In vitro diagnosis and the industry
In vitro diagnosis refers to products and services that obtain clinical diagnostic information by detecting human samples (blood, body fluids, tissues, etc.) outside the human body to determine disease or body function.
In vitro diagnostic products are mainly composed of diagnostic equipment (instrument) and diagnostic reagents. According to the National Food and Drug Administration (SFDA) “Medical Device Classification Catalogue” standard, in vitro diagnostic equipment belongs to the category of clinical laboratory analysis instruments.
The in vitro diagnostic industry and laboratory medicine constitute an organic whole that is both distinct and closely related. The in vitro diagnostic industry is the “tool” and “arms” of laboratory medicine, while the laboratory medicine is the “user” and “market” of the in vitro diagnostic industry. The common purpose of both is to perform in vitro diagnostics. About 80% of clinical diagnostic information comes from in vitro diagnosis, and its cost accounts for less than 20% of medical expenses. In vitro diagnosis has become an increasingly important part of human disease prevention, diagnosis and treatment, and an increasingly important part of safeguarding human health and building a harmonious society.
In vitro diagnostic reagents
In vitro diagnostic reagents refer to in vitro diagnostic reagents administered by medical devices, including alone or in combination with instruments, instruments, devices or systems, in disease prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation, and hereditary diseases. In the process of predicting, reagents, kits, calibrators (objects), and quality control products (objects) used for in vitro detection of human samples (various body fluids, cells, tissue samples, etc.).
Classification of in vitro diagnostic reagents
According to the level of product risk, in vitro diagnostic reagents are divided into Class I, Class II and Class III.
Class III: 1. Reagents related to the detection of pathogenic pathogen antigens, antibodies and nucleic acids; Reagents related to blood type and tissue matching; 3. Reagents related to human genetic testing; 4. Reagents associated with hereditary diseases; 5. Reagents related to the detection of narcotic drugs, psychotropic drugs, and medical toxic drugs; Reagents related to target detection of therapeutic drugs; 7. Reagents associated with tumor marker detection; Reagents associated with allergies (allergens).
Class II: in addition to the products that have been identified as the third category and the first category, the others are the second category of products, including: 1. Reagents for protein detection; 2. Reagents for sugar detection; 3. Reagents for hormone detection; 4. Reagents for enzyme detection; Reagents for ester detection; Reagents for vitamin testing; 7. Reagents for inorganic ion detection; Reagents for the detection of drugs and drug metabolites; Reagent for autoantibody detection; 10. Reagents for microbial identification or susceptibility testing; A reagent used for the detection of other physiological, biochemical or immunological indicators.
Class I: 1. Microbial culture medium (not used for microbial identification and susceptibility testing); 2. Sample processing products, such as hemolytic agents, diluents, staining solutions, etc.
Application prospects of in vitro diagnostics:
In vitro diagnostic technology is rapidly evolving, from gene-level gene sequencing, SNP screening, point mutation gene diagnosis, to protein levels of various biomarkers (eg, cancer biomarkers, breast cancer biomarkers, inflammatory biomarkers, lung cancer biomarkers, prostate cancer biomarkers, liver cancer biomarkers, nephropathy biomarkers, pancreatic cancer biomarkers) detection, to the cellular level of circulating tumor cell detection ( CTC), thin-layer liquid-based cytology (TCT), and PET/CT at the tissue level. In general, in vitro diagnostics are moving toward easier, faster, non-invasive, and more informative. The application prospects mainly include the following aspects:
- 1. Physical examination
Modern people are paying more and more attention to their own health. Many people have become a habit every year. In vitro diagnosis by detecting and testing blood, urine, feces, secretions, etc., disease prevention and early detection can be achieved.
- 2. Chronic disease management
Worldwide, the incidence of diabetes, high blood pressure, and chronic stomach diseases has increased year by year. The incidence of diseases such as hyperlipidemia and osteoporosis is also high. These chronic diseases require regular monitoring of changes in blood sugar, blood pressure, blood lipids, Helicobacter pylori, and bone calcium. The use of in vitro diagnostic equipment, especially various wearable devices, enables monitoring of blood glucose, blood pressure, heart rate, etc. anytime, anywhere.
- Critical illness monitoring
After many cancer patients undergo surgery and chemotherapy, doctors can use in vitro diagnostic techniques to regularly monitor tumor markers, predict cancer metastasis, and guide medication. For example, breast cancer patients should have regular chest X-ray, bone scan, liver B-ultrasound, blood routine, and tumor-associated antigen examination. Researchers at the British Columbia Cancer Research Center have found high expression of αB-crystallin gene in the brain through in vitro diagnostic techniques. Breast cancer patients who are positive (negative) face a three-fold or higher risk of brain metastasis of cancer cells than patients with low-expression (negative) breast cancer. This allows doctors to target patients at high risk to prevent cancer metastasis.