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.”