Hematology analyzers are specialized automated systems that count leucocytes, red cells, and platelets in blood, and also determine hemoglobin and hematocrit levels. Hematology technology has come a long way in a relatively short space of time. In the 1950s, complete blood counts (CBC) were performed manually by a technician in front of a microscope. Hemoglobin was also measured manually using a cyanmethemoglobin method, which was slow and time consuming.
Modern-day analyzers are capable of processing hundreds of samples an hour. Modular structures and advances in automation enable the systems to accommodate numerous analyzers, slide makers/strainers, and archiving facilities.
The global hematology instruments and reagents market is expected to reach USD 3.13 billion by 2019, at a CAGR of 5.2 percent from 2014 to 2019.
North America holds the largest share of the global market, followed by Europe. This is with the regions' high disposable income and increasing adoption of automated hematology instruments by diagnostics laboratories in these regions. However, the Asia-Pacific market is expected to grow at a highest CAGR of 9.4 percent, according to MarketsandMarkets. A number of factors including developing healthcare infrastructure, large patient population, increasing funding/investment toward development of hematology products, and growing focus of both international and domestic players on the Asia-Pacific countries are stimulating the growths of the market in the region.
Usage of microfluidics technology in hematology analyzers and introduction of digital imaging systems in hematology laboratories could open up opportunities for new players in the global market. In addition, increasing focus toward emerging markets, such as India and China, could also open up opportunities for new players. Safety and quality of hematology analyzers could be a challenge for the growth of the market. Increasing instances of partnership among manufacturers is one of the recent trends in the global market.
Valuation Considerations When Buying Hematology Analyzers
There is a wide variety of hematology analyzers available in the market that are designed to meet the needs of every size laboratory, from the small analyzers to be used at point-of-care settings such as the physician's office or ITU, to the high-throughput modular configurations designed to meet the demands of the large automated hematology laboratory. Modern analyzers use electrical impedance methods, optical methods, or a mixture of both of these to count and classify white and red blood cells. Vacuum pump fluidic systems deliver perfectly precise volumes of diluents, samples, and reagents to analysis chambers. Fully automated analyzers have the advantage of being objective, high-throughput, and cost-effective; they can flag up abnormal results and have increased measurable parameters such as platelet distribution (PDW), red cell distribution width (RDW), nucleated red cells (NRBCs), and reticulocyte (RET) counts.
Optical method. Visible wavelength light is passed as a laser beam through the sample stream. As each cell passes through the sensing zone, the light is scattered and measured by a photo conductor, which converts it into an electrical impulse. The more sophisticated analyzers use multi-angle optical scatter analysis (up to five different angles and pulse times), combined with flow cytometry to distinguish different cell populations and identify immature and atypical cells. These analyzers are capable of producing dozens of histograms, giving detailed information about white cell population.
Flow cytometry. Traditional flow cytometry is considered to be the most effective method for differentiating cell types. This method of cell differentiation is, however, costly and time consuming. Some manufacturers have managed to adapt basic techniques of flow cytometry to enable its incorporation into the automated hematology analyzer. Flow cytometry can provide information on forward light scatter, side scatter, and side fluorescence to generates a WBC differential, NRBC, RETIC, and optical platelets.
Sysmex, Horiba, Beckman Coulter, and Abbott Diagnostics have all incorporated flow cytometry technology into their analyzers.
Red blood cell counting. Red blood cells (RBC) can be counted using impedance or optical methods. Even small hematology analyzers are capable of giving information on MCV, HCT, MCH, and MCHC. Larger automated analyzers also give information on red cell morphology and the RDW.
There are several situations that may lead to abnormal red cell counts, including the presence of cryoglobulins, cold agglutinins, and lipids. One abnormally measured parameter will lead to abnormalities in the calculated red cell indices, most significantly the mean cell hemoglobin content (MCHC). The most sophisticated analyzers are able to flag the possible causes of spurious red cell counts and parameters. However, analyzers without the ability to produce white cell scattergrams will not be sensitive to these situations.
White cell differential. Depending on the size and complexity of the analyzer, a 3-part, 5-part or 7-part differential might be reported. Analyzers use a variety of technologies to determine this white cell differential. These can be broadly grouped into optical, impedance, and flow cytometry methods, and often an analyzer might employ a combination of these methods to gather data.
The manufacturers of some of the most sophisticated analyzers have also managed to adapt flow cytometry principles to make it practical and cost effective in differential analysis. Flow combined with optical and/or impedance methods can be used to create detailed scatter plots, which determine the populations of each cell type. All large analyzers will give a 5-part differential, and in some cases, they might give a 7-part differential, which includes large immature cells and atypical lymphocytes.
Cellular interferences. There are four common causes of cellular interferences in the white cell chamber. These are nucleated RBCs (nRBCs), giant platelets, intra-cellular parasites, and platelet clumps. The latest generation of analyzers now offers several additional histograms that are generated by two new angles of light. This additional information can be used to distinguish between the four types of cellular interference.
Platelet counting. All automated hematology analyzers will provide a platelet count, by impedance, optical methods, or both of these methods combined. More sophisticated analyzers will also provide extra parameters such as the PDW.
Hemoglobin measurement. Hemoglobin measurement is based on a modification of the traditional, manual hemoglobin-cyanide (HiCN) method. Some manufacturers use a non-toxic method such as sodium lauryl sulphate solution instead of HiCN.
Point-of-Care. Some hematology analyzers for use at the point-of-care give only Hb and HCT results. Other point-of-care systems use dry hematology technology, which operate without bulky and costly reagent packs. Even small analyzers using this technology can give a white cell differential including granulocytes, lymphocytes, and monocytes, as well as HCT, Hb, MCHC, and platelet counts.
Automated slide makers & morphological review. There are numerous analyzers available in the market that can automate slide preparation and staining, and several instruments that are capable of reviewing the slides themselves.
If a fully automated imaging system is beyond the scope of the laboratory, one could look at investing in a digital image capture system. With this option, the user can share images remotely with other clinicians or laboratory staff, as well as storing images for future review.
While considering the core technology of the analyzers, additional factors including robotics and automation, storage, random access, throughput, maintenance and downtime, cap piercing, and quality control management need to be taken into account.
What Is Next for the Hematology Laboratory?
Manufacturers are increasingly incorporating additional tests into the routine hematology analyzer, such as CD61 for immunoplatelet counts and CD3/4/8 assays. These tests increased the utility and efficiency of the analyzer. The advantages of digital morphology include lower manual review rates, increased efficiency, and the ability to store digital data for traceability, sharing and future review. Manufacturers are likely to partner increasingly with digital imaging suppliers to develop in-house technology. As this technology becomes more widely available, it will become more accessible for hospital laboratories. Latest generation analyzers are capable of giving detailed cellular information to the operator, such as blast cell differentials. Some are also able to give suggestions of pathological conditions. The additional information available to hematology laboratories through automated hematology technology increases the efficiency and productivity of the laboratory, and ultimately, when used correctly, improves patient care.