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Planning for respiratory season is always tricky but never more so than this year.
“Uncharted territory for influenza” is how Frederick Nolte, PhD, D(ABMM), of the Medical University of South Carolina, describes the prospect of testing for influenza at the scale labs have been testing for SARS-CoV-2. And does a positive test for influenza mean the patient doesn’t have COVID-19?
In a child with mild illness, how will it be known if it’s COVID or a rhinovirus? Having to make the latter diagnosis “will make for a long winter season,” says Christine Ginocchio, PhD, MT(ASCP), of BioMérieux/BioFire Diagnostics.
Drs. Nolte and Ginocchio were two of nine people who joined CAP TODAY publisher Bob McGonnagle on Aug. 14 to talk about the respiratory season converging with COVID. The others were Margie Morgan, PhD, D(ABMM), of Cedars-Sinai; Bobbi Pritt, MD, MSc, of Mayo Clinic; Alan Wright, MD, MPH, of Roche; Sherry Dunbar, PhD, MBA, of Luminex; James Wassenberg, PhD, of DiaSorin, and Michelle Tabb, PhD, of DiaSorin Molecular; and Maurice Exner, PhD, of Hologic.
Here is what they told us.
Rick Nolte, can you give us an overview of what we mean by the problem of COVID and flu coming together?
Frederick Nolte, PhD, D(ABMM), professor of pathology and laboratory medicine, vice chair of laboratory medicine, and director of clinical laboratories, Medical University of South Carolina: Several problems need to be addressed. There is a significant overlap in the clinical presentations of COVID and influenza patients, and we’re struggling to figure out if it’s possible to construct an algorithm that might put you down one road or the other. I don’t think we’re going to have much success with that, but there are others on this call who represent industry and who can probably speak to it better than I can. Many manufacturers are considering making a multiplex test that at the very least includes the SARS-CoV-2 coronavirus, influenza A and B, and RSV. If we have a bad flu season on top of a continuing demand for COVID testing at the level we see now, I’m not sure any of us can sustain that. The manufacturers that are shifting over to the production of combined assays are already announcing there’s going to be temporary shortages or decreased allocations as they make those transitions.
We are considering every option, from antigen detection to point-of-care molecular to in-lab assays, both with a rapid turnaround time and the more traditional turnaround time, and trying to figure out how to fit all these pieces together. We’ve been working on this for about a month, and it all gets tied up not only with the diagnostic testing we’re doing for COVID but also with the increased testing labs are being called to do of asymptomatic patients for back-to-business applications. We have tremendous demand for testing from our several colleges in South Carolina, and we’re figuring out how to cope with those applications, which are still focused exclusively on COVID, versus the diagnostic issues that will become more muddled when the other respiratory viruses are mixed with COVID.
Before I move to the representatives of those companies that will face that supply dilemma, I have one more question about flu. Do you anticipate having a much greater demand for flu testing, given that COVID exists and there will need to be a differential diagnosis made of asymptomatic people who might otherwise not get a flu test but just recuperate?
Dr. Nolte (MUSC): Yes, this is uncharted territory for influenza. Testing for influenza at the scale we’re testing for COVID and including asymptomatic, presymptomatic, tests-of-cure is uncharted territory. And there is not much data about COVID and influenza and coinfections. We collected a little data in March of this year when we started testing widely and we were using the BioFire respiratory panel to try to define what the landscape looked like, and we found very few coinfections of respiratory viruses with COVID. We found a lot of the other coronaviruses, we found a few cases of influenza, but we found very few patients with COVID and another respiratory virus. Data that just came out from Stanford says the opposite, but that’s an interesting part of the epidemiology and how we’re going to approach testing. Does a positive test for influenza mean you don’t have COVID? How does that play out?
Christine Ginocchio, PhD, MT(ASCP), VP of global medical affairs, BioMérieux/BioFire Diagnostics: The coinfection rates have been a fascinating story, and you can separate it out by areas of low and high COVID prevalence. In the beginning of March we were in a normal respiratory season, according to the BioFire Syndromic Trends data. We were running about a 50 to 55 percent positivity rate for any virus, of which flu is generally only about 20 to 35 percent of the total viral positives. People forget about all the other viruses and call it flu season. It’s not—it’s respiratory season.
As COVID came in, we went from that rare case, where you could almost rule out by ruling in, to, “No, we know now we can’t do that.” The rates of co-circulation of other respiratory viruses, according to the data in May, dropped to less than 10 percent, when we’re in a high prevalence area where COVID has taken over. But as we’ve gone from quarantine to outside but socially distancing, those rates now are back up to about 20 percent of other viruses co-circulating but still below the normal levels we see of about 30 percent. So if you prevent spread of COVID, you’re not giving somebody RSV, you’re not giving them parainfluenza virus, because we’re all staying at home.
The numbers of gastrointestinal infections also went way down in May for the five viral pathogens in the BioFire GI panel—adenovirus, astrovirus, norovirus, rotavirus, sapovirus. So the impact of social distancing and masks had a high impact on the decirculation of other communicable pathogens. But as people have come out, we’re seeing that trend go up also, and as we think about getting into September, when rhinovirus starts to predominate, those numbers may likely spike. So I agree with Rick Nolte. This could be an impossible fall into winter season because of the potential for these viruses to come back. It will be especially difficult in kids who don’t get that sick with COVID—how do we know if it’s COVID or a rhinovirus? Having to make this diagnosis will make for a long winter season.
Those of us in industry now are trying to produce every test we can, three shifts a day, seven days a week, and it’s not physically possible for us to produce every test needed, even though we would love to do it. We all know we will sell the tests, but we cannot physically gear up overnight to deal with these kinds of situations.
Alan Wright, what are you and others at Roche thinking about the complications of COVID and flu coming in the same season?
Alan Wright, MD, MPH, chief medical officer, Roche Diagnostics: We’re continuing to scale up our COVID-19 testing portfolio, whether it’s antigen, antibody, or PCR testing, and we just introduced a multiplex PCR test that detects and differentiates between SARS-CoV-2 and flu A and B. Regarding the complications, we also have immunoassays that look at the cytokine storm and evaluate critically ill patients. There’s less data around it than other parts of COVID-19 disease, but we’re seeing clinicians and laboratorians explore the use of some of these critical care markers, like IL-6, procalcitonin, and C-reactive protein, to manage patients who are critically ill with COVID-19 disease.
Margie Morgan, what is your perspective at Cedars-Sinai as you look to the respiratory season?
Margie Morgan, PhD, D(ABMM), professor of pathology and laboratory medicine and medical director of clinical microbiology, Cedars-Sinai, Los Angeles: We’re still trying to recover from our last big problem with COVID, but we’re starting to have meetings, and we have a testing algorithm developed, but we do not know if what we have planned will work. You never know what is going to happen, and that’s been the biggest problem with COVID.
Can you tell us about the algorithm?
Dr. Morgan (Cedars-Sinai): We’re still in discussions. We’ve worked through plans for offering both COVID and influenza A/B testing for the emergency department, employee health department, and inpatients, but we will not be able to offer this testing to the community. It becomes an issue of overwhelming volume. How do we approach this? That’s been our issue with COVID. Planning for the testing needs of our community for respiratory season is a major problem. Los Angeles is a big community.
Bobbi Pritt, what is the perspective at Mayo? You serve a big community not only in the Mayo networks but also in an important reference laboratory. How is your thinking evolving in Rochester?
Bobbi Pritt, MD, MSc, chair of the Division of Clinical Microbiology, Mayo Clinic, Rochester, Minn.: We too are trying to cover our local community and make sure we can provide for its needs. We are also in the process of formulating our algorithms, although we’re looking at tests that can perform COVID testing along with influenza A and B and ideally have an option for RSV when needed as well. Those talks are ongoing. And we’ll have a plan soon.
Mayo Clinic Laboratories is an international reference laboratory, and we were challenged early on, like many labs, in trying to provide testing for COVID. The demands outstrip our capacity, and despite everyone’s best efforts, getting ahold of enough tests to provide testing has been challenging. We’ve had to diversify. By end of August we will have eight nucleic-acid amplification tests for SARS-CoV-2. So we are initially at about 10,000 SARS-CoV-2 net tests a day. By the end of this month we’ll be at more than 30,000 tests a day. We know that can handle the COVID capacity for our own practice in the state of Minnesota, with capacity left over to help out some of the hot spots in the country. But when you add influenza A/B and RSV into the mix, that’s going to pose additional challenges.
We are looking at high-volume options for testing all of those analytes at the same time because we know influenza A and B and COVID-19 presentations are going to overlap. You could argue it’s medically necessary to test for them all at the same time. By having the diverse menu but also having high-volume options for testing all those analytes at once, we won’t be able to provide testing for everyone in the United States, but we are feeling confident we’ll be able to provide testing for our local and regional practice, and at least be able to help out with the hot spot, hard-hit areas in the United States.
Sherry Dunbar, you’ve been with Luminex for years. What’s your perspective on this looming COVID-flu conjunction?
Sherry Dunbar, PhD, MBA, senior director of global scientific affairs, Luminex: I have the same thoughts the others have. Will the social distancing and good hygiene we’re practicing, which are things we should always do to prevent the spread of flu but don’t, have an impact? Flu season is predictably unpredictable. We do everything we can to prepare based on what we think will happen, and then we have a 2009 pandemic or the 2017–2018 season, when the number of cases was twice what it had been in the previous year.
The labs we’ve talked to are using the same strategy, where they’re adopting multiple platforms to accommodate all samples, whether they’re from outside or inside the hospital and any time of day or night, and also as a mitigation strategy in case one vendor is having a backorder. They keep a lot of balls in the air, to keep everything moving along as the need arises.
Luminex has ramped up its manufacturing since March. We immediately hired 13 more people, and we’ve continued adding on to manufacturing. We have three shifts going. We’ve increased our capacity from about 200,000 tests a month to 800,000 tests a month. It’s humbling to see us move this quickly.
If two years ago anyone from a clinical laboratory had been on this call and said his or her lab had seven or eight systems in place to do essentially the same tests, this lab would’ve been run right out of the Lean club. It’s interesting the effect of a pandemic.
Dr. Morgan (Cedars-Sinai): We’re not nearly as large as Mayo Clinic but we have four methods to do SARS right now, because of the pipeline for reagents.
Dr. Nolte (MUSC): We’re working on six.
Jim Wassenberg, what’s the perspective from DiaSorin on this issue?
James Wassenberg, PhD, director of product development, DiaSorin: It does seem there is going to be a rush on testing for flu because, as was said, people who otherwise wouldn’t bother to come in because they’re not afraid of the flu may be concerned about COVID. So the numbers for flu testing could go through the roof this year, and that’s a public health challenge to prepare for.
I’m on the immunodiagnostic serology side at DiaSorin, and we’re faced with an enormous number of unknowns on the application of serology and how the testing modes are going to change from qualitative tests to semiquantitative tests and moving into tests to try to establish immunity. Extensive clinical studies need to be done to get us to the point where we can know more about established immunity and be able to apply these tests to the vaccination scheme, where we either want to know if someone is a candidate for having a vaccine or if an individual vaccine is effective or not.
The serologic tests seem to have raised more questions than they’ve been able to answer to date. Jim, do you imagine there will be better serologic answers and results in time to guide us during some of the flu season? Or is it still going to be a clinical question to resolve?
Dr. Wassenberg (DiaSorin): In time for this flu season? I don’t know. My dream study is that 1,000 or several thousand patients who have been infected can be enrolled and followed for their antibody levels. Look for reinfection and levels at which people no longer have protection or where there’s the ability for people to become reinfected. That’s just on the serology side. Then there’s the T-cell immunity side, which is a bit of a black box. And we’re not sure what’s going to confer necessary immunity. Maybe serology tests are of limited utility in establishing immunity.
Michelle Tabb, would you like to comment on the molecular diagnostics side at DiaSorin?
Michelle Tabb, PhD, chief scientific officer, DiaSorin Molecular: We’ve heard from a lot of our customers that they are implementing several different platforms to meet demands for COVID testing. We’ve talked to our customers about the needs for the upcoming season, and we’re watching what’s happening in Australia, whose flu season precedes ours, and there’s been less flu than previous years. Here in the U.S. we’ve mostly opened back up across the country, and I expect that we’re going to start to see all of the usual respiratory viruses.
We have increased our production capacity. We’re on three shifts per day, and we hired a lot of people for manufacturing. We’ve had to make decisions about what our manufacturing priorities are. We have our SARS-CoV-2 standalone test, and we just received FDA 510(k) clearance for our next-generation Simplexa Flu A/B and RSV test. We changed the parameters so that it can run at the same time on the same disc consumable as our Simplexa COVID-19 test.
That was our decision, at least going into this flu season, to be able to offer flexibility—a SARS-CoV-2 standalone or joining that with flu A/B and RSV, when it’s desired on certain patients, and having a joint report. We did that instead of having a multiplex flu A/B and SARS-CoV-2, for example, at least for now. We’ll continue to monitor to see what happens next. We are making these decisions moment to moment, based on what we see with these viruses.
Maurice Exner, what are your thoughts on this discussion and how is this topic playing at Hologic?
Maurice Exner, PhD, VP of research and development, Hologic: Our discussions at our facility are of the same flavor. We’re trying to take the clinical and medical aspects of the disease, predict the future, and convert that into production line implications. We’re actively working on a combined SARS/flu assay, and so the question is, how much of that do you make versus the coronavirus-alone assay? What’s the flu season going to look like? So it’s that juggling of the manufacturing side. We’ve been used to doing large-volume testing—tens of millions of tests for chlamydia and gonorrhea every year—so we had the ability to convert that volume into COVID-19 tests. But no matter what the size of the company, it’s the same question: Can you get more tests out? We’re doubling our capacity and more, hiring in the neighborhood of 150 people to keep ramping up. Demand is nonstop.
I want to return to the serology question. Alan Wright, do you think our understanding of COVID serology antibody testing will be sufficient in time to affect how we’re treating patients in the COVID-flu season, or will that be deferred into next year?
Dr. Wright (Roche): Most likely it will be next year. The clinical trials we’re participating in, and the nature of studies that focus on describing immunity, take time and there’s no way to accelerate that.
Bobbi Pritt, are you in agreement?
Dr. Pritt (Mayo Clinic): Yes, I am. We’re going to learn a lot over the coming months—for example, what a good quantitative cutoff is for neutralizing antibody testing. But to direct patient care, it’s probably going to be later in 2021 before we have that knowledge with serology testing.
Christine Ginocchio, you’ve been on both sides of this. You’re a distinguished clinical practitioner and have been at BioMérieux/BioFire for a long time. What would you like your former laboratory colleagues across the board to understand about the supply chain right now for these tests?
Dr. Ginocchio (BioMérieux/BioFire): That’s a good question, and I know that as the user your lab is always the most important laboratory and your patients are the most important patients. That’s your number one premise. And your administration feels you have to be on top of everything and that your institution deserves the best. We all do that, not because we think we’re the best but because we have such a deep concern and love for our patients and our health systems and we want to do what’s best for them. We were in a different situation with the flu pandemic in 2009 because we already had flu tests that couldn’t tell you H1N1 but could tell you we had another flu, a nontypable flu. Back then I was using Luminex, and we had a nontypable flu, so we didn’t have to invent a new test to make a diagnosis.
In 2020 we had to come up with a new test. And all my industry colleagues on this call within weeks to a few months developed assays that were brought through the FDA for EUA. High-complexity labs have the ability to also do laboratory-developed tests. You can develop a test fast; you can validate it. But most people don’t think about gearing up production to make 10 million tests a day or 10 million tests a month. Maybe we can make 20 million tests, but we now have to make another 50,000 of the instruments to accommodate the test, and the smallest component can be the weakest link. If that OEM vendor in the middle of Arkansas can’t supply us with a tiny fitment that goes into those 50,000 new machines, we can’t make them. So it’s a supply chain nightmare for the manufacturers. Literally there’s a handful of suppliers globally that can make one of the critical nucleic-acid extraction reagents that many manufacturers use in their tests. Many manufacturers have to go to the same person and say, “I need to gear up my production 1,000-fold,” and they can’t accommodate it.
When you’ve been on the industry side, you begin to appreciate the issues beyond the desire to make the test and supply your customers, because every customer is important. It’s the need to allocate. There’s only so much we can do at a single time, and it’s hard to be on calls and try to explain, “I can’t guarantee you that I can bring you 10,000 tests tomorrow.” We have to look at it also not only from a U.S. perspective but from a global disease perspective because it’s hitting globally.
In the beginning we switched over production to mainly COVID tests. But people get other diseases, so we can’t stop manufacturing tests for meningitis and pneumonia and gastrointestinal disease, even though those numbers have gone down because people are in isolation. Luckily, we had a good reserve we could use. But eventually you have to make your other products too. Then it becomes the same type of balance: I want to make a million COVID tests a month, but how much of that do I take away to make meningitis or to make blood culture identification panels?
Margie Morgan, are you finding yourself in endless meetings trying to explain the supply chain and diagnostics?
Dr. Morgan (Cedars-Sinai): We’ve been fortunate to work with people who have been honest with us about our allocations so we could alert the medical center about what to expect. It’s been challenging. We have one person who is talking to companies about supply chain issues and doing little else.
I have friends in industry, and I understand what they’re going through; we’re trying to work together. If we know the situation, we can explain to those involved and move forward. It’s upsetting to expect a product to arrive and then it doesn’t. You need to be consistently on guard for alternative methods and supplies—not only for COVID but also for routine microbiology work. It is truly exhausting.
Bobbi Pritt, have you found it difficult at times to explain to a large administration at Mayo Clinic the realities of the supply chain in the IVD world, particularly in this COVID era, and now to prepare them for the flu season as well?
Dr. Pritt (Mayo Clinic): We’re fortunate that pathology and laboratory medicine is extremely highly involved and highly visible in this whole process, and the credit for that goes to our pathologists and leaders in lab medicine who have put themselves at the table so often that we now get invited to the table and we’re part of the discussions. One of our laboratory leaders is at all of the major discussions about planning for strategic testing, for all of our initiatives at Mayo Clinic in Minnesota. So we’re honest with them. It’s fortunate that we get good information, and as we have it we share it. Sometimes we have to say we’re not sure if we’re going to be able to meet certain volumes, but we’re having good discussions. We all have the same needs and desires, and we meet now several times a week. Lab leadership and institutional leadership at Mayo set up regular meetings, and that structure has continued. It’s been really key, and laboratory medicine and pathology has a representative at all of those meetings.
Rick Nolte, back to you for a brief comment about the evolution of understanding of the laboratory and the supply chain for testing. How have those evolved at MUSC?
Dr. Nolte (MUSC): Our experience has been similar to Bobbi’s experience. At least four hours a day we are on a Webex call discussing something COVID-related, whether it’s supply chain, new testing strategies, how to satisfy increased needs. And the supply chain has been relatively good for us. We have a great supply chain team that runs down a lot of leads. Our chief operating officer is happy to step into the fray to try to motivate some of our colleagues in industry to send what we need. I think all of the clinicians on this call understand that the folks in the diagnostic companies are doing the best they can.
And it’s the same for us—we’re under the same pressures. Our molecular pathology lab went from a one-shift, five-day-a-week operation to 24/7. I don’t even know the number of people who are now churning out COVID results for us. We had new staff members every day to try to keep up with demand. As for what Christine Ginocchio said about her company having to make diagnostics for other disease states, we’re having the same problem because all of our molecular pathology instruments and manpower have been converted to COVID testing, and we’re fighting to maintain our routine test menu in that laboratory. The nuclear option for us would be to send those routine tests—for chlamydia, gonorrhea, CMV, viral load—to a referral lab so we could keep up with the insatiable demand for COVID. That’s the topsy-turvy world we’re all living in now.
Maurice Exner, you also have responsibility for a broad product line at Hologic. Does the flu season make you nervous because it would imply that the demands are only going to go up exponentially?
Dr. Exner (Hologic): We’ve been fortunate in some ways in that with people staying home and not seeing their physicians, the volume of other testing has gone down. That’s a dangerous situation in itself for the patients, but it’s enabled us to scale up, and we’re looking to meet that demand. If today the demand for the non-COVID-19 testing was what it was previously, a lot of hard decisions would have to be made.
Sherry Dunbar, as you listen to this, are you feeling better or worse about the upcoming flu season?
Dr. Dunbar (Luminex): I don’t think my feelings changed. I’m pretty scared of the unknown but also motivated to keep going.
It’s been amazing to me how every time an obstacle was put in the way, laboratories and industry worked together to come up with a way to get over the obstacle. I think everybody could agree on that. We all want the best for our patients and everyone who’s affected. While it’s hard to predict what’s going to happen this flu season, I think we’ll figure it out like we always do.
Michelle Tabb, can you comment on how you’re seeing this upcoming flu season in light of the discussion we’ve had and how relationships with customers might be affected as they worry about the supply chain?
Dr. Tabb (DiaSorin Molecular): We’re going to need to remain flexible and stay energetic and keep our fingers on the pulse of this because we’re probably going to need to make changes still. We don’t have crystal balls and we’re doing the best we can at this moment. We are transparent with our customers and it’s appreciated. That’s going to be key, whether it’s instruments, consumables, or assays, as is just watching the trends and being able to react quickly and flexibly, with the support of agencies like the FDA.
Jim Wassenberg, I believe you wanted to speak briefly about a vaccine.
Dr. Wassenberg (DiaSorin): I’ve mused on the use of a vaccine that may not be 100 percent effective for all people and how that will overlay with the attitudes toward COVID in the United States. People could become less cautious in their behaviors after receiving a vaccine even if it’s known to not be 100 percent effective. This is a place where serology could come in handy to determine the effectiveness of vaccines not only in populations but also in individuals to help modulate their behavior—if people knew whether a vaccine was truly eliciting immune response in them. So it might be reasonable to couple vaccination with post-vaccination serology treatment.
Dr. Nolte (MUSC): I heard a piece on NPR about supply chain issues for diagnostics and the discussion turned to a vaccine and putting the vaccine into a glass vial. If we need billions of doses of vaccine immediately, we may not have the containers to put the vaccines in.
Alan Wright, Rick mentioned NPR and I can’t resist asking what your impression is of the national coverage.
Dr. Wright (Roche): As far as recognition of laboratory medicine and what it does for clinical medicine, this is our time to get our message out, through laboratory industry spokespersons and clinicians. The public has moved away from the impression that diagnostics are ambient—whenever you need one they just kind of appear—to the understanding that they’re manufactured. It’s not like you’ve saved the day, but they understand now what goes into laboratory medicine.
Christine Ginocchio, what are your thoughts on the coverage?
Dr. Ginocchio (BioMérieux/BioFire): From the laboratory medicine side it’s been a boom. It shows that laboratory medicine personnel are highly needed and provide a critical service. We did this in anthrax. We did it in 2009 with H1N1, and we’ve shown now that you can’t do this without good laboratory skills. As a former lab director for many years, I take great pride in that—that we get our due for the hard work we have to do under extenuating circumstances.
As far as testing, overall the impression has been positive, but there’s also been negative. Some of it has been due to the release of bad tests, particularly some tests that came from outside the U.S. that didn’t work well. So as good as it is, it also brings doubt back into people’s minds and questions about laboratory testing—can they rely on it?
I still don’t think people understand why they can’t get a test, and that’s a huge dilemma. If they need a test, it takes seven, eight days to get a result, and that part of it is still hard for them to comprehend. It’s a black box. You need a test, you go get a test. What’s the big deal? It can be a very big deal. On that side we need more community education on not the political reasons but the practical reasons why someone may not be able to get a test, and if they get a test, why it takes seven or eight days, and that’s because of the urgency of the situation. Public affairs work like that would be powerful.
As we contemplate greater demand for flu tests while COVID is still raging, the time is right to get that understanding more widely disseminated. Would you agree?
Dr. Ginocchio (BioMérieux/BioFire): Yes, and companies are handling it differently. Some are developing low-plex tests that have flu and COVID, which is good because that’s a primary differential, particularly in the outpatient setting. BioFire has bigger syndromic panels. We’ve added or are in the process of adding COVID now to all our respiratory panels because we feel that is part of the critical diagnosis. So there will be a lot of great options, but they have to be available quickly. The question is whether the needed volumes can be delivered. I question whether manufacturers can provide enough tests for this upcoming winter season, even if a laboratory can use seven or eight different tests at a time, which is only the big labs. A community hospital lab can have one test or two tests, and if they don’t have that in their supply chain, they’re going to have a difficult time this fall.
Sherry Dunbar, what grade would you give to the national coverage in terms of its clarity and accuracy about testing and supply?
Dr. Dunbar (Luminex): I would give it a grade of C. In many respects it’s been positive, but I don’t know that it’s been detailed enough for people to really understand the pluses and minuses, as Christine pointed out. I’ve been helping out answering the phones of our county’s COVID hotline, and most of the calls that come in are from people who want a test, want it now, and we have to explain they have to fill out a questionnaire, because they have to be prioritized, because of all the different limitations.
Initially we needed the COVID tests out quickly and so some of the companies came out with standalone tests because they could do that quickly. But now as we move forward we have to think about how we are going to manufacture all of these things, maybe a strategy more like what BioMérieux/BioFire has done—incorporating that target into all of their tests. It’s less testing for the lab if it can run one instead of two, and it’s less manufacturing for the company if it is manufacturing one instead of two.
Rick Nolte, how would you grade the national coverage?
Dr. Nolte (MUSC): I’d give it about a C, maybe a B-minus. I’ve been on NPR several times, and they always reach out to me for background information. I’ve been on CNN once or twice. I don’t know how the talking heads on the nightly news get there. But I think enough reputable journalism is going on where they seek out opinions from people who know what they are talking about, although they may not be the talking heads you see. At least they’re a source of information.
Would anyone like to ask a question or make a point not yet made?
Dr. Morgan (Cedars-Sinai): I’d like to know how all of you would advise a laboratory to move forward.
Christine, if a laboratory calls you and says, “I need advice on how to move forward. I’m also concerned about COVID and flu”—how would you advise the laboratory?
Dr. Ginocchio (BioMérieux/BioFire): It would be not to keep all your eggs in one basket, if at all possible. You’re going to have to have multiple options available. Stockpile what you can, if you can, and that includes transport media, nasal swabs, or whatever. People need to have more than one option for doing testing. And even if it’s in a small, local community hospital, they have different options. It may be difficult if you’re a new customer to get tests put into your facility, but that’s what they need to have. And then come up with good algorithms for who gets tested first, the most critical patients, and work your way down from there. If there are five people in a household who have the same symptoms and one is COVID-positive, there’s probably no need to test the others. They’re all going to be in quarantine together anyway.
Prioritize the patients at risk. Who is immunocompromised? Long-term chronic care facilities are the big scare; the mortality rates in some have been exorbitant, up to 30 percent of the patients. Every day is going to be a battle. What specimens can get tested? What specimens can’t get tested? Who needs to come first? It’s a tough triage. It’s an emergency-department–type triage, which is what the lab is going to have to do.
One final point: We have to praise the people at the FDA for the incredible amount of work they have done. They get bashed every time there’s a problem, but problems are a very small fraction of all the incredible good work. I imagine it has been a nightmare for them since January, February. They work with vendors, with labs, with all kinds of suppliers, bending over backward to make testing approval as easy but as safe as possible under these emergency circumstances.
Dr. Exner (Hologic): Yes, and that goes back to the press question. You can understand the patients’ and the media’s questions about why this is happening—concerns with testing—but they don’t understand the story of this being unprecedented for test manufacturers. It normally takes two to three years to get a product out. We’re doing it in two months. And the unprecedented volume of testing. That’s what doesn’t get out on the media, and they don’t understand what has been done to get products to market, and the role of the FDA is key to that.
Dr. Dunbar (Luminex): All of our professional societies came together to reach out to the FDA to point out the problems with running the normal procedure. “This is a whole different situation. We’ve got to come up with a new rulebook,” they said.
When you’re coming up with your algorithm about who gets tested first and who gets tested when, a lot of that is going to come down to the local community. There isn’t going to be a one-size-fits-all, so each region will have to decide the appropriate algorithm for its patient population and its COVID and flu prevalence rates. Maybe that will help create the decision tree on how to handle all of this testing.