Immunoassays are biochemical tests that are used to quantify a specific substance or detect an analyte in a body fluid sample or in a blood using an antibody or antigen. Immunoassays are highly specific due to the use of purified antigens and antibodies as well as being sensitive. The common uses of immunoassay include hormones, measurement of drugs, tumor markers, markers of cardiac injury, and specific proteins. Immunofluorescence assays are different types of immunoassays. The advantages of a fluorescent detection system include higher sensitivity recognition of an analyte, simpler assay designs, and simplified reagents. Over the past few decades various advancements such as portability, compactness and real-time monitoring of analyzer have supported the application of fluorescent-based immunoassay system in point-of-care.
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A modern immunofluorescence assay-based analyzer uses a florescent compound that absorbs light energy at a specific wavelength and emits energy at a different wavelength. The difference between these light energy is called strokes shift. Immunofluorescence assay analyzers are extensively used in the field of clinical diagnostics, research and development, and quality control. Lack of skilled workforce and increasing test volume have led to the growth of immunofluorescence analyzer market size.
For instance, in 2016, AESKU group received clearance from the Food and Drug Administration (FDA) for its new HELIOS automated immunofluorescence system with AESKUSLIDES ANA HEp-2 gamma assay. HELIOS is based on automated system for the immunofluorescence processing with image recapturing with integrated software and fluorescence microscope. In a single run, HELIOS can process and analyze patient samples. Over 300 HELIOS systems are used worldwide in clinical research in more than 40 countries. Moreover, the importance of care is now shifting towards early detection and prevention of diseases. Therefore, private companies are investing huge amounts of capital into the development of rapid diagnostic testing solutions and low cost imaging technologies for point-of-care testing. For instance, in 2017, clearance to Quidel’s point-of-care Sofia® 2 immunoassay analyzer for use with Sofia influenza A + B assay. The next generation version, Sofia 2, is based on Quidel’s bestselling Sofia instrumented system. Sofia 2 is integrated with wireless connectivity and uses the florescent chemistry design with optical system to provide automated, accurate results in 3 minutes.
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Key vendors:
Abbott Laboratories, bioMerieux, EMD Millipore, Siemens Healthcare, Thermo Fisher Scientific, and DiaSorin SpA
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