Hematology moving toward digital transformation

Hematology analyzers have undergone significant technological advancements and automation in recent years, leading to improved accuracy and efficiency in cellular analysis. These advancements include better flag optimization, digitized morphology, and the integration of artificial intelligence and machine learning algorithms, which help in detecting abnormal cells and incidental findings that may be missed during manual microscopy.

Moreover, automation technology has also been increasingly adopted by companies in the hematology diagnostic devices industry. This automation reduces the errors caused by manual practices in diagnostic centers, leading to more reliable results and better patient outcomes. The demand for hematology analyzers is also driven by these advancements in automation technology, making it easier for healthcare professionals to perform blood tests and diagnose blood-related disorders.

Overall, these advancements in hematology analyzers and automation technology have made a significant impact on the healthcare industry, improving the accuracy and efficiency of blood analysis, which is essential in the diagnosis and treatment of various diseases.

Hematology analyzers today are now well-equipped with cutting-edge methods to gather data on cell traits, and identify illnesses. The practice of hematology has also been altered by new technology, and with the availability of information on blood cells, this evolution has propelled it to the forefront of medical technological advancement. It enables the detection of reticulocytes and immature granulocytes, among other types of white blood cells. With the use of immunofluorescence, automated cell counting, and flow cytometry techniques, it also provides a more straightforward diagnosis of benign and malignant hematological illnesses, and a better understanding and etiology of many diseases.

Due to the quick pace of product development at Covid-19 times, numerous manufacturers and significant international corporations introduced novel products to meet changing consumer needs.

Additionally, the introduction of digital imaging systems in hematological laboratories, and the use of microfluidics technology in hematology analyzers, are likely to provide new potential for emerging market players.

Moreover, heavy investments by leading industry players for new product launches, and the presence of robust distribution chains, are expected to drive market growth during the forecast period.

Over the years, the study of complete blood count (CBC) disorders has served as a paradigm for gaining insight into a variety of diseases. To date, more than 1000 disorders of the synthesis and/or structure of CBC and its concentration in the blood have been identified and characterized. On the other hand, marked increases or decreases in blood cell counts could result not only when a genetic disease occurs but also because of treatments for certain diseases, such as cancer.

CBC can include many hematological indices, such as MCH, LYM, MCHC, HB, RBC and subsets, immature granulocytes, immature platelet fraction, and reticulocyte hemoglobin, among others.

While conventional methods entail time-consuming and costly laboratory tests, and necessitate accompanying the patient to the laboratory for analysis, the latest requirements for home care involve the use of point-of-care (POC) diagnostics to evaluate hematological indices through fast, cheap, and disposable tests. These technologies could bring diagnostics to bedside and home testing, minimizing the workload in centralized laboratories. POC blood tests typically performed during the treatment of diverse diseases are intended for main targets as hemoglobin, leukocytes, hematocrit, and platelet, among others.

However, complete blood count (CBC) analysis was not available as a POC test until recently. The newly FDA-approved HemoScreen could fill this gap, being a central example of a small, easy-to-use device that uses disposable cartridges However, HemoScreen entails laboratory setup instrumentations and is not suitable for home testing.

Sight OLO® (S.D. Sight Diagnostics Ltd., Israel) is a novel hematological platform designed to address some of the limitations in current near-patient and POC test hematology analyzers. Sight OLO was able to produce results from finger pricks that are equivalent to those obtained using venous blood draws.

There have been several attempts to develop miniature simple-to-use analyzers that would fit the POC setting and standard operator profile, including the Chempaq XBC, Ativa, SpinIt, HemoCue WBC, and QBC Star. However, the development has either been abolished or ended with instruments that only provide a subset of the CBC parameters. None have received a CLIA waiver, with the exception of the Sysmex XW, which has an intended use that is limited to normal individuals. The reasons that the CBC is missing from the large variety of POC tests lie in the complexity of this test. First, it is a cellular-based measurement, in which several types of cells need to be differentiated, based on nuances in their size and morphology. Moreover, cell maturity and staining vary between blood samples; as cells mature their appearance changes, creating a continuous spectrum of characteristics in a single sample for the same type of cells. Further, a major concern in analytical hematology is interference; a variety of interferences affect different measurement parameters, depending on the underlying technique. For example, pre-analytical errors, such as hemolysis and platelet clumps may cause laser or impedance-based techniques to confound debris/clumps with other cells. Other known interferences include cold agglutination, microcytosis, bilirubin, nucleated RBC, high lipid content, etc., all of which arise from limitations in the measurement method.

This is despite CBC ranking among the most commonly ordered tests. The relative absence of POC CBC analyzers had also hampered the adoption of other POC tests that tend to be ordered alongside the CBC (e.g., complete metabolic panels); in particular, if a CBC is required but must be performed in the central lab due to its absence at the point of care, its companion tests may as well be ordered from the central lab.

Benchtop hematology analyzers, designed for POC operation, have a rather large footprint, require substantial maintenance, and frequent calibration procedures that must be performed by trained laboratory personnel. Furthermore, due to the more basic technology employed by benchtop analyzers, they are less adept in coping with pathological samples and raise more flags indicating further review is required.

Availability of a small, about half the size of a toaster, easy-to-use CBC analyzer with WBC 5-part differential would shorten TAT and likely benefit patients in ICUs, operating rooms (ORs), and emergency departments (EDs). In the ICU and OR, hemorrhage is a major concern that is controlled, apart from surgical procedures, by transfusion of blood constituents. Transfusion management is based, in part, on a combination of hematocrit (HCT), hemoglobin (HGB), red blood cell (RBC), and platelet (PLT) counts; yet total laboratory TAT is in most cases 60 minutes or more. Thus, treatment is frequently administered based on hemoglobin values only. Immediate CBC results would substantially improve transfusion management and allow better use of blood resources. Another example of a healthcare setting that would substantially benefit from decentralized CBC testing is oncology outpatient clinics. These are centers where patients are administered treatments, such as chemotherapy, and where patients in remission are monitored. Here patients must be tested for neutropenia (usually absolute neutrophil count, WBC, RBC, and PLT are reviewed) prior to administering treatment to ensure its safety as well as adjusting dosage. In most cases, the patient’s wait time is largely due to having their blood tested in a central laboratory. This prolongs their clinic stay and delays treatment in the clinic. Immediate CBC with 5-part differential improves workflow, use of resources, such as the pharmacy, and, most importantly, patient experience.

The global POC diagnostics market is expected to reach USD 72 billion by 2027 from an estimated USD 43.2 billion in 2022, at a CAGR of 10.8 percent from 2022 to 2027.

The technological advancements and product launches by key players have been driving market growth. In June 2022, Thermo Fisher Scientific Inc. introduced the new EliA RNA Pol III and EliA Rib-P blood tests for aiding in the diagnosis of systemic sclerosis and systemic lupus erythematosus (SLE).

In April 2022, Sysmex Europe launched its new three-part differential system XQ-320 XQ-Series automated hematology analyzer, equipped with a multitude of different features.

In March 2022, Mindray launched the new BC-700 series, a revolutionary hematology analyzer series that incorporates both CBC and ESR tests.

Challenges abound
Hematology, like many fields of medicine, is moving toward a digital transformation where data is the key to diagnostic insights and building an effective plan of treatment. While this is an exciting evolution that brings with it incredible opportunities for improved clinical capabilities and ultimately, improved patient outcomes, there are challenges that need to be overcome before this transformation is complete.

Hematology laboratories are challenged with the organizational management of a shrinking workforce, increasing testing volumes and complexity of cases, limitations of remote-work capabilities, and inter-user variability of results.

Staffing shortages. There is a well-documented staff shortage that has grown more severe in recent years. But while workforce shortages are affecting the entire healthcare ecosystem, there is a particular strain being felt in hematology laboratories.

Rise in testing volume and increased patient complexity. A contributing factor to the strain placed on clinical labs is the increased demand for services. With the advancement of diagnostic and therapeutic techniques in hematology, more people are being diagnosed with cancer and other blood-related diseases. Consequently, labs are faced with a difficult question – how to maintain the standard of care.

Limitations of remote-work capabilities. The traditional hematology analysis method, manual microscopy, has been utilized for generations. While today’s instruments have improved, one significant inherent limitation they have is the inability to remotely view or analyze slides. A sample is smeared onto a slide and viewed manually by an expert in the lab. This requires an expert to be physically present in the laboratory to conduct the analysis. It also means that there is no way to share slides easily between laboratories.

Inter-user variability of results. Traditional hematology laboratories rely on educated and experienced staff to make consistent clinical decisions, using manual instruments, leading to the variability of test results. Inconsistencies in every stage of the testing process can affect the results. Improper handling or storage of the sample before testing, analytical errors, type and quality of instruments used, and errors in interpretation or reporting of the results can all lead to the variability of results.

Increased demand for spending reductions
Laboratory directors are charged with reducing costs, and maximizing product and instrument lifespan. In an ever more expensive world – the core inflation rate exceeded 9 percent in 2022, while national wage growth has experienced a 5.1 percent increase in the past year – labs are rightfully concerned about budgeting. Finding technological solutions that meet the needs of the lab, improve workflow, and help the lab reduce costs is a boon to hospitals and hematology laboratories.

These struggles can be met with proper lab management, implementation of helpful technology, and laboratory automation.