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Technological innovations fuel a bright future for urinalysis

Technological innovations fuel a bright future for urinalysis

New technological innovations will enable new paradigms for healthcare, including diagnostics testing in non-traditional venues as well as home testing and companion diagnostics to guide and monitor the efficacy of treatments for chronic diseases.

Urinalysis is playing an indispensable role as an indicative apparatus for the analysis and management of ailments as high incidences of obesity coupled with hypertension, kidney infections, and diabetes increasingly rely on urinalysis. In addition, the changing way of life and shifting nutrition preferences are required to fuel interest for urinalysis over the globe in the next few years. In addition, the introduction of fully automated urine-strip readers and automated urine-sediment analyzers, increasing adoption of wireless technology for communication purposes coupled with development of miniaturized point-of-care urinalysis instruments, growing usage of technologically advanced, fast-acting, non-invasive, and easy-to-use tools for urinalysis are anticipated to drive urinalysis market in the coming years.

Total non-attendance of sufficient medical services and absence of high-end diagnostic tools in the developing economies, high cost of R&D, and stringent regulatory procedures are anticipated to limit market progress to a certain extent.

The global urinalysis instruments and reagents market is estimated at USD 2.14 billion by 2022. Globally, the market is predicted to grow at a CAGR of 7.5 percent over the next 3 years, providing numerous opportunities for players to invest in research and development in the market. The consumables segment dominated in 2019. Pregnancy and fertility kits accounted for the largest share of this market in 2019. These kits have witnessed wide adoption amongst end users across the globe owing to their cost-effectiveness and ease of use. In 2019, the disease-screening segment accounted for the largest market share as urine analysis came to be included in the general check-up in hospitals and clinics. Pregnancy and fertility testing is carried out using the kits available in the market either in homecare settings or in clinics.

The market is seeing increasing demand for urinalysis with unmet clinical needs in the under-developed regions across the globe. Factors in charge of bolstering the rise of urinalysis industry incorporate presentation of highly advanced diagnostic tools, expanding unmet clinical needs, and rising demand for cost-effective solutions.

Technology trends

There is an urgent need for rapid, sensitive, and affordable diagnostics for urinary pathogens at the point of care. New technological innovations will enable new paradigms for healthcare, including diagnostics testing in non-traditional venues, such as pharmacies and storefront clinics, as well as home testing and companion diagnostics to guide and monitor the efficacy of treatments for chronic diseases.

Image transmission. Microscopic urine dregs examination continues to be the key technique for urinalysis; however, the required ability is not generally accessible at any time, which may prove to be inconvenient. Telemedicine can subsequently be useful for getting symptomatic data, enabling meeting with specialists in regard to uncommon or circulation of findings, and the flow of intriguing discoveries all through the therapeutic and academic network.

Automated urinalysis. New technological advancements have brought about noteworthy advancements in automated urinalysis, while paper or dipstick test keeps on doing great on account of its accessibility and cost-viability. Quantitative perusing of urinary test strips using reflectometry has become conceivable. Complementary metal oxide semiconductor (CMOS) advancement has improved descriptive affectability. Microscopy-based urine-particle examination has inconceivably progressed, enabling high throughput in clinical research. Urinary flow cytometry is a possibility for computerized microscopy. Progressively, thorough examination of urine cytometric information has enabled speedy segregation of urinary microorganisms, thus making it easier for clinicians to deduce an accurate analysis, reduce turnaround time, and enhance the workflow. Mechanized urinalysis can be used for urinary tract screening and for diagnosing and checking a far-reaching assortment of urological and nephrological conditions.

Test strip technology. A classical dye-binding-based albumin test strip in combination with a CMOS-based strip reader could enable clinicians to obtain quantitative albumin readings in the micro-albuminuria range. The creatinine-specific test pad allows correction for urinary dilution, which is useful in albuminuria’s diagnosis. Similarly, reflectance data can be used for quantitative analysis with the additional advantage of improved sensitivity of albuminuria test strips. The usage of smartphones for perusing and deciphering urine test-strip results is expanding because of the increasing number of smart phone users, thus making this technology more accessible to patients. Mobile healthcare platforms, such as apps along with a pocket-sized colorimetric peruser and widely accessible 10-parameter urinalysis paper strips, are enabling patients and doctors to send information by means of smartphones.

Flow cytometry. Urine-particle flow cytometers (UFCs) have improved count precision and accuracy compared with visual microscopy and offer significant labor reduction to the clinicians, reduces microscopy review, and saves time and cost without diminishing clinical utility. It has an acceptable linearity over clinically useful working ranges, with an imprecision that is consistently and significantly less than that of microscopy and with negligible carry-over. The classical argon lasers in UFCs have been replaced by semiconductor lasers, which have a much longer lifetime and hence are more economical. The introduction of semiconductor lasers has impelled developers to completely redesign the system and adapt the dyes for accurate analysis of the urine sample. The most popular approach is to combine test strips with UFCs for primary screening, either using UFC and strips or utilizing the test strips for analytes unrelated to the UFC-analyzed particles. Both test modalities are based on user-definable decision rules, thus benefitting the patient and diagnostic facilities simultaneously.

smaRT-LAMP system. The low-cost, low-tech, smartphone-based diagnostic technology would enhance clinical utility in low-resource settings. The smartphone camera takes pictures of a fluorescent chemical reaction that detects the presence of bacterial DNA by analyzing the level of fluorescence. The applicability of smart-LAMP to even the most severe cases of sepsis, with the advantage of accurate and rapid diagnosis at the point of care in these cases, and the potential to greatly accelerate directed therapy for UTIs is an uplifting factor in the urinalysis diagnosis. The device could also be used for rapid detection of UTIs in pregnant women, which can cause kidney infections and increase the risk of miscarriage, if they go untreated. This device’s cost-effectiveness, minus the smartphone, would be a leveraging factor to the clinics and hospitals alongside reducing the workload and increasing accuracy of results. SmaRT-LAMP thus offers the potential to deliver rapid diagnosis and treatment of urinary tract infections and urinary sepsis with a simple test that can be performed at low cost at the point of care, especially in the underpenetrated regions of the emerging economies.

Digitally enabled home urine test. Rapidly maturing smartphone-enabled home urinalysis is intensively researched upon keeping in mind the convenience of the users who increasingly prefer home-based urine tests, particularly pregnant women and diabetic patients. Easy-to-use, embedded, pull-out urine-testing strips, along with a smartphone app can scan the postcard to provide accurate analysis from home while reducing the clinician’s workload and smoothening the work-process. UTI and pregnancy testing include prostate health screening, pre-eclampsia and gestational diabetes, and kidney health diagnosis. The test produces a result that is easy for a patient to read. This technology is still in the nascent phase and has not been rolled out yet, although considering its potential in making the urine testing seamless, it will be a crucial factor in advancement of diagnostic procedures in the medical facilities.

Outlook

Labs are compelled to deliver precise and valid outcomes that provide clinical incentive to the doctor, all while meeting and reducing turnaround time with less staff and budgetary constraints. Decreasing repayments, expanded test use, and managed clinical-quality measurements add to the pressure of lessening clinical research center test volumes and spending plans while expanding quality-confirmation checking and documentation. In view of the difficulties faced by the present labs, solutions are required to streamline work process and diminish the work-escalated manual procedures of conventional urinalysis strategies while incorporating technological innovations in a cost-effective way to given an edge to the urinalysis market.

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