Connect with us

Urinalysis Instruments and Reagents

In the last two decades urinalysis has showcased remarkable technical progress

Automation is a key technological advancement, affecting the efficiency and accuracy delivered by the next-gen urinalysis devices, and hence, the persistent demand for novel urinalysis instruments.

Urinalysis represents one of the most-ordered laboratory tests. Initially, the technique was regarded as a necessary, labor-intensive procedure that provided invaluable but limited information for clinicians. However, in recent years, various innovations have been introduced, and new technologies have been integrated to improve the clinical outcomes of the technique with high-accuracy testing instruments and reagents.

Major IVD companies have developed automated urine analyzers for use in clinical laboratories that combine and conduct all urinalysis components. Analyzers are divided into two categories, each based on a distinct technology. The first is an image-based microscopic urine sediment analysis, which employs a video camera to record and sort particles, depending on predefined particle size, while the second is based on the flow-cytometry concept.

Recently, a new generation of analyzers that integrates and automates the two primary functions – chemistry and microscopic particle analysis – have been introduced. Automated microscopic and strip analyzers have been combined into fully automated workstations. These automated solutions are gaining popularity, which offer 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.

The Indian market for urinalysis analyzers and reagents in 2020 is estimated at ₹145 crore. Reagents continue to dominate with an 80-percent share, valued at ₹145 crore. The market took a major hit in 2020, and continues to be on lower levels than 2019, since urinalysis has minimal role to play in COVID-19 testing or treatment.

The fully automated analyzers segment is estimated at ₹13.05 crore in 2020. In the semi-automated instruments category, amounting to ₹15.95 crore, the entry-level instruments are marginally higher, contributing 54 percent to the segment, by value.

Indian urinalysis market–2020

Fully automated instruments

Segment Brand
Urine chemistry Dirui, Beckman Coulter, Rapid, Siemens, Roche, and Agappe
Urine sediments Sysmex, Dirui, Roche, URIT, Beckman Coulter, and 77 Electronika (Suyog)
Integrated Sysmex, Dirui, Transasia, 77 Electronika (Suyog), Siemens, and Roche

Semi-automated instruments

Tier I

Tier II

Tier III

Transasia Dirui and
Mission
Standard Diagnostics (Abbott), Agappe, Iris, and Rapha
*Vendors are placed in different tiers on the basis of their sales contribution to the overall revenues of the Indian urinalysis instruments and reagents market.
ADI Media Research

One of most popular routine health-screening tests, 2020 has not been a great year for this segment. Molecular diagnostics, the mainstay for COVID-19 testing is completely different. A team in India comprising Supraja Sundaram, Mamta Soni, and Rajeev Annigeri have put forth their study that urine abnormalities predict acute kidney injury in COVID-19 patients. Their results suggest that urine analysis is a simple test, which can be used to predict development of AKI and mortality, and may be used for risk stratification of COVID-19 patients, especially in low-resource settings. With the opening of the lockdown, 2021 seems more promising, although not expected to reach 2019 levels.

The global urinalysis market size is projected to reach USD 4.9 billion by 2026 from USD 3.5 billion in 2021, at a CAGR of 7.2 percent. Market growth is driven by the increasing burden of UTIs, diabetes, and kidney and liver diseases; rising geriatric population and the subsequent increase in age-associated diseases; and increasing adoption of POC diagnostic tests.

Based on product, the consumables segment is expected to grow at a faster rate, compared to instruments segment. The introduction of CLIA-waived urine reagent strips, such as CLIA-URS-10, CLIA-URS-10-3PROMO, and CLIA-URS-10-10 provide for an effective screening tool for rapid testing in urine analysis, which are estimated to enhance the usage rates of urinalysis reagents, thus accentuating the market growth over the next five years.

Rapid advances in technology pave the way for automated urinalysis’s stellar progress. By using reflectometry, urinary test strips’ quantitative reading has become easier. On the other hand, incorporation of cutting-edge technology, like CMOS (complementary metal oxide semiconductor), has shown promise in the testing of microalbuminuria, enhancing analytical sensitivity. Analysis of urine particle, which is microscopy-based, has progressed steadily over the years, enabling clinical laboratories’ throughput. As an alternative to automated microscopy, urinary flow-cytometric data analysis has helped in the differentiation of distinct urinary microorganisms. Automated urinalysis aids in the monitoring and diagnosis of a broad array of urological and nephrological conditions, and screening of urinary tract. Latest applications of automated urinalysis show fruitful outcomes in the fast identification of urothelial cancer. Concomitantly, for early detection of the urinary pathogens, the introduction of MALDI-TOF MS has provided positive outcomes. Automated urinalysis has showcased a remarkable technical progress in the last two decades. Instruments based on flow cytometry and microscopy generate effective and clinically useful results, whereas the reading of automated test strip provides further value.

The availability of refurbished instruments acts as a challenge in the growth of this market as these instruments offer the same functionalities as new equipment at a lower cost. Several end users, mainly small- and medium-sized laboratories, opt for cost-effective and refurbished systems. In particular, the markets in developing countries, which are price-sensitive, prefer instruments that are cheap and offer similar functionalities. In the absence of well-grounded regulatory frameworks, there may be an influx of low-quality and refurbished products into the economy. Considering these factors, the demand for refurbished analyzers can be expected to increase in the coming years, as these systems offer the same functionalities at a lower cost. This is expected to hamper the revenue of companies offering branded analyzers, and thus restraining the overall growth of the market.

To gain a significant market share in the global urinalysis market, the key players are now focusing on adopting strategies, such as product innovations, mergers and acquisitions, recent developments, joint ventures, collaborations, and partnerships.

For instance, in February 2021, 77 Elektronika Kft. (Hungary) launched LabStrip U mALB/CREA urine test strips.

In January 2021, Arkray, Inc. (Japan) launched AutionIDaten AE-4070 compact automated urine analyzer.

In August 2020, Sysmex America, Inc. announced an exclusive agreement with Siemens Healthineers that granted North American rights to distribute and service Siemens Healthineers Clinitek Novus automated urine analyzer for hospital and reference laboratory use.

It is fascinating to see urinalysis technology advance. Although manual microscopy is still considered the gold standard in urine sediment analysis, the battle between automation and manual inspection appears to be over, with machines clearly winning. Machines are quick, inexpensive, and effective. Some machine labor, notably that conducted by automated urinalysis devices, can be classified as artificial intelligence. These equipment software algorithms are intended to identify certain cell kinds in urine, just like the human brain does.

Automated urinalysis has showcased a remarkable technical progress in the last two decades. Instruments based on flow cytometry and microscopy generate effective and clinically useful results, whereas the reading of automated test strip provides further value.

Copyright © 2024 Medical Buyer

error: Content is protected !!