CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
December 2019—What do users of urinalysis systems want? According to those in the know, the answer is instruments that are scalable and modular, maximize automation, reduce hands-on time, improve workflow, and more. CAP TODAY publisher Bob McGonnagle convened a panel in October to discuss these topics and other aspects of urinalysis testing. On the panel were Megan Nakashima, MD, of Cleveland Clinic; Michelle Dumonceaux, of Beckman Coulter; Maya Daaboul, of Siemens Healthineers; and Jason Anderson, MPH, MT(ASCP), of Sysmex. What they said follows.
Dr. Nakashima, in these discussions, we tend to focus on three areas: workflow, the importance of scalability for instrument solutions across a wide network and of maximizing automation, and reducing manual tasks, in part due to labor shortages. Are these factors applicable in the urinalysis area?
Megan Nakashima, MD, staff hematopathologist, Department of Laboratory Medicine, Cleveland Clinic: Absolutely. Those are things that I consider when I’m looking at urinalysis instruments.
Can you expand on reducing manual examination? What are you doing in the clinic to eliminate that bottleneck?
Dr. Nakashima (Cleveland Clinic): We have an automated microscopy system that does the dipstick, reads it, and then reflexes to the microscopic analysis if needed. The only time manual work is needed is if results from the automated microscopy are unclear or the sample volume or type is not sufficient for the automated analyzer.
Michelle, are you, at Beckman Coulter, hearing these same themes from your customers as you discuss your solutions with them?
Michelle Dumonceaux, senior manager of product management and global marketing, urinalysis, Beckman Coulter: Yes, those are the three top items we discuss from a global perspective: workflow, scalability, and reducing tech hands-on time. The market continues to move toward full automation with efforts to greatly reduce microscopic work. This all moves toward standardization between technologists and laboratories. Ideally we want to minimize the number of times the sample is handled while providing consistent results quickly.
Urinalysis instrumentation interactive guide
December 2019
What are one or two of the highlights or initiatives at Beckman Coulter to help solve some of these issues?
Michelle Dumonceaux (Beckman Coulter): Our instruments use digital flow morphology with auto particle recognition. We can autoclassify 12 particle types with 27 subcategories with onscreen digital imaging to reduce the need for manual review.
We look at the holistic problem: What do customers need as health care continues to evolve? The needs of customers in the United States vary a little from customer needs viewed from a global perspective. So we also need to consider how we can meet global needs as best as possible.
Maya, I’m assuming you’re hearing many of these same themes from Siemens Healthineers’ customers and potential customers. How is Siemens fulfilling the needs of folks in the urinalysis market?
Daaboul
Maya Daaboul, global marketing manager of centralized urinalysis-POC, Siemens Healthineers: I agree mainly with the three pain points you brought up: workflow, scalability, and reducing manual work. And I would like to add standardization as well, as we hear more about it from our high-volume labs. They want to make sure they have standardized processes and results. From Siemens’ perspective, by offering a solution such as the Clinitek AUWi Pro system, which combines the Clinitek Novus chemistry analyzer and Sysmex UF-1000i flow cytometry analyzer, we provide our customers with an integrated system that—like Dr. Nakashima mentioned—reflexes from the chemistry into the sediment and, by doing so, reduces the need for the operators to do that manual work while maintaining a standardized workflow.
Do you envision this reflex capability from chemistry into the urinalysis and flow cytometer occurring on an automated line?
Maya Daaboul (Siemens Healthineers): The Clinitek AUWi Pro is an integrated system between the chemistry and sediment parts. We have also been working with our lab-diagnostic counterparts in Siemens to have a solution partially or fully on an automation track.
Jason, what can you tell us about Sysmex’s approach to these challenges in urinalysis raised by your customers?
Jason Anderson, MPH, MT(ASCP), manager of product-urinalysis solutions, Sysmex: We hear the same things from our customers—workflow, scalability, modularity, maximizing automation, reducing manual processes—themes that are important to laboratories dealing with staffing shortages, increasing workloads, and budget constraints. By pairing the accuracy, precision, and standardization of fluorescent flow cytometry particle counting with digital imaging, the new Sysmex UN-Series is a unique solution that helps address these challenges that laboratories are facing. For example, our system is modular and scalable, which allows us to tailor a configuration that best suits the workflow needs of our customers. In addition, the reflexive and complementary combination of technology allows labs to harness the walkaway efficiency of automated particle counting via flow cytometry but still allows for reflexing to digital image review for those abnormal samples that require it. The result is less “screen time” and more freedom to address other critical laboratory tasks.
As we all know, urinalysis is one of the more tedious areas in the clinical lab, in part because of the high testing volumes. It doesn’t have the caché of the advanced-technology tests we associate with next-generation sequencing, or other types of tests that might be top of mind to people looking for new laboratory technologies. Dr. Nakashima, do you think that the clinical yield of urinalysis can be improved through some new directions in testing, perhaps new product innovation?
Dr. Nakashima (Cleveland Clinic): I think so. One thing that can be difficult in the interpretation of urinalysis is that some clinicians forget that the UA dipstick is meant to be sort of a screening test. Some clinicians—when you report, for example, in specific units—believe that the result you’re giving them is precise. I’ve had clinicians say, “Can we stop ordering urine protein by chemistry and just use the dipstick?” Considering the types of targets they’re looking for, I don’t think just a dipstick is necessarily precise enough to guide them. So, in terms of expanding the scope of what can be done by basic urinalysis, I’m not sure we need to go much further unless the technology improves to the point where the results are reliably precise.
Let me ask our experts from the three companies: Do you hear from customers that they have difficulty communicating with their clinicians the value of urinalysis as a screening test, as opposed to a confirmatory-type diagnostic test?
Dumanceaux
Michelle Dumonceaux (Beckman Coulter): Yes, that is something we hear. We get a lot of requests about what is the specificity, sensitivity—how customers can tweak it and make more decisions off it. We have to constantly remind them that it is a screen. We find people are utilizing a feature on our instrument, which is our urine culture indicator checklist, which combines the urine chemistry and some of the particle tests of urine microscopy, to help decide if samples should go to microbiology for culture testing.
Jason Anderson (Sysmex): Semiquantitative result information and subjective particle identification by nature come with challenges when compared to quantified methods. From my experience, clinicians have found value in the insights provided by automated urinalysis analyzers, such as the UN-2000, notably with RBC, WBC, and bacteria enumeration, assisting the clinician in the diagnostic pathway. Our customers have shared with us that they greatly value the standardized quantified results that fluorescent flow cytometry brings to patient care in their facilities.
Maya, I’m hearing that urinalysis might be ripe for additional studies into its value and into areas of rules, standardization, and interpretation. Do you believe that to be the case based on dealing with Siemens’ customers?
Maya Daaboul (Siemens Healthineers): It depends on where on the globe they are located. The system is used for screening. However, when you have a flow cytometry-based instrument, you can significantly reduce urine culture in the lab due to the technology precision. There are always going to be areas in the lab where the skills of the operators need to still be used; therefore, we need to free their time wisely. So, yes, I agree that it is a screening analyzer and that customers basically want to see a reduced urine culture rate.
Some of you mentioned testing rules. Are the rules in urinalysis changing, and are those rules being reflected in some of the instrument and laboratory information system interfaces?