Urinalysis instruments show off expanding feature sets designed to meet diverse testing requirements
By Steve Halasey
Among those who make and sell instruments to clinical laboratories, urinalysis is generally considered a mature field. Not only is the menu of tests a known and rarely modified group, the technologies involved in performing urine testing have not changed much over the years.
But laboratorians and clinicians may have other ideas. And over the past decade they have contributed to a long list of desirable features that manufacturers are now working to incorporate into the latest versions of their urinalysis systems. The result is a growing diversity of instruments shaped especially to meet the needs of those who conduct urine-based testing, in whatever healthcare setting they may be working.
For this article, CLP spoke with representatives of a number of in vitro diagnostics manufacturers about how their current products are responding to the needs of their customers. Their views suggest that there’s still plenty of life left in this mature field—and maybe some surprise achievements still to be found down the road.
JUST THE BASICS
At some level, high-end capabilities and advanced feature sets may be essential for meeting the needs of the laboratory marketplace. But urinalysis still begins with the basics of clinical testing—a menu of analytes, a means of detection, and a whole lot of healthcare professionals, including laboratorians, physicians, nurses, and medical assistants.
Main Menu. Urine chemistry testing is typically performed using test strips that incorporate a reaction pad for each of the analytes being detected. When a urine sample is applied to the test strip, the reaction pads change color and can be read by the lab technician or by an automated instrument. The degree of color change provides a qualitative or semiquantitative measure of the analytes present in the specimen. The 10 most common tests detected by urinalysis strips are bilirubin, blood, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen.
These tests cover a broad screen of disease states, including metabolic and kidney disorders, and urinary tract infections (UTIs). The test strips are used to detect early indicators of disease; abnormal findings are a warning that something may be wrong and should be evaluated further.
The great advantages of such urine chemistry tests are that they are early indicators, fast and easy to perform, and very cost-effective. Although the common menu for urine chemistry testing is broadly accepted, researchers are keeping an eye out for additional disease markers detectable in urine. According to Trevor McCarthy, business segment manager for central laboratory products at EKF Diagnostics, Cardiff, UK, “the Stanbio Uri-Trak 120 research team is constantly looking for other analytes to bring onboard and keep the Uri-Trak at the forefront of technology.”
In some cases, manufacturers’ test strips incorporate pads for additional analytes as a means of expanding the capabilities of the test system. The Clinitek Status Connect system by Siemens Healthcare, Tarrytown, NY, uses the company’s Microalbumin brand of urinalysis test strips, which include reaction pads for albumin and creatinine. As a result, the analyzer is able to provide a specimen’s albumin-to-creatinine ratio, considered an early test for possible chronic kidney disease.
The Status Connect analyzer can also accept the Siemens CliniTest hCG cassette test for human chorionic gonadotropin (hCG) to detect pregnancy. The analyzer is especially suited to duty in low- to mid-volume physicians’ offices, hospital emergency departments, or urgent care centers, where quick determination of pregnancy may be required before performing imaging procedures or administering drugs. It can perform one test at a time, delivers results in 2 to 5 minutes, and offers a simple connection to the laboratory information system (LIS) or patient’s electronic medical record (EMR), so that test results can be stored automatically. “Performing hCG testing on the Clinitek Status Connect analyzer helps eliminate the subjectivity associated with visual testing, and also ensures that the results go straight into the patient’s record,” says Lauren Foohey, MPH, senior director of global point-of-care (POC) marketing at Siemens Healthcare. “With our system, administrators can be more certain of being reimbursed for the pregnancy testing they perform. Having results automatically interpreted and recorded eliminates transcription errors, ensures results are stored in the patient’s EMR, and facilitates reimbursement.”
Microscopic Examination. Typically performed only when urine chemistry findings are abnormal, microscopic urine sediment analysis has traditionally been performed manually. “Manual microscopy and urine sediment analysis have not changed very much in years,” says Leslie Williams, MLS(ASCP), urinalysis product manager at Sysmex America Inc, Lincolnshire, Ill. But more recently, the application of flow cytometry or camera-based optical technologies has opened the door to less time- and labor-consuming methods of examination.
“Today, there are a variety of technologies available for sediment analysis, and laboratorians have varying opinions about which is the best,” says Foohey. “The Sysmex UF-1000i uses flow cytometry, where the urine sample passes through a flow cell, and each cell in the sample is inspected and characterized individually. But other instruments use optical technologies to accomplish the same task. The manufacturer’s choice depends in part on the patient population their analyzer is designed for.”
More and more, laboratories are looking for automated urine sediment analysis. “In North America Siemens meets this demand by offering the Clinitek AUWi Pro automated urine workstation, which uses a track to link the Siemens Clinitek Novus urine chemistry analyzer with the Sysmex UF-1000i urine sediment analyzer,” says Foohey. “For customers who don’t want to be bothered going to a microscope, this combination provides the option of full automation for performing urine sediment testing.”
Shrink to Fit. Making urinalysis readily and efficiently available to clinicians has sometimes been simply a matter of space. Whether in central labs or patient care settings, few healthcare environments have space to spare for bulky instruments. So it’s no wonder that manufacturers have been working hard to match the size and capabilities of their offerings to the varied needs of their customers.
The Stanbio Uri-Trak 120 urine analyzer by EKF Diagnostics is an economical system designed especially for clinics and physicians’ offices, and measuring just 10.7 inches x 10.6 inches x 5.7 inches. “The small size of the analyzer means that users don’t need a lot of bench space to have access to the accuracy and consistency of advanced technology in urine chemistry testing,” says McCarthy. “The analyzer uses state-of-the-art electronics to accurately and efficiently read Stanbio Uri-Chek 10SG urinalysis reagent strips, which are manufactured to the highest quality standards with all major tests available.”
Size considerations also influence the design of fully automated and integrated urinalysis instruments, such as the Aution Hybrid AU-4050 by Arkray USA Inc, Minneapolis. “We all know that laboratory space is very tight, so the small footprint of the AU-4050 is very attractive to customers,” says Jessica Donlan, MLS(ASCP)CM, marketing manager at Arkray USA. “The instrument is 30% to 50% smaller than other fully automated urinalysis instruments that can perform both urine chemistry and urine sediment analysis. With a width of just 31.5 inches, it can often fit in the same benchtop space required for a small semiautomated urine analyzer, whereas some competing systems wouldn’t be able to fit in the lab at all.”
FROM MANUAL TO AUTOMATION
“The first challenge that labs tell us they are facing is a shortage of skilled laboratory professionals,” says Donlan. “They are trying to figure out how to get all of their work done with reduced lab resources, or how to accomplish more work with the same amount of resources. And because of that, they are looking for some type of automated solution that will essentially enable them to do more with less. They are looking for equipment that reduces the amount of hands-on tech time required to produce the same number of test results.”
“Customers want us to automate the manual,” agrees John Ebbs, group marketing manager at Sysmex America Inc. “They want us to take high-complexity tests that are very labor- and time-consuming and put them onto a platform that not only provides relief from those concerns but also drives enhanced clinical utility in the form of more parameters or greater sensitivity.
“Any time a lab is performing a manual high-complexity test, unfortunately, there is inevitably a great deal of operator-to-operator variability,” Ebbs explains. “Automation enables labs to eliminate that variability, and can also make it possible to look at more fields, to quantify results that were previously qualitative, or to provide more-detailed analyses than would have been possible using manual testing. It’s our mandate as diagnostics manufacturers to try resolve these issues so that labs can do more with less.”
The contribution of a fully automated system is especially apparent to laboratory staff who are accustomed to a semiautomated urinalysis system, where urine chemistry testing is automated, but microscopic urine sediment examination is performed manually. “With a fully automated system, a lot of labs that used to perform microscopic examination manually find that they are performing significantly fewer such tests,” says Donlan. “Our customers have experienced a urine chemistry autoverification rate somewhere between 80% and 95%. This means that they perform microscopic examination for only 5% to 20% of all test results. That’s a significant decrease in the hands-on time required of laboratory staff.”
Walkaway Capability. One measure of the impact of an automated lab system is its “walkaway capability”—the extent to which the system permits lab staff to initiate testing and allow the instrument to complete its tasks unattended. Arkray’s Aution Hybrid AU-4050, for instance, is loaded using racks that have 10 sample positions, and can accept six racks at a time. With a throughput between 100 and 200 tests per hour, each fully loaded instrument can provide more than a half hour of walkaway time.
“The Aution instrument allows technologists to load a specimen on the instrument, and then go do other things,” says Donlan. “We’ve had customers tell us that they don’t hesitate to walk away from the instrument in order to perform some coagulation or hematology tests, returning later to review the urinalysis results. This capability really minimizes technicians’ hands-on time.”
“Labs that are running 50 or more urine tests per day seek out instruments that provide good walkaway capability,” says Foohey. “A lab that busy unquestionably has many other things for its staff to be doing, and the premium for skilled laboratory labor is high, so maximizing walkaway time is important.”
Integration. “As part of the drive for automation and to do more with less, in the past 5 years or so laboratories have started looking for ‘integration’—that is, combining urine chemistry with urine sediment analysis,” says Williams. “We’ve been successful in partnering with Siemens to offer that to customers, creating an integrated system—the Clinitek AUWi Pro—that meets the needs of mid- to high-volume laboratories very nicely.”
For laboratorians who conduct clinical testing, quality control (QC) is always Job One. Many small urine analyzers have waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), permitting testing to be performed in physician offices and other sites without following stringent QC policies. But in a hospital environment, regardless of their target population, type of testing, or testing volume, clinical labs must meet CLIA QC requirements. Finding ways to safely manage a lab’s QC obligations is thus a major preoccupation of laboratory directors and managers—a task that is made all the more complex by the rapid increase in POC testing for which they have oversight responsibilities.
Urinalysis instruments are no exception to the rule. “The Clinitek Status Connect analyzer is CLIA waived, but if a physician office or decentralized testing site is performing testing under the central laboratory’s license, the POC coordinator often wants assurance that QC is being performed on a daily basis,” says Foohey. “Consequently, they want an instrument that will prompt nurses or other operators to perform QC, and will not permit patient testing until it is successfully performed. The Clinitek Status Connect system manages this task wherever the testing is being performed, and also has operator management features that prevent an untrained individual from using the analyzer.”
“The Uri-Trak 120 incorporates safety features such as a QC lockout, which prevents an operator from performing a urine test without the instrument first passing required QC tests,” says McCarthy. “The frequency of QC testing can be programmed to once every 8 hours, daily, weekly, or monthly—and the analyzer will alert the operator when to run the QC test. This feature helps to ensure that the Uri-Trak remains accurate, reliable, and convenient in daily use.”
The greater the sophistication of the urinalysis system, of course, the greater the demands on the QC functions built into its instruments. But manufacturers have taken on the challenge of simplifying and automating such QC functions to keep operators’ direct involvement to a minimum. “On the Aution Hybrid AU-4050 we have two separate QC parameters, one for the chemistry side, and one for the flow cytometry side,” says Donlan. “The analyzer uses the Sysmex information processing unit software, which includes a module that makes it very simple to run QC. The operator simply presses the QC button, presses again to select QC analysis, and the instrument then performs the chemistry or flow cytometry analysis. The instrument tells the operator whether the results are within range. If they are outside the acceptable range, the QC results are marked in red, and the instrument provides an instruction to repeat the sample.”
Quality through Consistency. An important consideration for many healthcare systems and their providers is making sure that a patient’s test results are consistent and comparable, regardless of the setting in which the patient is being tested. Siemens has addressed this need with its volume-segmented Clinitek series of urine analyzers, each of which incorporates key capabilities and features most often needed in settings that perform a particular volume of testing.
The Clinitek Status Connect is suited to emergency departments, small clinics, and physician offices that want automated testing to reduce the subjectivity associated with visual testing, and also offers simple connectivity to a provider’s electronic medical records. The Clinitek Novus chemistry analyzer is a fully automated system that can run up to 240 cassette-based tests an hour, with complete walkaway capability. And the Clinitek Advantus urine chemistry analyzer can perform 514 tests per hour—one test every 7 seconds—and permits the operator to enter the results of a patient’s microscopic urine sediment examination in order to produce a single, consolidated report.
“As patients move from the physician office into the hospital environment, clinicians may be concerned about whether they are receiving comparable test results,” says Foohey. “That consistency is assured when patients are tested with Siemens instruments, because we use the exact same chemicals in all of our reaction pads.”
Integrating QC. In recent years, healthcare groups and hospitals have taken ownership of an increasing number of freestanding healthcare clinics and physician practices, including their associated laboratories and diagnostic instruments. As a result, POC coordinators are finding themselves responsible for testing in a much greater variety of settings where patient care is being provided. “Now, POC coordinators need to exercise control over who’s doing the testing, how well they’ve been trained, and how they are performing their QC,” says Foohey. “In these situations, there is an increased need for systems that can help to automate the activities required for operator management, QC management, and even patient identification via barcoding. Siemens’ Clinitek series of urine analyzers offers those capabilities, simplifying the tasks that point-of-care coordinators face during the integration of several organizations.”
Siemens extends the reach of coordinators across a wide variety of POC instruments through its RapidComm data management system. “We’re just coming out with the latest version of the software—RapidComm software version 6.0—which will be connecting to Siemens’ POC Stratus CS200 cardiac system,” says Foohey. “It will also deliver enhanced capabilities when the Clinitek Status Connect urine chemistry analyzer and the DCA Vantage HbA1c analyzer are connected.
“Enhancing the software capabilities of these analyzers will certainly help POC coordinators, who may be managing hundreds and hundreds of such instruments—and especially urinalysis instruments—across all of an institution’s settings,” Foohey adds. “Enabling coordinators to monitor all those analyzers remotely—to make sure that QC testing is being performed, to review instrument performance records, and to manage consumables—is a big deal. The RapidComm 6.0 software upgrade will also provide POC coordinators with greater capability to manage operator competency at the site of training.”
Quality Outcomes. Measuring quality doesn’t stop at the laboratory door. Clinical lab results are now also being reviewed as indicators of patient outcomes, and as a means of holding providers responsible for reducing the spread of healthcare-associated infections. One of the conditions under review is secondary UTIs. Under rules recently implemented by the Centers for Medicare and Medicaid Services—and followed by many other third-party payors—hospitals receive less reimbursement if a patient is found to have a secondary UTI. In some cases, hospitals have begun to screen patients both on admission and at discharge, to make certain that they are not liable for patient outcomes involving secondary UTIs.
To screen patients appropriately for UTIs, labs are looking for systems that can offer very sensitive and specific bacteria detection. “Arkray’s Aution Hybrid AU-4050 provides customers with that capability, because the analyzer’s flow cytometry technology is highly sensitive and specific,” says Donlan. “The system’s diluents and stains eliminate amorphous sediments and other interferents from the sample, and the system stains the bacteria for direct enumeration. They are very accurately screened.”
Not many modern lab instruments have avoided the trend toward greater connectivity, and today’s urine analyzers are no exception. More and more, instruments are being designed in such a way that full feature access depends on technologies that connect instruments to one another as well as to the facility’s LIS.
Even the smallest benchtop urine analyzer incorporates connectivity capabilities as well as other IT-driven features. “The Uri-Trak 120 features easy data management, including an RS232C port for data transfer to an external computer or LIS, and safety and backup systems with unique lockout features,” says McCarthy. “The lockout features prevent unapproved users from initiating a test, while permitting up to 10 lab-authorized users to perform testing. The system also enforces a restriction so that only the lab administrator can change analyzer settings.”
“As a result of the Patient Protection and Affordable Care Act—Obamacare—physician offices are asking for instruments with the capability of connecting to the EMR,” says Foohey. “That is something that certainly has changed.
“As health systems and hospital groups acquire and absorb physicians’ offices and clinics into their larger networks, physician office laboratories and clinic labs have a greater need for connectivity with whatever information system the network is using,” Foohey adds.
According to Donlan, Arkray’s Aution Hybrid AU-4050 interfaces directly with all of the major LISs, as well as with a lot of smaller and homegrown LISs. “The analyzer communicates test results with the LIS, where they are reviewed and approved,” she says. “Other competing analyzers rely on middleware for their communications, but the AU-4050 does not require middleware.”
“The UF-1000i was launched in 2007 with enough updated technology and connectivity capabilities that we haven’t had to make changes to the instrument software,” says Williams. “It works very well as part of the Siemens Clinitek AUWi Pro integrated system, which is powered by a middleware platform developed by Sysmex. And in standalone situations, customers have had good luck connecting the UF-1000i directly to their LIS.
“Some laboratories have a standalone urine chemistry test strip analyzer and a standalone UF-1000i, and that setup also works well,” she adds. “Results from the urine chemistry analyzer upload to the LIS, where reflex rules determine which samples require urine sedimentation testing. The LIS issues those orders to the UF-1000i, which then performs testing on only the samples that need it.”
DOWN THE ROAD
Urinalysis may be the oldest form of clinical testing, but that doesn’t mean the field is done making advances to improve patient care. Down the road—way down the road, some say—urine may again become the specimen of choice for detecting cancer and other diseases with a genetic component.
“What I see in the literature is an ongoing search for early-detection biomarkers that are expelled into the urine,” says Williams. “But while there have been many such studies, the medical community doesn’t yet seem to be in agreement about which markers are best to use for particular disease states. And until there is some agreement about which markers are suitable for use, it’s unlikely that vendors will make any large-scale moves toward offering those tests on an automated platform.
“I could potentially see that happening 5 or 10 years from now,” Williams adds, “but there will still be a lot of work to do just to determine the appropriate detection method. Right now, some proposed biomarkers can be detected using enzyme-linked immunoassay technologies, and others are detected using molecular or other forms of reactivity. But none of the biomarkers now being considered is ready for large-scale automation.”
“The next frontier of urine testing may not look like traditional urinalysis, even though it’s using urine specimens,” says Ebbs. “There may be new types of devices and instruments involved, and they may approach specimens from an entirely new angle.
“Personally, I’m very interested to hear what some of the wet chemistry devices might have to offer. But in any case, it’s exciting to consider what the future might hold. Urinalysis as a whole is a pretty mature marketplace, but this gives us an avenue for growth and expansion—and one that no doubt every vendor will want to explore.”
Steve Halasey is chief editor of CLP. He can be reached via [email protected].