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Urinalysis Instruments and Reagents

Technological advances are opening the door for urinalysis

The technological advances that have enabled more advanced and efficient urinalysis techniques in 2023 can help diagnose various medical conditions and lead to improved patient outcomes and overall health.

Technological advances have indeed opened the door for more advanced and efficient urinalysis techniques in 2023. In recent years, there have been significant developments in the field of medical diagnostics and testing, and urinalysis is no exception.

Newer technologies, such as microfluidics and lab-on-a-chip platforms, have enabled the development of portable and handheld devices for urinalysis, which can provide accurate and reliable results within minutes. These devices can detect a wide range of analytes in urine, including glucose, protein, ketones, and various metabolites, which can help diagnose various medical conditions, such as diabetes, kidney disease, and urinary tract infections.

Potential of technologies for future
Dipstick tests, urine culture, urine Gram stain, and urine microscopy are conventional methods used for urinalysis and due to easy handling, low cost, and quick response, the dipstick test is most popular but still this test also has some limitations and for this reason, the potential of combining of technologies, and continuous monitoring devices will be explored for the early detection and personalized management of chronic diseases, and these future trends help in shaping the future.

New technological advances have paved the way for significant progress in urinalysis. Many novel and improved trends are introduced in the market, and have helped significantly in increasing the accuracy and decreasing the time of the test; a good example would be multiplex PCR, biosensing technologies and approaches, microfluidics technologies and approaches, and point-of-care (POC) diagnostics.

Multiplex PCR application on urinary samples is relatively new to UTI diagnostics in which bacteria and yeasts DNA are targeted, using nucleic acid amplification via PCR. These tests are preferred for their ability to detect microorganism, which sometimes is missed in culture process and also as testing can be completed the same day, allows expedited identification, treatment decisions, and patient satisfaction. PCR multiplex testing allows for detection of co-infections, which again may be harder to identify in conventional methods like Gram staining or microscopy.

With its promising future, the use of urine PCR in urology clinics has been praised for its ability to quickly detect possible uropathogens and recommend treatments. However, it is important to exercise caution when selecting prefabricated panels and relying solely on PCR results, as it may lead to inappropriate therapy selection, antimicrobial resistance, and increased healthcare costs. Current guidelines suggest that urine PCR testing should not replace parallel culture testing. While urine PCR may improve detection of UTIs, there is currently no literature supporting improved patient outcomes. Therefore, a combination approach of various diagnostic methods may be necessary for complete diagnosis and treatment management.

Biosensing and microfluidics technologies
In recent times, the progress made in biosensor design and fabrication has resulted in the creation of more sensitive, selective, and fast biosensors, which have improved detection limits, response times, and specificity. These advancements have been facilitated by the incorporation of nanotechnology and microfluidics, as well as the usage of new materials and fabrication techniques. Given these advancements, the field of biosensors is expected to play an increasingly crucial role in various applications in the future.

Microfluidics devices have the capability to provide a quick and precise diagnosis by allowing for the analysis of different sample types, including urine, blood, and saliva. These devices have been applied to detect various substances, such as creatinine, hormones, and sweat biomarkers, and can be used to diagnose complex diseases like cancer and genetic-based disorders.

Researchers have developed several microfluidic-based devices, including BioFET immunosensors and microposts coated with antibodies, to detect specific biomarkers and monitor various health disorders. These advancements have the potential to revolutionize the diagnosis and treatment of diseases, leading to improved patient outcomes.

POC diagnostics
Commonly available POCT urinalysis devices include dipsticks, lateral flow assays, paper-based devices (mPADs), and microfluidic assays.

Dipstick tests are frequently employed due to their simplicity, speed, and affordability. However, these tests have shortcomings in terms of sensitivity, selectivity, and reusability.

Smartphone-based colorimetric biosensing. An important breakthrough has been achieved in the development of a new optical device for POCT of urine analysis. The device incorporates a black box and color calibration curve to eliminate any influence from ambient light, along with an independent internal lighting system. The device is equipped with a Raspberry Pi and a CSI camera, programmed to automatically capture strip images and identify their HSV values using an image processing algorithm. Corrected colors are then converted to concentration values by preloaded standard curves. The proposed POCT device can quantitatively and automatically detect glucose in human urine samples within one minute, with a linear detection range of 2 mM to 60 mM and a detection limit of 1.16 mM. Furthermore, the device has demonstrated satisfactory accuracy and quantitative analysis of ketone bodies, glucose, protein, occult blood, pH, and leukocytes in human urine samples, achieving high-resolution concentrations comparable to those obtained with hospital instruments. This portable and user-friendly device provides a convenient colorimetric analysis of urine.

Overall, smartphone-based biosensors have the potential to revolutionize the field of urinalysis by providing rapid and accurate diagnostic information at the point of care, enabling early detection and personalized management of various health conditions.

Unlocking the power of AI
Over the past decade, there has been a significant growth in the field of AI. The emergence of AI technology has opened up new possibilities for processing and utilizing urine-based information. The integration of AI technology with urine detection has not only enabled more precise and individualized diagnosis and treatment of diseases but has also facilitated non-invasive diagnosis and treatment.

AI applications in the field of urinary health management. One example is Yodoc-m, which utilizes ubiquitous technology to enable self-diagnosis by uploading the results of urinalysis onto a web-based server, allowing users to monitor their urinalysis results in real time.

Toilet tracker is another product that allows users to input their number of defecations/urinations directly on a smartphone.

Additionally, image-based urinalysis function using a mobile terminal has been developed, which can detect 25 diseases and measure levels of glucose, protein, and ketone by smearing urine on a test strip.

Healthcare check services have also been developed, which detect 17 diseases based on urination into the toilet bowl, with a sensor pre-installed in the toilet measuring urine components, transmitting data to a cloud server, and presenting analysis results.

Smart toilet services have been integrated into the construction of systems and devices to collect and analyze data on urination and defecation, supporting precise healthcare. Domestic and international institutions are promoting smart toilet services to achieve digital healthcare based on AI and IoT technology.

AI applications in the field of urinary disease diagnosis, namely, prostatic hyperplasia, ureteral stricture, urolithiasis, and urinary tract infections. This technology has the potential to improve the diagnosis and treatment of urinary diseases.

Researchers are exploring the use of imaging techniques, such as microendoscopy and computed tomography (CT) to aid in the diagnosis of diseases like ureteral stricture and urolithiasis.

New sensor can diagnose cancer, using urine. With the developed POC biosensor technologies for clinical applications also could be adopted in near future because of their advantages, such as low cost, ease to use, extreme sensitivity, real-time response, simple sample preparation, and simple instrumentations.

AI is currently in its nascent stage of development, and urine-based AI is predominantly utilized for assisting in the diagnosis of urinary system disorders. There is a need for enhancing the precision and specificity of AI-based diagnosis. Nevertheless, the continuous advancements in computer technology and medicine are anticipated to render AI in combination with urine detection a significant tool for diagnosing and treating ailments. This technology is also predicted to be extensively employed for early detection, treatment, and post-treatment monitoring of a diverse range of diseases.

Today, more researchers are participating in this field as it is the potential gold mine for urinalysis. It may greatly accelerate the development of medical laboratory science and change the face of medical research and medical practice in the next century.

A research team has succeeded in developing a strip-type urine sensor that can amplify the light signal of metabolites in urine, and in diagnosing cancer in the field. This result came from an effort to find metabolites in urine that was led by Dr Ho Sang Jung of the Surface & Nano Materials Divison of the KIMS, a government-funded research institute under the Ministry of Science and ICT in joint research conducted with Professor Junsuk Rho of POSTECH and Professor Samjin Choi of Kyung Hee University Medical School.

This technology can be applied for the examination of prostate cancer and pancreatic cancer, without an additional analysis process, by only irradiating light after a small volume (10 uL) of urine dropping at the time of need for a test. The test device is manufactured in the form of a strip so that cancer can be diagnosed quickly and with high sensitivity in the field.

The research team paid attention to the difference in metabolomic components present in the urine of cancer patients and normal people. When cancer cells proliferate in the body, they secrete different metabolites into urine due to abnormal metabolism. In order to classify this as an existing technology, expensive and large equipment was required, limiting on-site field application. The research team developed a surface-enhanced Raman scattering sensor that amplifies the optical signal of metabolites in urine more than 1 billion times by forming a coral-shaped plasmonic nanomaterial on porous paper. When urine is dropped into the sensor and light is irradiated, cancer metabolite signals are amplified on the sensor surface, making it possible to diagnose cancer. The research team applied an AI-based analysis method to the acquired spectral signal and succeeded in distinguishing up to 99 percent of prostate cancer and pancreatic cancer patients from normal people.

A number of currently used cancer diagnosis techniques detect the presence of cancer through blood tests or radiological methods, and diagnose cancer through histological analysis. Many people try to track the occurrence of cancer through annual health checkups, but in many cases, cancer is detected late and treatment is delayed or death occurs. In particular, it is difficult for people who are in the medical blind spot to receive regular checkups, so it is often discovered after cancer has already advanced considerably. This study used urine, a biological sample that anyone can easily obtain. It can be used for a new cancer diagnosis method using urine, on-site rapid cancer patient screening, and recurrence monitoring technology after cancer patient treatment. In addition, since the production price of the strip-type sensor is less than KRW 100 per unit, it is expected that it can be used for mass inspection.

Technological advancement with such technologies could significantly improve access to urinalysis and enable the early detection and diagnosis of diseases. 

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