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Urinalysis Instruments and Reagents

From the era of microscopy to automation and beyond

From traditional microscopy to cutting-edge automation, urinalysis has evolved dramatically, revolutionizing diagnostic accuracy and efficiency, promising new insights, and enhancing patient care in healthcare.

Urine analysis is one of clinical laboratories’ most widely used analytical methods. Through urine dry-chemistry analysis, urine’s multiple physical and chemical properties can be obtained simultaneously. Urine-formed element analysis mainly includes identifying red blood cells (RBCs), white blood cells (WBCs), casts, and other formed components in urine.

Urine microscopy was introduced into clinical practice in 1830, and as microscopy technology has advanced, it has gradually become a diagnostic standard for patients with suspected kidney disease. Urine analysis may detect various diseases, such as urinary tract infection (UTI), kidney disease, and diabetes, at an early stage, and it plays a key role in evaluating acute kidney injury (AKI).

Currently, the main methods for analyzing urine formed components are manual microscopy and various types of fully automated urine analyzers. Although urine analyzers are more convenient and faster than manual microscopic examination, examining urine sediment by microscopy is still a reference for urinalysis.

Non-invasive biomarkers have been implemented in the medical sector for several decades, with their usage expanding significantly as technology and medical research have advanced. This transformation has made diagnostics more accessible, efficient, and patient-friendly. As technology progresses, the use of non-invasive biomarkers is expected to grow, bringing new opportunities for early disease detection and personalized medicine.

Indian market dynamics
The Indian market for urinalysis analyzers and reagents 2023 is estimated at ₹256 crore. Reagents dominate with an 80-percent share, valued at ₹205 crore.

The fully automated analyzers segment is estimated at ₹20 crore in 2023. In this segment, urine chemistry instruments are now more popular, with their counterpart, the urine sediment analyzer segment, being catered to by a handful of companies. The integrated instruments, a combination of urine-formed elements analyzer and urine analyzer, continue to dominate, with medium-sized diagnostic centers showing a strong preference for them. Combining urine chemistry and microscopy, they are easier to maintain. The labs also prefer analyzers with minimal consumables, where only cuvettes are needed, and no liquid reagents, with consumable exchanging taking less than 3 minutes.

Major players*

2023

Fully automated instruments & reagents

Urine Chemistry Siemens, Beckman Coulter, Transasia, Sysmex, Agappe, Mindray, Rapha, Arkray, and Roche
Urine Sediments Siemens, 77 Electronika (Suyog), Sysmex, Dirui, Matrix (AVE), Roche, Mindray, URIT, and Beckman Coulter.
Integrated Matrix (AVE) , 77 Electronika (Suyog), Sysmex, Transasia, Beckman Coulter, and Dirui

Semi-automated instruments & reagents

Tier I Siemens and Transasia
Tier II Agappe, Rapid and Tulip
Tier III Iris (Beckman Coulter), Rapha, AVE China (Matrix), Abbott, Dirui and Mission

*Vendors are placed in different tiers on the basis of their sales contribution to the overall revenues of the Indian urinalysis market.

ADI Media Research

The larger diagnostic centers are finding success with rental instruments, and more companies are giving in to placements. Smaller machines are more prevalent in space-constrained labs in metros, where fewer samples and high recurring costs force the hospitals to economize.

Urine automation is set for a revolutionary change, moving to a more compact and accurate hybrid system with the latest AI connectivity and AI system. Although hybrid machines are finding great popularity worldwide, in India, they have yet to make an impression. A fully automated hybrid urinalysis analyzer uses flow image analysis technology; it separates the same types of particles and puts them all in one category to review, allowing much higher linearity. This three-in-one compact analyzer allows urine dry chemistry, physical, and sediments to be performed on one instrument. It enables routine analysis, urine-formed element analysis, and counting through one sampling. Various strip choices and as many as 14 dry chemistry parameters provide doctors and patients with more diagnostic data. With flexible and quick responses to customers’ requests, the software has relatively frequent upgrades with new features. The instrument saves lab space as well as time with its constant throughput of 240 t/h in dry chemistry mode and 120 t/h in sediments or hybrid mode.

The semi-automated instruments category amounts to ₹31 crore while the entry-level instruments continue to constitute 65 percent of the market by value.

Global market dynamics
Due to rapid growth in the senior population, the prevalence of age-associated diseases, such as diabetes and liver and kidney diseases, is expected to increase significantly. The diagnosis and management of such diseases are responsible for the increasing number of prescriptions for the basic metabolic panel, lipid profile, and liver and renal panel tests. These tests are performed by urinalysis analyzers, thereby positively impacting market growth.

The urinalysis market is bifurcated into disease screening and pregnancy and fertility testing. Disease screening segment is expected to account for the highest CAGR over the next five years. As urinalysis plays an integral role in diagnosing such diseases, the urinalysis market for disease screening applications is expected to grow in the coming years. Additionally, many conditions detectable through urinalysis, such as early-stage kidney disease and diabetes, often do not exhibit symptoms until they are advanced. Regular urinalysis enables early detection and intervention, significantly improving patient outcomes and reducing long-term healthcare costs. This will bolster the extensive use of urinalysis in disease screening, ensuring its position as the largest segment in the market.

Urinalysis market has grown significantly over the last few years due to the increasing adoption of point-of-care (POC) testing products in home care and hospitals. The convenience of these tools has driven their adoption, particularly considering the rising prevalence of chronic and lifestyle diseases, technological advancements in POC testing products, growing patient awareness of POC testing, shortage of technicians to conduct conventional lab tests, and the rising number of clinical laboratory improvement amendments (CLIA) approvals for POC tests. POC testing in urine analysis positively impacts the operational efficiency and care of patients with chronic kidney disease (CKD). The global urinalysis market is estimated to reach USD 6.8 billion by 2029, from USD 4.3 billion in 2024, growing at a CAGR of 9.6 percent.

Recently, researchers at Flinders University, Adelaide, Australia, have developed a portable POC device for urinalysis that can significantly improve the monitoring of CKD. With CKD affecting 8–10 percent of the global population, this device enables more frequent and accessible diagnostics, particularly in remote and low-economic areas. Designed as an open platform, it uses a camera and image-processing software to read colorimetric test strips from any manufacturer, showing a strong correlation with clinical values and improved accuracy over traditional methods. The innovation is particularly beneficial for high-risk populations with higher CKD rates. An Australian patent has been filed, and further development is ongoing.

The urinalysis analyzers market is poised for significant growth due to several cutting-edge trends in the coming years. The adoption of automation and robotics is streamlining the testing process, reducing human error, and improving efficiency. Integrating artificial intelligence (AI) and machine learning enhances the accuracy of test results, improves decision-making, and provides quicker diagnoses. Additionally, the rising demand for portable and handheld analyzers meets the needs of remote or decentralized settings, providing rapid results.

Furthermore, the focus on digitization and connectivity allows urinalysis analyzers to integrate with electronic health record systems and cloud-based platforms, facilitating seamless data management, remote monitoring, and real-time communication between healthcare providers.

Market dynamics are also influenced by regulatory frameworks and reimbursement policies. Stringent regulations governing diagnostic procedures, and the approval process for new products, impact market entry and competitiveness. Moreover, the availability of reimbursement for urinalysis tests influences the adoption rate among healthcare providers and end-users.

Urinalysis has undergone significant technological advancements in the past few decades. Visual analysis of test strips for early screening was initially replaced by manual strip readers, providing a better analysis of test results. With the increasing workload, automated analyzers were developed for biochemical analysis. Such systems minimize operator interference in performing tests.

Sediment analysis is conducted via manual microscopy worldwide, particularly in developing economies. The urine sediment microscopic examination is often hampered by manual procedures and high costs. Current instruments are bulky and expensive, limiting widespread adoption.

Performing manual sediment analysis for all patient samples with a higher patient count is challenging. Thus, automated sediment analyzers that utilize digital microscopy or flow cytometry to identify the different infectious agents and other casts and crystals in urine samples entered the market. These devices also help standardize sediment analysis. Urinary flow cytometry is an alternative to automated microscopy, and a more thorough analysis of flow cytometric data has enabled rapid differentiation of urinary microorganisms.

A system that combines acoustofluidic manipulation and a passive hydrodynamic mechanism is also useful. This system achieves a high throughput of 1000 μL/min and a concentration factor of 95.2±2.1 fold, meeting the demands of urine examination. The system automatically dispenses the concentrated urine sample into a hemocytometer chamber, where images are analyzed using a machine learning algorithm. The entire process takes only 3 minutes, with detection accuracies for erythrocytes and leukocytes at 94.6±3.5 percent and 95.1±1.8 percent, respectively. Testing with samples from 50 volunteers showed a correlation coefficient of 0.96 compared to manual microscopic examination. This system promises to save time and labor in clinical laboratories and enhance POC urine testing in various settings.

By introducing laboratory-on-a-chip approaches and microfluidics, new affordable applications for quantitative urinalysis and cell phone readout may become available in the coming years.

Indian market trends for urinalysis instruments and reagents

Thomas John
Managing Director,
Agappe Diagnostics Ltd

The Indian market for urinalysis instruments and reagents has witnessed significant growth over the past decade, driven by a combination of factors, such as increasing healthcare awareness, the rising prevalence of chronic diseases, and advancements in medical technology.

The market is segmented into instruments and reagents, with both segments showing robust growth. The instruments segment includes automated and semi-automated analyzers. The reagent segment encompasses dipsticks, test strips, and chemical reagents used in conjunction with urinalysis analyzers, including point-of-care testing and home-based urinalysis kits.

The field of urine chemistry has seen several technological advancements aimed at enhancing diagnostic accuracy and efficiency:

Automated urine analyzers. These instruments are equipped with advanced sensors and imaging technology to provide quick and accurate results. They reduce human error and increase throughput in clinical settings.

Biosensors. These devices detect specific chemical compounds in urine, providing precise measurements of biomarkers related to various diseases. Biosensors are being integrated into point-of-care devices, making diagnostics more accessible.

Artificial intelligence (AI) and machine learning. AI algorithms are being used to analyze complex urine data patterns, improving diagnostic accuracy. Machine learning models can predict disease progression, based on urinalysis results, aiding in early intervention.

Microfluidics. This technology involves the manipulation of small fluid volumes and is used to develop compact and portable urinalysis devices. Microfluidic devices enable rapid testing and are ideal for use in remote and resource-limited settings.

Agappe is introducing AI-based, state-of-the-art Make in India analyzers in urine chemistry, named a Mispa U-Series, revolutionizing the urine chemistry solutions in pathology laboratories. Fully automated dry chemistry urine analyzer, Mispa U500, is with 500T capacity per hour. This system can detect 12–14 parameters with precision and accuracy. Besides, another semi-automated urine chemistry analyzer, Mispa U30, also is being induced shorty. This system requires no configuration, it has deep learning AI recognition functions as well as machine vision technology. Yet another fully automated urine analysis system called Mispa-U280 is also introduced with multilayer multifocal imaging technology with dry chemistry in collaboration with urine sedimentation analysis, having autoloader facility for optimal speed and accuracy.

Strategic expansion. Partnerships and expansions reinforce its market dominance, enhancing technological integration across its offerings. For instance, in November 2023, KDx Diagnostics, an innovative medical devices company recognized for its non-invasive urine test for bladder cancer, the URO17Ò test, declared strategic collaborations with top distributors in Europe. These partnerships represent a significant achievement as they make early and precise bladder cancer detection available globally.

Digital technologies are revolutionizing urine testing
In clinical diagnostics, the evolution from manual dipstick analysis to automated urine analyzers has been a paradigm shift, marking a new era of precision and efficiency.

The detection and treatment of urinary tract infections (UTIs) have significantly evolved, with manual dipstick analysis and microscopic examination playing crucial roles. Dipstick analysis, is favored for its quick, easy-to-use nature, particularly effective for ruling out UTIs, offering high positive predictive value (PPV) and negative predictive value (NPV) for leukocyte esterase and protein tests.

However, environmental factors and user interpretation variations can compromise its accuracy, leading to false positives and negatives. Similarly, microscopic examination provides a higher sensitivity, confirming UTIs more accurately. Despite its effectiveness, this method is time-consuming and labor-intensive and requires trained personnel and specialized equipment.

Emerging trends in urinalysis

Sourav Saha
Product Manager – Urinalysis,
Transasia Bio-Medicals Ltd.

Urinalysis plays a crucial role in enabling clinicians to deliver precise and timely diagnoses across a spectrum of diseases. The global urinalysis market is poised for significant growth, projected at a compound annual growth rate (CAGR) of 6.7 percent from 2024 to 2032. This expansion is driven by segmentation across products, test types, applications, end users, and regions.

In the Indian market, visual urine strips dominate, with laboratories from A to D class favoring combinations of 2, 4, 5, 8, and 10 parameter urine strips due to their practicality in workload management. Semi-automated to automated strip readers are employed, based on workload, although maintenance concerns, such as frequent cleaning to remove urine deposits on critical components, remain a challenge.

Despite these challenges, automated strip and sediment analyzers are gaining traction among high-workload users, although cost remains a barrier to wider adoption. The transition from manual or semi-automated methods to these advanced systems presents a significant opportunity for companies poised to meet the evolving market demand.

Technological advancements are pivotal in driving market growth, particularly in:

Speed and productivity. Advanced automated analyzers equipped with cutting-edge optical and digital technologies have revolutionized urinalysis, enhancing throughput and efficiency. Larger institutions and chain labs increasingly favor sediment analyzers for microscopic analysis.

Automation and data integration. Automated microscopy, enabled by digital imaging, allows comprehensive evaluation of urine samples, facilitating precise identification and enumeration of cellular elements. Seamless integration with laboratory information systems ensures efficient data management and retrieval, enhancing workflow and accuracy in reporting.

Integration of machine learning (ML) and artificial intelligence (AI). AI and ML algorithms are enhancing urinalysis interpretation by identifying patterns and abnormalities in data that traditional methods may overlook. AI-powered systems provide personalized insights into patient health status, supporting early detection and management of diseases.

As AI technology continues to evolve, the future holds promising advancements in the field of urinalysis, reinforcing its critical role in modern healthcare diagnostics.

The medical community is gradually shifting toward automated urine analyzers. Technological advancements are at the heart of this transition. AI and machine learning algorithms improve the accuracy and speed of diagnosis by identifying patterns and anomalies in test results. Digital microscopy and flow cytometry enhance sediment analysis, allowing for rapid identification of infectious agents and other abnormalities. Moreover, developing cloud-based platforms enables remote monitoring and real-time communication between healthcare providers, improving patient care.

Novel approach
Some novel approaches have been taken, and after hematology, urinalysis is the most common biological test performed in clinical settings.

Lab-on-chip cartridge and AI tools. A novel lab-on-chip cartridge (gravity sedimentation cartridge), an in-house-built AI100 device (image-based autoanalyzer), and AI tools for auto-analyzing urine elements are developed. This innovative cartridge design uses gravity-based sedimentation to concentrate urine cells and particles without needing external pumps or centrifugation, completing the process in 5 minutes. This approach replaces traditional centrifugation and slide preparation.

The chamber’s optimal depth ensures accurate cell counts, and its design minimizes evaporation, extending sample shelf life from 10–15 minutes to 90 minutes. The cartridge allows simultaneous analysis of three urine samples, reducing costs. Enrichment and staining of cells occur within 5 minutes, simplifying the workflow. After enrichment, the GSC is loaded into the AI100 for automated high-power imaging. Using deep learning, the AI model accurately detects and quantifies RBC, WBC, bacteria, yeast, epithelial cells, crystals, and casts. Compared to manual microscopy, the system’s performance shows high sensitivity, specificity, precision, and accuracy. The GSC and AI100 system improves the urinalysis process by reducing preparation time, labor intensity, and manual errors through advanced AI tools.

Urinalysis – Automation is leading the way

Shobhit Jain,
Sr. Manager, Product – Clinical Chemistry & Urinalysis,
Sysmex India Pvt Ltd

Urine analysis comprises of physical, routine, and microscopic examination. It is an integral part of clinical laboratories, and one of the most performed diagnostic tests. This simple, noninvasive test is potent screening tool for clinicians, which can provide as much information as possible on the status of renal, urological, infection, and metabolic function in the body. Apart from routine screening, it may also be helpful in uncovering status of the disease that may not be showing significant signs or symptoms.

A lot of vital information can be obtained through urine examination; still its clinical utility is affected to a great extent by limitation of its conventional manual methods, including bio-chemical and microscopy. Biochemical analysis has improved with reagent strips, but challenge remains in microscopic part. Other challenges like non-standardization of process, person-to-person variation, centrifugation, and slide preparation needed a whole automated system in place with minimum human involvement and maximum automation.

In the last decade, there was a paradigm shift in laboratory operations, and now automation is leading the way for urinalysis testing. Technological advancement in biochemical analysis and microscopic examination in urinalysis has helped to standardize the process. Automation has changed the way of testing, reporting, and documentation of laboratories, with improved quality and lowered TAT. Some of the key features of automation in urinalysis are standardization, quality control, added clinical values, data management, accuracy, and reproducibility.

Automation in urinalysis can be further categorized into biochemical analysis and particle analysis (microscopy). In bio-chemical analysis, CMOS sensor has played a great role in identifying strip pad position, optimizing detection area and correction of abnormal coloration. This cutting-edge technology has eliminated all possible errors due to manual process. Similarly, for particle analysis, fluorescence flow cytometry technology has great advantage as it can recognize specific and unique properties of different particles by size, labeling DNA, complexity, and specific features, and so determining the particle type. Also, high accuracy of bacteria counts and accurate differentiation in RBC morphology (isomorphic and dysmorphic) is helping in faster diagnosis and better patient care. Looking at the facts, it can be concluded that the future of urinalysis lies in automation.

YOLOv5 models. This study proposes an advanced deep-learning model, based on YOLOv5, to improve urine sediment particle detection for kidney disease diagnosis.

Traditionally, urinalysis involved manual centrifuge processes, which were prone to errors and were labor-intensive. The study proposes an advanced deep learning model based on YOLOv5, which includes five variants (YOLOv5n, YOLOv5s, YOLOv5m, YOLOv5l, and YOLOv5x) to detect six types of urine particles (erythrocytes, leukocytes, crystals, casts, mycetes, epithelial cells) from microscopic images. The dataset comprised 5376 images. The models were fine-tuned using a genetic algorithm (GA) named evolutionary genetic algorithm (EGA). Mycetes achieved the highest performance with a mean average precision (mAP) of 97.6 percent, while crystals had the lowest with 81.7 percent using the YOLOv5x model. YOLOv5l and YOLOv5x were the best performers, with mAPs of 85.8 percent and 85.4 percent, respectively. The detection speed per image was 23.4 ms for YOLOv5l and 28.4 ms for YOLOv5x. This method demonstrated strong performance in urinalysis, providing a faster and more accurate automated microscopic model for detecting urinary particles.

This study illustrates that using advanced deep-learning models like YOLOv5 can significantly improve the automation of urine sediment analysis. Automated urine analyzers equipped with these models can achieve high accuracy and speed in detecting various urine particles, thus enhancing the efficiency and reliability of kidney disease diagnosis.

Urinalysis – Automation and semi-automation

Parshant Kumar
Application Manager,
Suyog Diagnostics Pvt. Ltd.

Urine analysis is a crucial tool for diagnosing and monitoring renal and urinary tract illnesses, and it has significantly evolved in the laboratory setting over the past few decades. The urine test is the most common laboratory test performed worldwide and is semi-quantitative. Currently, reagent strips are used for the rapid, semi-quantitative determination of chemical parameters based on reflectance photometry. Alongside this, microscopic examination, which has its own clinical significance, has also seen considerable technological advancements.

Fully automated urine analyzers are available for large laboratories, operating on principles such as reflectance photometry, flow cytometry-based cell evaluation, or the cuvette-based sedimentation method, the current gold standard. Numerous semi-automated urine analyzers cater to small-and mid-sized laboratories where bench space and operator-dependent procedures, such as maintaining inventory, are significant concerns. A cost-effective urine analyzer with a small footprint that can analyze a complete list of urine chemistry parameters, and is integrated with real-time microscopic imaging, is highly sought after for small laboratories.

The UriSed Mini urine microscopy analyzer and the LabUReader Plus 2 urine chemistry analyzer, both manufactured by 77 Elektronika, meet these requirements and provide a comprehensive solution for small- and mid-sized laboratories with a common database similar to fully automated solutions.

The UriSed Mini is a semi-automated urine microscopy analyzer that captures whole-field microscopic images of urine samples, enabling the automatic classification and enumeration of urine sediment particles. It can be integrated with the LabUReader Plus 2, a semi-automated instrument designed to read and evaluate LabStrip U11 Plus urine test strips.

Together, these technologies eliminate the most time-consuming and operator-dependent procedures in the laboratory, enhancing throughput. Additionally, the UriSed Mini can now be used for body fluid measurements (RUO), testing cerebrospinal fluid, ascitic fluid, pleural fluid, pericardial fluid, and more. It provides quantitative and differential counts for red blood cells (RBCs), white blood cells (WBCs), mononuclear white blood cells (MN), polymorphonuclear white blood cells (PMN), and other nucleated cells (ONC).

Automated systems for urine chemistry and sediment analysis are preferred in major laboratories. They minimize physical handling of samples, ensure complete traceability, and facilitate proper transmission of combined results through LIS or LIMS connectivity.

Integrating such technology reduces manual errors, labor intensity, and computational complexity associated with traditional methods, marking a substantial advancement in automated urine analysis.

Development of a quantitative digital urinalysis tool. This is another novel approach in urinalysis screening with a cost-effective, quantitative, point-of-care solution targeting nitrite, protein, creatinine, and pH in urine samples. The development of a portable, transmission-based colorimeter controlled via smartphone application allows at-home monitoring, addressing the critical needs of early UTI detection through nitrite measurement and kidney health management via urinary protein-to-creatinine (UPC) ratios. Multiple colorimetric detection strategies were tested for sensitivity, specificity, and stability across various urine types, demonstrating reliable detection within clinically relevant ranges. The colorimeter outperforms traditional dipstick reflectance photometers with more comprehensive sensing ranges and enhanced sensitivity, while its integrated cloud connectivity enables versatile data storage and remote monitoring capabilities.

Future directions include clinical trials for validation against established instruments, integration with electronic health records for seamless telemedicine applications, and expansion of biomarker assays to enhance diagnostic capabilities.

Recent advancements in medical diagnostics have shown promise for detecting oncology diseases, such as ovarian and lung cancer, using innovative methodologies and technologies.

Joseph Reiner’s research at Virginia Commonwealth University highlights a urine-based test for ovarian cancer that utilizes nanopore sensing technology. This method identifies small molecules, or peptides, in the urine by measuring changes in electrical current as they pass through a nanopore, with gold nanoparticles aiding in detection by their unique current signatures. This technique successfully identified 13 peptides, including those from LRG-1, a known ovarian cancer biomarker, to enhance early-stage detection when combined with other tests like CA-125 blood tests and transvaginal ultrasounds.

MIT researchers have developed an inhalable nanoparticle sensor system for diagnosing lung cancer, potentially simplifying early detection to a urine test. These nanoparticles, delivered via an inhaler or nebulizer, detect cancer-linked proteins in the lungs and produce a signal that can be identified in the urine using a paper test strip.

This approach aims to supplement or replace low-dose CT scans, particularly in low- and middle-income countries with limited access to CT technology. This method has shown promising results in mouse models by detecting cancer-specific proteases through unique DNA barcodes. Plans are underway to test the sensors on human biopsy samples and conduct clinical trials, potentially revolutionizing lung cancer screening and early detection globally.

These advancements underscore the potential of cutting-edge technologies in transforming the early detection and diagnosis of various oncology diseases, offering more accessible and non-invasive options for patients worldwide.

POC as a pivotal approach
Smartphone-based POC urinalysis. Vivoo App represents a rapidly evolving field with immense potential to transform health monitoring and disease prevention. This mobile application is designed for convenient health monitoring, providing users with precise health parameter readings comparable to traditional laboratory methods. In a comprehensive study using artificial urine samples, Vivoo demonstrated high accuracy and reliability, with nearly all 2618 tested strips yielding expected results. The app’s strong agreement with laboratory standards, indicated by a 95-percent confidence interval, underscores its effectiveness as a reliable wellness tool.

Leveraging smartphones’ ubiquitous presence and sensor capabilities, POC urinalysis enables the detection of critical biomarkers in urine, offering valuable insights into individual health and disease risks. However, challenges, such as standardization in urine analysis methods persist, impacting accuracy and consistency across different devices and users. Addressing these challenges requires ongoing validation efforts to enhance reliability and broaden the spectrum of measurable biomarkers with increased sensitivity.

Future advancements in this field may integrate AI and machine learning algorithms to analyze urine data more comprehensively, identifying nuanced patterns and correlations for personalized health recommendations. Additionally, ongoing research aims to advance sensor technologies, enabling the measurement of a more comprehensive array of biomarkers with higher precision.

While apps represent a significant milestone in smartphone-based POC urinalysis, collaboration among healthcare providers, technology developers, and regulatory bodies is essential to harness its transformative potential fully. By overcoming current challenges and pursuing innovative developments, smartphone-based POC urinalysis is poised to revolutionize healthcare, empowering individuals with convenient and trustworthy tools for proactive health management.

Biomaterials and biomarkers for urinalysis using POC testing are gaining prominence in developing flexible sensors due to their solubility, mechanical strength, active binding sites, biocompatibility, and biodegradability. Recent advancements in paper-based biomaterials have introduced a novel approach to biomarker identification, using portable and affordable POC testing devices. These devices are crucial for rapidly detecting biomarkers in biological fluids, driving innovation in materials science through their interaction with biological systems.

Point-of-care (POC) devices utilizing biomaterials enable non-invasive diagnostics. They can assess various biomarkers in biological fluids quickly and accurately without requiring specialized equipment or trained personnel. POC urinalysis, in particular, holds promise for widespread health monitoring and diagnosis, especially in settings with limited access to clinical laboratories.

Digital health technology for automatic urine analysis. Digital urinalysis devices represent a significant advancement in healthcare, leveraging high-resolution cameras and powerful algorithms to analyze urine test strips. These devices interpret the test strip’s color and intensity to identify specific biomarkers in urine samples, displaying the results on a digital screen within minutes. This method provides healthcare providers with precise and reliable outcomes, enhancing the diagnosis and treatment of kidney disorders, urinary tract infections, and other related conditions. The automation of urine test strip interpretation is expected to become increasingly crucial as the demand for POC testing rises, positioning digital urinalysis systems as essential tools in the healthcare sector.

Self-tracking technologies, including digital urinalysis, revolutionize health monitoring and disease prevention. These technologies enable early disease detection and support health management in various scenarios, such as during space missions to Mars. The Covid-19 pandemic underscored the potential of self-monitoring protocols but highlighted challenges like user comprehension, perceived benefits, and high abandonment rates.

This research lays the foundation for further exploration and advancements in designing effective, user-centered urine tracking technologies, ultimately improving patient outcomes and transforming health monitoring practices.

Artificial intelligence in urinalysis – Is the future already here?
Urinalysis is crucial for diagnosing diseases, and AI advancements are revolutionizing this field. AI enhances clinical decision making by enabling accurate diagnosis and personalized therapy. Urine analysis involves assessing proteins, electrolytes, and creatinine, which vary based on health conditions. Advanced methodologies like urine proteomics and metabolomics have improved data extraction, but processing this data has been challenging. AI optimizes this process, making non-invasive and precise illness detection through urine analysis more feasible.

Fraunhofer Austria and the AULSS2 Marca Trevigiana Institute in Treviso developed an AI-based method to reduce laboratory workloads. Traditional urinary tract infection diagnosis via urine culture is time-consuming. The new AI filters out negative samples more accurately, reducing laboratory workload by 16 percent and providing quicker results. The algorithm uses decision trees for transparency, mirroring doctors’ criteria, and uses seven parameters to achieve a sensitivity of 95 percent. However, further validation in diverse settings is needed to ensure robustness and applicability.

AI in urinalysis marks a significant advancement in medical diagnostics. By enhancing accuracy and efficiency, AI-driven technologies promise to transform disease diagnosis and management. The future of AI in urinalysis is promising, with ongoing research paving the way for broader adoption and improved patient outcomes.

Outlook
With ongoing technological advancements and biomaterials, the future promises even more precise, efficient, and personalized urine analysis. This relentless pursuit of innovation ensures that urinalysis will continue to play a pivotal role in healthcare, driving our ability to detect, monitor, and manage diseases with greater accuracy and accessibility than ever before.

Second Opinion:-

Urinalysis – Current and future trends.

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