1. In vitro diagnosis, referred to as IVD, refers to taking samples (blood, body fluids, tissues, etc.) from the human body and testing them for diagnosis, which is compared to in vivo diagnosis.
2. In vitro diagnostic products mainly consist of diagnostic equipment (instruments) and diagnostic reagents. According to the standards of the "Medical Device Classification Catalog" of my country's State Food and Drug Administration (SFDA), in vitro diagnostic equipment belongs to the category of clinical testing and analysis instruments.
3. In vitro diagnostic technology has developed rapidly, from gene sequencing, SNP screening, point mutation gene diagnosis at the gene level, to various biomarker detection at the protein level, to circulation at the cell level. Tumor cell detection (CTC), thin-layer liquid-based cytology detection (TCT), and then to PET/CT at the tissue level, etc. In general, in vitro diagnosis is developing in a direction that is simpler, faster, non-invasive, and multi-information.
4. In vitro diagnostics are extremely helpful in people’s physical examinations, chronic disease management, and monitoring of serious diseases.