Medical IVD: in vitro diagnostic products.
"IVD" full name "invitrodiagnosticproducts", the Chinese translation for in vitro diagnostic products, IVD refers to medical devices, in vitro diagnostic reagents and drugs, IVD as a branch of medical devices have specific definitions and regulations. IVD refers to medical devices, in vitro diagnostic reagents and pharmaceuticals, and IVD as a branch of medical devices has a unique definition and regulation.
Introduction of IVD:
Internationally, IVD as a separate branch of medical devices has its own unique definition and regulatory system, especially the U.S. Food and Drug Administration (FDA) and the European Union (CE).
IVD mainly includes instruments, reagents or systems used for in vitro diagnosis. However, the situation is different in China, where IVD is not independently distinguished and defined, i.e. there is no concept of IVD.
Instead, the usual international concept of IVD includes products that are broken up into Medical Devices (MD), In Vitro Diagnostic Reagents (IVDReagents), and Pharmaceuticals.
Expanded:
Application Prospects:
In vitro diagnostic technology has developed rapidly, from gene sequencing, SNP screening, and point mutation gene diagnosis at the gene level, to a variety of biomarker (biomarker) assays at the protein level, and to the cellular level of circulating tumor cell testing (CTC), thin layer liquid-based cytology (TCT).
Then to PET/CT at the tissue level. In general, in vitro diagnosis is developing in the direction of simpler, faster, non-invasive, and multi-informatics. The application prospects are mainly in the following areas:
1, physical examination
Modern people are paying more and more attention to their health, and many people's annual physical examination has become a habit. In vitro diagnosis through the blood, urine, feces, secretions and other analysis and testing, you can realize the prevention and early detection of disease.
2. Chronic Disease Management
Worldwide, the incidence of diabetes, hypertension, and chronic gastric disease is increasing year by year. There is also a high incidence of hyperlipidemia, osteoporosis and other diseases. These chronic diseases require regular monitoring of changes in blood glucose, blood pressure, blood lipids, Helicobacter pylori, and bone calcium. The use of in vitro diagnostic equipment, especially a variety of wearable devices, can be realized at any time and anywhere on the blood glucose, blood pressure, heart rate and other monitoring.
3. Critical illness monitoring
After many cancer patients undergo surgery and chemotherapy, doctors can use in vitro diagnostic technology to regularly monitor tumor markers, predict cancer metastasis, and guide the use of medication. For example, breast cancer patients should have regular chest X-rays, bone scans, liver ultrasounds, blood tests, and tumor-associated antigen tests after surgery.
Researchers at the British Columbia Cancer Research Center have found, through in vitro diagnostic techniques, that breast cancer patients with high expression (positive) of the alpha B-crystallin gene in the brain face a threefold or even higher risk of brain metastasis of the cancer than breast cancer patients with low expression (negative). This allows doctors to target treatment to high-risk patients to prevent cancer metastasis.
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