Medical laboratory diagnosis begins with qualitative urinalysis using random voided urine for sugar and micro albumin to diagnose symptoms associated with infection, diabetes, and renal failure. Biochemistry plays a significant role in quantitative measurements of metabolites and its end products excreted in urine to correlate their levels in blood. Combined with latest innovations, longstanding laboratory practices for urinalysis are being revised with significant benefits to hospitals in quality, turnaround time, cost savings, and improved physician and patient satisfaction. Technology advances now allow hospitals to switch from manual to fully automated urinalysis to improve accuracy, streamline workflow, enhance productivity, and reduce overall costs.

The urinalysis market is witnessing an admirable growth with high incidence rate of obesity along with diabetes, hypertension, and chronic kidney diseases. With rising geriatric population, the demand for urinalysis tests for detection of various age-related diseases will also increase. Technological advancements, together with the launch of advanced products in the market are also fueling growth.

Portable and battery-operated urinalysis stimulates the growth of the urine sediment analyzers. In addition, non-dipstick analytes could develop an opportunity for growth. Market trends in this analyzer market include development of low cost urine analyzers and innovations in the electronic industry, such as increased memory and enhanced computing power. However, maintaining a comprehensive diagnostics interpretation would be a challenge. Factors such as stringent and varied regulatory environment that delays the launch of product and low adoption rate of fully automated solutions in developing countries might also hinder the growth of the market.

Global Market

The global urinalysis market is forecast to reach USD 1286 million by 2019 at a CAGR of 7.6 percent from 2015-19 dominated by North America, followed by Europe, Asia, and the Rest of the World (RoW), according to Markets and Markets. Over the next five 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 urinalysis devices have opened an array of opportunities for growth of the urinalysis systems market. However, lower adoption rate of fully automated urine analyzers in the developing countries and lower awareness regarding kidney diseases, diabetes, and urinary tract infections are expected to restrain the growth of the market.

The sediment urinalysis segment is likely to witness highest growth in the forecast period with technological advancements. The disease diagnosis application is expected to gain greater prevalence in the forecast period with rising prevalence of various chronic diseases. Hospitals and clinics are the major end users of the urinalysis systems.

Key players in the global urinalysis systems market include Alere Inc., ARKRAY Inc., Bio-Rad, Danaher, Mindray, Roche Diagnostics, Siemens Healthcare, Sysmex, and Urit Medical.

Technology Trends

Traditional urinalysis has been prone to variability. But in recent years, urinalysis has been quietly tiptoeing into a new era, using automated urine microscopy and urine chemistry to their full potential. Automation has become a standard norm in the industry and new demand in the market is mostly for such analyzers. Demand for reagents continues to grow, especially with the need to cater to a large installed base of IVD instruments.

An effective diagnostic strategy for urinalysis is based on standard procedures for collection, transport, sample preparation, and analysis. In view of a better reproducibility of the analyses, the pre-analytical requirements are becoming stricter. Fully automated urinalysis and sedimentation processors with the capability to automate urine strip reading as well as performing sedimentation cell analysis for abnormal samples have gained widespread adoption.

Integrated analyzers. Manufacturers are offering hospitals and clinicians seamless wireless connectivity and improved bar-coding capabilities for point-of-care urinalysis testing. These enhancements have enabled greater flexibility, risk management, and speed. Standalone systems with a full range of tests have simplified routine analysis. A major development in techniques was the automation of microscopy by image analysis of native urine samples. This technique has been a step toward the right direction, since the number of particles analyzed was much larger, resulting in improved results.

Combining an automated image-based urinalysis system and a chemistry dipstick analyzer allows images to be stored and viewed on the workstation screen, thereby eliminating the need for manual microscopy in most cases.

The auto particle recognition software categorizes structures putatively identifiable as bacteria. The automated analyzers use a different technology to classify and quantify urine sediment particles and offer an improvement in standardization over manual microscopy by eliminating potential inter-technician variability during slide interpretation.

The current generation of urine sediment analyzers are capable of interfacing with automated strip analyzers to produce comprehensive routine urinalysis reports. Both physicochemical and microscopic examination appear necessary for effective screening purposes, and use of a fully automated system allows this to be accomplished while avoiding the cumbersome and labor-intensive process of manual microscopy.

These systems have built on the foundation of conventional analyzers and are offering features such as a new digital imaging measurement system to improve results accuracy, intuitive user interface, enhanced ease of use, and automatic entry of cassette lot numbers and expiration dates. Patient results can now be wirelessly transmitted from the urinalysis system to laboratory information systems, or electronic medical records.

Flow cytometry in urinalysis. Implementation of flow cytometry in the analysis of urinary particles was a leap forward in basic urine diagnosis. A large number of particles can be evaluated in a short period of time, using only a small amount of native urine (without centrifugation). Moreover, automation has allowed standardization of particle analysis. Flow cytometric analysis renders higher numbers for erythrocytes, leukocytes, and epithelial cells in comparison with manual microscopy. Fully automated urine fluorescence flow cytometer for mid-sized laboratories have been designed to bring efficiency and quality to routine urine microscopic analysis. This has offered precise and selective bacterial detection with an individual channel and no special pre-analytical handling for sample turbidity or volume, and no image review or sub-classification is necessary.

Automated microscopy. Integrated urine analyzers analyze all physical and chemical characteristics of urine and sediments in urine on a single platform; however, some formed elements present in urine, casts for example, require manual microscopic examination of the urine sample following the use of the automated urine analyzer. While automated methods for urine chemistry are not all that new, automated microscopy is transforming laboratories by allowing for more accurate, efficient, and standardized results. One of the most valuable components of urinalysis'microscopy'continues to be performed by hand at many institutions, even large medical centers.

Individual labs strive to standardize urinalysis results by establishing reference ranges for their patient populations, reporting the number of blood cells per high-powered field. It is a challenge for the laboratory to control the steps in the pre-analytical phase that contribute to pre-analytical variability. It is still complex to standardize the results of manual microscopy across institutions, given the myriad of variations in the volume of urine being spun down, the speed and duration of centrifugation, and the volume of supernatant used to resuspend the sediment.

Manual microscopy counts are still required when a sample is flagged by the hematology analyzer and are still the reference method for WBC differential counts. Automated microscopy analyzers can provide accurate WBC differential counts, which may replace manual microscopy, but not the eye of the cytologist. To reduce the variability, it is necessary to look at the pre-analytical process as a complete entity, from test ordering to the moment of specimen processing. Automation of microscopy by image analysis of native urine samples is a step in the right direction, since the number of particles analyzed is much larger, resulting in improved results. In recent years, automation has had a tremendous impact by allowing labs to standardize and improve the accuracy of urinalysis results. Automation has improved precision by analysing a larger number of cells in comparison to visual methods.

Industry Speak
Automation - The Only Way Forward

Urinalysis is recognized as an integral parameter for diagnosis. Analysis of the visual and chemical composition of urine plays an important role in disease detection. Earlier, the process of urinalysis was only through visually studying the color change and turbidity. For obvious reasons, the method was error-ridden. With the advent of latest technology, the process is now done either through visual detection with urine strips and/or automation.

Urine strips. Urine chemistry strips are mainly used for routine testing, treatment monitoring, and preventive medicine. There are different types of strips available in the market providing high diagnostic specificity and sensitivity. Laboratories aim to provide accurate results and hence do not compromise on using quality urine strips. Strips are available with a compensation pad that nullifies the color interference, thereby reducing the possibility of misleading results, especially in colored urine samples.

Automated analyzers. Considering the vast scope, majority of the labs/hospitals are moving toward automation to provide cost-effective results with high quality. Mid- to large-size laboratories mainly look out for speed and accuracy. Hence, automated analyzers that provide objective evaluation of urine samples are gaining momentum with their ease of operation and faster turnaround time. The continuous loading analyzers offer added advantages over strip readers such as higher memory, LIS, throughput, and QC. On the other hand, sedimentation analyzers are proving to be more efficient to those laboratories where the sample load is quite high.

Transasia Bio-Medicals Limited has been providing urine analyzers of the highest quality. Laura M analyzer is produced by ERBA Lachema, the Czech Republic subsidiary of ERBA -Transasia Group. Laura M Urine analyzer provide objective evaluation of urine samples, which helps eliminate any subjective interpretation and operator bias of the color reaction of the diagnostic pads.

Major features of Laura M include - smooth workflow management with continuous loading and results in 60 seconds; efficient data management with internal memory capacity of 2000 measurements; cutting-edge hardware features providing hygienic disposal of used strips by waste container and in-built thermal printer that flags all abnormal results; and PHAN diagnostics strips that are protected against the common concentration of Ascorbic Acid (200-800 mg/dL).

Mahendra Paranjape
Sr. Product Manager,
Transasia Bio-Medicals Limited

Industry Speak
Automation - Need of the Hour

Urinalysis in India. Urinalysis market in India is dominated by urine chemistry and is broadly used with limited differentiation between products. Traditional urine microscopy is done by 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. Sediment analysis by manual microscopy has lot of limitations.

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 urine samples that lack pathologic findings. In our experience 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. The automated sediment analyzers provide improved standardization over manual microscopy.

Advanced solution for automation. 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 International Society for Laboratory Hematology (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 last two 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.

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

Pravin Gundewar
Product Manager-Urinalysis & Biochemistry,
Sysmex India Private Limited

Industry Speak
From Uroscopy to Urine Particle Flow Cytometry

Urinalysis has been an integral part of pathology since ages, yet traditionally it occupied a corner space in any medium to bigger medium laboratory. Despite the fact that urinalysis can provide lots of vital information, limitations of manual methods including microscopy affected its clinical utility to a great extent. Biochemical analysis with reagent strips improved the scenario to some extent but challenges remained in the microscopy area.

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

We at Mindray have a core belief that innovation is the only way ahead and we have been successful in bringing refreshing technologies in various fields of healthcare including urine sediment analysis.

In our EH Urine Sediment Analyzer series, we employ certain unique technologies to bring ease in urinalysis.

Coordinate positioning tracking recognition (CPTR) uses low power lens: 10 × 10 (100 fold enlarged); high power lens: 10 × 40 (400 fold enlarged); low power lens can screen negative samples (takes 10 images), detect and count particles, remembers the coordinates, also identifies cats and epithelial cells; and high power analysis can Identify RBC, WBC, crystals, yeast, small round cells & casts classification.

Dynamic intelligent focusing (DIF) ensures accurate recognition and clarity of images.

Once images are captured, image morphology is analyzed by MV (machine vision) technology, which offers whole viewfield microscopic images of the sediment. DIF is closest to the gold standard manual microscopy; provides both LPF and HPF images; operators can review the images to make modification or custom more classification.

With above mentioned intuitive methods we have able to counter traditional roadblocks in urinalysis and look for a rapidly emerging market in urine sediment analysis.

Varun Kumar Sharma
Assistant Application Manager (IVD),
Mindray Medical India Private Limited

Second Opinion
Technology Trends - From Past to Present

Traditional urinalysis was said to be messy, tedious, and prone to variability. For many clinicians it was just a screening tool, with an emphasis on just. Then we had a golden time when urinalysis was very important; even before there were such things as doctors, people were looking at the color, consistency, and smell of urine.

In recent years, urinalysis has been quietly tiptoeing into a new era. We are in the period of resurgence, using automated urine microscopy and urine chemistry to their full potential.

Medical laboratory diagnosis begins with qualitative urinalysis using random voided urine - an excellent specimen of choice for the detection of HIV-antibody, screening for TB, cytology for high grade tumors, apolipoproteins, kidney injury markers, bladder cancer markers, fibrinopeptide A for ovarian and gastric cancers and many other biomarkers.

In recent years, automation has had a tremendous impact by allowing labs to standardize and improve the accuracy of urinalysis results. We do not have to worry about differences between technicians reading a specimen and the area of the slide they are reading.

Racks containing urine specimens can be loaded into the analyzer, which automatically pipettes samples onto dipsticks and prints the urine chemistry results. Positive samples are sent to the flow channel where the specimen is aspirated and subjected to flow cytometry. Though flow cytometry has been used in hematology assays for many years, it took a long time for the technology to transfer to urinalysis.

Within the application of flow cytometry to urinalysis, evolution is occurring on a smaller scale. Different dyes are used, separate channels are created, and more companies are interested which means greater competition and even upcoming of better technology.

Digital imaging, another option for automated microscopy, tends to have a lower positive predictive value compared with flow cytometry. Having the pictures from digital imaging, and being able to save the pictures, is valuable from a teaching perspective and an accountability perspective. Automated systems do not eliminate the need for manual microscopy, but they greatly reduce the lab technician's burden.

Dr Somika Sethi
Lab Director,
Delhi Heart & Lung Institute, New Delhi

Second Opinion
Moving toward Automation

Urinalysis happens to be one of the most commonly ordered tests by clinicians for assessing the urologic conditions of patients, comprising almost one-third of all lab tests. The easiest and most cost-effective device used in urine analysis is paper or dipstick which allows quantitative or semi-quantitative analysis of urine samples in the shortest possible time by simple observation. The global urinalysis market is expected to reach USD 1.28 billion by 2019 from USD 0.89 billion in 2014, growing at a CAGR of 7.6 percent from 2014 to 2019.

Technology trends. While the visual strip analysis continues to be dominant in the urinalysis market, in the last few years, we have seen gradual growth in the preference for automated or semi-automated instruments. With these automated analyzers, the chances of errors in reading by the naked eye in visual strips are minimized significantly. The newer equipment also come with print-ready features and have on-board quality control (QC).

The fully automated instruments have barcode readers integrated into it, which allow easy identification of patients and other demographic details. Added with features like the ability to integrate with laboratory automation system (LIS), these instruments provide an easy walk-away, hands-free capability minimizing the laboratory technologist's intervention.

Smart reagents enable temperature and humidity checks and also ease lot specific calibration of all analytes. The smart strips are featured with watermarks such as hologram or 2D barcodes that include details like lot number, expiry date, and lot calibration. Point-of-care (PoC) urinalysis offers fast and accurate results with a wide menu of analytes including albumin, protein, creatinine, glucose, and urea.

Key growth drivers. Increased spending on healthcare and the fast-growing diagnostics sector are major growth drivers. Demand for urinalysis instruments for drug abuse is also on the rise. There is also a gradual shift in the preference from manual analysis to more sophisticated and fully automated instruments.

Future outlook. More and more laboratories are opting for automation and in the coming years, we will see laboratories upgrading to fully automated analyzers. This will reduce the work pressure on the laboratory technologist and also allow standardized results with shorter turnaround times.

Dr Th Dhabali Singh
Managing Director,
BABINA Diagnostics, Imphal

Second Opinion
Automation Is the Key

Urinalysis is undoubtedly the most important and useful test for the prediction of many diseases in the medical field. It gives an insight to the overall physiological or pathological status of the body as it is an ultra-filtrate of blood which is undoubtedly the elixir of life.

Urinalysis has a broad spectrum of utilities ranging from newborn babies to geriatric age group and from medical to surgical patients.

Conventional urinalysis inolves physical, chemical, and microscopic analysis. A brief physical examination comprises appearance, amount, odor, and specific gravity of urine, while chemical examination includes the presence of different abnormal components in the urine like sugar, protein, and ketone bodies.

Microscopic examination is useful for the detection of the presence of cast, crystals, and different types of cells like RBC, WBC, and epithelial cells. All these parameters indicate the kidney disorder.

Physical and chemical analyses are now done using specialized automated analyzers like Uri-scan optima that uses dipstick technology read by reflectance photometry.

This technological advancement has virtually replaced the lengthy and somewhat subjective manual methodologies of physical and chemical urine examination. Most small laboratories have single channel urine analyzer that can perform upto 36 tests/hour in routine mode, consuming just 100 seconds for analyzing a single urine sample. The microscopic analysis however remains the fortress of the pathologist.

Urine can be cultured for specific bacteria in case of infections, as well as antibiotic sensitivity can be performed to combat with the specific bacteria, which reduces the morbidity of the patient and improves the accuracy of the treatment.

Finally where a large number of urine samples are required to test, automation is best and nowadays in the market it has uprising trend for best and fast result.

Dr Suman Lata Verma
Professor, Department of Pathology,
GSVM Medical College, Kanpur

Second Opinion
Automated Urinalysis in Clinical Laboratories

Urinalysis is a valuable, most frequently performed tool to diagnose and monitor renal and urinary tract diseases, typically representing upto 30 percent of all samples received in a moderate to high sample volume test in clinical pathology laboratories.

Microscopic examination is performed manually on sediment from centrifuged urine samples. This process is both time consuming and labor intensive, requires advanced technologist training for accurate interpretation, can be subject to errors, and there is inter-technical variability during slide preparation.

Automated urinalysis offers the benefits of convenience, efficiency, and increased productivity for detections of renal and urinary tract abnormalities. The true value lies in the ability to efficiently screen and report urine samples that lack pathologic findings.

The first method uses digital imaging to capture and analyze 500 images of each sample and auto particle recognition software to classify isolated images of urine particles on the basis of texture, contrast, shape and size.

The second method uses automated fluorescence FC based on diode laser technology together with hydrodynamic focusing on conductometry. The sample is delivered to a flow cell using HDF to ensure each formed particle stained by use of specific fluorescent dye. The particles pass through the laser beam. The scattered light is detected by a photodiode. FSC provides information on the size and the SSC gives information on the surface and internal complexity. Fluorescence intensity provides information on nucleic acid content of each particle.

In the third method, digital imaging and automatic particle recognition software are used to classify urine particles. Size, shape, and texture are used by software to classify each image. Automated microscopy of urine sediment is achieved by specially designed cuvettes. Samples are centrifuged to form a monolayer in one plane at the bottom of the cuvettes. A camera takes 5 to 20 digital images and image recognition software detects and classifies the particles. Since automation improves accuracy and precision of urine screening, faster results lead to faster diagnosis and treatment of patients.

Dr Vanajakshi S
HOD & Sr. Consultant,
Department of Hematology & Clinical Pathology,
Apollo Health City, Hyderabad

Automation at the urinalysis bench has the potential to aid the clinical laboratory in achieving quality metrics for incentive payments. Labs can lead the way to smarter, more cost-effective testing by evaluating urinalysis automation as a tool for reducing the number of urine cultures. In recent years, automation has gained traction by allowing labs to regulate and improve the accuracy of urinalysis results.

Fully automated urinalysis provides the ability to create a high level of standardization for the lab. Lab directors are looking for an automated system that is accurate and efficient, and that streamline workflow, fits in the desired lab space, and has a high level of bacteria detection. They also are keeping in mind the over-arching objectives of automation in the clinical lab - to lower costs, increase efficiency, and help improve the quality of patient care.


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