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Urinalysis Instruments and Reagents

Automated Urinalysis Is Undergoing Remarkable Progress

Technological advances have paved way for significant progress in automated urinalysis and have led to  mechanical integration of test strip readers and particle analysis in urinalysis.

Diagnostic screening of urine samples is the third most common analysis performed by clinical laboratories and thus, the balance of economic constraints and diagnostic accuracy is highly relevant. Until recently, microscopic urine sediment analysis was the most widely accepted urinalysis methodology. However, this time-consuming methodology is associated with extensive analytical errors. Manual urine sediment analysis is still the gold standard in the laboratory. However, over the past 25 years, new automated technologies and informatics have greatly reduced the labor intensity of urinalysis and have created new technical possibilities. Recent advances have led to the production of automated instruments based on flow cytometry or digitized microscopy and are currently available for routine use in large clinical laboratories. These tools allow the examination of large numbers of samples in a short period of time.

Technological advances have also paved way for significant progress in automated urinalysis. Quantitative reading of urinary test strips using reflectometry has become possible, while complementary metal oxide semiconductor (CMOS) technology has enhanced analytical sensitivity and shown promise in microalbuminuria testing. Integration of dilution parameters (e.g. creatinine, specific gravity, and conductivity) in urine test strip readers and urine particle flow cytometers enables correction for urinary dilution, which improves result interpretation. Automated urinalysis can be used for urinary tract screening and for diagnosing and monitoring a broad variety of nephrological and urological conditions; newer applications show promising results for early detection of urothelial cancer. Concomitantly, the introduction of MALDI-TOF MS has enabled fast identification of urinary pathogens. Automation and workflow simplification have led to mechanical integration of test strip readers and particle analysis in urinalysis. 

Indian market dynamics

The Indian market for urinalysis analyzers and reagents in 2017 is estimated at Rs 153.82 crore. Reagents continue to dominate with an 81 percent share, valued at Rs 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 Pharma, 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 Rs 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 by Dirui, Siemens, and Roche. While the transition in the larger laboratories is taking place in favor of fully automated instruments, 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 five 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 Rs 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 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 Rs 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 the last 4-5 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.

Technological advances

Innovation in laboratory technology, which includes both new tests and advances in instruments and testing techniques, has made testing more efficient and automated. 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.

Smartphone-based PoC urinalysis. 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 the HSV space with the circular reference array.

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.

Automation. It is expected that at a large clinical lab, about 70–90 percent of urine samples can 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.

Integration. As part of the drive for automation and to do more with less, in the past five 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.

Road ahead

Over the past two decades, automated urinalysis has undergone remarkable technical progress. As the information obtained by urinalysis is complex, the introduction of expert systems may further reduce analytical errors and improve the quality of sediment and test strip analysis. With the introduction of laboratory-on-a-chip approaches and the use of microfluidics, new affordable applications for quantitative urinalysis and readout on cell phones may become available in the years to come. Both microscopy- and flow cytometric-based instruments generate reliable results that are clinically useful, and automated test strip reading provides added value. Additional integration of existing technologies may further reduce turnaround times. Despite improvements in standardization, most of errors in urinalysis occur outside of the analytical phase; pre-analytical steps, in particular, are much more vulnerable. As analytical variation has been greatly reduced, more efforts need to be focused on the pre-analytical phase.

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