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Clinical Chemistry

Evolving role of automation and AI in clinical laboratory disciplines

Clinical laboratories are dramatically impacted by two disruptive technologies – automation and AI. These technologies are also expanding the scope of laboratory medicine.

With the majority of clinical decisions relying on diagnostic tests, the onus is on clinical laboratories to process a high volume of clinical chemistry tests as efficiently and accurately as possible. This has been made possible by increased reliance on automation.

To meet this high demand, automation has been an integral part of most clinical chemistry workflows for decades. This was partly due to the high number of test requests and also the fact that common assay principles allowed multiple tests to share common detection modules, such as absorbance readers on a single system.

Common automation solutions include random access analyzers that no longer pause when reagents and consumables need to be loaded, as well as automated calibration and quality control onboard analyzers that decrease hands-on time with equipment, according to Lisa Rose, executive vice president of Core Laboratory Solutions and Diagnostics.

Several factors have contributed to the recent demand for more automation in laboratories. The barrier to entry for automation in smaller-size laboratories has decreased with laboratory staffing shortages, and the ability for pre- and post-analytical solutions to handle more complex tests and workflows for labs has improved over the past decade.

Another big consideration is finding ways to reduce costs. By giving labs the ability to handle larger test volumes without the need for breaks, automation cuts the cost per clinical chemistry test significantly, and these solutions are also less prone to expensive errors when handling dull tasks, such as decapping tubes or transferring over volumes. Research suggests that an estimated 46 percent to 68.2 percent of errors – such as mislabeling or using an incorrect tube – occur in the pre-analytical phase, which is why providers are looking to offer automated solutions earlier in the process.

Laboratories are experiencing innovations at every level in the clinical chemistry testing process. The clinical chemistry hardware itself is also improving, with smaller footprints and more digital tools on the horizon. For example, additional sensors could give labs advance warning when a pump is about to fail to help labs maximize uptime. More recent advances in instrument technology and engineering have opened the door for sophisticated testing capabilities on chemistry systems, such as consolidating specialty assays into routine chemistry operations and longer, uninterrupted run times to improve testing capacity and efficiency. Additionally, reducing patient sample sizes through pre-dilution can reduce the impact of draw volumes for sensitive patients.

There is definitely a role for Artificial Intelligence in automated systems down the road. It is too soon to guess what this will look like. Recent AI integration into the clinical laboratory has centered on molecular and digital pathology, and for good reason. Chemistry and immunology are a tempting next step, with a treasure trove of structured data and decision-support applications. AI in the clinical chemistry and immunology departments has potential applications with internal operations, as well as with external relations to multidisciplinary teams in the provision of data beneficial to holistic clinical algorithms.

Among the primary operational benefits of embedded AI is the ability to eliminate managerial guesswork adjustments for staffing resources. Computational analysis of monthly, quarterly, or annual test volume by the literal second can illuminate patterns in real time. This information can then facilitate both a predictive and prescriptive staffing model. Alternatively, AI can help optimize reagent material inventory by analyzing historical purchasing and stock against time and use trends. Likewise, AI could incorporate trending in supplier reagent availability, technical bulletins, recalls, and customer feedback.

Other operational applications of AI involve equipment monitoring and predictive modeling, the incorporation of which can help save time and money by reducing incidences of equipment failure and downtime.

A glimpse into the future – FISH probes and flow cytometry synergize for enhanced diagnostics

Vikram Patil
Deputy Product Manager – Flow Cytometry,
Sysmex India Pvt Ltd

Healthcare and diagnostic technologies are ever evolving. In this dynamic field, FISH probes (fluorescence in-situ hybridization) and flow cytometry have emerged as powerful complements to each other. These two distinct technologies, with their unique strengths, on combination have potential to provide insights into the world of healthcare.

FISH uses fluorescent labelled DNA/RNA probes, which bind to specific complementary DNA/RNA sequences in the sample cells. When illuminated with specific wavelengths of light, these probes emit fluorescent signals that can be detected under a fluorescence microscope. This enables researchers and clinicians to identify presence of specific genetic sequences in cells. This technique has found applications in cancer research, genetic disorders, prenatal screening, and infectious disease diagnosis.

Flow cytometry analyzes individual cells, based on their physical and chemical properties, by passing cells through a laser beam and measuring the scattered and emitted light. Flow cytometry provides information about cell size, granularity, and surface marker expressions. This technology has been instrumental in hematology, immunology, and infectious disease diagnostics and research.

By combining the molecular specificity of FISH probes with the high-throughput capabilities of flow cytometry for single-cell analysis, clinicians and researchers gain the ability to simultaneously examine genetic and cellular characteristics within a single sample. This opens a world of possibilities in several areas of healthcare diagnostics:

Cancer diagnostics. Early cancer diagnostics are enhanced by combining FISH probes’ genetic mutation detection with flow cytometry’s identification of abnormal cell populations.

Prenatal screening. These technologies improve non-invasive prenatal screening, enabling the detection of chromosomal abnormalities and genetic mutations in fetal cells within maternal blood.

Infectious disease diagnosis. Rapid and precise pathogen identification is vital in infectious disease diagnosis. FISH probes target pathogen DNA/RNA sequences, while flow cytometry analyzes host immune responses.

Genetic disorders. This integrated approach helps to learn more about complex diseases, providing insights of relations between genetic mutations and cellular phenotypes.

While the synergy between FISH probes and flow cytometry holds potential, its widespread adoption and optimization requires further research and collaboration within the scientific and medical communities.

In conclusion, as we glimpse into the future of healthcare, these innovations hold promise together for a better health and well-being.

Each of these operational applications are currently under investigation and/or are involved in active testing in other industries; as an example, AI is being utilized in waste management of biohazardous materials with smart waste bins that incorporate computer vision, robotics, and machine learning to sort waste efficiently and accurately at the time of disposal. It is reasonable that if success is observed within these outside markets, the clinical laboratory’s industry partners will take notice and seek to capitalize.

Training data sets and end-user validation are essential pieces of a quality control AI (QC AI) program. Additionally, AI allows for larger practice conversations on patient-based reference ranges and patient-based real-time QC. These concepts have gained attention as an alternative for today’s binary-derived population-based ranges and current internal QC programs.

Global market scenario
The global clinical chemistry analyzers market size is projected to reach USD 16.5 billion by 2028 from USD 13.0 billion in 2023, at a CAGR of 4.9 percent, according to Globe Newswire. This includes analyzers for basic metabolic panels, electrolyte panels, liver panels, lipid profiles, renal profiles, thyroid function panels, specialty chemical tests and reagents.

In 2022, the lipid profile tests segment exhibited the highest growth rate. This can be attributed to the escalating obesity rates globally and the subsequent increase in obesity-related diseases. These factors significantly drive the demand for lipid profile tests.

The reagents segment exhibited the highest growth rate in 2022. This growth can be attributed to the substantial demand for reagents, which are required in larger quantities compared to analyzers. The continuous need for reagents and repeat purchases contribute to significant market growth.

Additionally, the adoption of point-of-care testing devices and the growing demand for laboratory automation contribute to market expansion. Undoubtedly, fully automatic analyzers dominate the market due to their ability to process a large volume of samples efficiently and with minimal human intervention. These analyzers offer high throughput and a wide range of test panels, making them suitable for high-capacity laboratories. Semi-automated analyzers are commonly used in small-to medium-sized laboratories. These analyzers offer flexibility in test customization and are cost-effective compared to fully automated systems.

The increasing number of hospitals and clinics being set up will continue to drive this segment. Rising incidences of diseases and disorders, coupled with advancements in technology, have contributed to the significant growth of this segment in the clinical chemistry analyzers market. Research laboratories and institutes also contribute to growth.

The rising geriatric population and the increasing burden of chronic diseases create a significant demand for advanced diagnostic solutions.

The growing per capita income, improving healthcare infrastructure, and the substantial investments forthcoming from the key market players further fuel the growth of the market. Asia-Pacific region is exhibiting the fastest growth, with the increasing demand for cutting-edge technologies and the expansion of private-sector hospitals into rural areas in various countries, with China and Japan leading the pack.

The China market is expected to continue to be a dominant market till 2030, thereby, achieving a market value of USD 1259.3 million by 2030. The Japan market is registering a CAGR of 5.4 percent during 2023–2030. Additionally, the India market would showcase a CAGR of 6.7 percent during 2023–2030.

That said, North America is expected to hold the largest share of the clinical chemistry analyzers market. The major factors contributing to the market growth in the region include the rising prevalence of chronic diseases; the increase in healthcare expenditures; and product innovations by the key market players in the region.

According to the CDC data on chronic diseases updated in July 2022, chronic diseases are the leading cause of death and disability every year in the United States. The rising number of chronic diseases in the nation adds to the growth of clinical chemistry analyzers in the North American region. The high burden of the target and chronic diseases in the region and increasing demand for early diagnostics are the other major factors that are driving the growth of the studied market in the North American region. For instance, according to the Canadian Cancer Society’s 2021 report, about 229,200 new cancer cases will be diagnosed in Canada in 2021, and on average, 628 Canadians are diagnosed with cancer every day, which is further expected to increase in the future. Also, as per the same report, lung, breast, colorectal, and prostate cancer are the most diagnosed types of cancer in Canada (excluding non-melanoma skin cancer).

The major market players are launching new technologically advanced products into the market. Thermo Fisher Scientific partnered with Mindray to provide customers in the United States and Canada with two clinical chemistry analyzers for drug screening in clinical and forensic laboratories. Thermo Fisher and Mindray entered into an agreement to offer the USD FDA-cleared and Health Canada-approved BS-480 (400 tests/hour) and BA-800M (800 tests/hour) analyzers to toxicology labs.

However, market growth may be constrained by challenges, such as high capital investment requirements, a shortage of skilled clinical laboratory technicians, and the presence of refurbished products.

The major players operating in the global clinical chemistry analyzers market are F. Hoffmann-La Roche Ltd., Danaher Corporation, Abbott Laboratories, Thermo Fisher Scientific Inc., Siemens AG, HORIBA Ltd., Sysmex Corporation, Hitachi, Ortho Clinical Diagnostics, Mindray Medical International Ltd., Trivitron Healthcare Pvt. Ltd., Randox Laboratories Ltd., Medica Corporation, Meril Life Sciences Pvt. Ltd., Erba Mannheim, Genrui Biotech Inc., Dirui Industrial Co. Ltd., Teco Diagnostics, Balio Diagnostics, Snibe Co. Ltd., and AMS Alliance.

The healthcare system witnessed enormous challenges as a result of the Covid-19 pandemic. All outpatient treatments were postponed or restricted during the Covid-19 pandemic to reduce the risk of viral transmission as most chronic therapies were regarded as non-urgent. However, with the advent of the Covid-19 infection, large-scale clinical chemistry tests for people affected by the SARS-CoV-2 virus were performed. The clinical chemistry tests, along with the serological tests, helped in monitoring the overall health. Several clinical chemistry tests for patients with Covid-19 in the emergency setting were recommended by the IFCC. The tests also consider pre-analytical, analytical, and post-analytical variables that can influence the test interpretation. Some of the clinical chemistry tests listed included albumin, lactate dehydrogenase (LD), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin, among others. The increase in the utilization of these tests during the Covid-19 pandemic played a significant role in the growth of the market. However, now with Covid-19 behind us, the clinical chemistry analyzers market has stabilized at pre-pandemic level.

WHO is upbeat for this segment. The clinical chemistry analyzers run assays on samples, such as blood, plasma, urine, and cerebrospinal fluid to detect the presence of analytes relating to disease or drugs. According to the WHO, by the year 2030, around 1 in 6 people will be over the age of 60, about 1.4 billion people in the year 2030. The numbers are further projected to rise to 2.1 billion by 2050. Thus, the increasing elderly population is vulnerable to several chronic diseases, resulting in high demand for clinical tests.

Advances in clinical chemistry testing

Anant Shethji
Vector Biotek Pvt. Ltd. (A Beacon Group Company)

Clinical chemistry refers to healthcare and molecular diagnosis and genetics system, designed specifically to assist clinical decision support for healthcare professionals, laboratory researchers, pathologists, and general physicians. All biochemical tests come under chemical pathology, which can be performed on any kind of body fluid like serum or plasma. Clinical chemistry has a wide scope in endocrinology and metabolism, clinical immunology, nutrition monitoring, and regulatory system.

The rapidly increasing number of diabetic patients, growing prevalence of chronic diseases and various cardiovascular diseases are expected to boost the demand for clinical chemistry solutions, and hence foster the market growth. According to World Health Organization (WHO), the burden of chronic diseases is rapidly increasing worldwide. In addition, increasing aging population is also supplementing the demand for clinical chemistry. The clinical laboratory is being highly developed, and growing technologically advanced methodology and research platforms for the diagnosis of diseases has created enormous opportunities for the growth of the clinical chemistry market.

Laboratory technology is often at the forefront of medical advances. In some cases, testing techniques to diagnose or screen for a particular condition are available before effective treatment. Innovation in laboratory technology, which includes both new tests and advances in equipment and testing techniques, has made testing more efficient and automated. Information technology (IT) has revolutionized the transfer of data by decreasing the time it takes to order and receive test results, and by creating opportunities for research on large datasets.

Dry chemistry, Gen technology, and biosensors are amongst the latest techniques that are being widely used in clinical chemistry. The major diagnostic application of Gen technology is detection of genetic disorders like beta thalassemia as well as cancers like CML. On the other hand, biosensors, whose function is to selectively respond to analyte in biological sample and convert their concentration in measurable electrical signals, are also frequently employed in clinical chemistry testing.

Beacon group is amongst the leading suppliers for clinical chemistry products, including reagents and sophisticated high-speed automated analyzer in India and >85 countries of the world, and enjoying a front contender position in this segment of IVD. 

With the majority of clinical decisions relying on diagnostic tests, the onus is on clinical laboratories to process a high volume of clinical chemistry tests as efficiently and accurately as possible.

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