FDA approved the first zinc transporter 8 autoantibody (znt8ab) ELISA kit to help diagnose type 1 diabetes

Source: Biovalley 2014-8-22 US Food and Drug Administration (FDA) approved the first zinc transporter 8 autoantibody (znt8ab) enzyme-linked immunosorbent assay (ELISA) test kit on August 20, which can be used to help identify patients with type 1 diabetes rather than other types of diabetes The znt8ab ELISA kit was developed by Kronus, an autoimmune testing expert in Idaho When used in combination with other detection methods and patients' clinical data, znt8ab ELISA kit may help some patients with type 1 diabetes get timely diagnosis and treatment Type 1 diabetes is the most common type of diabetes in children and adolescents, but in some cases, adults may also have type 1 diabetes In patients with type 1 diabetes, the immune system attacks and destroys the pancreatic β cells that produce insulin, resulting in little or no insulin production in the body Insulin is a hormone that can convert the glucose from food into the energy needed by the body in the future Insulin injections are needed to regulate blood glucose levels in patients with type 1 diabetes because proper regulation is essential to reduce the risk of long-term complications, including blindness, renal failure, and cardiovascular disease Many patients with type 1 diabetes have an immune system that produces zinc transporter 8 autoantibodies (znt8ab), but other types of diabetes (type 2 diabetes and gestational diabetes) do not This znt8ab ELISA kit can detect znt8ab in the blood of patients The early treatment of type 1 diabetes is very important to prevent the further deterioration of pancreatic β cells The znt8ab kit can help patients get timely diagnosis and start the correct treatment earlier Kronus's znt8ab ELISA kit has been reviewed through a comprehensive pre market review approach, which is used for the review of some low to medium risk medical devices that are not substantially equivalent to listed devices The FDA reviewed the data of a clinical study involving 569 blood samples, 323 of which were from patients with type 1 diabetes, and the positive rate of znt8ab detected by znt8ab ELISA kit was 65%; the remaining 246 were from patients with other types of diabetes, autoimmune diseases and other clinical diseases, and the false positive rate of znt8ab detected by znt8ab ELISA kit was less than 2% 。 FDA pointed out that the negative result of znt8ab test does not exclude type 1 diabetes The kit should not be used to monitor the stage of disease or response to treatment Zinc transporter 8 (ZnT8) and its autoantibody (znt8ab): zinc is an important component in the mechanism of insulin storage and secretion β cells need effective and specific transporters to accumulate enough zinc Zinc transporter 8 (ZnT8) is a newly discovered type 1 diabetes autoantigen with high β cell specificity It plays an important role in insulin synthesis and secretion by affecting the concentration of zinc ions ZnT8 autoantibody has an important value in the diagnosis and prediction of autoimmune diabetes, especially for other autoantibody negative patients The polymorphism of ZnT8 gene (SLC30A8 gene) affects the specificity of ZnT8 autoantibody Original link: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm410830.htm