Testing has become a key issue during the COVID-19 pandemic, with many countries struggling to perform enough diagnostic tests because of a shortage of staff and resources. The response to COVID-19 has also involved a large-scale lock-down, with many people isolating at home and avoiding the workplace.
The economic consequences of this COVID-related unemployment are dire, and many experts are predicting that a significant economic recession will follow the pandemic. Allowing people to return to work as soon as possible would help to mitigate this, but it simply isn’t safe at present because of their risk of contracting and spreading the virus.
However, one category of people that may be safe to return to work early are those who have already been infected by the virus and have recovered, as they may have a measure of immunity against re-infection (although this matter is not yet completely understood for this new virus). As we learn more about the virus, it will become clearer if those who have recovered from the infection have long-term immunity or not. If so, one idea that has been proposed is the “immunity passport,” which is a permit that confirms that someone has already been infected by the virus and has recovered, and so they could potentially be allowed to return to work.
However, with limited diagnostic testing happening in many countries, many people who were infected and symptomatic never received a formal diagnosis, and many people have been infected but didn’t display any symptoms and so never knew they were infected in the first place. One answer to this dilemma is an antibody test that can be used to detect the presence of antibodies to COVID-19 in patient samples, to confirm that they have been infected, and so may have immunity.
Medgadget recently covered the release of the new VITROS COVID-19 antibody test, developed by Ortho Clinical Diagnostics, a company based in Raritan, New Jersey. Now, we talk to Chris Smith, CEO of the company, about this development.
Conn Hastings, Medgadget: Please give us an overview of the importance of testing during the current COVID-19 pandemic.
Chris Smith, Ortho Clinical Diagnostics: The most powerful thing anybody can have at a time like this is information, and that’s exactly what a diagnostics test provides. Diagnostics companies need to be supporting those at the forefront of care during this pandemic. Whether it’s diagnosing COVID-19 so that correct isolation or treatment efforts can be executed, or detecting antibodies, leading to the identification of those with immunity and the ability to go back to work, those in diagnostics have a great responsibility to inform those making key decisions. Without it, public health officials and health care providers are effectively flying blind. They don’t know how or where the disease is spreading, or they don’t know if a patient exhibiting symptoms has a different disease that requires different treatment. Without proper testing being available, unnecessary lives are lost. We must remember that every test is a life.
Medgadget: How does the new VITROS antibody test work? How does it differ from PCR tests?
Chris Smith: The VITROS antibody test works by detecting antibodies the body creates in response to the viral infection. Every virus uses certain anchor proteins to enter human cells. The human immune system typically develops antibodies that can block the viral entry, and measurement of the antibodies can be indicative of immunity. This test is sensitive enough to identify only COVID-19, even at low levels, by only interacting with the unique antibodies that were generated against the virus, instead of generic proteins that may have been a result of related coronaviruses.
PCR tests on the other hand, are only able to detect active genetic material from the virus. This means that while they are useful for determining who has COVID-19, they can’t tell when the virus has passed and if patients have fully recovered and built immunity. Ortho’s test targets and identifies antibodies that the body creates as a result of the virus, which can help doctors decide who is immune and can return to work.
Medgadget: Could such tests be a crucial factor in the granting of “immunity passports” that have been discussed in several jurisdictions to allow people with immunity to return to work?
Chris Smith: As mentioned before, the Ortho test does identify antibodies to COVID-19. This means that it can find out who was infected with the virus but has since recovered. This can be one key in determining who is immune to the disease, which will be critical in allowing populations to return to work. Research is still ongoing as to whether antibodies indicate immunity to future infections, and how long immunity may last in someone before they’re susceptible again. As researchers continue to learn more about the virus, we can determine the future application of Ortho’s test to facilitate potential “immunity passports.”
Medgadget: When will the test be available? Have you faced any challenges in terms of approval and manufacturing?
Chris Smith: We began shipping our first tests last week and will be in full production in a few weeks. The plan is to provide a few hundred thousand tests by the end of April and then move into full production, producing a few million tests per week beginning in May. On April 14, we received Emergency Use Authorization from the FDA.
Medgadget: Will the test be easy to perform using existing hardware? How many tests will be possible in a day using one machine?
Chris Smith: Our test was designed to run on five of our systems, and 1,500 instruments are already installed in over 1,000 locations in the U.S. alone. When running infectious disease tests such as our COVID-19 tests, those instruments can process up to 150 tests per hour alongside other tests without interruption. Each analyzer can test approximately 3,500 samples a day. Lab technicians who are trained on Ortho’s system will be able to seamlessly operate the COVID-19 antibody test.
Medgadget: Many of the infected will be treated and tested in field hospitals. How is the test well adapted for use in these non-traditional conditions?
Chris Smith: Ortho’s system is uniquely positioned to be able to help those being diagnosed in non-traditional situations. Ortho solutions can be quickly installed in pop-up hospitals and Ortho’s VITROS systems do not require any external water, plumbing, or filtration systems – just access to power. Most other systems utilize external water sources. This means that in situations where it may be difficult to provide adequate water hookups or there are limited resources, Ortho’s analyzers are able to function at their usual high efficiency.