National Sales Manager – In Vitro DiagnosticsNihon Kohden India Pvt Ltd
Hematology instrumentation developers are now equipped to meet the challenges of high technology coupled with customers’ demands for cost efficiency.
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 & an important development in the field of management of the quality control data, which is simplified using these instruments.
The hematology instruments and reagents market is centered on hematology analyzers. These instruments can take the form of a relatively simple handheld unit, a more sophisticated point-of-care diagnostic instrument, or a highly complex clinical laboratory analyzer. While all blood analyzers are designed to be accurate and reliable, the primary factors that set these three types of instruments apart from each other are sample throughput rate and the number of blood parameters measured.
Most of the vendors have expanded their base in India and are providing excellent after-sales service. Increasing dependence on evidence-based medicine and awareness about diagnostic tests has triggered a phenomenal increase in demand for sophisticated, user friendly, and accurate automated analytical systems.
Automated analyzers are being developed for analysis of bone marrow aspirates and peripheral blood to aid in the preliminary classification of peripheral blood and bone marrow disorders. Newer parameters are being made available as components of the extended differential count (hematopoietic progenitor cells, immature granulocytes, and erythroblasts), the immature reticulocyte fraction, the reticulocyte indices, the fragmented RBCs, and the immature platelet fraction. Point-of-care testing (POCT) is becoming an important adjunct to hematologic laboratory practice. Analyzers with capability to perform 5-part WBC differential leukocyte counting are becoming available for use in the areas such as intensive care units.
Modern cell analyzers are multi-channeled and perform automated hematology measurements simultaneously using different techniques. Newer, specialized type of flow cytometry techniques like fluorescence-activated cell sorting are now available and these are based upon incorporating certain substances known as fluorophores as labels into the cells. Immunological analysis for cell antigens (such as on the lymphocytes) is now possible by fluorescence flow cytometry using monoclonal antibodies.
The automated hematology analyzers may produce cell counts, which are falsely increased or decreased. Some analyzers, particularly the impedance-based counters check only the volume and number of particles and may not be able to correctly distinguish tiny clumps of platelets and nucleated red blood cells. Platelet clumps may be misclassified as leukocytes or erythrocytes, and nucleated red blood cells can be misclassified as leukocytes or, specifically, lymphocytes. Furthermore, large or unidentifiable atypical cells, toxic immature neutrophils, and markedly reactive lymphocytes can also be misclassified. Moreover, large or unidentifiable atypical cells, toxic immature neutrophils, and markedly reactive lymphocytes can also be misclassified.
These flags are warnings generated and displayed by the machine to alert the laboratory personnel that the machine has detected some abnormality in cell population or distribution that needs attention. The machines are pre-programmed by the manufacturers to generate certain flags according to an internal algorithm. Some examples of these flags include blast flag, atypical flag, flag for discrepancy of the WBC counts, nucleated RBC (NRBC) flag, flag for immature granulocytes, and so on.
While automated blood analyzers count significantly more cells to create a differential count than technicians, they are perhaps still less efficient in detecting abnormal WBCs. Therefore, whenever a hematological malignancy or rare hereditary disorder is suspected in a patient, a microscopic differential count must be performed independently of whether the automated hematology analyzer gives a suspect flag message or not. At present, the automated analyzers are not error-free. With further technological refinements, this situation may well change.
The market would experience growth in this segment as the future holds well for laboratory sciences and for hematology in particular, with many new breakthroughs in areas such as stem cell research, hemoglobinopathies, genetic therapies, proteomics, pharmacogenomics, and disorders of hemostasis encompassing the hematology laboratories.
Today, the hematology lab is in the midst of gaining the most from scientific and technological advances, and the future for the IVD industry in this segment looks promising and full of possibilities.