Jun 22, 2020
Returning to “normal”: How each COVID-19 test plays a role

Around the world, communities have banded together to fight COVID-19. Some areas are ramping up efforts to minimize the impact from a second wave the infection, while others hope they’ve made it past the worst of the outbreak. Amid devastating effects on the health of millions worldwide, the virus has also stalled economies.

In the United States, after months of stay-at-home orders with varying degrees of strictness, the unemployment rate reached a high of nearly 15%, which has fallen again to 8.4% as areas reopen—still almost 5% higher than the unemployment rate in February. Many small businesses have shuttered. Experts predict that some large businesses or even entire industries may never fully recover. From Singapore to Italy to the United States, people are experiencing unexpected financial hardship. So, as we see the number of new cases per day begin to drop in impacted areas, governments are eager to further restart their economies.

When can we go back to “normal”?

Effective therapies and vaccines will be integral to restoring a sense of hope and security for interacting with neighbors, friends, even family members. Along with many med tech companies, BD is doing everything we can to accelerate production of products that are used to help researchers better understand COVID-19 and help the pharmaceutical industry develop vaccines and treatments; but at the same time, we recognize that dealing with the COVID-19 pandemic is a marathon, not a sprint. Even as good treatments and vaccines emerge, testing will remain critical to our success as a society.

In addition to helping clinicians provide early and appropriate treatments for better patient outcomes, quickly identifying COVID-19 and any secondary infection(s) is invaluable for disease containment. Communities will continue to need high-quality diagnostic testing to properly identify disease status and transition out of stay-at-home status as safely as possible in the months to come. To know if you’re “safe” from infecting your community or risking your own health, you need to know:

  • Do you have it?
  • Have you had it?
  • Where will it spread to or re-emerge next?

Do you have it?
Before we can safely return to work and school, we need to contain the spread of active cases. Depending on many factors—including symptom severity, care setting and testing availability—either a polymerase chain reaction (PCR) or an antigen test may be used to detect and diagnose COVID-19.

PCR test
If there’s a concern that you might have an COVID-19 infection, you may receive a PCR test. PCR molecular technology detects specific genetic material from the virus; the test will recognize a specific known COVID-19 RNA pattern. It was the first test developed for COVID-19 on a large scale and remains the most accurate and most sensitive way to detect the SARS-CoV-2 virus (which causes COVID-19) to date.

PCR tests are done in a laboratory setting and can detect the virus within 15 minutes to 3 hours, depending on the platform. A benefit of having the full testing and analysis experience take place within the hospital is that its labs can deliver results to patients within hours. When testing is done at drive-through or alternative locations, where samples are sent for analysis at a central laboratory, patients and clinicians wait longer to learn results.

Antigen test
Patients may also be tested in point-of-care settings, which often already have rapid test devices for illnesses like the flu and strep. “People are able and would be able to go directly to their doctor or pharmacy and get a test done right there as soon as they develop symptoms and know within a matter of 10 to 15 minutes whether or not they're positive,” said Kristin Weidemaier, senior director, Life Sciences at BD.

With the potential for wide availability and speed, COVID-19 point-of-care tests are considered “game changing” in stopping the spread of the disease. Having an easy-to-use and mobile test means that organizations (including employers or schools) can test people before they enter buildings in order to prevent anyone who tests positive from further exposing others.

Did you have it?

Understanding our exposure as a community can help researchers determine how widespread our immunity is and how long that immune response may last. “This is a critical part of assessing a community infection and assessing the prevalence of the infection,” said Dave Hickey, worldwide president, Integrated Diagnostic Solutions at BD. “It's potentially going to be a critical piece of the get-back-to-work strategy.”

As restrictions continue to ease, knowing your own status can help you make personal choices about social interaction and responsibly resuming activities that had been suspended—especially since it is possible to transmit the disease without showing symptoms. Even if you’ve felt healthy throughout this crisis, you may choose to get tested to determine whether you have or have had an asymptomatic infection.

Antibody test
A rapid antibody (also known as serology) test can tell you if you have SARS-CoV-2 antibodies. Your body produces antibodies when fighting a virus, so the presence of antibodies indicates that you’ve had the infection and have possibly built up immunity for it. While researchers are still studying the relationship between the presence of SARS-CoV-2 antibodies and immunity, having SARS-CoV-2 antibodies may mean that your risk of getting COVID-19 again in the near future is low. If that’s the case, it would be less risky (than if you hadn’t had the disease) to return to work, to provide essential services or to otherwise support your community. Antibody tests are also very valuable from an epidemiology perspective, helping to better understand where and how the virus spread in the past, and what percentage of the population has already been in contact with the virus.

Where will it spread next?
To put in place responsible measures to slow or prevent an uptick in the spread of the virus, health system and public health leaders must understand the bigger picture. It’s more important than ever to have a comprehensive ecosystem of integrated care and cutting-edge informatics and surveillance technologies that can analyze and report real-time data from multiple hospital systems. By transforming a series of individual results into a broader map of the infection’s spread, such technologies can help detect anomalies and provide early alerts to hospitals before infections become outbreaks. They can also help hospitals better understand ICU utilization and drug inventories, so that they can more precisely optimize vital resources while staying alert to outbreak trends.

Why is it hard to get a test right now?
SARS-CoV-2 emerged as a novel virus, meaning that humans had not been exposed to it before, so no test existed to diagnose it. We had to create one. Under normal circumstances, bringing new tests to market is complicated. “It would take between 18 months and three years to go from start to finish, through development, validation and approval,” said Nikos Pavlidis, vice president and general manager, Molecular Diagnostics and Women's Health and Cancer at BD. However, the healthcare community has rallied around one another in a spirit of collaboration for the common good—including partnering with peer companies to develop tests, solve shortages and answer other critical problems. In addition, the FDA facilitated a compressed timeline for testing approval through the Emergency Use Authorization pathway. “Everything happened in five weeks,” Pavlidis said of the experience developing a new BD COVID-19 test

Importantly, supply chain and manufacturing challenges, as well as laboratory bandwidth, have been barriers to immediately being able to test everyone. For example, there’s no way to get an accurate test result without collecting and transporting samples properly, but the incredible surge in demand has led to supply shortages for critical collection devices, such as nasopharyngeal swabs. “It sounds very simple to collect the right specimen with the right collection device, the right swab, but, in reality, it’s been complex,” said Patrick Murray, vice president of Scientific Affairs at BD. Just as companies work at unprecedented speed to develop and bring new tests to market for COVID-19, they’re continuing to ramp up manufacturing to help facilitate the scale required to test the extremely large populations within impacted areas all around the world.

Ongoing testing needs
As stay-at-home and public gathering restrictions continue to lift, providers will also look to increasingly resume noncritical or elective care for a broader range of important public health needs. “While COVID-19 has been a horrific disease and has had impacts on literally millions of people around the world, unfortunately other conditions like cancer, like diabetes, like peripheral vascular disease, like renal disease haven't stopped in this period of time,” said Tom Polen, chief executive officer and president of BD. As a healthcare community, “we've got to get back to treating and helping those patients as well.”

Throughout this period and until researchers find a safe and effective vaccine to help quickly increase herd immunity throughout the population, testing will continue to play a vital role in helping to reduce the risk for exposure to COVID-19 and increase confidence for both patients and professionals.

Additionally, as we continue to learn more about how this virus spreads and impacts patients, new diagnostic tools may emerge. In the future, prognostic tests may also help to stratify patients based on immune status (so that higher-risk patients may receive appropriate preemptive treatment) while alleviating pressures on health systems.

To learn how BD is helping throughout this crisis, visit our COVID-19 response page


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