Enhancements in Urinalysis Testing

Vol. 19 • Issue 2 • Page 46

Examination of urine dates back to ancient times, when it was a primary diagnostic tool called uroscopy. Urinalysis remains a frequently ordered test, regularly requested as both a screening tool and a diagnostic exam utilized at wellness visits, upon being admitted to the hospital, as part of a surgical work-up and during pregnancy check-ups.

Traditional urinalysis is comprised of three distinct phases: a visual examination to evaluate color, clarity and concentration; a chemical examination to test for specific gravity, pH, protein, glucose, ketones, blood, leukocyte esterase, nitrite, bilirubin and urobilinogen; and a microscopic examination to identify and count cells, casts, crystals, bacteria and mucus that may be present.

Urinalysis has evolved, however, and particularly in recent history, both automation and point-of-care testing (POCT) have opened doors for numerous quality improvements.

“There are two key areas of evolution in urinalysis testing technology,” states Maria Peluso-Lapsley, global commercial marketing manager, Urinalysis, Siemens Healthcare Diagnostics. “First, technology that delivers improvement in process management, including the movement from manual to instrument-read testing for both the POC and in the core laboratory; second, options to expand menus, including quality indicator markers.”

Improving quality and efficiency remain every lab manager’s ultimate goal; ðautomation and POCT for urinalysis can be utilized to achieve that objective.

A Segmented Journey

Despite some major advancements, parts of urinalysis have lagged behind other clinical laboratory modalities when it comes to automation. The visual elements of ðurinalysis have been incorporated into the chemical examination, and there’s a great deal of automation there, explains Carl Trippiedi, senior product manager, Sysmex, but automated urine microscopy is still catching up.

Technology for automated microscopy was lacking until the late 1990s and into the new millennium, and even then the market remained in the neighborhood of 70% manual microscopy until around 2003 or 2004, Trippiedi explains. “Then, we started to see a steady growth of labs moving to automation. This was the last section of the lab where people started to budget for automation,” he continues, “and it was spurred on by the lack of qualified laboratorians to do the work.”

For a long time, many labs were in a position where they had to make trade-offs in terms of labor. Trippiedi says that labs that don’t have automated urine microscopy might decide to do reflex microscopy only if the chemical portion is positive and warrants further investigation. “The chemical side is telling you if there are leukocytes or proteins, so if there is bleeding, they can move to the microscope and see it,” Trippiedi explains.

“The trade-off that happens when you’re not doing a complete urinalysis is that you may be missing some pathologies that are not picked up by the test strip.” This doesn’t mean the lab was putting out inferior results, he clarifies, but since the urine microscopic exam would be used in conjunction with other methods, they could rely on those other methods in cases where microscopy was skipped for a strip-negative patient.

“But when the urinalysis exam is fully automated, labs can perform a complete urinalysis for each patient, resulting in better patient care. What’s more, manual microscopy is a subjective science. That means there’s a level of variability that can also impact reported results. A complete automated urinalysis with standardized results means real quality improvements for the lab, Trippiedi asserts.

Widespread Benefits

The improvements garnered from automation don’t end there. Trippiedi points out the Medicare initiatives from CMS made in October of 2007, which targeted urinary tract infections (UTI) and hospital-acquired infections (HAI) for cost savings. The term “present upon admission” became a big deal. Say, for example, that a patient is being admitted to the hospital for a heart condition, and he has the beginnings of a UTI but the infection is not caught at the time of admission. If that UTI fully develops later in their hospital stay, CMS may consider the condition an HAI and the hospital is unable to submit a separate diagnosis related group (DRG) and must treat the condition without reimbursement.

“With new pay-for-performance initiatives, the hospital could be held accountable for subjecting the patient to an HAI, when the infection was there to begin with. With an automated complete ðurinalysis, perhaps the evidence would have been there upon admission with a two-minute screen. It would have detected the elevated bacteria and white blood cell level,” Trippiedi says. The physician would have had the evidence to delve deeper and determine that the patient has a UTI present upon admission and the hospital isn’t inaccurately assumed to have caused a nosocomial infection. In the end, that’s an impressive quality gain.

POC Perspective

Automated analyzers in the core lab aren’t the only option for quality improvements-the chemistry side of urinalysis is also assessed at the POC, where it can contribute directly to improved workflow and efficiency as well as patient satisfaction.

“Whether in the emergency department [ED] or in the physician’s office, POC urinalysis helps the physician initiate rapid treatment options such as drug therapy, further testing or patient discharge,” notes Peluso-Lapsley. It offers a physician a whole range of rapid results that serves as a window into a person’s health or wellness, she adds.

“In the ED environment, this efficiency can translate into more rapid bed turns. For the physician’s office, the rapid response opens the possibility for the doctor to have immediate discussion with the patient regarding test results,” Peluso-Lapsley says.

The challenges in near-patient urinalysis testing mirror those traditionally seen throughout POCT, but can be magnified, Peluso-Lapsley continues, because other POCT analyzers for glucose testing, coagulation and blood gases have had more sophisticated capabilities, ðespecially in terms of connectivity. Recent improvements in urinalysis at the POC have reflected customer requests: operator identification, operator lock-out, quality control lock-out, interference identification and connectivity options.

“The POC marketplace is steadily advancing the adoption and integration of information technology solutions through incremental expansion of system connectivity and informatics offerings,” Peluso-Lapsley explains. This is one of the most exciting areas of opportunity in near-patient testing, as effective data management opens the door for far-reaching improvements in healthcare.

Laboratories have choices regarding technology, footprint and volume. The automated urinalysis microscopy product from Sysmex, for example, utilizes a technology very similar to their hematology flow cytometry, while Iris Diagnostics utilizes more of a visual technology. There are connected systems on which a laboratorian can place a rack on a track and the system automatically does chemical strips and microscopy. Small footprint urine chemistry analyzers for the POL and POC also are available, making improvements in workflow and patient satisfaction an attainable goal for labs of all types and sizes.

Kelly J. Graham is associate editor.