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H2 2020 seems more promising

H2 2020 seems more promising

One of most popular routine health screening tests, 2020 has not been a great year for this segment, at least not H1 2020. With the COVID lockdown opening in some areas geographically, the second half of 2020 seems more promising.

Laboratory medicine began with the analysis of human urine, referred to as uroscopy till the 17th century, and today termed as urinalysis. Out of all the analyses performed in the clinical laboratory the urinalysis has one very distinct advantage–it is completely non-invasive!

Until the last decade, semi/automated urine chemistry and manual microscopic urine sediment analysis was the only available and widely accepted urinalysis methodology in India. However, manual microscopic sediment examination is labor-intensive, time-consuming, and lacks standardization in moderate and high-volume laboratories. In addition to these limitations, one important factor is centrifugation loss (unsettled urine particles thrown out in supernatant after centrifugation), which is ignored in the manual sediment analysis process. Still, this methodology is practiced in more than 90 percent of laboratories in India.

Automated technologies and informatics have greatly reduced the labor intensity of urinalysis and have paved the way for significant progress in urinalysis with better accuracy and precision. 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. Microscopy-based urine particle analysis has greatly progressed over the past decades, enabling high throughput in clinical laboratories. Urinary flow cytometry is an advanced alternative for automated microscopy. More thorough analysis of flow cytometric data has enabled rapid differentiation of urinary cells and formed elements with many additional parameters and value-added information and flags.

In addition to UTI flagging, RBC morphology, and bacteria class information, flow cytometry-based urine sediment analyzers provide urinary dilution parameters, namely, conductivity and osmolality, which further improves result interpretation along with specific gravity obtained from urine test strip readers. In a nutshell, automation brings standardization to the whole process and reliability and confidence to report urinalysis results.

Indian market
The Indian market for urinalysis analyzers and reagents in 2019 is estimated at Rs 181.75 crore. Reagents continue to dominate with an 80-percent share, valued at Rs 145 crore.

The fully automated analyzers segment is estimated at Rs 16.75 crore, with integrated analyzers and urine chemistry instruments being almost similar in numbers. The urine sediments trail behind at about 30 percent volume of their counterparts. Automated urine analyzers, based on fluorescence flowcytometry have improved count precision and accuracy, compared with the traditional methodology. However, automation instruments have not really gathered steam.

In the semi-automated instruments category, amounting to Rs 20 crore, the entry level continues to hold sway by the number of instruments procured at 1680 units; albeit the high-throughput instruments bring better revenue, Rs 720 crore in 2019.

One of most popular routine health-screening tests, 2020 has not been a great year for this segment, at least not H1 2020. With the COVID lockdown opening in some areas geographically, the second half of 2020 seems more promising.

Global market
The global urinalysis market is projected to reach USD 4.6 billion by 2024 from USD 3.2 billion in 2019, at a CAGR of 7.6 percent from 2019 to 2024, says ResearchAndMarkets. The growth of the market is largely driven by factors like the growing global prevalence of kidney diseases and urinary tract infections, the shift toward automation in sediment analysis, and the increasing adoption of point-of-care urinalysis. Integrated systems for urinalysis and the emerging economies are expected to provide a wide range of growth opportunities for players in the market.

The consumables segment dominated the market and is the fastest-growing segment owing to rising incidence of urinary tract infections and kidney diseases, which creates the demand for regular urine checkups.

Integrated systems and urinalysis via smartphones and technological advancement present opportunities that are boosting the market. Increase in diabetes cases leads to increased sales of urinalysis dipsticks, disposables, and devices across the globe. However, implementation of excise tax on some devices by the US government, stringent regulatory procedures, and the lack of adequate healthcare infrastructure in low-income countries are factors hindering the growth of the market.

Some of the key market players for this market are Hoffmann-LA Roche AG, Danaher Corporation, Siemens AG, Sysmex Corporation, Bio-Rad Laboratories, Inc., Mindray Medical International Limited, Acon Laboratories, Inc., Arkray, Inc., and United Medical Electronic Group Co., Ltd.

Technological advances
Urinalysis has been a useful diagnostic tool since thousands of years. Although urine was the first body fluid to be examined by mankind for the diagnosis of diseases, it is still one of the most common specimens used in clinical and diagnostic laboratories. New technological advances have paved the way for significant progress in automated urinalysis. Time and accuracy are the two key factors for diagnosis. In UTIs, urine dipsticks are very fast and easy to use, but it lacks the accuracy, whereas on the other hand, urine culture for antimicrobial susceptibility testing shows clinically reliable and accurate results, but it takes up to 3 days to give results.

Many novel and improved diagnostic technologies and tools are introduced in the market, and some of them are already approved for clinical use, and help significantly in increasing the accuracy and decreasing the time of the test; a good example would be nucleic acid tests and mass spectrometry. Some other technologies show promising future like the utilization of smartphone for urinalysis.

Test strip technology. Major improvement in the test strip technology has been made in recent years. Not only are highly sensitive test strips being introduced, but also, now one can find strips, which give quantitative results for urinary proteins.

The financial aspect is also of great importance, especially in the Third World and developing countries; inexpensive test strips for various diagnostic reasons, such as the diagnosis of diabetes from urine sample are available. Test strip method also shows promising results in antibiotic susceptibility tests; if optimum diagnostic requirement is reached, it can reduce the test time significantly from 2 to 3 days to a few hours.

Automated microscopy. Urine microscopy is one of the most important diagnostic methods for UTIs and other kidney diseases. Manual microscopy is time-consuming and can be labor-intensive. Furthermore, with centrifugation, decantation and re-suspension always lead to cell loss and cellular lysis. With the currently available digital microscopy technologies, a significant time reduction can be archived with much more sample being processed in a significantly shorter time in comparison to manual microscopy.

In addition, with the ability to process uncentrifuged urine sample, issues like cell loss and lysis are of no more concern. Many automated analyzers are now available in the market with different kinds of technologies like laminar-flow digital-imaging technology and pattern-recognition technology.

MALDI-TOF. The proteomic method, matrix-assisted laser desorption ionization-time-of-flight mass spectrometry (MALDI-TOF MS) for identification of microorganisms directly from culture, coupled with Gram stain, has given new direction, saved considerable amount of time in diagnosis of UTI, and contributed greatly in the field of clinical microbiology in general.

It can identify different pathogens accurately and significantly in a short time. The utilization of this technology for the diagnosis of UTIs and furthermore in performing antibiotic-susceptibility tests to decrease the testing time from days to as fast as 2 hours can open wide doors.

Urinalysis and smartphones. Smartphone technology has improved the quality of life on countless fronts, and it has large potential for applications in the medical field. With PoC testing attracting much attention in recent years, smartphone solutions can be a valuable tool in this regard. It can, for example, increase the compliance of populations with screening programs by offering an easy and fast screening method. Studies exploring the possibility of establishing a smartphone-based diagnostic platform for rapid detection of Zika, chikungunya, and dengue viruses showed valuable prospects. Several other smartphone applications utilizing urinalysis for various diagnostic reasons have been tested and look promising, which can greatly help medical practitioners and patients alike.

Flow cytometry. Flow cytometry is being introduced as a reliable method for fast diagnosis of UTIs by counting the bacteria in the urine specimen. With the improved counting precision over visual counting methods, highly accurate results can be obtained by this method. Detection of bacteriuria can be achieved with clinical standards, using flow cytometry technology.

Immunochromatographic test strips. Lateral-flow immunochromatographic assay (LFIA) strips are often used for the detection of proteins and hormones. Escherichia coli and Neisseria gonorrhoeae have been detected by mie scattering as indicators of sexually transmitted infections. The LFIA method is based on ELISA, which is considered the gold standard in protein detection. The ELISA relies on captured antibodies to concentrate the target molecule, and a labeled secondary antibody binds the captured targets. The concentration of target molecules is determined by a measurement of the rate of color development, fluorescence generated, or magnetic field, depending on the label used.

The LFIA typically uses antibodies deposited in lines along a test strip. The test strip has a higher detection limit compared to ELISA. A chemiluminescent LFIA design has been produced for the measurement of serum albumin. Light is generated as a result of a reaction catalyzed by horseradish peroxidase (HRP), concentrated at the test and control lines to be detected by a photodiode. Enzyme-multiplied immunoassay technique (EMIT) relies on the use of an antigen, linked to an enzyme that competes with the target analyte for binding sites.

The enzyme is inactivated by binding and enzyme activity can be monitored as a measure of target concentration. Devices are available for the detection of drugs, using EMIT. Multiplexed lateral-flow tests are being developed to improve the utility of portable test strips.

Portable reagent strip readers. Reagent strip readers are an effective way to objectively assess colorimetric test strips. They can be designed to read fluorescent tags, and could work with cell phone cameras, making them particularly useful for diagnosis in low-resource settings. Rapid improvements in the quality of smartphone cameras and image-processing techniques have enabled low-cost devices for quantifying colorimetric test strips. Recently, there has been a significant interest in the development of portable urinalysis reagent strip readers for PoC testing applications.

Outlook
Laboratory medicine’s oldest practice continues to be relevant to this day. Urine is easily obtained and will continue to provide valuable information that is not available from any other source.

Continuing development of microfluidic detection methods for the analysis of urine will lead to reliable sensing modules for many diagnostic indicators. Many of these sensing modules may be integrated in a single device to allow for the simultaneous detection of several analytes. The development of new microfluidic microscopies and lensless imaging techniques provide an opportunity to dramatically reduce the size and cost of microscopic examination of samples. High-throughput microfluidic microscopy has the potential to detect infections with low concentrations of bacteria without long incubation times, significantly reducing the time for test results.

PoC diagnostic devices may be developed that are capable of continuously monitoring urine samples on an ongoing basis, enabling the early detection of diseases and the monitoring of chronic diseases. These monitoring devices may be portable units to be deployed, or permanently installed in the home such as smart toilets. Most of the new PoC urinalysis devices are based on reagent strip readers. The reagent strip design has inspired several chip-based sensors employing a wide range of detection methods. It is not recommended that one should simply develop more test strips to cover a wider range of analytes or concentrations owing to the complex nature of the sample and the interactions among different components. Making a device that incorporates redundancy by measuring several parameters using independent methods may provide more reliable information about sample contents. Not all of the methods used in urinalysis testing need to be translated into microfluidic devices.

Advances in urinalysis automation will certainly improve sensitivity, specificity, and standardization. The recent push toward fully automated systems will set the new standard for accuracy and efficiency in the clinical laboratory. The vast number of metabolites being compiled by the Human Urine Metabolome Database Project will undoubtedly reveal new biomarkers of disease and exciting new breakthroughs for this divine fluid.

Industry Speak

Automation for urinalysis

Naveen Sarda
General Manager,
Suyog Diagnostics Pvt. Ltd.

 

Keerti
Product Manager,
Suyog Diagnostics Pvt. Ltd.

The automated solutions are gaining popularity, which offers the phase-contrast images to classify the cells that are difficult to recognize. Microscopic images can be viewed in three different optical modes–bright field, phase contrast, and composite a synthetic one. With the help of the stored images, the lab technician can use the system for new personnel training. With the phase-contrast option, particles like isomorphic, dysmorphic, and acanthocytes can be easily identified.

Automated systems for urine-chemistry analysis and urine-sediment analysis are the preferred equipment in major labs where minimal physical handling of the samples, complete traceability of urine sample is required, proper transmission of combined results through LIS or LIMS connectivity. Easy quality-control management by a fully automated analyzer helps the laboratory in its internal and external quality audit for accreditation purpose.

With the current COVID-19 situation, the demand for automation from various customers is expected to give a big jump in this market.

Suyog is the only company promoting semi-automated urine sediment analyzer, manufactured by 77 Elektronika Kft., Hungary.

Suyog has presence in various big customers like Dr. Lal PathLabs at their National Reference Laboratory as well as in satellite labs of Delhi–NCR, Metropolis Laboratory, Mumbai, JIPMER, Pondicherry, Unipath Laboratory, Ahmedabad, Sun Path Lab, Ahmedabad, Deenanath Mangeshkar Hospital, Pune, MG Hospital, Jaipur, Asian Gastroenterology Hospital, Hyderabad, Dr. B. Lal Clinical Laboratory, Jaipur, and Medical Trust Hospital, Cochin, to name a few.

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