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• W2793478982 abstract "Since the seminal discoveries of the relationship between the underlying genetic mutation and the altered expression of GPI-linked antigen expression that underlies the pathobiology of paroxysmal nocturnal hemoglobinuria (PNH), flow cytometry and the immunophenotypic detection of PNH clones has played an increasingly important role in the diagnosis, monitoring, and clinical management of patients with PNH 1-3. With the successful introduction of complement blockade therapies for PNH 4, the condition has changed from one with a poor outcome 5 to one where life expectancy matches that of the normal population 6. With complement blockade therapies well established for PNH, and more alternatives on the horizon, diagnosis of PNH and monitoring of treatment efficacy has never been more important, given the particularly high cost of therapy. Since the publication in 2010 of the International Clinical Cytometry Society (ICCS) Consensus Guidelines for detection of PNH by flow cytometry 7, a significant “climate change” in the provenance of clinical flow cytometry testing in general has occurred. Contemporary guidelines are now driven by the expectations that clinical flow cytometry laboratories will work to ISO15189 standards or National Regulatory requirements that require documented validation of all tests offered. Furthermore, regulatory bodies and other stakeholders now require validation of methods used for clinical trials where flow cytometry methods are used for diagnosis, to monitor responses to therapy, or define clinical endpoints. On this background of accreditation and validation, professional societies such as ICCS and ESCCA are now actively enlisting expertise to produce practical guidelines that address all aspects of clinical flow cytometry assays. In this edition of Clinical Cytometry, four articles are presented that provide an updated and significantly improved comprehensive practical guide to PNH testing. In the first of these, Dezern and Borowitz 8 present a detailed account of the role of PNH testing and how it contributes to the diagnosis, classification, and monitoring of patients. When interpreted correctly, the results from PNH flow cytometry testing, including presence and size of the clonal populations and the cell types involved, can allow the clinician to classify the disease appropriately, evaluate the risk of disease progression, and subsequently monitor response to therapy. The second section of these updated ICCS PNH Consensus Guidelines concentrates on specific instrument setup for PNH assays, together with the identification and testing of appropriate antibody conjugates 9. Assay design is also covered in great detail and underlines principles that can be transferred to other immunophenotyping procedures. In part 3, Illingworth et al. offer practical guidance on the analysis and reporting of PNH results using a fully optimized assay 10. They also address the most common analytical challenges for accurate reporting of results. Furthermore, the authors supply an extensive case library to assist in the interpretation of more difficult cases, drawn from their many years of experience. In the final section, Oldaker et al. not only provide a comprehensive guide on how to validate the flow cytometric procedures described in parts 2 and 3, but also detail the differences between cell-based and traditional soluble analyte assay validations 11. The procedures described are based on the recommendations of a number of stakeholders who provide external guidance and general recommendations together with the published experience of experts in the area of PNH testing. The overall goal is to provide practical assay-specific guidelines for the validation of high-sensitivity flow cytometric PNH assays. For clinical laboratories it is important recognize that the ultimate beneficiary of the complex process of assay development, optimization, and validation processes has to be the patient. For a rare disease such as PNH, diagnostic testing with the knowledge that an assay has been through a comprehensive validation process is critically important. When a new diagnosis of PNH is made this can have life changing and potentially lifelong implications for individual patients. These updated and comprehensive guidelines for PNH testing are the result of many hours of dedication from all contributors. Specific thanks have to go to Andrea Illingworth and Rob Sutherland who have remained the driving force behind their production and can be justifiably satisfied with their efforts. Stephen J. Richards, PhD FRCPath Consultant Clinical Scientist HMDS St James's University Hospital Leeds, United Kingdom" @default.
• W2793478982 created "2018-03-29" @default.
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• W2793478982 date "2018-01-01" @default.
• W2793478982 modified "2023-10-17" @default.
• W2793478982 title "Introduction to ICCS/ESCCA Consensus Guidelines to Detect GPI‐Deficient Cells in Paroxysmal Nocturnal Hemoglobinuria and Related Disorders" @default.
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• W2793478982 doi "https://doi.org/10.1002/cyto.b.21617" @default.
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