With Infectious Diseases Flourishing – Could Mobile Enabled Diagnostics Offer New Hope In The Battle For Global Health?

With Infectious Diseases Flourishing – Could Mobile Enabled Diagnostics Offer New Hope In The Battle For Global Health?

Dr Neil Polwart, NovarumTM founder and BBI Group Head of Mobile, has over a decade of experience in the delivery of next generation diagnostic technologies within mobile health (mHealth).

With waves of major outbreaks of infectious diseases being unleashed on communities across the globe, finding new and improved solutions to tackle these fast-spreading diseases is becoming ever-more critical.

The World Health Organisation (WHO) has highlighted Dengue, Ebola, and HIV amongst its top ten threats to global health in 2019 - a challenge which is exacerbated by a combination of challenges such as drought, famine, conflict, and population displacement.

Many of the diseases currently afflicting communities across the world have been held at bay through careful treatment and monitoring, but growing instability and climate change, particularly in areas experiencing climate warming, are creating conditions where poor infrastructure and lack of access to basic healthcare offer fertile ground for disease to flourish.

Dengue, a mosquito-borne disease that causes flu-like symptoms, can be lethal and has been a growing threat for decades.  A high number of cases occur in the rainy seasons of countries such as Bangladesh and India. Now, its season in these countries is lengthening significantly (in 2018, Bangladesh saw the highest number of deaths in almost two decades), and the disease is spreading to less tropical and more temperate countries such as Nepal that have not traditionally seen the disease. An estimated 40 per cent of the world is at risk of dengue fever, and there are around 390 million infections a year – according to official WHO statistics.

HIV is another disease where great strides have been made in diagnosing, managing, and eradicating the disease, but more remains to be done. The progress made against HIV has been enormous in terms of getting people tested, providing them with antiretrovirals (22 million are on treatment), and providing access to preventive measures such as a pre-exposure prophylaxis (PrEP, which is when people at risk of HIV take antiretrovirals to prevent infection). 

However, the epidemic continues to rage with nearly a million people every year dying of HIV/AIDS. Since the beginning of the epidemic, more than 70 million people have acquired the infection, and about 35 million people have died. Today, around 37 million worldwide live with HIV. Reaching people like sex workers, people in prison, men who have sex with men, or transgender people is hugely challenging, and these groups are often excluded from health services. Another group increasingly affected by HIV are young girls and women (aged 15–24), who are particularly at high risk and account for one in four HIV infections in sub-Saharan Africa, despite being only 10 per cent of the population.

With cases still devastating communities across the globe, malaria is another killer that although cowed, is still a real threat, particularly for the world’s most vulnerable populations: over 435,000 people died from the disease in Sub-Saharan Africa in 2017.*1

The disease is also developing resistance to key drugs. Parasites resistant to first choice drugs have spread rapidly across South East Asia, according to UK and Thailand researchers. According to a recent study published in the Lancet Infectious Diseases Journal; parasites have moved from Cambodia to Laos, Thailand and Vietnam, where half of patients are not being cured by first-choice drugs.

However, although this disease is often the scourge of poorly-resourced, rural communities – cases are also rising rapidly in the Western world. Over 1,600 people were diagnosed with malaria in the UK in 2017, with cases at the highest number they have been for 15 years.*2

Progress in tackling the disease has stalled in recent years. Recent statistics from the World Health Organisation (WHO) show that although incidence of the disease had declined over several years,

in 2017 and 2018 progress plateaued – with an estimated 219 million cases of malaria recorded in 2017, compared to 217 million the year before.

Countries with ongoing transmission are increasingly falling into one of two categories: those moving towards elimination, and those with a high burden of the disease that have reported significant increases in malaria cases.

Without urgent action, we risk losing the major gains which have been won in the battle to bring an end to these infectious diseases. A new approach is needed to strengthen the charge against these diseases and technology has a key role to play in tackling the disease - and could help to rebalance the scales, particularly in remote, resource-poor areas.

Traditional methods of testing for infectious diseases are challenging in communities which lack basic medical infrastructure, but technology has the potential to redefine what is possible and provide new hope in the battle to tackle these diseases which are ravaging communities across the globe.

Fast, accurate diagnosis is a crucial first step, and smartphone-enabled point of care testing (POCT) including other breakthrough technologies could fundamentally redesign the way we monitor, test and treat outbreaks of fast-spreading infectious diseases, particularly in areas with limited public health infrastructure.

Lateral flow technology offers huge potential to healthcare providers to more quickly diagnose and treat patients outside the clinical lab. However, with this promise, comes a need for enhanced scrutiny and security to ensure that control measures are in place to minimise common user errors in- field which can cause concerns in misdiagnosis, limiting wider adoption outside controlled environments.

Other challenges inherent in the use of remote testing in field include the risk of accessing out of date or recalled assays – or tests which are compromised through environmental factors, such as heat or moisture.

Inexperienced staff operating remote tests in field without training is another potential obstacle to the successful delivery of the test - with risks including testers collecting ineffective sample sizes or not sharing them effectively with clinicians or people who need the data.

Challenges like this mean it’s essential that there are gatekeeping processes in place to monitor efficacy and delivery of remote diagnostic tests. Globally, regulators are keen to ensure that systems used outside laboratories are subject to additional safeguards, to prevent unskilled users introducing errors.  Recognition schemes such as CLIA Waiver in the USA provide an effective benchmark which recognise the least complex devices and offer independent assurance that manufacturers have demonstrated that devices are simple to use, have low risk to public health, and have clear instructions which mean that an untrained person can get accurate results by following them. 

At BBI Solutions, we’re passionate about the potential mobile offers to transform the remote testing landscape and offer a smart way to read diagnostic tests and share the results with healthcare providers all over the world.

We are working to transform the diagnostic testing approach through intuitive Novarum mobile technology to empower lateral flow at the point of care and delivering test results of lab quality to users in the field.

But the challenges presented by operating in the field in changeable conditions with inexperienced staff can’t be understated, so we are pioneering mobile-enabled diagnostic solutions with features which minimise human errors, safeguard result accuracy and simplify the process for the end user - unlocking powerful tools which can be the difference between life or death.

Our patented image-capture technology allows users to obtain qualitative or quantitative results from rapid tests clearly, quickly, and accurately, regardless of the user’s location. While concerns around untrained testers capturing the appropriate amount of a sample have been combatted by creating configurable features that can be easily integrated into a mobile app that supports your test use, along with simple, easy to follow visual guidance and instructions.

In areas where infrastructure is poor – mobile is transformational, offering the potential for test results to be shared between users using a dedicated web portal interface or through existing data management platforms.

To ensure that people don’t inadvertently use expired tests, Novarum has developed a custom bar code scanning feature that disables the test when it has expired - improving patient safety and managing quality control. While in-built timers enforce the window of opportunity ensuring timely use and minimise exposure to humidity.

Clear visual instructions enable users to perform their tests with little or no training, and our patented image capture software corrects for misalignment. Upon use, the results show an immediate pass, fail or quantitative result, removing subjectivity. Results can be shared instantly with professionals to initiate the correct action and follow up quickly, improving patient outcomes.

Although infectious disease can seem an impossible challenge to tackle, embracing the potential presented by enhanced diagnostic tools could enable a reframing of how we diagnose and treat infectious diseases.

The potential presented by the advances in capability that enhanced diagnostic tools offer to manage and combat this global threat and protect our most vulnerable communities cannot be overstated.  As we enter a new era where a lethal cocktail of political instability, mass global movement of people, and climate change creates the perfect conditions for disease to flourish; it’s vital that this potential is explored and that we look to new technologies which will enable us to protect our most vulnerable global citizens.

For more information and to see how we can transform your test so that it is equipped for a new era of mobile diagnostics, join us at AACC 2019 in Anaheim where we will be launching a new mobile app demonstrator. To register for a demo, visit: bbisolutions.com/aaccdemo

1* https://www.who.int/malaria/en/

2*www.pharmatimes.com/news/malaria_cases_remain_at_highest_level_since_2011_1293442



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