Type 1 diabetes is the most common type of diabetes in children and adolescents, and sometimes may develop in adults. Many patients with type 1 diabetes produce the autoantibody ZnT8Ab, unlike those diagnosed with gestational or type 2 diabetes. The Zinc Transporter 8 Autoantibody (ZnT8Ab, Kronus) ELISA assay is a blood test designed to detects the presence of the ZnT8 autoantibody.
To determine the effectiveness and safety of the ZnT8Ab ELISA assay, the researchers examined 569 blood samples from a clinical study. Of the samples, 323 were from patients diagnosed with type 1 diabetes and 246 from patients with other types of diabetes, autoimmune diseases, and other clinical conditions.
The test was able to correctly identify 65% of samples from patients diagnosed with type 1 diabetes, and incorrectly gave a positive result in less than 2% of the samples, according to the FDA.
A negative test results, however, should not rule out a diagnosis of type 1 diabetes, cautioned the agency. In addition, the test also shouldn’t be used to monitor the body’s response to treatment
“Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin producing cells,” said Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health at the Center for Devices and Radiological Health. “This test can help patients get a timely diagnosis and help start the right treatment sooner.”