Standardization Is Becoming The Key Focus In Urinalysis

Smaller-scale technology and standardization are just some of the features that laboratories need right now, and it is where the manufacturers are in part focusing on.

Urinalysis tests have meaning not only in diagnosis but also through the patient’s entire course of life. It remains a potent screening tool for the clinician. No other laboratory test can provide as much information on the status of metabolic, renal, infectious, and urologic functions in the body. Indeed, in an era when failure to quickly detect hospital-acquired infections, such as catheter-associated urinary tract infections (CAUTIs), means the loss of significant revenue to a hospital, the need to integrate urine chemistry testing with urine particle analysis is paramount. Being useful in the diagnosis and monitoring of renal and urinary tract diseases, urinalysis has become one of the most commonly ordered laboratory tests, comprising almost one-third of all lab tests.

Urinalysis testing is recently being used as the frontline diagnostic tool in the diagnosis of various UTIs and metabolic abnormalities or chronic diseases such as diabetes. The World Health Organization predicts that by 2020, chronic diseases will account for about three-fourths of all deaths across the globe. India is the diabetes capital of the world because of its incidence in terms of sheer numbers affected by diabetes. There is a need for creating a mass awareness campaign for diabetes prevention and control with a proper monitoring mechanism among people of the country. The need of the hour is forging partnership at stakeholders’ level to develop infrastructure to address the after-effects of diabetes with proper control and prevention mechanism.

The easiest and most cost-effective device being used in urinalysis is paper or dipstick, which allows quantitative or semi-quantitative analysis of urine samples in the shortest possible time by simple observation. New analyzers use fluorescent flow cytometry technology for quantitative cell counts and can detect as few as five bacterial particles in a urine sample to give clinicians an early indication of UTI. Further integration of instrumentation and a slight downward trend in standalone systems is where the market is trending toward nowadays. In addition, time consuming manual microscopy is being replaced by fully automated urine analyzers. These systems are quickly becoming part of routine work in both large and small laboratories as a fast way to exclude urine samples from healthy individuals, increase productivity, and reduce inter-observer variability. The same type of advancements seen in hematology is being witnessed in urine analyzers such as managing reporting and alerts and callbacks, and reruns and flags for pathological elements. However, the challenge is being able to package the technology in smaller pieces while keeping the pricing competitive.

While the visual strip analysis continues to be dominant, in the last few years gradual growth in the preference for automated or semi-automated instruments is being seen. With automated analyzers, the chances of error in reading by the naked eye in visual strips are minimized significantly. The newer instruments also come with print-ready features and have on-board quality control (QC). The fully automated instruments have barcode readers integrated into them, which allow easy identification of patients and other demographic details. Added with features like the ability to integrate with a laboratory automation system (LIS), these instruments provide an easy walk-away and hands-free capability, minimizing the laboratory technologist’s intervention. Smart reagents enable temperature and humidity checks and also easy IoT-specific calibration of all analytes. Smart strips are featured with watermarks such as hologram or 2D barcodes that include details like loT number, expiry date, and calibration. PoC urinalysis offers fast and accurate results with a wide menu of analytes including (but not limited to) albumin, protein, creatinine, glucose, and urea.

Smaller-scale technology and standardization are just some features that laboratories need right now, and it is where the manufacturers are in part focusing their work. The strategy is to continue to build out a urinalysis portfolio to serve each urinalysis market segment. Customers are looking for one vendor to supply all urinalysis needs. The requirements range from visual reads all the way to total lab automation. They also want a single strip strategy, which helps streamline purchasing. Identical strip pad technology used across all platforms makes it possible for laboratories to standardize results within a healthcare network. The prime objective for any urinalysis vendor is to eliminate the need for manual microscopy. That would require refinement of existing technologies to improve the images themselves, enhance any classification or grouping performed by the device, and perhaps provide the user the option to focus up or down on an image as they would with a microscope to get a better view of the cell.

Indian market

The Indian market for urinalysis analyzers and reagents 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 urine chemistry market is growing at a faster rate compared to the last decade where the specimen growth was only 4–5 percent annually. The last 5 years have shown a good growth in the segment with a CAGR of ~20 percent. The sale of strips in India does not correlate with the total tests performed annually; this is because of the fact that 60 percent of the strips are still read visually and majority of the customers are cutting the strips reducing the consumption of the strips. The majority of the sales in urine strips come from the glucose and protein strips, which well correlate with the increase in the diabetic population in India.

Handheld systems are also available mainly for the clinician’s office. More players are entering this market with affordable hardware. This segment is highly price sensitive and only few players are able to give quality solutions to the customer. It is estimated that urine analysis systems held a market of `58 crore in the year 2017. The urine sediment system which is used for urine sediment analysis is slowly gaining acceptance in the market. One of the reasons for the slow growth in this segment is the high cost of the instrument, consumables, and the cost per test. Majority of the urine estimations are performed in the medium-segment laboratories and the test cost to the patient is very low, which is one of the major reasons for the slow growth in the sediment analyzer segment. Only few systems are installed in India mainly in the corporate segment where the sample volume is very high and there is total laboratory automation. One of the major growth factors in this segment is the cost of the urine strips, which at present mainly depends on import. With the current growth rate, it is expected that the urine strips reagents business held a market of around `200 crore in the year 2017, and the Indian manufacturers are moving toward localization of the strips, which will push demand in the coming years.

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.

Global market

The global urinalysis market is projected to expand at a CAGR of 5.4 percent during 2018–2024 to reach a value of USD 1.5 billion by the end of 2024, according to Transparency Market Research. Rising prevalence of UTI and kidney diseases, growing number of diabetic patients, and increasing technological advancement in diagnostic tool for urinalysis are some of the major growth drivers in the market globally. The market gains from the availability of excellent repayment options for urinary catheters. While this could develop the growth of the market, the progressive adoption of urinalysis on the global platform to evaluate endocrinological variations from the standard and metabolic or renal clutters has been anticipated to set the tone for a valuable rise in demand.

Medicare installments usually secure urinalysis procedures when charged along with any other assessment. Furthermore, the growing interest in point-of-care testing (PoCT) technologies and the accuracy they bring to the table could work as a leading growth factor for the market. Since geriatrics are almost in constant need of healthcare and treatment for various diseases, their swelling population size has been predicted to bode well for the world urinalysis market. Even powerful organizations such as WHO have expected the demand for procedures such as urinalysis to grow heavily in the near future. Although the market could witness the lead secured by consumables, instruments have been foreseen to come out as a more promising segment expected to post a 6.8 percent CAGR.

North America is the largest region in the urinalysis market. The major driver for the large market share includes presence of key market players in the region such as Alere, Inc., Bio-Rad, Siemens Healthcare, and Beckman Coulter. Moreover, introduction of the automated urine sediment analyzers such as digital flow morphology (digital imaging) and fluorescence flow cytometry together with high healthcare expenditure in this region are driving the growth. However, Asia-Pacific is expected to observe the fastest growth owing to increasing penetration rate of advanced urine analyzers. The presence of local urine analyzer manufacturers, such as Mindray, Urit Medical, and a large base of the target population with unmet clinical needs are expected to strengthen the market growth in this region.

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. Biochemical analysis with reagent strips improved the scenario to some extent but challenges remained in the area of microscopy. Major challenges were, no standardization in centrifugation or slide preparation or slide review; very difficult to manage sample workflow in large labs; and no proper documentation or data management. 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.

Single-use dipper QC. Given the pros and cons of the dipper- and dropper-style controls, a single-use dipper style control, with extended RT stability, would be the ideal solution for urinalysis dipsticks QC performed at the point-of-care, particularly if the large volume requirement can be significantly reduced. A US patent has recently been granted for such a device whereby the control fluid is contained within a thermoplastic pouch that allows for the full immersion of a urinalysis dipstick in only 1.5 mL of control fluid, a mere fraction of the volume required for the traditional dipper style. Moreover, the single-use nature of the new format mitigates the risks associated with repeated use. Most important, this format directly simulates the analytical process used to test patient samples, thus providing the most robust and appropriate
form of QC for urinalysis dipsticks for any clinical setting.

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.

E-urinal. In future just a simple trip to the bathroom can provide up-to-date and useful knowledge to individuals about their overall health. The E-urinal is a concept-urinal that features a touchscreen attached to the top of the urinal that requires interaction before urination. Once the session begins, the individual urinates into the smart-urinal where the built-in sensors analyze the urine in real time. The smart-urinal takes various measurements to provide an overall health score. Having the smart-urinal in place for early detection will allow doctors to treat the patients before the disease progresses. For example, if the smart-urinal detected the early signs of kidney failure the patient could begin taking medicine before the kidneys actually fail. This could save a patient from having to get a kidney transplant. Lastly, instead of peeing in a cup at a doctor visit, the smart-urinal could enhance this uncomfortable experience.

Outlook

Urinalysis is evolving from a basic screening test to a much more involved testing panel that mirrors what is done today with blood. New systems feature automated particle recognition, which deploys neural networks to improve machine identification and classification of urine particles. The system works by pre-classifying particles and presenting only those particles that require review, thus standardizing the field of view, lighting, and format of data presentation. Technologies are being incorporated into smaller, faster, easier-to-use products that have significantly more analytical horsepower than their predecessors. There is the potential for new biomarkers along with more traditional urine chemistry tests to be added to routine urinalysis. Many labs conclude that the benefit of upgrading a urinalysis workstation will offset the space required. Moreover, there are new systems looming on the horizon, which will truly do more with less (space). These integrated platforms require half the bench space of older platforms. What is foreseen is a shift that will greatly reduce the physical burdens of lab work, shorten the time spent on necessary but non-value-added tasks, and provide better ergonomic experiences, thus supporting lab staff members throughout their careers!

Urinalysis has a dynamic future. New technology for instrumentation, new biomarkers, and new appreciation for the importance of urinalysis in modern medicine are combining to bring the focus back to where laboratory testing started so long ago – while also bringing urinalysis into the 21st century. According to Centers for Disease Control and Prevention (CDC), diabetes is one of the most common chronic diseases among humans. It is on a constant rise among the Indian youth and as urinalysis plays an integral role in the diagnosis of such diseases, the urinalysis market in India is expected to grow significantly in the near future. Increase in advanced urine analyzers adoption, coupled with large number of untapped population and the introduction of technologically advanced, rapid, non-invasive, and user-friendly tools for urinalysis are estimated to be the major growth drivers of this market. Government policies to promote health awareness accompanied by health insurance industry expansion may positively influence growth.

Industry Speak
Urinalysis Solution

The major factor boosting growth of the diagnostic market in India is the cost advantage that Indian laboratories offer over similar laboratories in other countries like USA. The magnitude of target diseases such as UTI, kidney diseases, and diabetes, is immense with the occurrence of millions of new cases every year. Urinalysis is used as the primary diagnostic tool for diagnosis and management of these diseases.

Albumin is the most common type of protein found in urine and testing for albumin in urine (known as albuminuria) can act as an early marker of kidney disease. Kidney function deterioration prevents adequate filtering of the protein. As a result, Albumin escapes from the kidneys into the urine. Testing may be used when for screening for kidney function, in attempt to recognize early stages of kidney disease and allow for appropriate treatment.

Creatinine is a by-product of muscle metabolism and is released into the urine at a constant rate, the creatinine measurement is used to correct for urine concentration in any urine sample.

Albumin creatinine ratio (ACR) levels lower than 30 mg/g (category A1) indicate normal to mild increase in albuminuria levels, normal kidney function. ACR levels between 30–300 mg/g (category A2), indicate moderately increased albuminuria levels, a sign of early kidney disease. ACR levels greater than 300 mg/g (category A3), indicate severely increased albuminuria levels, a sign of severe kidney disease.

On the basis of product, the market can be segmented as instruments and consumables. Automated and semi-automated biochemical urine analyzers, urine sediment analyzers, and microscopic urine analyzers are the majorly used instruments in the urinalysis market. The rising trend of automation being used in the urine analysis diagnostics is anticipated to provide an ancillary force for the growth of point-of-care and self-testing based urinalysis devices.

DiaSys India has ventured into urinalysis business domain by launching QDx Urilyzer DS 100.This comes with ACR. The aim has always been to reach the tier-II and tier-III cities by offering cost effective testing of ACR. QDx Urine DS 11 ACR strips would aid the diabetologists and nephrologists for accurate screening of patients by giving quantitative ACR, thus eliminating interference from the proteins.

Karthik Balasubramanian
Product Manager,
DiaSys Diagnostics India Pvt. Ltd.

Industry Speak
Clinical Value of Urinary Biochemical Parameters by ISE

Sodium is the principal cation of the extracellular environment and plays a central role in maintaining the water distribution and osmotic pressure in the extracellular space. The extra-urinary outputs (digestive tract, sweat) representing only a small part, the excess sodium is excreted by the kidneys.

Potassium is the major intracellular cation. Potassium filtered by the glomeruli is completely reabsorbed by the proximal tubule. Potassium urine is secreted by cells distal

Chloride is the major extracellular anion. Chloride anion is also the most abundant gastric and intestinal secretions. Chloride ions food are completely absorbed by the gastrointestinal tract.

Normal values

There are no fixed reference values for sodium, potassium, and chloride, since the kidney adapts its rate of excretion of different solutes to the needs of the body and food intake.

Usually normal values are: Sodium: 50 to 220 mmol/24 h; Potassium: 25-130 mmol/24 h; and Chloride: 50-220 mmol/24 h.

The interpretation requires knowledge:

• The clinical condition of the subject sign of dehydration-hydration, prescribed medications such as laxatives, diuretics, corticosteroids.
• Renal function (creatinine clearance or serum creatinine)
• The supply of water and electrolytes,
• The leakage by extrarenal (diarrhea, vomiting, sweating).

Diagnostic value of urinary sodium

For the differential diagnosis between organic and functional impairment, the sodium / potassium ratio in urine is usually greater than 1.

It is an indication of the mineralocorticoid activity. A ratio below 1 indicates a functional renal failure linked in general to hypovolemia by sodium leak.

Diagnostic value of urinary potassium

It is more limited in relation to urinary sodium. Urinary potassium can be used to evaluate patients with unexplained hypokalemia.

Diagnostic value of urinary chloride

The potential clinical value of urinary chloride exists only in patients with persistent metabolic alkalosis of uncertain cause. A chloride below 10 mmol / l directs to a “meet the chlorides alkalosis” due to a depletion of chloride of gastric origin.

George Ferrandi
Head – Automation,
Horiba Medical

Industry Speak
Automation In Urinalysis Important For Accurate Screening

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.

While visual microscopic sediment analysis remains the gold standard, in recent times, the focus has shifted to automating urine microscopy to minimize subjective variations, simplify laboratory workflow, improve standardization, reduce turnaround time, and human intervention, especially in high-volume labs. Most developments in automation are focused on enhancing the processes to decrease false negative results and thus improve the accuracy. Semi- and full-automation further address the major challenges of the visual microscopic technique such as no standardization in centrifugation, slide preparation and review, and data management.

Automated Digital Imaging Microscopy also Offers the Benefits of

• Increased sensitivity especially toward evaluation of urine particles of different sizes (ranging from 1 to 100 µm)
• Identifying casts (the most brittle component) and dysmorphic erythrocytes (important in the diagnosis of glomerular disorders)
• Obtaining clear pictures simulating microscopy images to accurately categorize the different urine elements

Further, in the past few years, laboratories have started preferring integration of urine chemistry with sediment analysis. The user stands to benefit since automation and integration of results offer rapid and accurate screening.

Transasia Bio-Medicals Ltd. has recently introduced its latest fully automated urine chemistry and sediment analyzer – Laura XL. This analyzer is designed to ease the routine workflow with complete automation. It employs the principle of automated bright field microscopy with the latest artificial intelligence technology, for advanced recognition of the widest range of urine sediments.

With many other features that aid high accuracy and reproducibility, Laura XL is set to revolutionize urinalysis for high workload labs.

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

Industry Speak
Malaria Diagnosis and RDTs

Monsoon brings with it raindrops, plenty of diseases which include malaria, dengue, chikungunya, typhoid, viral fevers, diarrhea, jaundice etc. Vector-borne diseases have continued to wreak havoc on millions of people, particularly in the poorest parts of our world. Dengue and chikungunya are viral diseases spread majorly by Aedes aegypti and also to some extent by Aedes albopictus. Malaria disease which is often called as king of all diseases continues to throw a severe challenge on the society to control diagnosis and eradicate the disease. Malaria is a life-threatening protozoal disease, transmitted by the infected female Anopheles mosquitoes and caused by parasites known as Plasmodium. These are majorly of four types P. falciparum, P. vivax, P. malarie, and P. ovale. It is a disease that can be treated in just 48 hours, yet it can cause fatal complications if the diagnosis and treatment are delayed.

Although peripheral blood smear is considered a gold standard and provides more comprehensive information it has its own set of constraints including the test to be performed in the hands of a pathologist or very skilled technicians. On the other hand, in last decades, rapid diagnostics tests (RDTs) have opened very exciting avenues for diagnosis of malaria. RDTs are based on principle of detection of either antibodies or antigen. In India however, the Union Health Ministry, a couple weeks before the World Malaria Day in April this year, banned the manufacture, use, and sale of malaria antibodies test. The order observed that these kits as a form of serological testing are not practical for routine diagnosis of acute malaria owing to the time required for the development of the antibody, the persistence of antibodies after clearance of an active infection, and the fact that serology does not detect current infection, but only measures past exposure.

J Mitra & Co. Pvt. Ltd has been manufacturing a wide range of malaria antigen detection cards for decades now. These rapid test devices include Advantage Mal Card (for pLDH-based detection of Pf & other Plasmodium species); Advantage Malaria Card (for differential detection of Pf (HRP-2) and P. vivax (pLDH); Advantage Pan Malaria Card (for pLDH-based detection of all four Plasmodium species); Advantage P.f Malaria Card (for HRP-2 based P. falicaprum detection); Advantage Malaria Pan + P.f Card (for HRP-2 specific P. falciparum & pLDH-specific PAN malaria detection)

All these tests have very high levels of sensitivities ranging from 97 to 100 percent and specificities ranging from 99.7 to 100 percent. These ranges of malaria products from J. Mitra have also shown excellent performances in the evaluations done in 2013 by WHO, Geneva, and FIND, Geneva.

Jatin Mahajan
Managing Director,
J.Mitra and Co. Pvt. Ltd

Second Opinion
The Role Of Automation In Urinalysis

Urinalysis is performed as part of most routine medical examinations and is necessary for the diagnosis and monitoring of conditions such as urinary tract infection, kidney, and bladder diseases. Routine urinalysis comprises urine chemistry and urine microscopy tests.

Current urinalysis in India

The traditional approach involves a two-step procedure in which semi-quantitative dipstick tests are used in the first step to evaluate chemical and physical parameters, while microscopic analysis of insoluble components is performed in the second step. Traditional urine microscopy is time consuming and requires a trained medical technician to characterize particles and cells based on their morphology. In order to reduce labor and time, many laboratories perform manual urine microscopy only in response to abnormal results from an initial urine chemistry test, despite evidence that urine microscopy can provide a more reliable clinical diagnosis.

Need for automation

Routine urine particle analysis typically involves a number of manual steps including centrifugation, re-suspension, microscopy, and finally manual documentation of the results. These numerous steps can make the process time consuming, laborious, and at risk for subjective and transcription errors.

During the last 10 years, the use of flow cytometry-based analyzers that measure quantitatively both leukocytes, RBCs, bacteria and other cellular elements have made their presence felt. Fluorescence flow cytometry, a proven technology used in 5-part differential hematology 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, reduces turnaround time and allows skilled technologists to devote their time to other laboratory priorities. Urine flow cytometry uses semiconductor laser technology for the analysis of the formed elements in urine. Superiority of fluorescence flow cytometry gives information as described in the table.

These systems have been further developed especially in terms of the most frequent findings in urinalysis and this advanced technology excels in providing the shortest turnaround time and improves workflow efficiency, reliably selecting out normal samples, more sensitive detection of samples with indications of UTIs, better detection and differentiation of hematuria, precise and accurate bacteria count helps in screening samples for cultures, and complete automation with quality controls and traceability.

Future of urinalysis

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

Dr Sanjay Arora
Director,
Suburban Diagnostics

Second Opinion
Urinalysis Market Trends

The urinalysis market is going to witness a growth owing to high incidences of obesity coupled with hypertension and diabetes. Rising kidney diseases owing to change in food consumption habits accompanied by growing concerns from the elderly population are among the major drivers. The magnitude of the target diseases is immense with the occurrence of millions of new cases every year. The huge base of the target population and the observed high, unmet clinical needs in the under-developed regions provide the market with a large pool of opportunities for potential growth. To capitalize on these opportunities, the development of diagnostic tools that can respond to these clinical needs at an affordable price is mandatory. Furthermore, the growing prevalence of an inactive lifestyle in individuals fuels the epidemic in many regions.

However, the lack of adequate healthcare infrastructure in low-income regions is a major restraint in the adoption of the latest diagnostic tools for urinalysis. Urinalysis testing is used as the front-line diagnostic tool in the diagnosis of various metabolic abnormalities and UTIs. Urinalysis is also used as a disease management tool for the treatment of chronic diseases, such as diabetes, chronic kidney disease (CKD), and urinary bladder cancer. Over the past decade, laboratories and clinicians have contributed to a list of necessary 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.

Rekha Dubey
CEO,
Aditya Birla Health Services Ltd