New Type 1 Diabetes Blood Test Approved
New Type 1 Diabetes Blood Test Approved – The FDA has allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test which can help determine whether a person has type 1 diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive a timely diagnosis and treatment for their disease.
The immune systems of many people with type 1 diabetes produce ZnT8Ab, but patients with other types of diabetes (type 2 and gestational) do not. The agency reviewed data from a clinical study of 569 blood samples — 323 from patients with diagnosed type 1 diabetes and 246 samples from patients diagnosed with other kinds of diabetes, other autoimmune diseases, and other clinical conditions.
The test was able to detect the ZnT8 autoantibody in 65% of the samples from patients with diagnosed type 1 diabetes and incorrectly gave a positive result in less than 2% of the samples from patients diagnosed with other diseases. The assay is manufactured by KRONUS Market Development Associates, Inc. in Star, Idaho.
This Tests for antibodies to zinc transporter ZnT8, a beta cell specific protein associated with the mechanism of insulin release. It is reported to be a better predictor of the development of type 1 diabetes than any other antibody currently known. ZnT8Ab levels decline rapidly during the initial year of disease and are associated with younger age & a high GAD antibody titer. GAD antibodies are present in everyone, with or without diabetes, and a “positive” test means they are higher or lower, depending on an arbitrary cutoff point that is not consistent among studies.
Mapping, monitoring and measuring are a continuous cycle when living with diabetes. You begin with a certain course of treatment in mind, which you mapped out with the help of your medical professional. You monitor your progress and measure it against your goals. Upon evaluation, you may find a new course must be corrected to compensate for successes and challenges.
Evaluating progress and results of the Health-e-Solutions lifestyle is essential to #MasterDiabetes in the healthiest way possible. This downloadable e-publication equips you with the key evaluation tools you need, along with some of the research behind them, to determine where you want to go and how to get there. We give you important tools to help you chart your course and stay on track to reach your destination.