Over the years, hematology instruments have evolved from simple manual red blood cell counters to sophisticated automated analyzers. Manufacturers are developing analytical automation systems that simplify the testing process, reduce manual work, and further increase the efficacy and productivity of laboratories. Demand for these systems is influenced by development of alternative technologies such as point-of-care (POC) instruments and integrated analyzers, advancements in product automation, and highly streamlined lab processes.

Technological developments in high-throughput hematology analyzers, integration of basic flow-cytometry techniques in modern hematology analyzers, increasing adoption of automated hematology instruments by diagnostic laboratories, technological advancements, and developments in the high-sensitivity POC hematology testing are some of the key factors that are fueling the growth of the hematology market. However, the high cost of hematology analyzers and intense competition among existing players are restraining the growth of the global hematology analyzers and reagents market. In addition, stringent and time-consuming regulatory policies for hematology instruments also impede the market growth.

The usage of microfluidics technology in hematology analyzers and introduction of digital imaging system in hematology laboratories could open up opportunities for new players in the global hematology analyzers and reagents market. In addition, increasing focus toward emerging markets, such as India and China, could also open up opportunities for new players in the global hematology analyzers and reagents market.

Moreover, safety and quality of hematology instruments could be a challenge for the growth of the global hematology instruments and reagents market. Increasing instances of partnership between hematology instruments and consumables manufacturers is one of the recent trends in the global market.

Global Market

The global hematology analyzers market is expected to reach USD 2.6 billion by 2020, growing at a CAGR of 5 percent from 2016 to 2020, estimates Technavio. By product type, the global hematology analyzers market may be divided into three broad categories - large capital equipment hematology analyzers, bench-top hematology analyzers, and POC hematology analyzers.

In 2015, the large capital equipment hematology analyzers segment dominated the market and accounted for more than 
49 percent of the overall revenue market. The global large capital equipment hematology analyzers market is likely to reach 
USD 1.3 billion by 2020, growing at a CAGR of over 4.5 percent. Large capital equipment hematology analyzers are automated integrated systems that combine all forms of sample processing, analysis, and presentation of results. These systems are controlled by laboratory information management system (LIMS) to generate high-throughput analysis of samples. They also help in pre- and post-analytical sample handling and management of reagent supply with limited user interference.

The global bench-top hematology analyzers market is projected to exceed USD 1 billion by 2020, growing at a CAGR of 5 percent. The working mechanism of a bench-top hematology analyzer is similar to capital equipment. However, these analyzers are smaller in size compared to capital equipment and can analyze smaller quantities of blood samples in one cycle run. These devices are employed in small and medium-sized laboratories. They are also employed in physician office laboratories (POLs).

The global POC hematology analyzers market is likely to exceed USD 349 million by 2020, growing at a CAGR of over 6 percent. The POC hematology testing fosters an opportunity for physicians to provide immediate feedback to patients and thereby administer efficient treatment. Hematology tests at POC include hematocrit, hemoglobin, platelet function, and WBC tests. Further, the multiplexed POC hematology testing enhances clinical care delivery and proves useful in disaster and emergency settings, urgent and primary care settings, and home care settings.

With the increase in blood donation campaigns in developing and developed countries, the market for hematology analyzers has a positive outlook in the coming years. According to WHO, 108 million blood donations were collected globally of which 50 percent were from developed countries. Also, there has been a rise in blood donations in low-income countries. A large volume of blood donations is necessitating demand for hematology analyzers, which will help generate high-throughput sample analysis. The need to analyze the blood sample accurately will propel the market for hematology analyzers until the end of 2020.

Outlook

The ongoing revolution of diagnostic testing, squeezed between reduced funding and increasing volumes, carries notable implications in the way laboratory resources are organized and coagulation tests delivered. It is, therefore, predictable that the newer generation of hemostasis analyzers may be designed to face these emerging needs while maintaining a high degree in the quality of testing.

The future of hematology is currently unpredictable. The challenge of coagulation analysis in the context of the widespread use of novel anticoagulants, which is very likely increasing further in the future, is a paradigmatic example. According to ongoing reorganization of laboratory diagnostics around the globe, continuous technological innovations such as miniaturization, improvement of hardware and software components, and predictable trends of disease prevalence, some basic ideas can be proposed to envisage a next-generation coagulation analyzer.

Varun Kumar Sharma, Deputy Application Manager-IVD, Mindray Medical India 
Private Limited
Industry Speak
Utility of Hematology Analyzer - A Paradigm Shift

Hematology analyzers have witnessed a lot of innovation since its inception in 1956. And major transitions have been from single-chamber to double-chamber, 3-part to 5-part, and so on. And until recently, its utility has been limited only to cell counting and differentiation. Now apart from structural changes, the utility of an analyzer in a lab has also taken a big leap. Today, laboratories not only need more reliable routine CBC plus 5-part diff WBC testing, by way of high processing speed, but are also looking for new parameters such as IMG, RHE and IPF, etc. This enables them to skip microscopy (which itself has its own share of limitations and significant degree of variance). This scenario demands hematology analyzers to deliver more in terms of output.

It is required that the analyzer reveals more information about abnormal morphology, and indicates minor changes at hematopoietic level. Mindray has lived up to this expectation in the form of innovative SF cube technology in BC 6800.

The new SF technology introduced by Mindray, especially with strong software clinical utility, has got a fresh lease of life. BC 6800 can not only help to see virtually a clearer picture of blood, it also aids the clinicians by intelligent flagging, such as malaria, RBC agglutination, blasts, ALY, fragments, lipid interference, cold agglutinins, etc.

With new technology platform SF Cube, BC 6800 can completely fulfill the requirements from medium to large labs. In SF Cube technology, the targeted blood cells undergo 3D analysis using information from scatter of laser light at two angles and fluorescence signals. Due to the 3-D scatter gram, BC 6800 can not only give parameters for CBC+DIFF, RET, NRBC, but also reveal more information about abnormal cells.

Apart from routine flags for abnormal cells, BC 6800 can also provide accurate flags for parasite-infested RBCs (mainly malaria in Indian cases), also give quantified results in the form of total number of infected RBCs and their percentage.

In cases of BMT or chemotherapy, it becomes necessary to assess whether bone marrow has resumed its functional capabilities or not and hematopoietic indicators can save precious time and unnecessary administration of costly medicines.

The new reported parameters in BC 6800 can give a lot of information about hematopoietic activity other than the matured cell counts. And this makes it a fresh clinical tool, with increased application areas.

Following are the new clinical tools offered with BC 6800: Leukopoietic indicators -

immature granulocytes, reportable

with every differential; erythropoietic indicators - nucleated RBC with every CBC, reticulocyte and its indices, Ret hemoglobin (RHE), and immature reticulocyte fraction (IRF); and thrombopoietic indicators - immature platelet fraction (IPF) and an optical platelet count (PLT-O) designed for very low platelet counts.

Along with the clinical tools, it also offers a great deal in ease of use, productivity and efficiency enhancements that are supported by automatic workload balancing; the loading and unloading area can hold up to 100 sample tubes at a time; remarkably smaller footprints to optimize increasingly precious laboratory space; and dedicated body fluid mode.

BC 6800 also supports upgradation to cellular analysis line (CAL 8000), which is a modular system consisting of more than one unit of BC 6800 and SC 120, which is a slide maker and stainer. This makes a lab a lot more independent as CAL 8000 can also do rerun testing, auto validation based on user defined criteria set by Lab. Since SC 120 offers open staining protocols, the lab is free to choose its own staining methods.

In a nutshell, BC 6800 is a complete package, which offers almost everything a lab needs, from ease-of-use to highly advanced clinical tools.

Varun Kumar Sharma
Deputy Application Manager-IVD,
Mindray Medical India 
Private Limited

Kanchan Jeswani, Product Manager-Hematology, Transasia Bio-Medicals Limited
Industry Speak
Automation of Body Fluid Counts

Cellular analysis of body fluids is clinically important in the diagnosis of infectious/inflammatory processes, hemorrhage, and malignancies involving body cavities and the central nervous system. WBC and RBC in body fluids can cause fluid formation in several diseases. Hence, their analysis is important for detecting organ injury or infection. For example, the presence of elevated WBCs and/or RBCs in cerebrospinal fluid may aid in the diagnosis of meningitis, encephalitis, brain abscess, multiple sclerosis and intracerebral hemorrhage. Diseases such as tuberculosis or congestive heart failure can be distinguished by the separation of pleural effusion into transudates or exudates (along with LDH and protein levels). Therefore, rapid laboratory results are of important clinical relevance.

Though manual differential counting has been the gold standard for the determination of WBCs and RBCs, it has limitations such as high inter-observer variability, high inaccuracy, and poor reproducibility. A variety of automated hematology analyzers provide acceptable alternatives to manual cell counts for most BF samples. The potential benefits of automation include accuracy, precision, laboratory efficiency, and cost effectiveness.

In an analyzer, the purpose of a BF mode is to optimize the analyzer's unique combination of technologies as the body fluids differ from whole blood in cellular composition, cellular stability, and many matrix effects. It is important to understand the technological modifications and software algorithms of the analyzer's BF mode. There are different approaches and gating strategies to exclude the mesothelial cells that are normally present in the serous fluids such as pleural, peritoneal, pericardial, peritoneal lavage, and dialysate fluids from the WBC counts. On their inclusion, the count is reported as the total count.

It is well documented that cellular deterioration, lysis, and bacterial growth can occur within hours of specimen collection, depending on the time elapsed, storage conditions, and sample type. The serous fluids can be collected in EDTA to prevent coagulum formation. Sample testing should occur while the sample remains stable, and the correlation between methods should be within two hours of each other. The analytical system must be controlled for the quantitation of BF sample. Two-level quality-control products are available that test the analyzer's AMR (analytical measuring range). Some analyzers report a two-part differential, which is included as part of the BF commercial quality controls.

Sysmex XN 1000 is based on the principle of fluorescence flow cytometry and offers the BF mode for WBC, RBC, total counts (includes large high fluorescent cells such as mesothelial and malignant cells) and a two-part differential count-PMN and MN in absolute counts and percentages. RBCs are counted in the RBC channel using sheath-impedance technology while the WBC, mononuclear cells (comprising lymphocytes and mononuclear/macrophages (MN)) and PMN cells (comprising neutrophils and eosinophils) are determined by flow cytometry in the differential channel. The differential channel combines forward scatter (size of the cell) with side scatter (inner complexity of the cell) and the fluorescence intensity (DNA/RNA content) to identify and cluster each cell. This channel also reports high-fluorescence body fluid (HF-BF) cells, such as macrophages, mesothelial cells, and tumor cells. If the numbers are increased, an abnormal WBC scatter gram flag is triggered, which would warrant a smear review. Additionally, if non-cellular particles such as bacteria or cell debris are present, leading to erroneous clusters, then also the WBC abnormal scatter gram flag is generated.

Automated differential counts must be validated against manual differential counts for preferably those performed on cytospin smears. The purpose of validation/verification of the BF mode is to determine that the analyzer is suitable for its intended use.

The introduction of BF modes offers potential to improve accuracy, improve TAT, standardize performance, which will make these results more clinically useful. Transasia Bio-Medicals Ltd. exclusively offer the entire gamut of hematology automation from Sysmex ranging from 3-PDA to the high-end 6-part XN series, in India.

Kanchan Jeswani
Product Manager-Hematology,
Transasia Bio-Medicals Limited

Dr Anjali Tewari, Director, Lab Sciences,Regency Hospital Ltd., Kanpur
Second Opinion
Choosing a Hematology Analyzer

From manual testing to modern-day modular hematology auto analyzers, technology has come a long way. There is a wide variety of hematology analyzers available in the market to meet the needs of all sizes of laboratories. Whenever any laboratory plans to procure a hematology analyzer, the basic issue to be considered is predicted workload. Once we have the tentative work load, the evaluation of the type of analyzer to choose becomes easier. In our case at Regency Health Care, the laboratory caters to a super-specialty hospital, a renal center, and a polyclinic, further expanding to an upcoming cancer and another general hospital. The hospitals provide services to approximately 2.5 lakh patients, leading to 1.5 lakh hematology samples per annum at present. Thus, for us the choice of analyzer is important for maintaining the turnaround time (TAT).

One should keep in mind that there are many players in the market and gathering information is the first prerequisite even before evaluating the performance of the instrument. One should gather the general information like manufacturer, instrument name, cost of the instrument, cost per test; number and names of the leading users; space requirement; information about the instrument; training of staff by manufacturer/vendor; specimen rejection; reagents; QC; data management; after-sales services; and possibility of expansion.

Once the logistical information suits the setup, shortlisted equipment is called for proposals and evaluation. Evaluation method should include Inter- and intra-run precision; linearity; carryover study; sample stability; interferences; technical support; reagent cost; review rate; data retrieval; interpretation of results; comparison of automated and manual mode and time taken to switch over from auto sampling/manual modes; user friendliness; robustness and noise level; and throughput among others

Manufacturers are incorporating additional tests/features into routine hematology analyzers like IPF, reticulocyte count, CD3/4/8 assay, automated slide maker and stainer, digital scanner, etc. that incur additional costs. This brings us to the budget. The options available are outright purchase and partial or full reagent rentals. However the three most important factors in decision making should be the present and future sample load, reliability of results, and technical support from the company

Dr Anjali Tewari
Director,
Lab Sciences,
Regency Hospital Ltd., Kanpur


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