Next moves for core labs—panel takes stock

Create PDF

June 2021—Pause and restart, or rethink and reorient? That’s the question CAP TODAY publisher Bob McGonnagle put to instrument vendors and James Faix, MD, and David Grenache, PhD, D(ABCC), about COVID and core labs and the instruments in those labs. 

What impact the pandemic had on them and their customers was a topic of discussion when they met on an April 27 call during which they talked, too, about antibody testing and the proliferation of SARS-CoV-2 testing labs during the pandemic. What follows is part of their conversation. The rest, on IT and the staffing shortage, will be published in July, as will our guide to chemistry and immunoassay analyzers for mid- to high-volume labs.

See CAP TODAY’s guide to chemistry and immunoassay analyzers for point-of-care and low-volume laboratories here.

David Grenache, we had a call like this about a year ago and we didn’t talk about COVID-19 until the end of our discussion. This year I’d like to begin with COVID-related issues and I will repeat what we said a lot of last year: What’s going on in chemistry and immunoassay? We have consolidation of lab sites, a real need for connectivity and scalability and platforms that are all in one family and can fit in the various sizes of testing sites that a given system may have. No one would disagree that these are still prime matters of interest on the part of companies and laboratorians. In your experience with COVID, running a core laboratory, how has that changed your outlook, if at all, about your core laboratory and the instruments we’re discussing?

Dr. Grenache

David G. Grenache, PhD, D(ABCC), chief scientific officer and medical director, core laboratory, TriCore Reference Laboratories, and clinical professor of pathology, University of New Mexico: When I look at our core laboratory processes in the past year through the lens of the COVID pandemic, I see what I’m sure many labs saw: an abrupt decline in the volume of testing we were receiving, as patients, particularly outpatients, were not seeking the care they normally would. But there was a quick rebound. The effect that had on our core laboratory operations was minimal except for the decline in volume and therefore the decline in revenue. But the way our core laboratory functioned was still largely unaffected by the pandemic.

‘We happened to be replacing our main automation line last April at a time when the volume of our routine testing had declined. That made that job easier.

We know that volumes dropped for a while and then largely caught up. Mike Massei, from Abbott’s perspective, do you think we’ve had a pause and then will resume with consolidation, connectivity, and scalability concerns? Or do you see signs that some people may reorient some of their testing strategies, including those of the core lab? I’m thinking in particular of labor and supply chain, both of which have been under pressure and scrutiny this past year.
Mike Massei, senior director, global marketing, core diagnostics portfolio innovation and strategy, Abbott: A couple of interesting things happened as a result of COVID. One is that the value of the clinical laboratory and in particular the core lab was in the spotlight. As a result, some elements of the health care ecosystem will take a look at how to spur innovation and focus on how to increase operational productivity.

The volumes have come back up—not quite to 100 percent but close to that in most regions. As a result, for future solutions and business continuity, laboratorians will be looking for solutions that continue to evolve the value proposition for the core laboratory.

Some of the attributes that the core laboratory, or any laboratory in the various volume segments, has been looking at in the past decade will continue to be important. But there is an opportunity now for greater innovation when we look at systems, quality of results, and efficiency from a workflow perspective and then the sharing of commodities, consumables, and commonality of results across the different system solutions, from the very low segments through the ultra-high segments.

Sean Roberts, would you like to add your own perspective?
Sean Roberts, senior product manager, chemistry/immunoassay business, Beckman Coulter: We experienced a slowdown in reagent sales and have now recovered in all geographies. We did see some deferral of new instrument installations as well. What the COVID crisis gave us is an opportunity to have a more intimate provider-customer relationship in terms of supporting clinical research. COVID raised many questions that we had to answer around immunology, and specifically about immunoassay being well suited to serology testing, antigen detection, and all the technologies that were put into play in a crisis mode. All of us had to address this on a scale we had likely not seen in our lifetimes. The stresses of COVID drove an intimacy between the customer and provider and research support that was escalated and compressed.

Did you find it difficult given your lack of direct access to laboratories?
Sean Roberts (Beckman Coulter): No, not at all. We have direct access to laboratories and great research partners, and we just redirected a number of areas of focus into COVID research, particularly around those aspects that lend themselves to the immunoassay and nucleic acid testing technologies.

Brittany Greiner, what was Roche’s experience with its customers and systems, and will there be a rethinking of things? Or is it more “We had a pause, we recognized how serious it was, we have addressed it as best we can, and now we’re moving back to normal in core labs in the instrumentation we’re discussing in chemistry and immunoassay”? 
Brittany Greiner, U.S. marketing manager, Roche Diagnostics: Everybody has had a similar experience. At Roche we are seeing an uptick not only in the core lab but also in decision-making. Customers are off the pause button and now making decisions because they might have systems that are old and breaking down and have to be replaced. Customers are asking how they can maximize their purchase with the vendors. For example, what are we doing to help with staff shortages? They also want to maximize their purchase with a vendor that is continuing to bring new tests to the market. In terms of COVID, customers want to know how manufacturers are continuing to expand menus and offerings for their patients.

Denise Pastore, what is the Siemens Healthineers perspective? How did COVID impact the core lab and the instrumentation in it? Is it a pause and now things will resume, or is there rethinking and reorienting?
Denise Pastore, director of global marketing, laboratory diagnostics, Siemens Healthineers: We are resuming like everyone else in terms of the volume of testing performed on our analyzers. What we all had to do is work on a couple of different levels, not only in the core lab with the antigen and antibody testing but also for the point of care because of the rapid tests and the demand for them. We had to expand in all of those directions. The core lab has rebounded well. Assays were added that will remain with us for the next couple of years. The biggest difference is the surge in point of care for the rapid SARS-CoV-2 tests.

James Faix, what was your experience in coping with COVID, particularly with your being in New York?
James D. Faix, MD, medical director, clinical chemistry and immunology, Montefiore Medical Center: It was a bad time, depressing and scary. Even though the number of cases nationwide wasn’t as large as during the second wave, New York seemed to be the epicenter. A lot of people worked from home and I too could have done a lot of work from home, but I felt it was important for me and for other leaders to be there, to be on site to support the people who couldn’t work from home—the technologists and phlebotomists. The phlebotomists bore the brunt of the psychological problems because they had to draw blood from patients who were dying day in, day out, and it was important for all of us to be there to support them.

Dr. Faix