ResourceClinical Diagnostics
Supporting clinical labs with new EU IVDR regulation
16 Oct 2022Citing a desire for improved patient safety and significant technological advances in recent years, the European Commission (EC) replaced the In Vitro Diagnostic Directive (IVDD) with a new, harmonized regulatory framework: the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. Here, Agilent shows how it aims to support you and your clinical lab through this regulatory transition.
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ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Flow Cytometry / Cell CountingFlow cytometers are used to count, sort and examine multiple characteristics of cells. Other cell analysis equipment includes image cytometers, cell counters, fluorescence-activated cell sorters (FACS), magnetic-activated cell sorters (MACS), and a range of flow cytometry assay kits. Flow cytometers can reveal information on cell viability, cell proliferation, apoptosis and cell cycle progression, as well as identify cell populations and intracellular or cell-surface molecules. Additionally, some flow cytometers, known as FACS, have an additional sorting function after analysis. Cell counters and image cytometers count live and dead cell populations and can also conduct cell proliferation assays. Find the best flow cytometers, cell counters and cell sorters in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.ImmunohistochemistryImmunohistochemistry (IHC) is a technique used to detect specific proteins in tissue samples by using antibodies that bind to target antigens. IHC is widely applied in pathology, immunology, hematology and cancer diagnostics. Explore IHC tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Digital PathologyDigital pathology involves the use of digital imaging and computational tools to analyze pathology slides. It is transforming diagnostics, research, and education by offering enhanced image storage and analysis. Explore digital pathology solutions in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.qPCRQuantitative PCR (qPCR) is a molecular biology technique used to amplify and measure the amount of a specific DNA or RNA target. It plays a crucial role in gene expression analysis, pathogen detection, and quantifying DNA or RNA in various applications. Real-time PCR provides precise, quantitative results and is widely used in research, diagnostics, and clinical studies. Browse our peer-reviewed product directory to find the best qPCR solutions; compare products, check reviews, and get pricing directly from manufacturers.GenomicsGenomics is the study of genomes, focusing on the sequencing, analysis, and interpretation of genetic material. It is key in understanding genetic diseases, evolutionary biology, and personalized medicine. Techniques like next-generation sequencing (NGS) are commonly used in genomics research. Browse our peer-reviewed product directory to find the best genomics tools, compare products, check reviews, and get pricing directly from manufacturers.In Vitro DiagnosticsIn vitro diagnostics (IVD) involve testing samples outside the body, typically in a laboratory, to diagnose diseases or conditions. IVD technologies include blood tests, molecular assays, and other bodily fluid tests, enabling accurate diagnosis and monitoring of diseases. These tests are essential for guiding treatment decisions in clinical settings. Browse our peer-reviewed product directory to find the best IVD solutions; compare products, check reviews, and get pricing directly from manufacturers.