WHY TEST AND TREAT IS THE WAY FORWARD

Biosecure EnvironmentCOVID testingLong COVID

20 Apr

Test and treat strategies are most commonly associated with the fight against HIV. Due to the advancements in both testing and treating technologies over the past two years, the application of test and treat strategies for COVID are not only possible but are also the way forward.

Our approach to combating COVID has not progressed as quickly or as dramatically as new variants have emerged. Consider that COVID has evolved as much in two years as the flu has evolved in up to 500 years, yet we continue pushing the same COVID narrative and strategies from the first year of the pandemic. A recent offspring of this strategy shifts the focus to vaccines. Freedoms are offered for fully vaccinated people, including test-free travel, reduced isolation period and even eliminating isolation altogether. Conversely, some countries and companies make vaccinations compulsory for employment. From the end of free testing to tests failing to detect COVID, from budgetary constraints to billions of COVID funds missing, and from the ever-increasing number of vaccine jabs to announcements that the pandemic is over, the public has lost trust and COVID fatigue seems immutable.

We argue that a new COVID strategy is needed to meet the new COVID world. Let us start with the mea culpa—it is long overdue. Vaccine efficacy wanes over time. Health authorities knew all along from experience with the MERS and adenovirus vaccines (two of the closest vaccines to COVID) but getting jabs in arms was deemed more important. Similarly, health authorities also know that current testing is not working. We have watched dramatic price swings, mass swab and reagent shortages, increased laboratory demand met with decreased supply, and failure to detect COVID variants.

The consequence of relying on existing COVID strategies has led us to where we are today. We continue seeing huge peaks throughout the world, not seasonally but as often as every 90 days (it is an interesting coincidence that the MERS vaccine only lasts that long). Supply chains are choked due to mass absences, exacerbated by lockdowns. Long-COVID is putting additional pressure on long-term care and already stretched resources. Instead of decreeing the ‘end of the pandemic’ or ‘living with COVID’ we need a reset to truly return to normality and protect against future waves.

In the new COVID world, we should not focus on coercion and dogma. Rather, we should focus on protecting an individual’s health and giving that individual the treatments to avoid serious and lifelong health issues resulting from COVID, while at the same time, protecting the public health system and strengthening the global economy.

In this new COVID world, we should reconstruct the government’s wargame-like risk assessments. These calculations determine the maximum number of sick people the NHS (or an equivalent public health body) can handle before the system collapses and that formula is used to dictate staffing, restrictions, tests and treatments. In the early days of the pandemic, these formulas were based on assumptions and targets that we now know are incorrect (or not exactly as we hoped). Lockdown is a good example of does more harm than good. Herd immunity is a good example of wishful thinking. Reinfection is a good example of unexpected outcomes. These wargame calculations are heavily biased toward old strategies and old technologies, and are slow to adjust to new variants, largely based on flu strategies that are inappropriate for handling coronaviruses, increased transmissibility and the impact of vaccination efficacy.

“Real-world performance for rapid antigen tests is “50% or lower than clinical…and 50% as sensitive as PCR.

”

— American Society for Microbiology

In the new COVID world, we should be brutal. If a test is not accurate, bin it. If a test is not frequent, forget it. The goal of testing is to break the chains of transmission, in effect, stop the spread of COVID, but the two most commonly used COVID tests, PCR and antigen (aka lateral flow) are unable to do that. These tests were ushered in with great speed as off-the-shelf solutions in the early days of the pandemic but both tests have failed to keep pace with a rapidly mutating virus like COVID. Both tests had a time and a place (and still do in certain circumstances). Both tests had advantages. However, whatever advantages those testing methodologies had in the past, they fade due to lack of accuracy and consistency. With Omicron especially, PCR has not offered any benefit because it cannot detect early enough and is requiring significantly more cycles and hours to give accurate results. Rather than acknowledging this PCR weakness, antigen tests were given pride of place. Cheap and fast was deemed more important than accurate and reliable.

In the new COVID world, we must look at true costs. The true cost of a test includes the raw materials, staff, transportation, machines, labs, insurance, accuracy risk and the environment. The impact on the environment is evident when you consider that in the first 18 months of the pandemic, more than 1.4 million tons of plastic was generated with more than 3.8 thousand tons released into the ocean. The impact of test reliability, especially in the case of false-negatives in a factory setting, can have dire impact on output due to mass absences. Global shortages of swabs and reagents together with the surge in demand for machines and equipment have put considerable pressure on prices. With reliable alternatives stuck in the long queue of awaiting regulatory approval, the problem has reached critical status and has forced many governments and companies to cancel testing programmes altogether—not because the pandemic is over, but because they don’t have options.

In this new COVID world, can we start over? We argue that the power should shift towards strategies that promote early detection and early treatment, boosted by vaccine protection. Despite our general COVID fatigue haze, this fresh approach will help regain trust and get ahead of COVID.

THE WAY FORWARD IS GETTING AHEAD OF COVID

If you can detect COVID before someone is contagious, then you can break the chains of transmission and stop the spread. If you can treat early, then you can reduce the infectious period and the risk of developing serious disease.

1. TEST: Mass testing in society to break the chains of transmission and create biosecure environments.

2. TREAT: Early treatment limits the severity of disease, reduces the period of illness and lessens the strain on the healthcare system.

Like all coronaviruses, COVID-19 is wave based. It is their biological evolution with increased transmissibility crowning the winner. If you need proof, look no further than the Omicron variants. BA is dominant with 1-5 sublineages. What does BA.4 and BA.5, the newest members, have to offer? Evades detection better? More transmissible? Affects lower respiratory? We need better and more frequent tests to understand how these variants affect the body and to protect society, especially those most vulnerable.

The world has been chasing COVID for more than two years; Virolens will help the world get ahead.

THE WAY FORWARD RELIES ON TESTING

In some circles, testing is viewed as the greedy, old villain, and not the wise, trusted protector. The moment testing was tied to freedom, people became annoyed; the moment results were no longer trusted, people became bitter. These feeling are so entrenched science is blocked and people ignore that testing saves lives. Based on our research, we suggest the only solution is a complete testing strategy reset, not more of the same, and that once people feel safe to work in crowded spaces, travel, use public transportation or participate in any activity allowing a return to more normality, trust in testing will return naturally.

From a public health perspective, trust will return immediately because the benefits of creating a biosecure environment through testing are too strong to ignore. When the UK announced in early April 2022 that they would stop routine COVID testing, the public went mad. At a time when hospitalisation rates were higher than the Delta wave in December, the move was reckless. Testing alone will not prevent another wave but shifting to a test and treat approach reduces the pressure on hospitals, both from the onset of symptoms to the treatment and recovery of the disease. Regular testing with early detection turns hospitals into a biosecure environment, protecting doctors, nurses, staff, patients and visitors.

Mass testing, as we have learned throughout the pandemic, is a powerful tool to identify hot spots and implement enhanced protective strategies. If we wait to see hospital beds full before acting, we are too late to stop a wave.

In a test and treat strategy, testing moves from COVID surveillance into a diagnostic tool to begin appropriate treatment.

Testing should also continue because vaccines alone cannot end COVID since they are unable to break the chains of transmission. Fully vaccinated people can catch COVID and spread COVID, symptoms or not. As we have seen with the Omicron BA.1 subvariant, it evades much of the protection that vaccines give. Additionally, protection against BA.1 and BA.2 wanes to 10% after four months. In March 2022, the FDA approved doses four and five despite “data showing that Moderna shot was only 11% effective, and caused side effects in 40% of recipients, and the Pfizer shot was 30% effective and caused side effects in 80% of people.” Therefore, to keep protection high, doses must continue every three to four months. Endless cycles of vaccines are expensive and impractical.

More than any other argument, without testing, we cannot stay on top of COVID’s rapid development or prevent an inevitable wave of high pathogenesis occurring.

THE WAY FORWARD RELIES ON TREATING

The goal of treating COVID is to reduce the risk of serious disease and shorten the recovery time—both goals are achievable thanks to advancements in medicine. The individual benefits for obvious reasons. The public health system benefits in the short-term with fewer hospitalisations and in the long-term with fewer people suffering from debilitating disease. The economy benefits because there is less disruption in production and less strain on employers covering short and long-term sick pay.

Like the argument for testing, treating faces similar objections and faulty comparisons to the seasonal flu. COVID-19 is the disease caused by the novel SARS-COV-2 virus, a coronavirus which are a family of viruses, including SARS and MERS. The seasonal flu (influenza A and influenza B) is another respiratory virus that can cause COVID-like symptoms, but they are not the same! SARS-COV-2 has both a high replication and recombination rate allowing the fixation of functional changes to its RNA to occur rapidly, being a novel virus in evolutionary terms it has plenty of functional paths to explore as selection pressures are applied.

“Every year, more than 38 million people become sick with influenza, 400,000 people are hospitalised and 22,000 people die (based on CDC data from 2019). In the first year of the pandemic, more than 1.8 million people died from COVID. To date, more than 500 million people have become infected and more than 6 million people have died.”

The flu does not shrink your brain, scar your lungs, give you heart attacks, cause infertility or leave you with crippling fatigue for months, possibly forever. If you are sick with the flu, you follow your mum’s advice: sleep, drink plenty of fluids and take paracetamol if you have a fever. Only in rare cases is more aggressive treatment needed. COVID, on the other hand, plays by a different set of rules. COVID is sneaky. It hides and disguises itself. It sends your body into super attack mode. It hits the upper respiratory tract, then comes back for the lower. You catch it, then you catch it again within months, even weeks. With the risk of long-COVID so high (up to 30% of people suffer) immediate action is needed beyond mum’s chamomile tea.

“Early treatment of patients with mild to moderate COVID-19 may be safe and effective for faster elimination of SARS-CoV-2 and in the prevention of progression and outcomes of COVID-19. ”

— Nature, 6 April 2022

"While the COVID-19 vaccines continue to be the first-line defence against COVID-19, we know that some people may not respond adequately to these vaccines,' MHRA chief June Raine said. The next sentence of the statement should have addressed waning efficacy as support for a testing and treating strategy.

Dozens of COVID treatments are available today with supplies increasing and funding into new treatments increasing as well. Pfizer’s Paxlovid (co-packaged tablets with nirmatrelvir tablets and ritonavir for oral use) is an approved treatment in both the United States and the United Kingdom. This treatment is strictly intended to avoid serious disease and must be administered in the early stage of infection. AstraZeneca's Evusheld, when administered within the first week of symptoms, can save lives and prevent disease progression. Furthermore, it can decrease the risk of developing symptomatic COVID by 77%. Molnupiravir, interferon, remdesivir and prophylaxis are also approved treatments and with many more in clinical trials.

Global research continues as the world recognises the value of early treatment. The US alone has allocated $3 billion of funds to “accelerate the discovery, development and manufacturing of antiviral medicines as part of the Biden Administration’s whole-of-government strategy to develop the next generation of COVID-19 treatments.”

Another triumph of science is COVID treatments designed to speed recovery and protect against serious illness.

THE CASE FOR VIROLENS

Central to the testing argument is accuracy and reliability. If tests are too slow or miss positive cases, then they have little impact on limiting the spread. Breaking the chains of transmission is the goal.

Virolens is designed for mass screening and immediate diagnostics at the point-of-care. Unparalleled for speed and accuracy, Virolens uses the power of physics over chemistry to detect COVID in 20 seconds and does not require a laboratory. Other tests, including PCR and antigen, rely on chemistry to detect COVID. Virolens is also more environmentally friendly because it does not use toxic chemicals and the test cartridges are 100% recyclable.

Inside the Virolens machine is a holographic microscope designed to look at nanoscale structures. When a sample is inserted into the machine, different light waves are projected to create identifiable diffraction patterns. Using artificial intelligence, the machine analyses the sample in 4D and compares it to the unique pattern of the virus, giving a clear positive or negative result.

98.1% sensitivity, 99.7% specificity, 96.4% PPV, and 99.9% NPV

“Virolens was born from the desire to reopen the world during the pandemic, but we are not stopping with COVID. We imagine a world where doctors take one sample from a patient and test for thousands of pathogens at the point-of-care, in 20 seconds or less.”

– GREG COMPTON, CTO iAbra and inventor of Virolens