The new-generation automated systems are equipped with on-board cooling, on-board laundry, high-quality mixing, and excellent QC statistics to make sure that the quality of results is maintained at all levels.
While the merging of chemistry with medicine has been traced back to thousands of years, the field of modern clinical chemistry, as it is known today, emerged in the early 1900s. As late as the early 1960s, most laboratories consisted of small enterprises in which technologists performed only a handful of manual tests, including glucose, urea, creatinine, electrolytes, cholesterol, basic enzymes, total protein, and albumin/globulin. These tests remain as some of the cornerstones of clinical chemistry today; however, the manner in which testing is performed has evolved substantially. Driven by a number of factors – including technological advancements and industry changes – clinical chemistry has grown to include large, integrated, and automated laboratories with sophisticated instrumentation that can perform hundreds to thousands of tests per hour.
The biochemistry segment in the Indian IVD has shown major growth in all directions. This includes the increase in the number of parameters performed and the addition of new technology systems to perform the tests with ease. The major change in this segment happened in the clinical chemistry automation wherein the entry-level segment has shown the highest growth. These new-generation systems are equipped with on-board cooling, on-board laundry, high-quality mixing, and excellent QC statistics to make sure that the quality of results is maintained at all levels. One of the breakthroughs in this segment is the reduction of size of the instrument which was one of the major concerns of customers in metro cities.
Another change that has happened in this segment is in modular automation. Till the last decade, the central laboratory concept was common in big hospitals and labs where all the different platforms are interconnected together with robotic platforms. Beginning of the current decade has shown a shift in the customer mind, where customers are shifting from modular systems to high-level independent platforms. With more and more parameters adding to the test portfolio and more laboratories entering into quality accreditations like NABL or QCI, exponential growth is expected in the automation segment in the years to come.
The global biochemistry analyzers market was valued at USD 3.1 billion in 2017 and is projected to reach USD 5 billion by 2026, exhibiting a CAGR of 5.4 percent, projects Coherent Market Insights. The market is expected to gain significant traction due to increasing usage of biochemistry analyzers in laboratories for diagnosis of increasing diseases. The specimens can be studied using a unique barcode number when automated biochemistry analyzers are used and the results obtained can be automatically viewed in the LIS. Manufacturers are developing analyzers with new capabilities and feature sets, including greater use of automation, increases from low- or medium-volume to high-volume devices, and upgraded technology to offer a wider array of tests and provide faster and more accurate results.
The industry is highly competitive in nature due to the presence of various local and international manufacturers. Major players are spending huge capital in product innovations, product/service extensions, and mergers and acquisitions, in order to dominate in the industry. For instance, in 2017, Thermo Fisher Scientific announced the US launch of Cascadion SM clinical analyzer, which combines the ease of use of clinical analyzers with the selectivity and sensitivity of LC-MS/MS.
Improvements in analyzer design and performance continue to be driven by a number of factors such as technological breakthroughs, enhanced manufacturing practices, the integration of software into the lab environment, and medical discovery. In addition, changes in the reimbursement landscape and user needs have spurred the development of systems that feature flexibility and performance that far surpass their predecessors.
Automation and robotics. Today, laboratories operate with greater efficiency than ever before. Processes that were, in the past, performed manually, are now performed via instrumentation. Automation has touched every facet of clinical laboratory operations, enabling increased throughput, elevating quality, enhancing safety from biohazardous materials, and improving workflow through greater system uptime and walkaway times. Full automation of pre-analytical, analytical, and post-analytical tasks enables laboratories to perform more work using less labor and fewer resources. Similarly, computers and microprocessor technology have enabled the creation of smaller-footprint units that accommodate higher test volumes. The advancements in the robotic mechanisms made it possible to have compact systems with higher throughput. From conventional systems with turn around table for samples, new generation systems are coming up with rack sampling technology for ease of use allowing continuous loading of sample without any interruption of the process and thus helping to reduce the turnaround time.
Integration of software. Quality has long been a driver of design and development. Advancements in software have had a profound influence on processing in the laboratory. Evolutions in software have opened pathways for automation, which heightens consistency and reduces operator error, and for fast and accurate analysis, predictive analytics, and data interpretation, which help to ensure the highest quality of results. The advancement in the software also allows easy operation and interfaces of the instruments to various connecting devices like mobile/personal computers that allow minimum human interference and records the results as it is so that there will be very less chance of manipulating the obtained results, thus increasing the test/report quality.
Positive identification with shorter turnaround time. Manufacturers are developing biochemistry analyzers with multiplexing capabilities. Such types of analyzers possess the feature of positive identification that reduces the process of repeated pathogen testing. This becomes a critical feature in cases of samples that have low volume such as neonatal units. This type of system with shorter turnaround time gives advantages of high clarity and result accuracy. The feature of positive identification helps acquire accurate results in shorter run time by avoiding the inclusion of too many targets.
IT advancement and remote monitoring. With advancement in the IT, most of the new-generation systems are equipped with reagent and sample barcodes having HIS/LIS connectivity. By integrating the systems to the HIS/LIS interface, the analytical errors are reduced drastically. Another new trend is remote diagnosis where the hardware is connected to the cloud-based server and is checked for errors periodically. Automation combined with cloud-based technology is helping laboratories to streamline daily operations and better manage patient information – all of which has become increasingly important due to trends in the workforce that have resulted in personnel shortages. Cloud-based systems ensure timely ordering of reagents and consumables across an entire network, helping busy laboratories avoid workflow disruptions due to the potential inefficiencies resulting from manual inventory control processes.
Chemistry analyzers have come a long way during the last few decades, and the fast pace of technological development will fuel further technological enhancements. The drivers that affect development today will catalyze change in the future, accompanied by new, as yet unforeseen, drivers. It is anticipated that growth will be most robust in the areas of automation and software. Manufacturers will work to meet the laboratory’s need to manage increasing workloads with decreasing resources, simplifying labor-intensive tasks that are still performed manually today. Areas targeted for higher levels of automation will include instrument maintenance, system troubleshooting, and consumables management. In addition to this, manufacturers will continue the trend of downsizing units to reduce footprint, allowing more testing capabilities with smaller-sized machines. This will help laboratories save valuable space while still meeting the demands of physicians and patients. This will also pave the way for new technology in the area of point-of-care devices, reducing, for example, the need for large sample volumes.
Customizing Analyzers Based On Laboratory Needs
Dr Parul Singla
Sir Ganga Ram Hospital
The Indian diagnostic industry is fast moving with an annual growth rate of around 12 percent. This industry is a collection of various segments of diagnostics including hematology, histopathology, microbiology, and molecular diagnostics. However the one segment which is at the forefront of automated diagnostics is biochemistry. Currently, the biochemistry auto-analyzers are the backbone of major diagnostic chains in the country. Clinical chemistry analyzers use measurement technologies including photometric, colorimetric testing, ion-selective electrodes, latex agglutination, immunoturbidimetry etc. to analyze samples such as blood serum, plasma, body fluids, and urine. Chemistry analyzers are used in all types of laboratories, from small point-of-care to high-throughput clinical labs, to test for analytes such as proteins, enzymes, and electrolytes. Benchtop analyzers are the most common type, but compact bedside models, usually with fewer test options, and high-throughput floor-based units are also available.
The biochemistry market in India is dominated by few major multinational companies including Roche Diagnostics, Siemens Healthineers, Ortho Clinical Diagnostics, Beckman Coulter, and Abbott Diagnostics. Manufacturers are developing biochemistry analyzers with low volume reagent consumption. The new instruments are able to automate repetitive sample analysis steps that would have otherwise been done manually. Manufacturers are customizing analyzers for use in smaller laboratories, use in very high volume situations such as in a large hospital, or in the field. As software capabilities continue to develop, clinical chemistry analyzers will be able to offer increased testing speed and degree of automation. Moreover, as a result of the convergence of system engineering, automation, and IT technology, a significant change has been brought in the global biochemistry analyzers market. Advances in clinical chemistry analyzers will be concurrent with the development of new assays, further improving patient care. The need of the hour is to validate multiple biomarkers in the field of cancer diagnostics in order to bring the molecular testing in the ambit of biochemistry analyzers.