Medical IVD: in vitro diagnostic products.
The full name of "IVD" is "in vitro diagnostic products", which is translated as "in vitro diagnostic products" in Chinese, and IVD refers to medical devices, in vitro diagnostic reagents, and pharmaceuticals. 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 (IVD Reagents), and pharmaceuticals. p>Application Prospects:
In vitro diagnostic technology has been developing rapidly, from gene sequencing, SNP screening, point mutation gene diagnosis at the gene level, to various biomarkers (biomarker) detection at the protein level, to the cellular level of the circulating tumor cell test (CTC), thin-layer liquid-based cytology (TCT).
And then PET/CT at the tissue level. In general, in vitro diagnosis is developing in the direction of simpler, faster, non-invasive and multi-informatics. Prospects for the application of the following aspects:
1, physical examination
Modern people pay more and more attention to their own health, many people have become a habit of annual physical examination. In vitro diagnosis through the blood, urine, feces, secretions and other analysis of the test, you can realize the prevention of disease and early detection.
2. Chronic Disease Management
Worldwide, the incidence of diabetes, hypertension, and chronic gastrointestinal diseases is increasing year by year. There is also a high incidence of hyperlipidemia, osteoporosis and other diseases. These chronic diseases require regular monitoring for changes in blood glucose, blood pressure, lipids, Helicobacter pylori, and bone calcium. The use of in vitro diagnostic devices, especially various wearable devices, can realize the monitoring of blood glucose, blood pressure, heart rate, etc. anytime and anywhere.
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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