A biotech startup’s take on the ins and outs of COVID-19 testing
At the end of 2020, we witnessed the FDA approval of two major COVID-19 vaccines, one from Moderna and one from Pfizer. As we see programs in the United States roll out their vaccination plans, it’s important to understand how COVID-19 diagnostics are still necessary in defeating the pandemic.
First and foremost, vaccine rollouts are performed in stages, focusing initially on older patient populations, frontline workers, and immunocompromised patients. What this rollout means is that there are many other people in the United States who will need to wait for the vaccine. While others wait, testing should still be performed for those who may have come into contact with someone who may have COVID-19, in order to safely go back into allowable workplace settings, or if they participate in necessary travel. The vaccine rollout also implies that one should still wear a mask, practice social distancing, and regularly wash their hands.
We have seen that rapid testing works. An article from Forbes shares that in Slovakia, COVID-19 spread was reduced by 60% in 1 week through widespread testing efforts. When looking at the United States, we see examples of Universities participating in frequent testing of students and staff to lower the case numbers. Testing needs to be continued, and distributed strategically, at a national level to lower COVID-19 cases while more groups wait for access to the vaccine.
Finally, there are still discoveries actively being made during vaccine rollouts. While the FDA and vaccine companies have done everything in their power to make sure testing is effective and safe, it is still early enough that new discoveries will be made over the next several months. Albeit unlikely, there is a chance that vaccinated patients may carry and transmit COVID-19, but not exhibit symptoms or infection. Therefore, other community members may be sick with COVID-19 who have not yet received a vaccine.
Another potential scenario to be further investigated is understanding how well patients respond to the vaccine. In 2014, a measles outbreak occurred in Disneyland, even amongst visitors who had their measles, mumps, and rubella (MMR) vaccinations. The MMR vaccine is known to be one of the most effective vaccines in the world. In some cases, a small percentage of patients’ immune systems just don’t respond to the vaccine quite as well as the general population, leaving them vulnerable. While the outbreak shocked the United States, it took diagnostics and clinical triage to identify that the outbreak was, indeed, measles, and patients were treated accordingly. There is a likelihood that COVID-19 vaccines, while incredibly effective, could have a percent of the population that does not respond as well and will need further diagnostics for disease identification and appropriate alternative treatment against infection.
Before we discuss how COVID-19 is tested for, let’s briefly go over what COVID is.
What is COVID and how is it transmitted and received by the body?
Coronaviruses are a type of RNA virus identified by the crown-shaped patterns on the surface of the virus. The name corona is derived from the Latin root of ‘crown’. There are several types of coronavirus that can infect humans. Notably, the SARS outbreak of 2003 was the result of the spread of a form of coronavirus. SARS-CoV-2 is a new strain of coronavirus that can infect people, causing the respiratory illness known as COVID-19.
The recently discovered strain of SARS-CoV-2 in 2019 has led to significant harm worldwide. Similar to most strains of coronavirus, outcomes include fever symptoms and illness. Symptoms from the virus have been reported to be anywhere from very severe to relatively mild. The risks of significant illness developed from a SARS-CoV-2 infection can escalate depending on an individual’s immune vulnerability, such as pre-existing medical conditions and age.
Coronaviruses spread from person to person due to small liquid particles carrying the virus in an infected person’s mouth and nose. These particles can be transmitted through coughing, sneezing, singing, heavy breathing, and speaking — summed up, anything that comes out of a person’s mouth and nose. Due to the physical proximity of transmission, the CDC recommends maintaining distance from others in public spaces and face coverings to prevent the projection of these liquid particles onto others.
Although SARS, a separate virus from the one causing COVID-19, had a higher average mortality rate, the spread of the SARS virus was lower than the SARS-CoV-2. The widespread transmission of COVID-19 was caused by some specific symptoms, such as conversations in close proximity. A possible explanation for the virality of COVID-19 is that the quantity of virus in an infected person’s nose and throat is highest shortly after symptoms are developed. Unlike COVID-19, SARS had a later viral load peak; this indicates that COVID-19 can be transmitted at earlier stages, even when an individual may not be exhibiting symptoms or symptoms are less severe.
People who may be infected with SARS-CoV-2 virus are most contagious in the 24–48 hours prior to exhibiting symptoms. Therefore, early detection of the virus prior to and between exposure with others is a good way to mitigate transmission on a community level. Although exposure to an individual with COVID-19 doesn’t guarantee an infection if recommended safety protocols are followed, it’s still recommended that an exposed individual be tested and quarantines themselves from others.
If an exposed individual were to contract SARS-CoV-2, the latent period for the virus to infect and become contagious is around 24–48 hours. After incubation, an individual may or may not exhibit symptoms, but may still be infectious for up to 14 days. This is why, even if an exposed individual is asymptomatic, the CDC recommends a self-quarantine of 14 days. Bruce Lee from Forbes provides a comprehensive overview of the stages for an exposed individual: https://www.forbes.com/sites/brucelee/2020/12/05/if-exposed-to-covid-19-coronavirus-how-long-before-you-have-symptoms/.
For a more detailed explanation of the coronavirus, we defer to the CDC: https://www.cdc.gov/dotw/covid-19/index.html
Why is Testing for SARS-CoV-2 Important?
A question that many people may be asking is, “what’s the point of testing?” With COVID being an illness that affects people in differing severities, asymptomatic individuals or those with mild symptoms may be questioning the need to test for COVID.
As of January 2021, we are one year into the COVID-19 pandemic. Although safety precautions have been strictly imposed and counties have derived their solutions to mitigating harm and revitalizing the economy, many areas are still under strict lockdown as the virus continues to peak. Although vaccinations are slowly being deployed globally, testing is still critical. Information from diagnostic testing will provide crucial information for public health officials to determine safety precautions and next steps towards reopening businesses while keeping people safe.
Although vaccines are being created, the normalization of society is still a ways off. Proactive, early, and rapid detection of SARS-CoV-2 will provide valuable information for public health officials while empowering people to take their health and the health of families and friends into better consideration. Rapid testing of SARS-CoV-2 will minimize the spread of the virus and allow for prompt medical care if necessary.
Which Test Should I Take: PCR vs. Antigen Test
When getting tested for COVID-19, two major diagnostic tests are the PCR test and the antigen test. A diagnostic test usually involves collecting a sample from one’s mouth or nose (areas with high viral concentration) and testing for the presence of the SARS-CoV-2 virus. This result is intended to indicate whether an individual is carrying the virus, regardless of whether they are asymptomatic — no symptoms exhibited — or exhibiting symptoms of the virus. For those who may be exhibiting symptoms of COVID-19, a diagnostic test will be able to differentiate between whether a person contracted COVID-19 or influenza (the common flu).
A PCR Test is a molecular test that takes a sample (usually from a swab) and uses lab equipment to detect the genetic material of the coronavirus, thereby allowing for the detection of the SARS-CoV-2 virus even with low viral loads. The PCR Test process is often long and costly, requiring trained professionals and expensive equipment. On the other hand, the antigen test detects for a certain protein within the SARS-CoV-2 Virus by mixing the sample in a solution that breaks down the sample to detect for the protein. If present in sufficient quantities, the binding agent will yield results in as little as 30 minutes. The antigen test offers faster results and is less costly. However, the accuracy of antigen tests is lower than a PCR test as the antigen test may yield a false-negative result, indicating that one doesn’t have the virus when they do, if there is an insufficient viral load at the time of testing.
Public health officials recommend frequent testing as a diagnostic test is only indicative of the period when the individual was tested. Even if a person tests negative for COVID-19 at one point in time, it’s possible to contract the SARS-CoV-2 virus through contact with an infected person in the future.
OmniVis’s COVID-19 Test Solution
OmniVis is developing a fully integrated geo-mapping detection platform for a rapid, portable, LAMP-based diagnostic tool to detect SARS-CoV-2 in saliva samples. Our solution has the potential to benefit communities that are affected by COVID-19 and reduce the rate of outbreaks by detecting the pathogen at low viral concentrations. The geo-mapping aspect of the platform will make it possible to automate COVID-19 epidemiological tracking for further progress toward COVID-19 control and suppression.
Our COVID-19 diagnostic test requires our detection device and a test kit composed of a cartridge or chip, a dropper, and a cup. The testing process with our platform is simple and only takes 30 minutes. It requires the user to collect their saliva into the cup included with the kit and to place a drop of their saliva into the test chip. The user can then turn on the detection device and insert the chip into the device. The device will guide the user through the testing process by indicating when their sample is being heated up to allow the LAMP reaction to take place. It will also indicate when the device is analyzing the data to determine if the patient has COVID-19.
Our handheld SARS-CoV-2 detection device solution can determine whether a person currently has COVID-19 in 30 minutes.
Read about COVID-19 Rapid Tests: https://omnivistech.medium.com/what-are-rapid-diagnostic-tests-and-why-are-they-important-dea8676e2e1c
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