Becton, Dickinson and Company (BD) has announced a newly published, peer-reviewed study indicates that the company’s antigen test may be more selective than polymerase chain reaction (PCR molecular tests when it comes to detecting patients who are contagious and can spread the virus.
Charles Cooper (CC), BD’s vice president for medical and scientific affairs, recently spoke with Outsourcing-Pharma (OSP) about the test, and the rapid advancements in COVID-19 diagnostic development.
OSP: Considering it’s only a little more than a year since COVID-19 landed on us, the fact that tests were in providers’ hands (and now, with at-home diagnostics, in patients’) relatively quickly is interesting. Can you talk about the industry’s efforts to develop, approve and distribute COVID-19 tests, and why that might be noteworthy?
CC: We’re in a worldwide pandemic. It’s a crisis situation, and the ability of diagnostic manufacturers to rapidly develop and make available diagnostic testing has been a critical component of the response to the pandemic.
Companies like BD have dedicated a huge amount of effort and resources to rapid development of diagnostic tests to support the effort to fight COVID-19 globally. The development cycle time has been reduced dramatically because of both the intensity of the effort and because of obligatory templates that allow us to get authorization faster.
So, as an example, typically it might take BD or any other company like ours two years to develop and antigen assay and get authorization through FDA to make it available on the market. In the current environment, we’re talking more about 60 or 90 days. And so, the time to development and availability has been reduced dramatically.
OSP: Could you please summarize what are some of the key differences between PCR tests and antigen, in terms of how they’re conducted, ease of use, cost, speed, etc.
CC: PCR testing—also known as molecular testing—is highly sensitive, which is a strength. However, it is also more expensive and requires a moderate to high complexity laboratory setting with skilled laboratory technicians; the turnaround time is also dependent on the ability to get a collection sample to such a laboratory and that laboratory has to work through its own volume and potential backlog.
So, it does have the advantage that it’s very sensitive. But it is also more expensive and requires a moderate to high complexity laboratory setting, which limits access in some ways.
Antigen testing, in contrast, is designed for use outside the laboratory setting, at the point of care. It’s very simple to use and doesn’t require a moderate to high complexity laboratory. It’s a diagnostic test that can be used in the community and by people who are not skilled laboratory technicians. It also has a turnaround time that’s much faster.
Antigen testing provides a 15-minute turnaround, so you get a result while the person being tested is still present. It’s also less expensive. And so, as a result, there’s the ability to make diagnostic testing more easily accessible in the community.
OSP: Please explain why it is important to accurately detect which COVID-19 patients are able to infect others.
CC: With COVID-19, you have the particularly challenging characteristic that people can become infectious before they develop symptoms. And by the time they develop symptoms, they’re highly infectious.
Because of that, it’s difficult to control transmission in the community because people are spreading the virus before they even know they have it. Additionally, there’s a large percentage of people who never develop symptoms and yet can still transmit the virus.
So, if it is the goal of public health officials in society is to interrupt transmission in the community, then diagnostic testing frequently in the community is going to be necessary, or certainly, frequent diagnostic testing is a critical component to the overall solution. Frequent diagnostic testing is critical in allowing you to identify people who are infectious and quickly gives you a result so you can apply infection control measures like quarantining more rapidly.
OSP: Is there anything else you’d like to share about the BD Veritor Plus system that we didn’t touch upon above?
CC: The study that was published in Clinical Infectious Diseases demonstrates that the BD Veritor System for Rapid Detection of SARS-CoV-2 was able to accurately identify people who had culture positive infectious virus present. And that’s the key conclusion for that study.
If you think about where antigen testing is occurring, we’re talking mainly about people in the community. And these people in the community are not severely ill.
Thirty percent of people who get infected with COVID-19 don’t have any symptoms, and of people who have symptoms, 80% show very mild symptoms – so these are not people who need to be treated in the emergency room or admitted to the hospital, yet they are very capable of transmitting the virus in the community. So, diagnostic testing in the community for the purpose of identifying people who could be infectious is a critical component of the response to COVID-19.