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Blood glucose monitoring, a smal...

In the 21st century, diabetes has become one of the most serious and dangerous health problems in the world, and at the same time it has also become a key public health service problem in China. According to statistics, there are now nearly 110 million people suffering from diabetes in China, and the total number of patients is still growing gradually. It is estimated that by 2020, the total number of diabetic patients in China will be 150 million.

Diabetes damage is slowly expanding

The confusion of diabetes to people is likely to be more serious than we expected. According to the IDF statistical analysis, 53% of patients in China have not been diagnosed, and the amount of potential diabetic patients needs to be released continuously. On the one hand, the prevalence of the number of people above 40 years of age in our country has been elevated, on the other hand, the rate of death from diabetes has decreased, the survival of patients, the treatment period has increased, diabetes treatment runs earlier and is delayed longer.

The horror is that diabetes itself is not so deadly, but the related morbidities are the prime elements that are considered frightening. For example, macrovascular degeneration, capillary degeneration and malignancy are now the key causes of death and disability in the Chinese population. Diabetes has caused great harm and economic pressure to the person and family, social development and our country.

The treatment of diabetes can be basically divided into basic treatment and intensive treatment. The basic treatment includes exercise and diet control, while the intensive treatment is the manipulation of insulin injections and other drugs. Moreover, the treatment plan for the patient is different with the different aspects of the disease, and the treatment requirements are humanized and diversified.

Therefore, the most essential focus of diabetes treatment and IVD ODM methods is blood glucose monitoring. Diagnosed diabetic patients must carry out precise measurement of blood glucose value three times a day, and carry out testing of their own platelet components; when physicians examine them, they must carry out precise examination instruments to distinguish diabetes; when carrying out treatment, the best choice is also to use continuous blood glucose monitoring instruments and equipment to carry out continuous testing, and to spray medication according to the final test.

A precise and accurate method of measuring blood glucose value has become an urgent requirement to relieve the pressure of diabetic patients and their families.

A "little happiness" for the IVD industry

In recent years, a variety of blood product products (IVDs) have emerged in response to the steadily growing demand for precise diagnosis and treatment of a wide range of medical conditions, convenient regulation and management of their treatment data. From home use testing to medical diagnosis, IVD products have continued to improve in the direction of lightness, accuracy and practicality.

The blood glucose value testing industry has not been a very accurate testing instrument and equipment.

At this stage, there are two types of blood glucose testing methods for diabetic patients: the Glucose Oxidase Biochemistry Method (GOD method, the basic blood glucose monitoring method used in general hospital outpatient clinics) and the paper tape method. The GOD method in large and medium-sized laboratories requires a large amount of blood, and it is very easy to produce dissolved blood glucose values during the test. It is not very suitable for glucose tolerance testing, and its testing result time is more than two hours, and its testing precision CV only achieves 3-5%.

As for the common hand-held blood glucose measuring instrument (paper strip method), although the blood volume of 20mL is faster, the detection error is 15-30% due to the limitation of its own detection methodology. The test results can only be used as a reference for blood glucose monitoring, and cannot be used as a basis for clinical medicine to confirm the diagnosis.

The inaccurate precision of the test or too long test time causes the dissolution of blood glucose value, which will jeopardize the final test result and immediately lead to the incorrect differentiation of the amount of medication to be administered and cannot guarantee the accurate treatment. If there is a 5% analysis error in the overall blood glucose measuring instrument, there is an 8-23% error in the misuse of glycine insulin, and when the precise measurement error (CV) and/or bias exceeds 10-15%, the important error in the use of glycine insulin, and the error of two levels or higher, will be 45%.

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