State of the Art and Science of Immunocytochemistry
Irena Srebotnik Kirbis
Abstract:Immunocytochemistry (ICC) is a widely available and extensively used ancillary method in diagnostic cytopathology with great variability in all test phases and a low level of adequate quality management.
The non-standardized ICC landscape is now challenged with the introduction of the new European (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR). According to this regulation, ICC on cytological slides falls under the category of Laboratory Developed Tests (LDT), which require rigorous standardizatio… Show more
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