Giscard Bechara, Managing Director, Starkey MEA FZCO, said “Starkey is the most innovative hearing aid company in the world, servicing hearing loss patients in more than 100 countries. Our core mission remains to service our patients better than anyone else. Our global partners understand this mission and reflect it in their own communities. Today we realize the need for our families and loved ones, our elderly and people of determination to be safe and to be able to hear and communicate clearly with their doctors, families and government health officials while being at home. We remain committed to our patients in the UAE and we won’t let them down despite of the current situation”.

Additional to the above-mentioned services, Star Key Mobile Center also provides hearing aids repair and wireless adjustment, custom earmolds production for behind the ear (BTE), completely in canal (CIC) and invisible hearing aids (IIC) are all performed with the support of the latest equipment available in the vehicle such as 3D printer and 3D scanner for scanning, modelling and printing to enable prototyping and manufacturing. These wireless equipment for hearing tests and unique hearing aids are manufactured by the international hearing aids leader - Starkey Technologies, worth to mention their leading product in the market which is the artificial intelligence technology.

Eng. Muhanad Jadallah, CEO, ASTEMED, stated: “We have the honor to supply Star Key mobile hearing centre with high-end internationally approved hearing screening devices, to better serve our sons and daughters, especially people of determination, inspired by the national initiatives in UAE, which is always the first when it comes to giving the best in the healthcare services”.

The AI technology helps its users track their body and brain activities and provide access to amazing features like translation to 27 languages and fall alert. It also helps visually impaired by identifying people and the surroundings around them. The vehicle is equipped with all means of safety, protection and sterilization for each patient’s safety, taking into consideration their health as the company’s top priority.

Five priorities for GCC health systems in the new normal

Article-Five priorities for GCC health systems in the new normal

Despite the immediate pressures of the COVID-19 crisis, GCC public health authorities should start thinking long-term about how to adapt to changed conditions when they emerge from this crisis. Public health authorities can take five sets of actions that build on important lessons from recent developments.

1. Build resilient and innovative supply chains

Given the difficulty of modelling projected demand, and understanding the necessary capacity, health authorities should build better scenario planning and demand forecasting capabilities. This can prevent future shortages of medicines, vaccines, testing kits, and equipment. Examples of advance planning can include repositioning and upgrading supply warehouses and their distribution systems and using drones. Health authorities will need to manage and meet surge demand from the public and healthcare providers—while safeguarding supply chain employees. Saudi Arabia’s centralisation of its Ministry of Health warehouses under the supervision of the National Unified Procurement Company, allows it to direct resources centrally and exploit its scale to meet demand in the whole country.

Countries should boost domestic manufacturing of critical products to counter shortages. National authorities can guarantee purchase agreements, offer fiscal incentives, and even provide state investment. They can reinforce emerging 3D printing capabilities in the region, potentially through increased funding for university-based research, to produce such items as respiratory valves and non-contact thermometers.

2. Decentralise testing to the point of care and beyond

Countries need a consistent and sustained approach to testing. Early efforts in many GCC countries, facilitated by the drive-through and public centres, have yielded many tests—including close to 1 million tests in the UAE alone. Countries should provide easy access to decentralised, more accurate testing, even in private homes. Health authorities should build the capability to collect, manage and analyse large volumes of samples frequently for multiple indications. Governments can achieve this by increasing substantially their testing capabilities, training a wider array of healthcare workers to support the public, and getting the public used to regular diagnostic testing.

3. Deploy predictive analytics and data forecasting with Artificial Intelligence

Countries should increase their use of the predictive analytics and data forecasting developed in response to COVID-19 to maintain heightened vigilance of this public health threat. Authorities should consider whether they need a minimum set of pandemic capabilities, including contact tracing tools. Countries can receive warning of emerging disease hotspots by using social media combined with online disease surveillance. In the region, such monitoring will provide insights into large cross border movements, including for religious tourism.

Artificial Intelligence has an important diagnostic role in identifying certain radiological patterns associated with COVID-19. This technology can play a larger role with more investment, greater access to datasets owned by different institutions, and a streamlined regulatory process.

4. Accelerate care delivery away from hospitals

Health systems should continue to improve care provision outside the hospital setting. Before this crisis, hospitals and healthcare networks were steering more patients towards ambulatory and primary care as these are more cost-efficient and promote preventative care. They also save beds for more complex interventions. Simultaneously, public and private payers are experimenting with payment models to incentivise physicians and patients to take this approach.

Authorities should continue to work with private and public providers to encourage the recent growth in telehealth. To accelerate this shift in care delivery from the hospital to patient’s home, authorities need to put in place the right enablers, such as data privacy, reimbursement policies, training, and remote care infrastructure. Telehealth should become part of the regular care package, which means that public and private payers should cover it.

5. Enhance healthcare workforce skills

COVID-19 has placed a significant strain on health systems and front-line professionals. In response, healthcare systems need to enlarge, strengthen, and reward this workforce. As part of this effort, there should be an emphasis on mental wellbeing, skills upgrading, and the use of technology. Such assistance can reduce burnout and safeguard longer-term productivity. Training in crisis management is particularly critical as the pandemic has revealed areas for improvement in clinical and administrative decision making. Meanwhile, non-clinical staff can be provided with the necessary tools and platforms to maintain productivity while working from home.

By taking these five sets of actions, public health authorities will have greater self-knowledge and a renewed sense of purpose, allowing them to better adapt to the new normal that will certainly emerge in the near future.

Dr Osama AbouElkhir, the physician fixing healthcare with AI

Article-Dr Osama AbouElkhir, the physician fixing healthcare with AI

As a visionary and self-described science geek with a hunger to change the healthcare industry at breakneck speed, it’s perhaps unsurprising that Osama AbouElkhir is at the helm of a Dubai startup named TachyHealth - any student of ancient Greek or medicine will recognise tachy as meaning "rapid".

AbouElKhir knows the internal workings of the industry intimately well – its strengths and its flaws. It comes from a background spanning multiple disciplines: clinical, administrative, management consulting and entrepreneurial.

Starting as a medical doctor in his early career he crossed over into hospital operations before making the leap into management consulting for the healthcare industry across the Middle East with Ernst & Young and IQVIA. Some of the more illustrious clients he worked for included Cleveland Clinic Abu Dhabi, Dubai Health Authority, the Ministry of Health in Malaysia and the Saudi Health Council.

Becoming an entrepreneur was a natural next step. Speaking to Omnia Health Insights, AbouElKhir described the business he co-founded as a deep technology R&D company focused on using machine learning and deep learning to solve challenging problems that mostly cannot be solved with traditional tech.

He described success in simple terms: “We try to save lives with technology. We help the healthcare focuses on what really matters - the patients - and in doing so, taking away all the waste, redundancies and inefficiencies.”

Founded in Delaware in October 2018, TachyHealth is a newcomer to Dubai, having been established in the UAE for slightly over six months. 

Despite the short tenure, the company has achieved rapid recognition, owing perhaps to a top team composed of machine learning PhDs, medical executives, software engineers, insurance leaders and Fortune 500 professionals.

It was selected for the first Artificial Intelligence Lab in the region, AIVenturelab, powered by Microsoft and Area 2071. It was also picked for the first of its kind mentorship program by HSBC Bank and TiE Dubai that encouraged startups to transform business in a sustainable way (in their case healthcare).

“If it can be automated, it should be automated”

TachyHealth delivers value-based healthcare solutions to help reduce inefficiencies in the system for both healthcare providers and payers (hospitals and insurance companies). 

One such inefficiency can be seen in relation to medical claims - like invoices, AbouElKhir said, only more complex as they contained medical information as well as financial.

Claims are generated by the hospitals with each insured patient encounter and sent to the insurance company, who have the function to audit and rationalise the payment and claims before paying out accordingly.

In the event of denial, however, a reason must be provided. It’s a cycle happening the world over, and most insurance companies are using manual methods or rule-based systems through software from 20-30 years ago – a clear opportunity to optimise.

To expedite the process, TachyHealth built a hybrid model that combines the best of machine learning algorithms with the best of the medical role-based system to automate the claim processing and adjudication. Today TachyHealth’s solution, named AiClaim, is able to automate 80 percent of the process.

tachyhealth-aiclaims.png

In addition to the congestive engine, a real-time insights dashboard meanwhile offers clients easy insight into the analysed claims data, to inform actions for better clinical and financial outcomes.

On the hospital side meanwhile, TachyHealth is piloting two solutions.

The first, AiGuide, is an AI software for physicians that eliminates inefficiencies at the electronic medical records (EMR) point of entry.

Studies show that clinicians spend much of their time on documentation: if a physician sees a patient for 20 minutes, AbouElKhir revealed, they will chart the records for an additional 10-15 minutes after. In the event that the insurance company needs further explanation, the physician will need to revisit the records and resubmit accordingly in what is overall a cumbersome process.

AiGuide eases the burden through its easy to use experience that leverages natural learning processing and intelligent search optimisation built on evidence based guidelines from NICE and the BMJ. The physician can be guided through order sets and medications so that time spent charting is reduced in half – five minutes instead of 10.

The second hospital solution, AiCode, takes this streamlining a step further – through an automated medical coding system for medical records.

Medical coders sift through hundreds of pages of medical documentation each day to understand diagnoses and procedures before ensuring that the correct medical codes are assigned. Again, many hospitals are using manual ways or legacy software of doing this, AbouElKhir reminded.

TachyHealth instead plugs medical charts into the AiCode system for immediate conversion into medical code. This frees up coders’ time – they simply verify rather than assign codes - so that more records are charted per day and the insurance company is billed correctly. 

AbouElKhir underlined the importance of security and privacy: through using Microsoft Azure datacenters in the UAE, any data containing protected health information stays within the country.

Pandemic pressure

Physician feedback on TachyHealth's AiGuide has been positive - doctors have reported satisfaction with seeing a user interface designed for and customised to a real practice. Sitting as a layer upon the EMR, the interface is a seen as a welcome addition to a system whose complexity has grown over the years (some systems date back to the 1970s).

AiGuide UX.png

Medical coders are also encouraged by AiCode solution, reporting a 70 percent elimination of redundant work through using it.

AiCode UX.png

Business prospects look promising. According to AbouElKhir, TachyHealth has commenced work with an insurance company in Kuwait and is in talks with a major group in the UAE over the deployment of hospital solutions.

While the adoption curve was previously “slow”, the current pandemic has changed all that – private healthcare providers are in survival mode (with elective surgeries for example postponed) and looking to identify ways to improve and transform without the extra cost.

Realigning, not replacing, workers

With resistance to adoption no longer a problem, a challenge now is how to realign the workforce. AbouElKhir was keen to stress that automation wasn’t about replacing workers but improving processes so that people did a better job in less time.

Another challenge is a disconnect between research, software and healthcare industry communities in the way they collaborate and communicate with one another.

The research community is 10 years ahead, AbouElKhir explained, while the software community is focused mostly on traditional software engineering, and industry of course adopts. The disconnect is especially manifested, he argued, in the way machine learning advancements are translated back to industry.  

To advance the conversation, TachyHealth has opened a “Tachy Transform Clinic” inviting clinics and hospitals to ask questions about how to use cutting edge technologies in practice.

The virtual clinic is offered through LinkedIn Live, the platform’s live video streaming service, using hashtag #TachyTransform, with the first launched on 11 April.

Unleashing innovation

Looking further ahead – 12 months from now, to when COVID-19 will (hopefully) be an event in the rear-view mirror – AbouElKhir sees a digital-first world better prepared for any emerging disease outbreak.

Anything considered redundant in healthcare today will be “cut off” or automated, particularly administrative costs not relating to the patient. R&D will be “nourished” better, solving problems such as contact tracing and population health big data analytics; public health institutions will receive higher funding than today; and the national healthcare expenditures will be increased, particularly in the Middle East.

AbouElKhir takes encouragement from developments in the US, where he believes a major change is happening on the regulatory front. He explained that traditionally years of work are required with the FDA for software, device or medication regulatory checks; this is now being accelerated.

For instance, the agency has announced a fast track approval for medical devices, software, and therapies that use AI. Also, the Department of Health & Human Services (HHS) finalised rules to provide patients more control of their health data which will allow for more data sharing and research based on this.

A leaner regulatory era combined with open healthcare platforms and patients owning their data would unleash powerful innovation – innovation that would furthermore benefit the patient, AbouElKhir believes.

It’s a compelling outcome.

Infographic: Digital Outreach

Article-Infographic: Digital Outreach

What does a healthcare decision-maker's journey look like in a digital age? 

The way business is conducted is changing – both in response to the current COVID-19 pandemic, and in response to evolving technology and the changing behaviour of consumers and businesses.

It’s a trend the healthcare industry has already been embracing with the rise of telemedicine, where virtual appointments allow for a higher volume of visitors and more flexibility for medical staff and patients. The way decision-makers are interacting with organisations has been transforming in according to the same principles: with a flexible, digital first approach.

 

Sources

Individuals with diabetes are among those who could be at higher risk of complications from COVID-19

Article-Individuals with diabetes are among those who could be at higher risk of complications from COVID-19

Diabetologists from Imperial College London Diabetes Centre (ICLDC) in Abu Dhabi, UAE, are calling for good diabetes management during the COVID-19 pandemic. Individuals with diabetes are among those who could be at higher risk of complications from COVID-19, and this is the time for them to be extra vigilant in monitoring their blood sugar and managing their condition.

ICLDC consultant endocrinologist and diabetologist Dr. Sara Suliman says that people with diabetes need to be even more careful than the general public in following preventative advice such as handwashing and social distancing. They also need to pay special attention to controlling their blood sugar levels.

Dr. Suliman explains: “Fluctuating blood sugar levels generally increase the risk of other complications, and this could mean worse outcomes in the case of COVID-19 since the body’s ability to fight infection is compromised. In addition, above-target blood sugar levels can mean that viral infections cause increased inflammation, which could make the reaction worse.”

She says some experts believe that if blood sugar is well controlled and there are no other comorbidities – in other words, no other conditions associated with diabetes such as heart disease – then the effects of COVID-19 might be no different than those of individuals with no underlying medical conditions.

However, Dr Suliman cautions: “We cannot state this for certain yet, it is too early, but it makes sense, and diabetes patients should be extra vigilant in monitoring their blood sugar levels and managing their condition during this pandemic.”

An important factor in protecting patients is to ensure wherever possible, they stay at home and avoid contact with others. For this reason, Suliman advises people, and especially those in high-risk categories such as pregnant women and the over 60-year-olds, not to visit the clinic for their regular check-ups, or if they feel unwell.

If a patient suspects they have COVID-19, they should contact the Department of Health – Abu Dhabi for advice on 8001717, but for everything else, they should call the ICLDC helpline at 800 42532, and they will be advised on the next steps.

Teleconsultation

In many cases, patients will be able to have their appointment kept as a teleconsultation, complete with prescription and medication delivery to their doorstep within 7-10 days if appropriate.

“Our ICLDC doctors are also working with our sister Mubadala Healthcare facility, Abu Dhabi Telemedicine Centre (ADTC), to provide consultations via telephone or video calls. All Daman Enhanced and Thiqa cardholders can call ADTC at 800-4959 at any time of day or night for medical advice,” Suliman explains.

“We also suggest that our patients download the ICLDC app so that they will have access to their medical information such as test results, targets, latest diagnosis and medication.”

Warning signs: When to call the health authorities

If individuals with diabetes have any of the following signs, they should telephone their relevant health authority to ask for about immediate medical care:

  • Shortness of breath
  • A fever that won’t go away after a couple of days, especially in the case of recent contact with someone who may have COVID-19
  • High levels of ketones (tested using ketostix)
  • Inability to keep food or liquid down for more than four to six hours
  • Persistently high (>250mg/dl) or low blood glucose (<60mg/dl), especially if insulin is used
  • Sleepiness, drowsiness or confusion

Pneumococcal testing market exceeds billion-dollar revenue

Article-Pneumococcal testing market exceeds billion-dollar revenue

Having surpassed the global market valuation of US$1 billion in 2019, the demand for pneumococcal testing continues to soar. A new study projects that the global pneumococcal testing market will exhibit a double-digit CAGR during the forecast period (2020 - 2030). These insights are based on a report on Pneumococcal Testing Market by Future Market Insights.

The use of pneumococcal testing is gathering momentum around the world owing to its current diagnostic landscape, including unmet needs and emerging technologies. Over the last decade, pneumococcal testing has undergone many technical improvements. Increasing focus on molecular diagnostic methods for respiratory pathogen detection has yielded a plethora of potential technologies. Pneumococcal testing has gained clinical significance in terms of effective ability to demonstrate high analytical sensitivity and specificity with the ability to process several respiratory specimens.

Development of advanced nucleic acid detection tests and advancements in POCT products are the key factors for the growth of the pneumococcal testing market over the forecast period. Moreover, a rise in awareness about the benefits of early diagnosis among patient pool has increased the number of diagnostic tests in developing regions such as India and Africa.

Additionally, the increase in adoption of molecular diagnostic testing and untapped markets in the developing regions are expected to provide new avenues for the growth of the pneumococcal testing market in the near future.

Key takeaways of pneumococcal testing market study

  • Point of care testing (POCT) remains the preferred testing method, representing about 2/5th of total market revenue. This is attributed to the rising need to provide results in real-time that help physicians make informed decisions in the treatment of diseases. Moreover, POCT is useful as medical care shifts to a focus on prevention, early detection, and managing acute and chronic conditions.
  • Analysers capture a leading value share in the market and will maintain the trend throughout the forecast period.
  • Hospitals account for over half of overall market value, given the availability of pneumococcal testing and skilled personnel for better clinical management of various diseases across several medical domains.
  • Enzyme-linked immunosorbent assay (ELISA) accounts for major revenue share, owing to its high sensitivity and specificity, and are easier to perform compared to other methods used for the detection of substances in the body.
  • North America and Europe collectively contribute over 70 per cent of market share in the pneumococcal testing market, with the former expected to grow at a CAGR of 12 per cent during the forecast period.
  • Increasing prevalence of pneumococcal diseases, recent advancements in pneumococcal diagnostics and government support for quality healthcare is driving the pneumococcal testing market in North America.

Coronavirus update: Randox unveils whole pathogen molecular controls for SARS-CoV-2

Article-Coronavirus update: Randox unveils whole pathogen molecular controls for SARS-CoV-2

Whole pathogen quality controls to support accurate coronavirus testing have been developed by scientists in the UK. The molecular controls, available from global diagnostics company Randox Laboratories, are currently being used as part of a nationwide testing programme for frontline NHS workers.

Alongside its pioneering Coronavirus Biochip, which includes tests for SARS-CoV-2 (the virus which causes COVID-19) and nine other respiratory viruses, Randox is using these third-party quality controls to ensure accurate coronavirus test and system performance, and ultimately, guarantee laboratory quality assurance.

Lynsey Adams, Randox Quality Control Manager, explained: “Accurate and reliable laboratory testing is an essential aspect of COVID-19 disease management and outbreak control.

“Designed specifically for laboratories currently managing COVID-19 testing, Randox SARS-CoV-2 controls help ensure the accuracy and reliability of molecular assays used in the testing of suspected coronavirus samples, and importantly, give clinicians absolute confidence in any COVID-19 diagnoses they may make.”

Available under the brand name Qnostics, the new SARS-CoV-2 controls are manufactured using whole pathogens. They, therefore, mimic the patient sample, providing the best sample matrix for laboratories.

Lynsey continued: “The Randox Qnostics SARS-CoV-2 controls are clinically relevant for full-process validation. Liquid frozen for user convenience and ease of use, the development of the controls using whole pathogen material ensures clinical relevance from extraction to amplification and detection.”

The new coronavirus controls from Randox, which contain the entire SARS-CoV-2 genome, including the conserved regions recommended by Centres for Disease Control and Prevention (CDC) and The World Health Organization (WHO), are compatible for use with both commercial and in-house testing methods and are quantified by digital PCR to ensure batch to batch reproducibility.

Lynsey added: “We are proud to be able to support the high demand for coronavirus testing by delivering a full COVID-19 testing package – not only our 10-plex Coronavirus Biochip but now also the corresponding molecular control material that will ensure the delivery of accurate, and reliable results.

“The WHO has been very clear about the importance of testing in the global efforts to contain and delay COVID-19 and we are pleased that our new controls comply with guidelines not only from the WHO but also from CDC.”

Randox Qnostics SARS-CoV-2 Controls are heat-inactivated to be non-infectious and are manufactured to ISO 13485 standards.

Key features:

  • Whole pathogen controls – the controls contain the entire SARS-CoV-2 genome meaning they are compatible with the majority of commercial and in-house assays, and target the CDC and WHO consensus sequences
  • Monitor the entire testing process – whole pathogen controls are the ideal clinically relevant material for full-process validation, from extraction to amplification and detection, to ensure ultimate quality assurance in laboratories.
  • Non-infectious – the controls are heat-inactivated and gamma-irradiation enabling safe handling of material.
  • Highly characterised – the controls are quantified by digital PCR to ensure batch to batch reproducibility.
  • Clinically relevant – performance data is available to support the clinical relevance and the compatibility with molecular assays currently in use in clinical laboratories.
  • High Quality – the controls are manufactured under ISO 13485 guidelines and are therefore suitable for a broad range of usage.
  • Liquid for Ease-of-Use – the controls are conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.
  • Negative controls available - delivering a complete testing package.