The newer generation of analyzers are now equipped with many analytical and technical innovations, which enable obtaining information other than that reported with the traditional CBC.
Hematology has constantly been advancing in parallel with technological developments that have expanded the understanding of phenotypic, genetic, and molecular complexity and extreme clinical and biological heterogeneity of blood diseases. This has in turn allowed for developing more effective and less toxic alternative therapeutic approaches directed against critical molecular pathways. Hematology analyzers are now commercially available as simple handheld photo-optical devices, sophisticated diagnostic point-of-care (PoC) instruments, and highly automated or complex laboratory analyzers. These instruments have even become complex and high-tech along with user-friendly and easy in operation, driving their adoption in the hematology laboratories.
Laboratory automation is regarded as one of the major advancements that occurred in blood diagnostics. It has been for long limited to clinical chemistry and immunochemistry platforms. The major hurdle encountered in developing models of automation for hematology laboratories is represented by the peculiar sample type, which is, whole blood anticoagulated with dipotassium EDTA. Nevertheless, a number of technological solutions have been developed for hematology in recent times. These basically include commercialization of modular, high-throughput and versatile analyzers, which can be easily interconnected by means of sample conveyers, and can fit the organization of small, medium, and large facilities; integration of pre-analytical workstations, which can be identical to those included in models of total laboratory automation, or can be specifically designed to suit hematological testing; connection with automated slide strainers, which help improving the entire slide making process (i.e. less manual activities and lower biological risk, improved standardization of slide preparation and staining, customization of staining protocols, reduction of TAT); as well as integration of automated image analysis systems.
The newer generation of hematology analyzers are now equipped with many analytical and technical innovations, which enable obtaining other information than that reported with the traditional complete blood cell count (CBC), and which may ultimately provide a substantial improvement for the differential diagnosis of blood diseases. Regardless of consolidated laboratory techniques, a major innovation has been represented by the application of mass spectrometry and molecular biology in the hematology laboratories.
Indian market dynamics
The Indian hematology instruments and reagents market in 2017 is estimated at Rs 1057 crore, an 11 percent increase over 2016. Reagents constitute 63.4 percent of the market. While, reagents increased by 11.6 percent in 2017 over 2016, and instruments by 9.9 percent in value terms, the increase of 19.1 percent of instruments in quantity terms was larger in the same period. Fully automated 3-part analyzers dominate the instruments market with an 86 percent share in volume terms and 63 percent share in value terms. Semi-automated analyzers are gradually exiting the segment, and have a mere 0.2 percent share in value terms.
Within the 5-part fully automated analyzers, the high-end command with a 21 percent share in value terms, whereas the entry level 5-part ones have a 16 percent share in quantity terms. The high-end 5-part are primarily bought by government institutions, the private sector favors the rental path. It is not so for the 5-part entry-level analyzers, where outright purchase is preferred and rentals form a very small part of the market. Rising demand for high-throughput hematology analyzers and development of high-sensitivity PoC hematology testing are fueling growth. However, the high cost of hematology analyzers and intense competition among existing players are the restraining factors. In addition, stringent and time-consuming regulatory policies for hematology instruments also impede the market growth.
Development of precise, flexible, and user-friendly technologies that are cost-effective has been a trend in the hematology market. Advancement in research has led to more professional demands and capabilities in these units of testing.
Integrated analyzers. The industry has come a long way in automating one of the most time-consuming tasks in the laboratory. It is no longer necessary for highly skilled and trained laboratory professionals to stand over the slide preparation bench. Staff can now spend more time on the difficult cases that require careful analysis and assessment. Together, automated slide making and staining integrated with automated cell image analysis enhances the level of service a laboratory provides its clinicians and patients. The market has currently seen introduction of various hematology testing solutions combining a cell counter, slide maker and stainer, and a digital morphology analyzer into one integrated solution.
Hydrodynamic focusing. It is one of the basic methods utilized by various analyzers in cell counting. However, the same focusing is now available with double power and thus, more reliable and accurate counting. The new double hydrodynamic sequential system (DHSS) provides more reliable and better results compared to previous conventional focusing techniques. The technology has a good potential with high resolution and accurate quantification of abnormal cells. Use of DHSS technology helps the pathologists in utilizing parameters like atypical lymphocytes (ALY) and large immature cells (LIC), which are helpful in diagnosis and differentiation of various blood pathologies.
Additional parameters. The hematology analyzers are being used predominantly for cell counts and differential leukocyte analysis; in addition, these analyzers are now capable of reporting many additional parameters and can provide much more information than what they are intended to provide. Recent technological advancements in the automated hematology analyzers have resulted in generation of many novel parameters to characterize the blood cells. Majority of the hematology analyzers are now available with an integrated reticulocyte count analysis with the routine CBC analysis which not only provides the reticulocyte percentage and absolute reticulocyte counts but also provides additional data in the form of reticulocyte hemoglobin content (CHr), percentage hypochromic cells, percentage microcytic cell or microcytic anemia factor, immature reticulocyte fraction, etc. These parameters, though currently for research purposes, hold a promising value to aid clinicians in certain clinical scenarios.
VCS technology. Volume, conductivity, and scatter (VCS) technology is an approach to WBC analysis where in addition to numerically quantifying and sub-classifying these cells, it also yields a large amount of information on their physical, electrical, optical, and hence, structural properties. The numerical VCS data or coordinates are visualized graphically in the form of a 3D cube. A total of 24 parameters are thus available with every routine differential leukocyte count without any further analyses or increased cost, and regardless of clinical suspicion.
Digital morphological imaging. Currently, the manual microscope method is considered the standard. However digital technology using digital images and software algorithms to classify hematological cells, such as leukocytes and red blood cells, leads to a faster, more efficient, and more standardized way of performing a morphological analysis of a peripheral blood smear. The current systems present in the market are equipped with software capable of not only detecting these cells, but also subsequently classifying them into the correct cell class. The software application is developed using an artificial neural network, and it considers a large number of features, such as size, roundness, and size and shape of the nucleus for the morphological classification of leukocytes. The number of cells counted by the system can be set by the operator, and the system will present the results in both absolute numbers and percentages. Integration of digital imaging with basic cell counter results leads to a faster detection, higher sensitivity, and specificity in the detection of hematological malignancies.
Automation in hematological slide makers. With today’s ever-changing healthcare environment, laboratory managers and directors are challenged to find ways to optimize the utilization of laboratorians and support staff while maintaining and improving turnaround times, and continuing to provide the highest quality patient care. Continuing to perform manual tasks such as preparing manual blood smears takes laboratory professionals away from tasks that require critical thinking that they were trained to do and are relied upon to perform. Today, there are automated and semi-automated slide makers and slide maker/stainers in the market that can ease the burden on the laboratorian while providing consistency in the smear preparation process. Customizable stain times, another feature of automated slide maker/stainers, allow for the laboratory to achieve the desired coloration not only for whole blood smears but also for body fluid or bone marrow smears.
Remote review software. The new hematology workstations provide not only a more ergonomic workspace but flexibility for lab staff and for pathologists also. Abnormal cells can be reviewed from any networked computer licensed with remote review software, allowing more frequent interaction between the laboratorian and pathologist, leading to faster interpretation and quicker result reporting.
Many technological advances made in laboratory medicine in recent times have enabled the introduction of a vast array of innovations, which have led the way to a more efficient patient care and a more convenient organization of resources and workflows within the hematology laboratory. In the foreseeable future, the better understanding of phenotypic heterogeneity of blood disorders, also supported by IT tools such as expert diagnostic systems or artificial neural networks, will predictably enable to improve the global management of these disorders at multiple levels.
Advantages of automated hematology instruments, rising technological advancements, and integration of basic flow-cytometry and mass spectrometry techniques in modern hematology analyzers will further drive adoption of these analyzers in the years to come. In addition, usage of microfluidics technology in hematology analyzers and introduction of the digital imaging system in hematology laboratories could open up opportunities for new players in the market.