Clinical Chemistry Has Come a Long Way

Innovative clinical diagnostics tests and technologies are the foundation for evidence-based medicine, allowing for early intervention that improves patients’ health outcomes, often lowering costs for the broader health system. It was during the first decades of the century that blood and urine were first measured using quantitative analysis and instrumentation, and the results applied to human disease and health. What might be called the golden age of clinical chemistry began during the years after World War II. Between 1948 and 1960, such products as radioimmunoassay and the autoanalyzer were introduced.

Several years later, the advent of computer- or microprocessor-based technology and software programming ushered in a new era for diagnostic testing—one that would eventually lead to automated environments that would enable laboratories to perform fast, high-quality testing, and gain workflow efficiencies. Mid-decade, a number of technological advancements were introduced; these included instruments dedicated to a single or dual test menu, such as the flame photometer, and the chloride/CO2 and glucose analyzers.

In the succeeding decades, the industry has witnessed a fast-evolving series of technological advancements in clinical chemistry instrumentation. With each new system generation, novel features have been introduced – such as closed tube sampling, automated maintenance processes, streamlined calibration, and internet-based remote diagnostics – all of which are intended to help laboratories better meet the needs of physicians and patients, while creating efficiencies, driving quality, lowering costs, and addressing fluctuations in the workforce.

Market trends
The global clinical chemistry market is expected to reach USD 10 billion in terms of value by the end of 2026, with an average year-on-year growth rate pegged at 5 percent through 2026, estimates Persistence Market Research. The increasing prevalence of lifestyle-related diseases, such as obesity and cardiovascular diseases, has immensely contributed to the growth of the clinical chemistry market. The increase in laboratory automation is also expected to be one of the most important factors leading to the growth of the clinical chemistry market.

Successive generations of stand-alone clinical chemistry analyzers led to an increase in the analytical speed, offered capabilities for testing higher volumes of patient specimens, and generated large assay menus. The development of various integrated clinical chemistry systems has immensely improved the efficacy of analytical phase of clinical chemistry laboratory testing and led to further automation being used for pre-analytical procedures such as sample sorting, centrifugation, identification, and post-analytical procedures like specimen archiving and storage. Point-of-care (PoC) testing volume has also evolved and increased over the years. The growth is immensely driven by changes in healthcare, which are focused on providing more affordable care. The technologies for point of care testing have undoubtedly evolved and been refined for delivering easy-to-use clinical chemistry testing devices with improvements in analytical performance. For instance, Dipstick is a point of care testing technology that is being frequently used and has stood the test of time. It can detect a single analyte or up to 10 analytes and can also be used in conjunction with a very small reading device to reduce potential operator errors. Countries worldwide are facing a limit in the growth of healthcare budgets and in some cases reduced healthcare expenditures. To compensate for these limitations, countries are focused on reducing relatively expensive care in tertiary and secondary hospitals. Point-of-care testing allows timely detection of infectious diseases, which has further led manufacturers of these devices to improve and enhance their product portfolio. The benefits of using PoC testing clinical chemistry devices have led to the growth in demand for these devices, which is expected to boost market growth for clinical chemistry.

Technological trends
Improvements in analyzer design and performance continue to be driven by a number of factors: 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 informatics. Computer technology has transformed clinical chemistry in two overarching areas: automation and informatics. Automation has touched every facet of clinical laboratory operations, enabling increased throughput to accommodate higher testing volumes; elevating quality by reducing human error and lessening the risk of sample cross-contamination; enhancing safety by reducing exposure to biohazardous materials; and improving workflow through greater system uptime and walkaway times. Today, laboratories operate with greater efficiency than ever before. Processes that were, in the past, performed manually, now are performed via instrumentation. 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. Today’s consolidated systems typically perform hundreds of tests on one platform, whereas preceding systems required a number of dedicated instruments, each performing only a few selected tests. Automation combined with cloud-based technology has helped laboratories 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. Automating routine responsibilities frees laboratorians to focus more on patient care and functions for which they are specifically educated and trained. A pivotal area in which laboratories have been able to improve uptime and avoid unplanned costs is in automating inventory management.

Cloud-based systems can help 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. In today’s world of Big Data, large amounts of information are available—but that can be more of a hindrance than a help to good practice if lab leaders do not manage the information effectively. Making that data relevant and usable for improving operations is important in helping laboratories achieve their continuous improvement goals. Today, lab directors need to coalesce actionable data into a single repository to drive decisions and provide valuable insights into laboratory performance network-wide. This can be accomplished via cloud-based analytics, and this will be increasingly important as the trend toward network consolidation continues to grow.

Software integration. 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.

Selecting a chemistry analyzer
Given all the benefits of modern instrumentation, the choice of an analyzer is not merely about the capabilities of the system. As with most technology, the choice should be based on user need. Laboratories must consider testing volume/throughput and the types of diagnostic tests that the system will perform. In addition, lab directors should think about the desired level of automation, as well as pre-analytical sample handling and post-analytical data management needs. Beyond instrumentation functionality, the laboratory must also examine space and cost constraints, taking into account footprint and system operating costs.

While choosing the right instrument is important to ensuring successful laboratory operations, it is only part of the equation. Laboratories today are looking for knowledgeable partners to help them apply proven continuous improvement strategies – borrowed from the manufacturing industry – to healthcare.

A partner who is able to offer a total laboratory solution beyond instrumentation placement can help the laboratory to achieve its patient care and operational efficiency goals. This includes supporting the use of the instruments, identifying opportunities for automation, detecting workflow gaps, and helping to create efficiencies in managing resources.

Clinical chemistry has evolved greatly over time, driven by numerous factors—not the least being technological advancements in the world at large. Computers, microprocessors, and robotics paved the way for automation and cloud-based technology. With this, laboratories no longer consist of small standalone, manually operated units that performed a handful of tests; instead, they have transformed into bustling hubs featuring large integrated platforms that produced thousands of tests per hour with sophisticated information management systems. Future growth will build on this foundation, providing more capabilities in smaller-sized units. Instrumentation alone is only part of the equation. A strategic partnership can optimize laboratory performance, strengthening system advantages by integrating them into a total lab solution.

Outlook
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.

Software development initiatives will target workflow inefficiencies and results processing. Cloud-based systems and integrated networks will enable patient histories to be recorded and recalled, regardless of where testing is performed.

In addition to this, designers 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.