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The ongoing pandemic has greatly accelerated the rise of digital technology in healthcare.

As the pandemic continues to sweep across the world, causing unprecedented disruption to the economy and posing a constant threat of overwhelming healthcare services, the need for digital transformation has never been greater. Already, our everyday lives have been changed beyond measure by stay-at-home orders and closed schools and businesses. All the while, even highly effective healthcare services in developed countries are buckling under the strain.

But with vaccination now underway in many countries, there is finally hope on the horizon. Technology is critical to scaling the monumental task of vaccinating billions of people, as well as the testing that will be needed for years to come to isolate and mitigate localized outbreaks. Emerging solutions like artificial intelligence are helping to scale testing and vaccination and automate critical manufacturing processes, to name a few examples.

What are COVID-19 tests, and how do they work?

While a vaccine is the most powerful weapon against the coronavirus, testing remains a vital part of the overall strategy. Regular testing will continue to help, even once the pandemic has been brought under control. Not only does it allow epidemiologists to track outbreaks and get them under control before they spread across the wider community – they can also help test the efficacy of vaccines. Furthermore, testing helps those who cannot be vaccinated due to medical or other reasons.

COVID-19 tests broadly fall into two main categories. There are tests designed to diagnose a current infection, and others to determine whether a patient previously had SARS-CoV-2 – the virus that causes coronavirus disease 2019 (COVID-19). Diagnostic tests for current infections include molecular testing and antigen testing, while antibody tests detect past infections.

Molecular testing

Molecular testing involves taking a sample of saliva or other bodily fluid using a nasal or throat swab. The sample is then analyzed on a molecular level to detect genetic material belonging to the virus. By far the most common method is the RT-PCR (reverse transcription polymerase chain reaction) test.

The FDA has also authorized a direct-to-consumer molecular testing system, allowing patients to collect samples at home before shipping them off to the laboratory for analysis. The testing kits do not require any prescription.

RT-PCR testing has become the gold standard, since it is the most accurate. According to research curated by the CDC, RT-PCR tests yielded a sensitivity of 80% and a specificity of 98.9% in symptomatic patients. In asymptomatic patients, these figures stand at 41.2% and 98.4% respectively. Moreover, these figures give the testing a confidence level of 95%, making them far more reliable than other methods.

Antigen testing

Antigen testing is also done using a nasal or throat swab. It works by identifying fragments of the viral protein, known as antigens. Antigen tests are readily available from pharmacies and other medical facilities without a prescription, so they can be used at home. They also deliver much faster results, since samples do not need to be analyzed in a laboratory. In this respect, they work rather like a rapid strep test or pregnancy test, delivering results in minutes.

The main drawback of antigen testing is that it is not as accurate as RT-PCR testing. Because of this, the FDA does not recommend relying on it entirely. Negative antigen test results should ideally be verified with a RT-PCR test, since false negative results occur much more frequently than they do with molecular tests.

Antibody testing

Antibody testing determines whether patients have previously been infected with the virus by detecting antibodies in the blood. Because this method requires a blood sample, it can only be done at a medical facility. Results are typically available within a few days. Accuracy rates vary heavily depending on when the test is taken, due to the fact it takes a week or two for the body produce antibodies following an infection. Antibody levels can decay after a few months, making it uncertain how long immunity lasts.

How are digital platforms enabling mass-testing?

Without digital technology, it would be all but impossible to scale with the massive demand of testing and vaccinating billions of people around the world.

Thanks to digitized healthcare, it is now possible to complete digital intake forms and schedule online consultations. For example, popular video conferencing platform Zoom has launched a plan that caters specifically for the needs of the healthcare sector. Now fully HIPAA-compliant to protect patient privacy, general practitioners and other healthcare professionals can use Zoom, among other platforms, for holding online consultations. Doing so allows them to reduce the risk of spreading the disease to both themselves and their patients.

Unsurprisingly, the pandemic has greatly accelerated the demand for telemedicine. When it comes to COVID-19 testing, patients can now attend online appointments and use their home testing kits to collect specimens with real-time guidance and supervision. They can then send the specimen package using a specialized return shipping container provided by the lab and receive results by email or text message. It typically takes up to 24 hours to receive a result, which is far quicker than it is without the help of digital technology.

Similar methods will prove instrumental in rolling out mass vaccination campaigns as well. In fact, many countries are using the same systems they have been relying on for months in their testing and contact-tracing strategies for vaccinations. That said, the need for regular testing, especially in high-risk environments, such as healthcare facilities themselves, will stay for the foreseeable future.

How is SDI Labs using technology to help fight COVID-19?

SDI Labs depends heavily on digital technology to meet patient needs during the pandemic. Our web-based form allows patients to order RT-PCR tests online, and we can supervise and guide patients through the home-testing process via Zoom. We can then communicate results to patients via email, while maintaining patient privacy according to HIPAA regulations.

We have also implemented an AI-based system to better identify false positives and negatives from point-of-care antigen testing kits. This is especially important, given that antigen testing has a relatively low accuracy rate in the region of 60 to 80%. Our proprietary system analyzes patient intake data to determine the likelihood of patients being negative or positive, before matching those insights alongside actual test results.

Moreover, our labs management system allows us to scale capacity according to patient demand, while our integrated customer relationship management platform allows us to deliver faster and more efficient patient support.

Final words

While it will likely be some years before the pandemic can truly be declared over everywhere in the world, the digitization of healthcare will only become more important. The pandemic has simply highlighted the preexisting need to streamline healthcare and provide better outcomes, and these priorities are always going to be the primary goals of the sector.

SDI Labs relies on digital innovation to adapt and scale to the rapidly evolving needs of today’s healthcare sector. Our proven four-step COVID-19 testing model is helping us achieve optimal outcomes, with test results delivered by post or email within 24 hours. Order your test today.

The COVID-19 pandemic has proved to be one of the deadliest pandemics of all time. The ability of this harmful virus to spread instantaneously and to lie undetected has thrown the world into turmoil.

Coronavirus originally broke out in a Chinese poultry market in December of 2019. Ever since then, economies have faced a downfall all over the world. Up to the publication of this article, about 89.7 million people have been affected worldwide, with about 49.8 million people recovering within a few weeks and 1.93 million losing their lives.

This article will cover all the updated and latest details of the COVID-19 vaccine, its efficiency, and testing requirements. We will also go through the mechanism of action of T-cells.

Preparation Of the COVID-19 Vaccine

The great majority of individuals are still prone to viral infection. The only thing preventing more unnecessary deaths are the present limits and restrictions. It would be fair to say that social distancing has helped a lot.

Right now, there is a dire need for the administration of the coronavirus vaccine. Fortunately, the vaccine will be available to the masses very soon. Vaccinations are the best escape plans for outbreaks, as they prepare our bodies to fight with the parasite.

Prior to the actual commercial usage among the public, vaccines normally need years of analysis and experimentations. However, researchers began working on the COVID-19 vaccine immediately and completed the trials in a minimum amount of time.

Testing procedure for COVID-19 vaccinations

The vaccinations are only authorized after complete analysis and research. Currently, the coronavirus vaccinations being introduced have undergone the following series of steps.

1. Preclinical Tests

Experts evaluate samples for a potent vaccine and then test them on animals like mice or monkeys to see whether an antibody reaction is produced.

2. Security Tests

Scientists inject a selected number of healthy individuals with a shot to monitor its efficacy and safe dosage. They also ensure that it activates the immune function.

3. Detailed Testing

To evaluate the success rate of vaccines in different people, researchers categorize hundreds of individuals into different age groups. These experiments also examine the security of the vaccination.

4. Efficiency Testing

Researchers calculate and compare the results of vaccination in the experimental and control groups. These experiments decide whether the vaccination will safeguard against a healthy viral strain. Furthermore, other tests are also conducted to look for any possible side effects.

5. Early Authorization

Consistent with earlier data that they too are reliable and efficient, Britain and other nations have started providing urgent approval for vaccines. On the other hand, China and Russia have accepted vaccinations without checking the outcome of Phase 3 tests, which scientists believe are at significant risk.

6. Complete Authorization

Regulatory bodies evaluate the full findings of the tests and allow the manufacturing of the vaccine. Besides, they determine whether they should grant it clearance or not.

7. Combined Phases

Combining phases are another method to improve vaccine production. For example, some vaccines are currently in phase 1/2 trials, which will add up this monitor as both phase 1 and phase 2.

8. Suspension

Researchers will stop the trials if inspectors detect worrying signs in participants. The trials can continue or get suspended after an examination.

Recent Coronavirus Vaccines

Fortunately, researchers have successfully developed three coronavirus vaccinations. These vaccines have been authorized and licensed. Even though WHO hasn’t authorized any of them yet, recent assessments have yielded positive results.

Testing of several candidates has brought fruitful results. The recent anticipations regarding corona vaccinations are constantly being updated. Here are the three vaccinations that have been rolled out.

Moderna Vaccination

This vaccine is based on the utilization of small parts of the virus’s DNA code. Hence, it is also known as RNA vaccination. The vaccine works by familiarizing the body with the coronavirus. After the creation of a weak strain in the body, the body prepares itself to fight the original danger that is to intrude.

This vaccination is special in the sense that

  • It can save and defend about 94.5 percent of people from the virus, as claimed by the firm.
  • The vaccine is provided in two shots with intervals of four weeks.
  • It is already being implemented by the UK. About 17 million doses have been ordered and will be available in the spring.
  • Thirty thousand individuals have participated in the trials.
  • It is similar to the Pfizer vaccine in its working mechanism but can be stored at -20 degrees celsius for half a year.

Pfizer-BioNtech Vaccination

This vaccine’s credibility was initially proclaimed in November. The only drawback, however, is its transportation and storage. It is stable at a temperature of -70 degrees celsius and must be transported in an optimized case.

It has a success rate of 95% and is given in 2 shots, with time intervals of 3 weeks. Moreover, the UK has pre-ordered 40 million shots.

The vaccine-implementation process of Pfizer-BioNtech to tackle COVID-19 includes:

  1. Transportation of the vaccine shots to the designated country in optimized dry ice cases with an amount of five thousand per vehicle
  2. Storage of vaccination shots in the ‘freezer farm’ that has the capability of storing shots for up to half a year at around -70 degrees celsius
  3. Transportation of Pfizer-BioNtech corona vaccine to the clinics in 10 days
  4. Storage of the shots in a fridge for up to 5 days if necessary

AstraZeneca Vaccination

This vaccine was finally announced on 5 January by Oxford. The authorization was given after the results were visible. Besides, these shots are popular for helping older people as they enhance their immune systems.

Moreover, the vaccination is provided in 2 shots. It is stable at comparatively greater temperatures, making it efficient for transport. Lastly, the shots are made from induced feeble impressions of the common cold virus from chimpanzees.

The manufacturing process of this vaccination includes

  1. The addition of spike proteins from the coronavirus and a benign virus
  2. Injection of the vaccine into the patient
  3. The creation of antibodies in the person’s body in reaction to the spike protein
  4. Activation of T-cells for the annihilation of spike proteins

Immune System Cells Fighting Against The Virus

Many of the citizens have regular exposure to viruses. Our body’s way of fighting off viruses is distinct from how we battle bacteria. Viruses can only live within our tissues and spread. This helps them to “cover” themselves from our immune response.

The cell releases cytokines as the virus attacks the tissues and signals other cells to clear the contamination. In particular, this warning stops other cells from getting contaminated. Unfortunately, this defensive technique can be outsmarted by certain viruses and result in the propagation of the disease.

T-cells and NK cells are notified of a viral attack and migrate to the location where the individual cells harboring the virus are destroyed.

As several of our cells can be destroyed in the cycle, this is a very damaging method for destroying the virus. Nonetheless, eradicating the virus is a successful operation.

The T-lymphocytes destroy the virus at the very same time, and they also advise the B-lymphocytes to develop antibodies.

When our cells encounter the same virus for the second time, the antibodies effectively deter the illness. Memory T-cells are also developed and help tackle the second infection easily. It also contributes to a relatively gentle infection path.

Effects of Vaccinations On COVID-19 Pandemic

Some variables rely on the effects of the COVID-19 vaccinations on the disease outbreak. These include considerations such as vaccine efficacy; how easily shots are licensed, produced, and shipped; or how many people are vaccinated.

Many experts expect that coronavirus vaccines, like many other vaccinations, would not be 100 percent successful. It is imperative to assure that the vaccinations authorized are as safe as possible so that they can assert a bigger impact on the disease outbreak.

This is too soon to predict whether vaccines against COVID-19 can have lengthy security. To clear this up, extensive study is needed.

The Bottom Line

The current evidence shows that almost all individuals healing from COVID-19 establish an immune reaction that offers latent infection safety for at least a certain amount of time. However, we are still studying how good and how prolonged this security is.

Two dosage regimens are used in most COVID-19 vaccines that are being evaluated now. Individuals behave differently to immunization. History shows that in senior citizens, any vaccination may be less effective because, just like with the annual flu jab, an aging immunity response does not react adequately. But the evidence so far shows that this might not be a concern for any of the COVID-19  vaccines. Lastly, adjuvants can enhance the immunity systems too. When taken alongside vaccines, they can remarkably help you manage the symptoms. Vaccinations usually come out late but the sheer determination of researchers all over the world along with the positive behavior of the general public has helped control the COVID-19 situation.

Understanding The Differences Between Infection and Infectious In COVID-19 – Implications For Prevention And The Emergence Of A New Variant

With the varying terminology related to COVID-19, it’s very easy for patients, their families and yes, sometimes even practitioners to get confused about the precise meaning of some terms. One area that can be especially confusing is the difference between having an “infection” and actually being “infectious.”

First of all, even if a person has been exposed to COVID-19, they may not have been infected, meaning their body has been invaded by the virus and is apt to begin replicating and spreading throughout their body. Even if they have been infected, they may not begin showing symptoms, such as fever, cough or shortness of breath, for up to 14 days after exposure.

To further complicate matters, people who may have been exposed and subsequently become infected, may be infectious (capable of spreading the virus to others) even if they are not currently showing any symptoms. Plus, some of those people who are infected and have no symptoms initially, may actually never go on to develop symptoms, but still be infectious!

Close Exposure and Quarantine

The CDC defines exposure as close contact with someone who has COVID-19, which means being within 6 feet of the person who is ill for 15 minutes or more. Close contact is also defined as having had direct physical contact with that person, such as touching them, giving them a hug or sharing eating or drinking utensils. A person is also deemed to have had close contact if the person who was infected sneezed or coughed on them, or otherwise got respiratory droplets on them. Also included as exposed are those people who actually provided care in the home for someone who was ill with COVID-19.

This is why people who have been exposed, or believe they have been exposed to someone who has COVID-19, should, according to Centers for Disease Control (CDC) guidelines, self-quarantine for 14 days to be sure they are not going to develop the illness. Quarantine means someone who may have been exposed to the virus stays away from others. Isolation, on the other hand, means keeping someone who actually has the virus away from others to avoid spreading the illness.

Although the CDC recognizes 14 days as the optimal quarantine period, they also realize that a shorter quarantine, following strict guidelines, may be recommended in some cases to both reduce the burden on the public health system and to make it easier for people to quarantine. Local public health authorities will make these decisions based on conditions in their geographic areas. Public health officials may consider ending the quarantine after ten days if there have been no symptoms or stopping the quarantine after seven days if there has been a negative test on day five or later after exposure.

Emergence of A New Viral Variants and Implications for Vaccines

In addition to confusion around terminology, there now appears to be a new coronavirus strain which is understandably causing quite a bit of concern. The emergence of the new strain, which is known as the B.1.1.7 variant, is not unexpected, as all viruses mutate over time. The B.1.1.7 variant, which was first seen in the Ul.K., is among several new variants which have been recognized globally.

The U.S. Food and Drug Administration (FDA) recently released a clinical alert to laboratories as well as clinicians warning of the emergence of the B.1.1. 7 variant. The alert underscores the importance of recognizing that false negative COVID test results may result if the part of the virus’s genome assessed by a molecular test has undergone a mutation. These false negative results can potentially occur with any emerging SARS-CoV-2 variant, not just the B.1.1.7 strain.

The FDA also cautions that the new B.1.1.7 variant has been associated with an increased risk of transmission, underscoring the urgency of early detection of the variant to reduce the chances of transmission. Although cases involving the new variant have been isolated in the U.S. the CDC states, that although the new variant does not make people sicker, because it is more easily transmitted, cases are likely to rapidly increase in the coming weeks and months.

Of course, the emergence of new variants, such as the B.1.1.7 strain raises concerns over the efficacy of the newly developed vaccines. A study published by the Imperial College of London (but not yet peer reviewed) suggests an alarming 50 percent increase in transmissibility over the more common form of the virus.

A team led by Jesse Bloom, a viral evolutionary biologist with the Fred Hutchinson Cancer Research Center in Seattle, Washington have found evidence that these mutated viruses can dodge recognition by antibodies in those people who have had COVID-19. The researchers are hoping that because vaccines induce such substantial levels of neutralizing antibodies, that the performance of the vaccines will not be substantially affected. Also, the scientists believe that the human T-cell response from the vaccines may not be affected by the variants.

“Covid-19 is a global pandemic and we are all in this together. Our little cooperation and awareness can contribute towards a greater cause of controlling this pandemic.”

This Pandemic can be controlled only if all of us become equally careful and responsible and understand the importance of three basic things.

  1. Testing
  2. Social distancing
  3. Mask use.

Testing

Amidst this pandemic, testing has proved to be very useful in controlling the spread of the virus.

Testing has helped the population to take necessary measures to prevent the spread of coronavirus causing COVID-19. Even when the vaccine becomes available, testing will help in prioritizing population who are more in need of immunization.

Types of tests:

There are two basic types of tests for Covid-19.

  1. Viral or Diagnostic tests:

A viral or diagnostic test helps us to know if we are currently infected with the coronavirus. It’s done when we face any symptoms and the doctor refers us based on our symptoms and other factors.

  1. Antibody Test:

An antibody test helps us know if we were previously infected or exposed to the coronavirus and if our body has created antibodies in an attempt to defend itself.

It helps to collect data about how the immune system fight off COVID-19.

When should you get yourself tested?

Many people are reluctant to get themselves tested or are unsure about when they should get themselves tested.

As said by WHO, the common symptoms of Covid-19 are fever, cough, difficulty in breathing, muscle pain. These symptoms can be easily assumed as common cold or influenza by many.

So testing helps in identifying people who actually have Covid-19.

Sometimes the symptoms can be so mild depending upon the general health and immunity of individuals that they might not even think they could have been infected by coronavirus but unknowingly they contribute towards spreading it to those who might get severely affected by it. That’s why testing plays a very crucial role in controlling the spread and taking necessary precautions.

Vaccine:

As the news of trials of vaccine SPUTNIK V that has been developed by Russia is spreading, it does bring the hope of getting the situation in control, but people shouldn’t become careless as the time by which it’d reach every corner of the world is yet not sure.

Russia calls it’s vaccine SPUTNIK V and as per the news its mass distribution will begin in October for the Russian population. Vladimir Putin’s own daughter has reportedly received the vaccine developing the virus’s antibodies but Russia hasn’t yet published any of its scientific data.

There’s growing skepticism about it by various researchers of US but even if the vaccine is made and is safe, it alone can’t control the situation and bring everything back to normal if we don’t co-operate and take the precautions and understand the importance of testing as we can’t rely on vaccine completely.

Why testing is important even after the vaccine is made?

“Prevention is better than cure”. Testing plays a crucial role in preventing further spread of the virus as it enables us to take necessary actions. The Faster you get yourself tested and if it comes positive the faster you isolate yourself the number of people who might be infected will decrease.

Moreover, as many countries are removing restrictions, the probability of the spread of the virus surely increases if individuals refuse to get themselves tested and take the precautionary measures, and if the cases of infected people rise, once again the restrictions would be made.

Laboratory confirmation diagnostic testing could indicate which population is still at risk of new coronavirus and which have already been recovered.

Testing has helped in decreasing the number of new cases as seen in Singapore and South Korea because it enabled them to take proper care of people suffering from it and manage it’s spread.

Increasing cases of Covid-19.

Covid-19 cases have increased significantly per day in many parts of the world because of a lack of mass testing and careless attitude of people and lack of social distancing. The US sets one-day record with more than 60500 cases and total cases in India being reported as more than 2.4 million is enough to tell the contagious nature of this virus and how fast and easy it could spread. But countries like South Korea, Fiji, New Zealand that have done mass testing and applied strict rules have shown significant improvement and decrease in number of new covid cases which is enough to show the importance of testing.

Conclusion:

Mass testing and social distancing is the need of the hour. The vaccine alone can’t defeat the pandemic. It’s important to get yourselves tested frequently.

It has been over six months since the world started grappling with the COVID-19 pandemic. The novel coronavirus, SARS-CoV-2, had never been seen before. That meant even our top researchers, scientists, and medical experts knew nothing about the virus. 

Today, we have a better understanding of the virus and how it affects patients compared to what we knew a few months ago. However, we are continuing to learn new things as we search for treatment and a vaccine. 

As the world continues to battle the pandemic and countries confront both a health and economic crisis, it is clear that until a vaccine exists, testing is essential to reopening and coexisting with SARS-CoV-2.  

Currently, there are two main types of COVID-19 testing kits approved for clinical use, the viral RT-PCR RNA testing kit and the antibody testing kit. SDI Labs offers both. SDI’s viral RT-PCR RNA test is one of only 37 molecular-based tests approved by the Food and Drug Administration (FDA) under Emergency Use Authorization (EUA). The antibody serology test is also FDA EUA approved.

“What people don’t recognize about medical tests is that you need to know what your goal is when you order a particular test, because every single test tells you different types of information, and it has a particular context in which it is useful,” said Dr. David Haase, SDI’s Medical Director.

The viral RT-PCR RNA test detects a current SARS-CoV-2 infection. It tests for SARS-CoV-2 genetic material, also known as RNA. If the viral RNA is detected, then the virus is present. Dr. Haase feels this is the most important test. 

“Now, the other test that has gotten a lot of press is the antibody test. That is a measure of the immune response of a human to a particular virus or bacteria,” Dr. Haase said. “This test is fraught with more challenges because there are other coronaviruses outside of SARS-CoV-2. Sometimes these antibody tests can create a false positive test or maybe that individual doesn’t produce a lot of antibodies because they don’t have the intact immune system, then you would get a false negative response.” 

Antibody testing uses a blood sample to detect two types of antibodies: IgM, which develop early on in an infection, and IgG, which are more likely to appear after an individual has recovered. Antibody tests can be used to supplement RNA tests, but should not be used as the sole basis for the diagnosis or exclusion of COVID-19, according to the CDC and the WHO.

“There are rapid tests, and then there are also tests that get done in a high complexity lab such as SDI. The high complexity lab has a higher degree of sensitivity and specificity because there are many more controls that can be placed on the process. Rapid testing has more false positives and false negatives,” Dr. Haase said. 

Combining the use of viral RT-PCR RNA tests and antibody tests allows patients to identify both if they are currently infected with COVID-19, and if they may have previously had it. 

With this information, patients have a better understanding of their health history. Meanwhile, employers are able to understand who is currently infected, who has been infected and who hasn’t been. Based on that data, they’re able to make informed decisions about safe workplace re-entry. 

“We do the viral RT-PCR RNA test to identify the current infection — whether the patient is currently infected or not,” Oz said. “If the patient is negative, if they are an employee, we evaluate their immunity to say whether they have developed antibodies to get back to work, to the greatest possibility with a mask and social distancing guidelines. That’s why we combine highly sensitive antibody testing with the wider testing of the viral RT-PCR RNA test.”

What is SDI’s testing solution?

“SDI’s approach to COVID-19 is an end-to-end solution focused on patient centricity,” Oz said. It involves four key steps: test, track, treat, and isolate 

First, SDI Labs believes in testing 100% of the patient population to determine a baseline of who has an active SARS-CoV-2 infection and who does not. Then, SDI Labs uses a digital intake process to collect essential data that, in the event of a positive diagnosis, informs the provider and enables virus contact tracing.

“The tracking part is very important at the patient population level, especially with this virus and infectious diseases so that we can inform the doctors and public health agencies on how to control the spread,” Oz said. “We have built-in systems, data solutions, mobile systems, and cloud applications to help us do that because we are not just a lab. We are a technology company that combined with a lab.”

SDI Labs connects patients to telehealth providers and empowers physicians with accurate data to appropriately assess and triage the patient, and determine the best therapies and care.

“We are partnering with telehealth companies to give the right level of guidance and data so that the doctor can assess and triage the patient — who needs quarantine, who needs the next level of care — based on the data that we have on symptoms, underlying medical conditions, medication, and the test results,” Oz said.

Finally, SDI Labs encourages patients who are infected, think they might be, or came into contact with someone who was, to stay home and isolate in an effort to halt the spread within their community.

“As humans to each other, it’s up to the private citizens,” Oz said. “It’s up to the private enterprises to step up and do their job. We are at war with this virus, and it’s the virus versus mankind. It’s not the virus versus the country. It’s not the virus versus a certain class. It’s the virus versus mankind.”

How SDI combines testing, tracking, treating and isolating to empower patients and providers

At SDI Labs, data, science and innovation are at the core of our work. Since the virus first appeared, we’ve been learning about it and focusing on the data, including what it means for our patients and their communities. 

SDI Labs CEO Oz Mohiuddin and Medical Director Dr. David Haase have been at the forefront of our work. They’ve been following the latest research and studies about the virus, and how it behaves. Even before the COVID-19 pandemic, SDI Labs centered its work around identifying complex infectious diseases. 

Leveraging their research, knowledge of infectious diseases and their individual expertise, Oz and Dr. Haase played integral roles in developing SDI’s comprehensive approach to COVID-19. 

“Our approach is an end-to-end solution focused on patient centricity,” Oz said. It involves four key steps: test, track, treat, and isolate.

First, SDI Labs believes in testing 100% of the patient population to determine a baseline of who has an active SARS-CoV-2 infection and who does not. Then, SDI Labs uses a digital intake process to collect essential data that, in the event of a positive diagnosis, informs the provider and enables virus contact tracing.

“The tracking part is very important at the patient population level, especially with this virus and infectious diseases so that we can inform the doctors and public health agencies on how to control the spread,” Oz said. “We have built-in systems, data solutions, mobile systems, and cloud applications to help us do that because we are just not a lab. We are a technology company combined with a lab.”

Then, SDI Labs connects patients to telehealth providers and empowers physicians with accurate data to appropriately assess and triage the patient, and determine the best therapies and care.

“We are partnering with telehealth companies to give the right level of guidance and data so that the doctor can assess and triage the patient — who needs quarantine, who needs the next level of care — based on the data that we have on symptoms, underlying medical conditions, medication, and the test results,” Oz said.

Finally, SDI Labs encourages patients who are infected, think they might be, or came into contact with someone who was, to stay home and isolate in an effort to halt the spread within their community.

“The system is extremely important not only for the data, but the efficiency,” Oz said. Leveraging a systems approach, providers are able to treat the whole patient and figure out what is really happening. If a patient tests negative, but still has symptoms, they can be tested for co-infections. Or, if a patient has medical conditions that put them at high-risk, their test can be prioritized. 

It is in using a thorough system of testing, tracking, treating, and isolating, that providers have all of the necessary information to make informed decisions with their patients. There are many different factors that contribute to a person’s health: their history, the medications they take, and any underlying health conditions. A comprehensive approach takes all of this information into account.

SDI leverages both the viral RT-PCR RNA and antibody tests

Currently, there are two main types of COVID-19 testing kits approved for clinical use, the viral RT-PCR RNA testing kit and the antibody testing kit. SDI offers both. SDI’s viral RT-PCR RNA test is one of only 37 molecular-based tests approved by the Food and Drug Administration (FDA) under Emergency Use Authorization (EUA). The antibody serology test is also FDA EUA approved.

The viral RT-PCR RNA test detects a current SARS-CoV-2 infection. It tests for SARS-CoV-2 genetic material, also known as RNA. If the viral RNA is detected, then the virus is present. Dr. Haase feels this is the most important test. 

RNA testing detects SARS-CoV-2 genetic material to identify if a patient is infected. According to documents published by the United States Food and Drug Administration (FDA) and the World Health Organization (WHO), RNA tests are the first choice in the diagnosis of COVID-19.

Antibody testing uses a blood sample to detect two types of antibodies: IgM, which develop early on in an infection, and IgG, which are more likely to appear after an individual has recovered. Antibody tests can be used to supplement RNA tests, but should not be used as the sole basis for the diagnosis or exclusion of COVID-19, according to the CDC and the WHO.

“This test is fraught with more challenges because there are other coronaviruses outside of SARS-CoV-2. Sometimes these antibody tests can create a false positive test or maybe that individual doesn’t produce a lot of antibodies because they don’t have an intact immune system, then you would get a false negative response,” Dr. Haase said. 

Combining the use of viral RT-PCR RNA tests and antibody tests allows patients to identify both if they are currently infected with COVID-19, and if they may have previously been infected.

With this information, patients have a better understanding of their health history. Meanwhile, employers are able to understand who is currently infected, who has been infected, and who hasn’t been. Based on that data, they’re able to make informed decisions about safe workplace re-entry. 

“We do the viral RT-PCR RNA test to identify the current infection — whether the patient is currently infected or not,” Oz said. “If the patient is negative, if they are an employee, we evaluate their immunity to say whether they have developed antibodies to get back to work, to the greatest possibility with the mask and social distancing guidelines. That’s why we combine highly sensitive antibody testing with the wider testing of the viral RT-PCR RNA test.”

What asymptomatic and presymptomatic carriers mean for the COVID-19 pandemic

As communities begin to reopen amid the COVID-19 pandemic, public officials, medical professionals and health experts ask that if community members feel sick that they stay home in order to prevent spreading the virus. 

However, as more is discovered about the SAR-CoV-2 virus, which causes the COVID-19 disease, it has become clear that not everyone who is infectious shows symptoms. 

“A big challenge that we have with COVID-19 is that it has a long incubation period, from the time when an individual is exposed to the virus to when they eventually develop symptoms,” said Dr. Haase, SDI’s Medical Director.

Even if a patient isn’t showing symptoms, they may still be infectious and could be unknowingly spreading the virus. Recent studies show that a substantial portion of individuals infected with COVID-19 are asymptomatic, or experience no symptoms. This means the only way to truly know who is and isn’t infected is through community-wide, accurate testing. 

“Some of those people will stay asymptomatic,” Dr. Haase said. “They will never develop symptoms. They will just be a carrier of the virus, some of these people we recognize as ‘super spreaders.’ They can go out into a community and spread the virus far and wide because they don’t know that they’re sick, so they don’t have any reason to be cautious.” 

Presymptomatic describes the period of time in which an individual is infected with COVID-19 and is highly contagious, but hasn’t shown signs of symptoms yet. 

“We talk about asymptomatic and presymptomatic, but we can’t really know who is who until after that person has been infected long enough to understand whether or not they’re going to develop symptoms,” Dr. Haase said. “The terms are very useful for researchers, but they’re not very helpful when it comes to changing the curve because the individuals that are already infected and asymptomatic, whether or not they develop new symptoms, they’re a danger, and they need to be identified.”

The only way to identify asymptomatic patients is through viral RT-PCR RNA testing, he said. This is why it is important to test everyone, not just those who show symptoms.

In response to this, SDI’s comprehensive approach to the COVID-19 pandemic, — which includes testing, tracking, treating, and isolating — recommends testing everyone within a community. 

“You need to start somewhere,” said Oz Mohiuddin, SDI’s CEO. “You need to baseline that patient population to say whether they are infected or not … The most amount of spread happens at the asymptomatic and presymptomatic level. The data is clearly showing that this is the approach. We believe it is the most prudent approach moving forward.”

SARS-CoV-2 — the virus that causes the COVID-19 disease — did not exist last year. At the beginning of 2020, as the world raced to slow the spread of the virus, scientists, researchers, and medical professionals set out to learn more about the novel coronavirus. 

“It’s a very novel virus,” said Oz Mohiuddin, SDI’s CEO. “I have to say, it’s acting very differently than what we have seen with other viruses. At this point in time, it’s about surviving, about caring for our communities, our families, and preventing the spread.”

While there are still a lot of unknowns, we now have a better understanding of the virus, its symptoms, and how it spreads. 

SARS-CoV-2 is a novel coronavirus, and a part of the coronavirus family, which are viruses that can cause a variety of illnesses. Coronaviruses cause one-third of common colds and sometimes respiratory infections. 

“Coronaviruses as a class are around us all the time,” said Dr. David Haase, SDI’s Medical Director. “It is a very specific type of coronavirus and it is the SARS-CoV-2 virus. When that virus causes disease, we call that disease COVID-19. It is very easily transmitted via droplets, via aerosols, via contact surfaces. It is sneaky. Once it has infected an individual, that individual can shed that virus to infect other individuals, before that person even knows that they are ill, or that person may never know they’re ill and still be able to spread the virus.”

A wide range of symptoms have been reported by people with COVID-19, ranging from mild to severe. Symptoms may appear within two to 14 days after exposure to the virus. However, a substantial portion of individuals infected with COVID-19 have shown no symptoms at the time of testing, or were asymptomatic. 

“It has a vast range of symptoms, and it is rather clear that the sicker you are before you’ve been infected with the virus, the more challenges you’re going to have with regard to symptoms and severity of illness after you have been infected,” Dr. Haase said. 

According to the Centers for Disease Control and Prevention (CDC), symptoms include the following: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea.

“Individuals that have particular risk are obese individuals with diabetes, individuals with preexisting blood vessel disease, coagulation disease, and immune disorders,” Dr. Haase said. “Therefore, it has disproportionately affected the oldest and the most frail groups in the United States.”

Severe symptoms can lead to hospitalization and the need for a ventilator. “The hope is that individuals can survive long enough with these supportive therapies, that they can come through, but once a person gets on [a ventilator], it has a very high mortality rate, nearly 80% of those individuals will die,” Dr. Haase said. 

“Treatment has been focused upon supportive therapies, and a host of studied new interventions,” Dr. Haase said. Some research has shown that treatment can affect patients differently. 

“An individual who has a suppressed immune system early on may benefit from medications that augment the immune system,” Dr. Haase said. “Individuals that have an overly aggressive immune response may benefit from immunosuppressants. We’re at the front edge of our learning curve in treatment.”

The time spent social distancing amid stay-at-home orders provided opportunities for scientists and researchers, allowing them to learn more about the virus and treatment options. 

“All of the efforts to slow the curve saved lives because it has given us knowledge, but there is a long way to go,” Dr. Haase said. “We do not have a cure. We do not have a vaccine. This is a disease that is best avoided, if at all possible, because there are also long term effects. I’ve mentioned that the very ill can be affected more deeply, but even the very young can have unexpected severe disease.”

How COVID-19 testing can ensure safe societal re-entry

As the world continues to grapple with the pandemic and countries confront both a health and economic crisis, individuals are eager for life to get back to normal, or at least to the “new” normal. However, there is a great deal of uncertainty as to how we do that, and what that new normal looks like.

“We do have to get used to a different way of being,” said Dr. David Haase, SDI’s Medical Director. “We are getting used to having different types of closeness with each other, but we can adapt. This is what humans are the best at doing, adapting.”

While there is still uncertainty surrounding the virus, we now know enough to take action, Dr. Haase said, and it’s essential that we do.

“We don’t know who is going to succumb to this disease,” Dr. Haase said. “Each one of us must take responsibility, personal responsibility, to protect freedom, to protect liberty, to protect the livelihood of our fellow community members. That’s going to be our solution.”

For instance, we know that COVID-19 spreads easily from person-to-person, primarily through liquid respiratory droplets. However, sneezing and coughing aren’t the only ways droplets can be transmitted. We also release droplets when we speak, sing, and breathe. SARS-CoV-2 spreads easier within indoor environments compared to outdoors. Masks also help prevent the spread.

Both Dr. Haase and SDI’s CEO Oz Mohiuddin emphasized the need to learn to coexist with the virus as we search for a vaccine. One part of this is widespread testing, tracking, treating and isolating. This way, we can understand who is infected with SARS-CoV-2 and who isn’t, and then make informed decisions for both patient and community health.

“We can’t not do this,” Dr. Haase said. “We must take action. The uncertainty that has plagued us is no longer there. We have certainty. It is now time to act in the most mindful, careful, and consistent way possible to obtain victory over this virus.”

Oz agreed with Dr. Haase, emphasizing the importance of communities, community members, countries, and organizations coming together to fight the virus.

“As humans to each other, it’s up to the private citizens,” Oz said. “It’s up to the private enterprises to step up and do their job because we are at war with this virus, and it’s the virus versus mankind. It’s not the virus versus the country. It’s not the virus versus a certain class. It’s the virus versus mankind.”

Through accurate testing, continued research, innovation, and collaboration, we will survive the virus, Dr. Haase said.

“COVID-19 is not going away. We must address it in the most comprehensive and compassionate way possible,” he said. “By accurate testing, by excellent data aggregation during that process, by a consistency of process, and by continuing to be a subject to better science, to better data. That’s how we’re going to get through this, and we will get through this together.”