Laboratories are realizing a greater impact on productivity with the advent of digital imaging technology and automation in urinalysis. Fully automated urinalysis has paved the way for easier standardization while being cost-effective. As the demand of hospitals and clinical labs to provide the highest level of care to the patient and the technology a lab utilizes is rising, there seems to be variation in how urinalysis technology fits into full automation.

Systems with continuous loading of test strips, easy user interface, and flexible software settings are the pre-requisites for urinalysis work area automation. Some urinalysis systems are being incorporated into large automation systems.

Another key differentiator is bi-directional interface, which helps in the integration of urinalysis work area into a lab information system. Likewise, multi-parameter urinalysis combined with automation is ensuring faster processing of urinalysis samples. This enables labs to focus on pathologically relevant samples and enhance quality of reporting. Such technological advancements, together with launch of advanced and new products in the market, and high incidence rate of chronic diseases are leading to an admirable growth of urinalysis market.

Worldwide Market

The worldwide urinalysis market is expected to reach USD 1286 million by 2019 from USD 960 million in 2015, at a CAGR of 7.6 percent due to implementation of the Affordable Care Act (ACA) and government initiatives for improving urinalysis services across the globe.

North America will continue to lead the worldwide urinalysis systems market in the forecast period, followed by Europe. Over the next 5 years, the growth of the urinalysis systems market in the Asian region is likely to be centered on China and India. The relatively untapped Asian market and increasing adoption rate of point-of-care (POC) urinalysis devices have opened an array of opportunities for growth of the urinalysis systems market.

The worldwide market for POC urinalysis reached USD 129 million in 2015. While overall urinalysis test volumes are growing negligibly in most developed POC markets, increasing test automation provides an ancillary boost to the market through instrument sales. POC users stand to generate revenue by maximizing volume for the low-cost tests.

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Urinalysis is already widespread and dipstick urinalysis is the highest-volume POC test in the world. Remaining market opportunity for dipstick urinalysis is largely limited in the placement of bench-top or portable dipstick readers. The instruments eliminate user subjectivity and qualitative reading of dipstick parameters while freeing practices and clinics to run significantly greater urinalysis volumes.

Technology Trends

As new technology emerges, moving forward, practices used in the past may no longer be relevant as urine automation continues to have broader implications for the patient population. While the visual strip analysis continues to be dominant in the urinalysis market, in the last few years, gradual growth is observed in the preference for automated or semi-automated instruments with the advent of digital imaging technology and with laboratories realizing a greater impact on laboratory productivity. In addition, fully automated urinalysis has paved the way for easier standardization while being cost-effective.

Automated urinalysis systems. Automated systems incorporate features that enable a complete integrated chemical and microscopic analysis, generally minimizing errors that occur with subjective interpretation of color change on dipsticks or cell counts done by microscopy. Features of these automated systems include automatic mixing of the specimen before each aspiration, archiving of both the results and images upon which the result was generated, and automatic flagging of samples for follow-up testing. Quality of results may also be improved since samples can be processed more efficiently and closer to their collection time, decreasing the likelihood of cell lysis, microbial contamination, or precipitation from prolonged storage.

Advanced chemistry modules. A typical chemistry module enables the machine to perform 12 or more chemistry tests simultaneously. Some machines have the ability to hold 200 or more dipstick strips at a time. The modules also include measurement of specific gravity by a refractometer. They contain dual wavelength reflectance technology, with color-compensation automatically eliminating interferences. The analyzers incorporate technologies like flow imaging and auto-particle recognition (APR) to auto-classify and quantify 12 types of urine particles as well as sub-classification of other urine particles. All urine particles are digitally imaged for recognizable results, automating microscopy completely with no sample preparation.

Improvements in urine sediment analyzers. Nowadays, automated urine sediment analyzers utilizing digital flow morphology (digital imaging) and fluorescence flow cytometry provide clinical and hospital laboratories the capacity for auto-quantitation and classification of urine microscopy results. In addition, manufacturers have bridged their automated microscopic analyzers with automated urine chemistry analyzers, creating fully automated walk-away urinalysis workstations.

Innovations in software. New software are being developed that drastically improve the data management process by providing auto-verification of urinalysis results directly from the workstation. By combining technologies, it allows users to perform total urinalysis for routine testing as normal specimens would be verified and released and for samples with discordant macroscopic and microscopic results, those samples are withheld from release until manually verified.

The Blockades

Despite the fact that urinalysis can provide lots of vital information, limitations of manual methods including microscopy affect clinical utility to a great extent. Biochemical analysis with reagent strips have improved the scenario to some extent but challenges remain in the microscopy area.

Major challenges include no standardization in centrifugation, slide preparation, slide review, difficulty to manage sample workflow in large labs, and no proper documentation or data management.

The high cost of urinalysis and strict laws and regulations for standardization of these devices is hampering the growth of the urinalysis market. However, lower adoption rate of fully automated urine analyzers in the less developed countries and lower awareness regarding kidney diseases, diabetes, and urinary tract infections are also restraining the growth market.

Future Outlook

More and more laboratories are opting for automation and in the coming years, laboratories may be upgraded to fully automated analyzers. This might reduce the work pressure on the laboratory technologist and also allow standardized results with shorter turnaround times. The new advances may lead not only to improved productivity, but might also have a significant impact on diagnosis and disease management.

Future changes may come in the areas of improved reagent performance, miniaturization of urine analyzers, product format changes, and reagent-less detection. These developments may be driven by the need to reduce sample handling while increasing the amount of clinically relevant information obtained from a given sample.

Moreover, the new models employing blue lasers and other technologies to improve precision and fraction could observe growth. The trend of modular concept enabling instruments to be added as the number of specimens grows may face uplift. This concept also allows for future linkage with urine chemistry analyzers and for transport connections among multiple devices at large-scale facilities.

Pravin Gundewar, Product Manager-Urinalysis and Biochemistry, Sysmex
Industry Speak
Automation − Need of the Hour

Urinalysis market in India is dominated by urine chemistry and is broadly used with limited differentiation between products. Traditional urine microscopy is done by the manual process, which is time-consuming and requires a trained medical technician to characterize particles and cells based on their morphology. To reduce labor and time, many laboratories perform manual urine microscopy only in response to results of initial urine chemistry test despite evidence that accurate urine sediment analysis can provide a more reliable clinical diagnosis. {mosimage}

Need for 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. In 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. The automated sediment analyzers provide improved standardization over manual microscopy.

Advanced solution for automation of urinalysis. 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 (isomorphic RBC and dysmorphic RBC information).

Future of urinalysis. Urine sediment automation is globally available for more than a decade, but in India it has actively started since the last 3 years. Sysmex is the first company to educate the customers on advantages of automation in urine sediment analysis. 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 cross the 100-mark.

Total automation in urinalysis will bring quality of urinalysis results into labs and standardization in urinalysis testing, impacting patient care as a whole.

Pravin Gundewar
Product Manager-Urinalysis and Biochemistry,
Sysmex

John Lutton, Business Development Manager, Randox Laboratories
Industry Speak
The Importance of QC to POC Testing

Urinalysis market in India is dominated by urine chemistry and is broadly used with limited differentiation between products. Traditional urine microscopy is done by the manual process, which is time-consuming and requires a trained medical technician to characterize particles and cells based on their morphology. To reduce labor and time, many laboratories perform manual urine microscopy only in response to results of initial urine chemistry test despite evidence that accurate urine sediment analysis can provide a more reliable clinical diagnosis. {mosimage}

Need for 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. In 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. The automated sediment analyzers provide improved standardization over manual microscopy.

Advanced solution for automation of urinalysis. 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 (isomorphic RBC and dysmorphic RBC information).

Future of urinalysis. Urine sediment automation is globally available for more than a decade, but in India it has actively started since the last 3 years. Sysmex is the first company to educate the customers on advantages of automation in urine sediment analysis. 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 cross the 100-mark.

Total automation in urinalysis will bring quality of urinalysis results into labs and standardization in urinalysis testing, impacting patient care as a whole.

John Lutton
Business Development Manager,
Randox Laboratories


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