The first differential diagnosis kit for type 1 diabetes was approved

Release date: 2014-08-28

Recently, the FDA approved the first antibody test to differentiate between type 1 diabetes. The test aims to detect type 1 diabetes earlier and help patients with early treatment to prevent insulin-lowering islet beta cell reduction.

Why do we need a type 1 diabetes antibody test?

Type 1 diabetes is the most common type of diabetes in children and adolescents, but in some cases, adults may also develop type 1 diabetes. People with type 1 diabetes have little or no insulin production in their body due to their immune system attacking and destroying insulin-producing pancreatic beta cells. Insulin is a hormone that converts food-derived glucose into the energy needed by the body. People with type 1 diabetes require insulin injections to regulate blood sugar levels, as proper regulation is critical to reducing the risk of long-term complications, including blindness, kidney failure, and cardiovascular disease.

Adolescents with type 1 diabetes, middle-aged and elderly patients with type 2 diabetes, which was recently agreed by everyone, often used age as a basis for diagnosis in differential diagnosis. However, with the development of society, the improvement of material living standards, the changes in life, work and entertainment patterns, the number of obese people has increased, and the incidence of diabetes has increased year by year, even among young people, teenagers and children. In recent years, the incidence of type 2 diabetes in adolescents and children has grown at an alarming rate. A survey of the incidence of type 2 diabetes in adolescents in Chicago, USA, showed that about 2 to 3 people per 1,000 people have developed symptoms and have been associated with children. The incidence of type 1 diabetes is similar. In Canada, the increase in type 2 diabetes in children is also doubled in type 1 diabetes. Manitoba statistics show that in the nearly 20 years from 1979 to 1999, it increased by about 30 times. Type 2 diabetes diagnosed in 1999 was type 1 Nearly 7 times, it can be seen that type 2 diabetes in adolescents and children will become more common and may exceed type 1 diabetes in the overall incidence. Children who are obese from childhood may develop type 2 diabetes at an early age, and an increase in obese children is bound to lead to an increase in obese type 1 diabetes, which will identify type 1 and 2 among young, young, and children. Type 2 diabetes causes difficulties. Therefore this ELISA test is crucial.

ZnT8Ab test approved by FDA

The zinc transporter 8 autoantibody (ZnT8Ab) test is used to detect the presence or absence of ZnT8 antibodies in the blood. This antibody is only present in patients with type 1 diabetes, and is not present in patients with type 2 diabetes or gestational diabetes.

The FDA reviewed data from a clinical study involving 569 blood samples, of which 323 were from blood samples diagnosed with type 1 diabetes. The positive rate of ZnT8Ab detected by ZnT8Ab Elisa kit was 65%; the remaining 246 were diagnosed with other types of diabetes. For the blood samples of autoimmune diseases and other clinical diseases, the false positive rate of ZnT8Ab detected by ZnT8Ab Elisa kit was less than 2%.

Many institutions are investigating the specific molecular markers that antibodies play in type 1 diabetes. In July, Dr. Brian Feldman and colleagues from Stanford University discovered a microchip capable of detecting type 1 diabetes antibodies and published the study in Nature Medicine? In the magazine. Dr. Brian Feldman also interrupted seeking FDA approval.

references:

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Source: Medical Endocrine Channel WeChat

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