IVD所有英文缩写

IVD, or In Vitro Diagnostics, refers to medical tests and analyses conducted outside the human body. These tests have become an essential part of modern healthcare, providing crucial information for the diagnosis, treatment, and prevention of various diseases. The field of IVD includes an extensive range of technologies, techniques, and methodologies, each with its own specialized terminology and abbreviations. In this article, we will explore some of the most common IVD abbreviations and their meanings.



ELISA: Enzyme-linked immunosorbent assay is a widely used test that measures the presence and levels of proteins, such as antibodies or antigens, in a sample.



PCR: Polymerase chain reaction is a technique that amplifies and detects specific DNA sequences in a sample, often used for the diagnosis of infectious diseases or genetic disorders.



NGS: Next-generation sequencing is a high-throughput method that allows the analysis of a large amount of genetic data, used in cancer diagnosis, personalized medicine, and research.



LDT: Laboratory-developed test is a diagnostic test that is not FDA-approved but is developed and validated by a single laboratory for use in their own institution.



CE-IVD: Conformité Européene In Vitro Diagnostics is a certification mark that indicates that a diagnostic product meets the regulatory requirements of the European Union.



CLIA: Clinical Laboratory Improvement Amendments is a set of regulations enforced by the US government to ensure the quality and accuracy of laboratory testing.



FDA: The Food and Drug Administration is a US government agency responsible for regulating the safety and effectiveness of pharmaceuticals, medical devices, and other products.



RUO: Research Use Only is a label that indicates that a product is intended solely for research purposes and is not approved for diagnostic or therapeutic use.



IVDR: In Vitro Diagnostic Regulation is a new set of regulations that will come into effect in the European Union in 2022, aiming to ensure the safety and effectiveness of IVD products.



IVD assays are a vital part of modern medicine, providing crucial information for the diagnosis, treatment, and prevention of various diseases. The growing complexity and diversity of IVD technologies demand a standardized approach to terminology and abbreviations, which allows for effective communication among healthcare professionals and the development of safe and effective diagnostic products. The understanding of these IVD abbreviations is essential for anyone working in the field of medical diagnostics.