The pandemic changed many aspects of American society, including the acceptance and prevalence of at-home testing. In a wide-ranging Q&A, BD’s Joseph Mann discusses what this means for the laboratory industry and society in general.
By Chris Wolski
The two-plus years long SARS-CoV-2 pandemic has shined a spotlight on clinical testing, with billions of COVID tests administered in the U.S. The pandemic has also led to changes in the way tests are being administered, with many millions more tests being administered at home.
At-home testing is rapidly changing patient awareness, expectations, and reliance on clinical labs. And this will likely continue apace as more at-home tests for more conditions become available. CLP recently spoke with Joseph Mann, MSN, FNP-C, global medical science liaison at BD, about how COVID-19 changed the laboratory landscape, the tension between individual testing and public health, and how at-home testing could change the industry.
The following answers have been edited for length and clarity.
CLP: How did COVID-19 impact laboratory personnel and what does it mean for the next health emergency—whether that’s COVID-19, monkeypox, or flu—or a combination of some or all of these?
Joseph Mann: At-home testing will help to a certain extent, but understaffing can still pose difficulties, especially during big surges or big demand. BD wants to do the most it can to automate testing and sample processing workflows, increase walk away time, and remove some of the burden and responsibility of testing from lab technicians and healthcare providers. We want to put people in the best position to be successful, which we’ve accomplished through integration of artificial intelligence (AI) and other technological advancements in our assays. These advancements are prevalent with our BD MAX System, a laboratory-based PCR. With our BD Veritor* offerings, our rapid antigen testing solutions integrate technologies that help healthcare providers enter results automatically into the patient’s electronic health record (EHR) and communicate those results with the patient after the testing process is completed. This reduces the amount of time technicians and providers spend on the phone or emailing patients with their results. An automatic result communication process to both patients and state and federal public health authorities improves not only time efficiency, but also helps to resolve a growing public health concern of many at-home COVID-19 tests going under reported.
Symptoms overlap between COVID-19 and the flu—so patients present very similarly—making it challenging for providers to confidently diagnose whether a patient has COVID-19 or flu. Multiplex testing will be incredibly important this upcoming flu season, especially since we now have FDA-approved and authorized treatments not only for the flu but also for COVID-19. Getting results as quickly as possible is incredibly important because antiviral medications must be started within a certain time period from the onset of symptoms to be most effective. Rapid multiplex diagnostics, like our BD Veritor COVID-19 and flu test, can distinguish between influenza A, influenza B, and COVID-19 from one patient sample in 15 minutes. Having access to instruments that can distinguish the difference and even detect co-infections with COVID-19 and the flu will allow prescribers to treat patients with antiviral therapies faster and more confidently.
CLP: Certainly, automation has been an answer, at least in part, to address laboratory technician shortages. How can automation help improve workflow and maximize scant personnel resources?
Mann: In laboratory settings, as well as in clinics, technology and AI can be leveraged in a variety of ways to take some burden and pressure off our healthcare providers. A primary benefit of integrating technology is that it can improve healthcare providers’ workflows and increase testing efficiencies. We want to prioritize the amount of time medical providers spend with patients and limit the amount of time they spend with testing, charting, documentation, and other administrative tasks that can be taken care of by technology. Utilizing and integrating AI in diagnostics can reduce the risk of provider error and allow healthcare providers to feel less overwhelmed, which is extremely important.
CLP: Throughout the COVID-19 pandemic, there has been a tension between individual testing and testing related to public health—how has home testing added to that tension? And how important is it to strike a balance?
Mann: Half the battle is getting people tested and getting people access to testing. We have definitely done that pretty well as of recently as at-home testing has become ubiquitous throughout the nation. The other half of the battle, though, is getting those results reported to public health officials who can make informed decisions about our health and implement measures that can limit viral transmission. To make those key public health decisions that keep us safe, authorities often rely on data and technologies that report results automatically from at-home tests taken in the privacy of one’s own home. Authorities use the results recorded from these tests to gauge the status of the public health and the amount of viral transmission occurring within our communities, which then allows them to make informed decisions about what actions we need to take to stop the virus from spreading.
Test result reporting to federal and state health officials is fully automated with the BD Veritor At-Home COVID-19 Test. Before testing is conducted, users are notified that their testing results will be reported to the relevant federal and state public health agencies to ensure public health officials have visibility into testing being conducted in the home to aid in tracking potential outbreaks. Results are sent in a secure, blinded, and encrypted fashion by zip code to protect user privacy. Business enterprise reporting is also available for businesses, governments, or schools that want employees or students to report their testing results to their organizations. This user-initiated feature is a streamlined process to share results in real-time with third-party organizations as part of a testing program.
CLP: It seems that at-home testing for COVID-19, and an increasing number of other disease states and conditions, is here to stay. Why do you think that’s the case? Is it just the convenience and accessibility factor, or are there other factors making home testing more ubiquitous?
Mann: The convenience factor is certainly there. Being able to save yourself a trip to the doctor and test yourself any time you develop symptoms can be incredibly attractive from a convenience perspective. We are seeing users wanting to take control of their own health, but also have more control over how they manage their health. Another added benefit of at-home testing is that it allows healthcare providers and laboratories to focus their attention and care on more acutely or severely ill patients.
At-home testing certainly will open the door to more access to testing, and we do have plans to expand the testing solutions that we offer on the BD Veritor At-Home COVID-19 Test. With the emergence of telehealth and figuring out ways to integrate with telehealth companies, we are envisioning an end-to-end solution developing in the at-home setting. This also allows people with potential monkeypox cases or other more private conditions like STDs and STIs to receive care and treatment where they may not necessarily feel as comfortable going to get tested at an urgent care or other provider office, and may appreciate the comfort and privacy of testing themselves in their own home.
CLP: What does the expansion of home testing mean for the future of the clinical laboratory and its relevance to the entire healthcare enterprise? Will home testing help maximize a lab’s resources?
Mann: The pandemic opened the door for at-home testing. Prior to COVID-19, at-home testing wasn’t a common practice, and we recognize that at BD, which is why we focused on developing an assay that was consumer friendly. This allows novice users, who don’t have diagnostic testing experience to use the Scanwell App via the BD Veritor At-Home COVID-19 Test. The test walks users through the collection and testing process with instructional videos and written instructions.
The app is also able to interpret the test for the user, so they’re not left looking at a test cartridge and questioning the number of lines they see. Many times, one of the lines are faint and can be difficult for someone with minimal testing experience to interpret. Our BD Veritor At-Home COVID-19 Test takes that guesswork out of interpretation and gives people a clear positive, negative, or potentially invalid result reading, which is another hidden benefit. We also have a sample adequacy line built into our test to make sure that an adequate specimen was collected prior to testing, adding another safeguard to ensure the user correctly performed the sample collection and testing process.
Chris Wolski is chief editor of CLP.
*DISCLAIMER: These products have not been FDA cleared or approved; the BD Veritor At-Home COVID-19 Test has been authorized by FDA under EUA; the BD Veritor System for Rapid Detection of SARS-CoV-2 and the BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B assays have been authorized by FDA under EUA for use by authorized laboratories. The BD Veritor At-Home COVID-19 Test and the BD Veritor System for Rapid Detection of SARS-CoV-2 have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; the BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens; and, The emergency use of these products is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
