In vitro diagnostic reagents refer to in vitro diagnostic reagents managed as medical devices, including reagents, kits, and calibration kits used for in vitro detection of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation, and health status evaluation. Products, quality control products and other products. It can be used alone or in combination with instruments, appliances, equipment or systems.
Modern people are paying more and more attention to their own health. It has become a habit for many people to have annual physical examination, and unit physical examination has also become a necessary employee benefit. The main purpose of physical examination is the prevention and early detection of diseases, and in vitro diagnostic reagents have a very large market in this field, and the detection can be completed by using the provided blood, urine, feces, body fluids, secretions, etc.
The incidence of diabetes in the world is increasing rapidly. The number of diabetic patients in developed countries is more than 10%, that of developing countries is more than 4%, and that of some developed regions is 6%. In recent years, the incidence of hypertension has been increasing year by year. The census data shows that there are more than 100 million hypertensive patients. According to statistics, the average incidence rate of hypertension among people over 15 years old is 11%. Stomach disease has become an extremely common disease in life. According to the statistics of the World Health Organization in recent years, the incidence rate of stomach problems is as high as 80%, that is, more than 8 out of every 10 people suffer from stomach problems. Also have hyperlipidemia, the sickness rate of these diseases such as osteoporosis also remains high. The characteristics of these diseases are chronic diseases, which require regular monitoring of changes in blood sugar, blood pressure, blood lipids, Helicobacter pylori, and bone calcium, and in vitro diagnostic reagents have corresponding equipment. In particular, there are various mobile wearable devices that can monitor blood sugar, blood pressure, heart rate, etc. anytime, anywhere.
Many cancer patients undergo surgery, and after radiotherapy and chemotherapy, they need to monitor tumor markers regularly, predict cancer metastasis and guide medication. For example, patients with breast cancer should undergo regular chest X-rays, bone scans, liver B-ultrasound, blood routine, and tumor-associated antigen examinations after surgery. As the disease progresses in breast cancer patients, systemic cancer cell proliferation and metastasis may occur, and brain metastasis of cancer cells is the most fatal. The prognosis of breast cancer with brain metastases is often very poor, and the patient may die within a few months. It has been reported that researchers from the British Columbia Cancer Research Center use positive gene expression as an indicator of brain metastasis of cancer cells, and also as an important evaluation of patient treatment prognosis, independent of other clinical biochemical detection indicators. This analysis of clinical data of 4,000 breast cancer patients found that, breast cancer patients with high gene expression in the brain face three times or even higher risk of brain metastases than breast cancer patients with low gene expression (negative test results). In vitro diagnostic reagents can monitor the prognosis of severe diseases and alleviate the pain caused by diseases to a certain extent.