Automation Leads The Way In Urinalysis

Smaller-scale technology and automation are just some of what laboratories need, and it is where the companies that make urinalysis analyzers have to focus.

The importance of urinalysis as a vital screening tool in the diagnosis of UTIs, kidney, or liver diseases, and diabetes, among others, cannot be underrated. It is the third major in vitro diagnostic screening test in clinical practice, next to serum chemistry and complete blood count. Even though, urine sediment automation has been globally available for more than a decade, in India it actively started since last 4 years. Now this concept is penetrating in the segment and by the end of this year, the installation base of automated sediment analyzers, with or without integrated urine chemistry, will touch 200.

Total automation in urinalysis will bring quality urinalysis results into labs and bring standardization in urinalysis testing, impacting patient care as a whole. However, the expensive cost of technologically sophisticated analyzers has been prognosticated to take its toll on the demand for urinalysis. The use of advanced urinalysis procedures may not receive the right support because of the lack of the required infrastructural or financial qualifications. The dearth of professional laboratory staff could be another deterrent of market growth.

However, the growing prevalence of renal diseases and diabetes and aggressive development of medical technology could help the market to make a strong comeback in the coming years. Emergence of portable and battery-operated urinalysis devices and increase in implementation of urinalysis will create new opportunities for the urinalysis market.

Market dynamics

The global urinalysis market is expected to reach USD 1.91 billion by 2021 from USD 1.42 billion in 2017 at a CAGR of 7.6 percent from 2017 to 2021.

The Indian urinalysis analyzers and reagents market in 2017 is estimated at `153.82 crore. Reagents continue to dominate with an 81 percent share, valued at `125 crore. The reagents may be further segmented as 76 percent being used by semi-automated instruments, catered to largely by Dirui and Transasia, and also by Roche and Siemens and 24 percent by fully automated ones catered to largely by Sysmex, Iris, and Dirui (Rapid). The overall market has seen an increase in all segments, albeit there is a gradual transition to fully automatic analyzers, which are almost 95 percent placed. The semi-automatic instruments are also now increasingly being placed, with major revenue anticipated from reagents.

The fully automated analyzers segment is estimated at `13 crore, with integrated analyzers seeing maximum growth. This segment is dominated by Sysmex, Beckman Coulter (Iris), and Dirui. The urine sediments fully automated instruments are dominated by Sysmex, Beckman Coulter, (Iris), and Dirui, while the urine chemistry instruments are catered to by Dirui, Siemens, and Roche. While the transition in the larger laboratories is taking place in favor of fully automated instruments, so many new smaller labs, with tight budgets and price conscious customers, are being set up and these prefer the semi-automated instruments.

The major factors driving the growth of this market are rising prevalence of kidney diseases and urinary tract infections, implementation of PPACA, technological advancements, increasing adoption rate of point-of-care urinalysis devices, increasing healthcare expenditure and increasing geriatric population. Demand in the urinalysis market is projected to slump in emerging economies due to exorbitant cost of advanced analyzers. Lack of laboratory professionals could also dent the growth of the market in the coming years. Furthermore, emerging economies lacking financial or infrastructural qualifications are forecasted to deter growth in the near future. Nonetheless, players could take advantage of rapid advancement of medical technology and aggressively rising incidence of diabetes and renal disorders to improve their shares in the international urinalysis market. Adoption of urinalysis tests could be supported by current procedural terminology (CPT) description and code for reimbursements. One of the important tactics adopted by players could be allowing accurate and rapid diagnosis with increased ease of use.

Technological advances

Despite the fact that urinalysis can provide lots of vital information, limitations of manual methods including microscopy, have affected its clinical utility to a great extent. Innovation is the only way ahead and has been successful in bringing refreshing technologies in various fields of healthcare, including urine sediment analysis. Innovation in laboratory technology, which includes both new tests and advances in instruments and testing techniques, has made testing more efficient and automated. Recently, analyzers that enable individuals to perform urinalysis via a smartphone have come up. The system works in conjugation with dipsticks for analyzing color changes in the dipstick and providing results. Moreover, microfluidic devices have a proven record of being effective analytical devices, capable of controlling the flow of fluid samples, containing reaction and detection zones, and displaying results, all within a compact footprint. Moving past traditional glass- and polymer-based microfluidics, paper-based microfluidic devices possess the same diagnostic ability, with the added benefits of facile manufacturing, low-cost implementation, and disposability.

Smartphone-based PoC urinalysis. Urine tests are performed by using an off-the-shelf reference sheet to compare the color of test strips. However, the tabular representation is difficult to use and more prone to visual errors, especially when the reference color-swatches to be compared are spatially apart, thus, making it difficult to distinguish between the subtle differences of shades on the reagent pads. Among the current technology devices, the smartphone is projected as the most promising imaging analytical device for paper-based colorimetric detection. The convenience of the embedded built-in cameras and small size of the smartphone makes it stand out as a distinctive alternative to conventional medical devices with spectrometric powers. A competing device such as uChek, provides a system for performing strip-based diagnosis using smartphones and other auxiliary equipment. A change in color is detected via the CCD camera of the smartphone and evaluated in HSV space with the circular reference array.

Furthermore, a smartphone-based colorimetric detection algorithm has also been developed to transform image data into diagnosis results, without the influence of surrounding illumination conditions. After the process is performed, the diagnostic results can be saved for health monitoring or transmitted immediately to clinical laboratories for professional therapeutic decisions. The smartphone algorithms have several advantages, such as, no calibration requirements, easy-to-go, compatibility with both Android and iOS-based systems, and equivalence in accuracy as compared to conditional urine-analysis machine (UAM). These advantages make it more appropriate for quick clinical use.

Multi-parameter dipsticks. Urinalysis using multi-analyte dipsticks or multi-parameter urine strips continues to be among the most commonly performed tests of any kind. Strips having 11–14 parameters are becoming popular, and it is one of the reasons for the increase in the sales urine strip readers. Urinalysis dipsticks contain discrete reagent pads to semi-quantitatively test for the presence of bilirubin, blood, creatinine, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen in a urine sample. These tests may be read visually by comparing the colors that develop on each reagent pad to a chart provided by the strip manufacturer, or by an automated urine dipstick analyzer which help to provide consistency in the timing and color interpretation regardless of lighting conditions or personnel.

Automation. Automated urinalysis offers the benefits of convenience, efficiency, and increased sensitivity for detecting renal and urinary tract abnormalities. The true value may lie in the ability to efficiently screen and report out urine samples that lack pathologic findings. It is expected that at a large clinical lab, about 70–90 percent of urine samples can thus be screened and reported without the need for a confirmatory manual microscopy, saving a considerable amount of time and labor. Automated sediment analyzers provide improved standardization over manual microscopy.

Fluorescence flow cytometry, a proven technology used in high-end cell counters since a long time, offers laboratories with a breakthrough in standardization and automation of urinalysis. Immediate analysis on native urine without the need for pre-treatment enhances laboratory workflow and reduces turnaround time. It provides standardization in urinalysis that complies with ISLH guidelines. Urinalysis by flow cytometry helps in sensitive detection of UTI and differentiation of hematuria.

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. When combined, these analyzers may provide a rapid and accurate screening in routine urine analysis. Several companies have partnered to create integrated systems to offer their customers, thus meeting the needs of mid- to high-volume laboratories very nicely.

Future

Use of total automation in urine chemistry and urine sediment will bring quality urinalysis results into labs and will bring standardization in urinalysis testing, impacting patient care as a whole.

 Second Opinion

Urinalysis: Easy And Reliable

Urinalysis is the detailed analysis of urine to diagnose and treat certain diseases. Urinalysis is performed on a small amount of fresh urine or through 24 hour collection and various physical and chemical parameters are observed. In order to perform urinalysis, various urine analyzers are used with consumables, reagent strips, and various chemicals. The latest fully automated instrument available works on fluorescence flow cytometry and photoelectron technologies.

They are truly walkaway seamless urinalysis workplace solutions from sample loading to the final digital image. All processes are automated: from automatic sample loading, accurate quantitative sample dripping, precise controlled reagent reacting time, reagent strip automatic loading, and automatic collecting of waste strips and liquids.

These instruments have self-automatic calibration and also provide rectification of test results influenced by ambient temperature, non-specificity of the strip, pH, specific gravity, and color. The fully automated system helps laboratories reduce time consumption and saves cost. Large LCD touchscreen and user-friendly operation interface ensure the system is easy-to-use for daily routine tasks.

In urinary tract infection (UTI), the flow cytometry procedure provides valuable information as to which antibiotic to prescribe with the Gram positive and Gram negative flags provided by instruments. It offers a faster and far easier way than the classic Gram staining. It identifies UTI faster and reliably as well as indicates the right choice of antibiotics so that the treatment can be started faster.

In the past, detecting RBC and crystals was difficult but with the depolarized scattering of light in flow cytometry we can differentiate whether the patient is having hematuria and to which degree and it also analyzes epithelial cells and casts. With these upcoming technologies and load and leave configuration; urine test per se has become an easy and reliable test for diagnosing certain diseases and also in starting treatment early.

Dr Somika Sethi
Laboratory Director,
Delhi Heart & Lung Institute