This article is sponsored by BD. In this Voices interview, Skilled Nursing News sits down with Chuck Cooper, BD’s Global Vice President of Medical and Scientific Affairs for Integrated Diagnostics Solutions to get his take on how BD is supporting the skilled nursing industry throughout the COVID-19 pandemic, specifically with its widespread and direct distribution of BD Veritor™ systems and rapid antigen tests for SARS-CoV-2. Cooper shares his take on the testing distribution in skilled nursing to date, how the BD Veritor Systems can best support the industry, and will continue to do so even as vaccinations become available to skilled nursing residents and workers.
Skilled Nursing News: Tell us a little bit about your career steps and your role at BD. How did you come to your current role?
Chuck Cooper: My background is that I’m an infectious disease physician, and still practicing medicine. I spent 13 years of my career at the Food and Drug Administration. Then in 2013, I joined BD as medical director. Since then, I’ve assumed the role at BD as the Global Vice President of Medical and Scientific Affairs for Integrated Diagnostics Solutions at BD. That’s a 30-second overview of my career.
BD is one of the largest biotech companies in the world. As such, BD is working very closely with governments and multilateral organizations around the world to expand access to diagnostic testing and to support patient management and treatment of COVID-19 patients. We’ve provided healthcare providers globally with millions of different products in the fight against COVID-19.
When it comes to the skilled nursing world, what is BD’s role right now with respect to the pandemic?
As I mentioned, BD has been supplying and increasing the manufacturing of many products in support of the fight against COVID-19—these include infusion pumps, drug infusion sets, catheters, diagnostic tests including the BD MAX molecular system and the point-of-care system BD Veritor Plus. There’s a large number of products that BD produces that have been heavily relied on in the fight against COVID-19.
In skilled nursing, BD has been working closely with the Department of Health and Human Services (HHS) to supply our point-of-care diagnostic BD Veritor Plus System to more than 12,000 nursing homes. We’ve provided almost 10 million SARS-CoV-2 antigen tests to run on the BD Veritor Plus Analyzer in support of those nursing homes across the U.S. To be able to do that, though, it’s important to know we’ve had to scale up our manufacturing significantly and we’re continuing to scale up as well.
Tell us about the BD Veritor Plus System. How does it work and what does it do?
The BD Veritor Plus System is a system that has already been on the market for several years for influenza, RSV and group A strep, and it has been launched as a rapid point-of-care test for SARS COVID-2 as well. It’s an antigen test, which means that it detects the presence of viral protein. For patients who are actively infected or who are showing symptoms, the system is able to detect the presence of virus in those patients by the detection of one of the proteins that the virus produces. One of the strengths of this test is that it gives you a result in 15 minutes.
That rapid turnaround gives you the opportunity to have information in a more real-time way, which helps health care practitioners with decision making with regard to patient management and infection control measures. Having an answer quickly, particularly in a vulnerable setting like nursing homes, increases the chance to interrupt transmission within that environment, thereby improving the chance of infection control. The BD Veritor Plus System is simple to operate. It’s not a big device, only slightly larger than a mobile phone, so it’s perfect for that setting.
PCR tests often take a while to produce results. Depending on demand, sometimes the PCR result can take several days and by the time you get that information, it’s ‘the cat is out of the bag’ sort of thing. Getting a fast result for the purposes of instituting infection control measures quickly is really one of the keys, especially for an infection with this extremely high degree of transmissibility.
You mentioned that BD is working with HHS to distribute the BD Veritor Plus System, having distributed it to 11,000-plus nursing homes. Can you talk a little bit more about how that distribution is going? Is it ongoing?
In this case, to ensure the nursing homes designated by HHS received the BD Veritor Plus System and test kits, we actually shipped directly to the nursing homes, which is different from our normal distribution. The other thing that I think is worth noting is that these test kits and the BD Veritor Plus System can be used to support a safe environment, not just for residents, but also staff.
Staff testing is something that the BD Veritor Plus System has been used for [frequently in] nursing home settings. The BD Veritor System is not the only test that’s being used in nursing homes, but it is the one that’s used in the majority. Over 70% of nursing homes have received these BD Veritor COVID-19 antigen tests and instruments.
For those skilled nursing workers who actually are administering the tests, where can they learn more? What is BD doing to help educate and train them?
It is a simple test to run. Prior to COVID-19, it has been used in outpatient doctors’ offices, and that kind of environment. But despite the fact that it’s simple to use, there still is a need for education and training for proper use of the system. BD has developed a variety of different tools to help people who are using this test in the skilled nursing facilities have all the education that they need to be effective. There’s an extensive education resource on the BD website that includes all sorts of instructions and videos on the intended use of the product and instructions for how it’s to be used. There’s a comprehensive training program, instructional videos, there’s even a call center as well as a dedicated website.
There’s a lot of information and material that’s available to give skilled nursing facilities the best chance to use this test in an effective way that gives you the best possible results. We actually have a training program that administrators and health care professionals at skilled nursing facilities can complete and receive a certificate. At this point, over 60% have actually completed this training program and have received a certificate. There’s an extensive amount of material to aid nursing homes. I think it’s important because in many cases, a lot of these skilled nursing facilities haven’t done this kind of testing before COVID-19. Providing sufficient training material and educational material is a critical way that we can support the effort.
In terms of some of the errors that SNFs might encounter when administering the tests, do you have any advice as to what they can do? What might happen and how do they resolve those issues?
One of the things that people need to realize and understand is that no test is perfect and all tests have a false positive rate and a false negative rate. That’s true for all diagnostic tests of any type. We have full confidence in the performance of our test and our instruments, but there are factors that can result in a false result if people are not following instructions properly, if they’re not collecting the specimen in the right way, or if they’re not managing the specimen after collection in the proper way.
It goes back to the importance of access to proper training material, and we have the online learning portal at BDVeritor.com where people can go to access YouTube videos, infographics and all the latest information on training.
What about false positive results?
The specificity of the BD Veritor Plus System was determined based on a clinical trial in the U.S. across 20 different sites. The confidence intervals for the false positive rate were somewhere between 0 and 2%. That means users might see a false positive rate somewhere between 0% and 2%. I don’t know if you remember, but when initial interest in the false positive rate was raised, even the HHS Secretary for Health, Admiral Brett Giroir, publicly stated that false positives are a fact of life in any diagnostic test. That’s also true here.
We have to be aware of that and we have to account for that in our interpretation and how we use the results. The rate is between 0% and 2%. It’s just something that people need to be aware of.
Of the [roughly] 11,000 nursing homes to which we’ve provided the kit, we’ve received a very small number of reports of false positives across all those nursing homes. When we receive such a report, we immediately conduct a thorough investigation to understand what’s happening; is it an issue with how the test is being conducted? We want to ensure that there’s no issue with the quality of the test. Those small numbers can generate a lot of attention, which is something you just have to be aware of.
Given that now there will be vaccines made available to skilled nursing residents and workers, how will the BD Veritor Plus System continue to support those organizations going forward?
Whenever some new breakthrough occurs, there’s always a lot of excitement and hope. The vaccines are very welcome news and we hope they’re effective and they can help aid in creating a safe environment in skilled nursing facilities. At the same time, there are lots of challenges that still lie ahead of us. The logistics of getting everybody vaccinated is a challenge. We also don’t [yet] understand the duration of protective immunity generated by these vaccines and new strains of these viruses can emerge, as we see with other respiratory viruses like flu.
The need for diagnostic testing is not going to go away as long as SARS-CoV-2 is circulating in the population because whenever someone has a respiratory tract infection, there’s a possibility it could be SARS-CoV-2. Diagnostic testing is still going to be important. We’ve received the question of whether or not the vaccines themselves could somehow cause false results for these antigen tests. We don’t believe it’s scientifically plausible that that could happen. We’ve carefully evaluated several of the major candidate vaccines and there isn’t a mechanism that we’re able to identify that would result in a false result in the vaccinated population.
I don’t think vaccination itself will result in inability to use these tests. We also think that, for quite a while, there’s still going to be a lot of demand and need to implement new testing to promote a safe environment in nursing homes.
We’re still scaling up manufacturing with a goal to reach 12 million tests per month by March of 2021.
BD is the leading provider of rapid COVID-19 (SARS-CoV-2) testing to nursing homes nationwide via its BD Veritor Plus System. To learn more about the BD Veritor and access additional resources, visit www.BDVeritor.com.
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