Type 1 diabetes is an inflammatory autoimmune disease of the pancreas, leading to destruction of the insulin-producing β-cells of pancreas, and resulting in a lack of insulin.[1] The lack of insulin leads to increased blood and urine glucose and produces classical symptoms of diabetes like polyuria, polydipsia and weight loss, etc.[2] Administration of insulin is essential for survival and it must be continued throughout the life, to lower the risk of long-term complications such as diabetic retinopathy, diabetic nephropathy, and cardiovascular disease.
Although of the total cases of diabetes, only 5% are of type 1 diabetes; it is the most common type of diabetes diagnosed in children and young adults.[3] Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin-producing cells.
To help an early diagnosis of type 1 diabetes, United States Food and Drug Administration (USFDA) recently approved the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. People with type 1 diabetes produce ZnT8Ab, while patients with type 2 and gestational diabetes do not. The ZnT8Ab enzyme-linked immunoassay easily detects the presence of the ZnT8Ab in the blood.[4]
Food and Drug Administration (FDA) approved the test based on data from a clinical study of 569 blood samples; 323 from patients with type 1 diabetes and 246 from patients diagnosed with other kinds of diabetes. The test was able to detect the ZnT8Ab in 65% of the samples from patients with diagnosed type 1 diabetes and gave a false positive result in less than 2% of the samples. FDA cautioned that a negative result from the test does not rule out a diagnosis of type 1 diabetes and that the test should not be used to monitor the stage of disease or a response to treatment.[5] When used meticulously with other tests and clinical information of the patient, the test may help some people with type 1 diabetes receive timely diagnosis and treatment.
Footnotes
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Conflict of Interest: None declared.
REFERENCES
- 1.Cihakova D. Type 1 Diabetes Mellitus. Johns Hopkins Medical Institutions. [Last accessed on 2014 Sep 22]. Available from: http://www.autoimmune.pathology.jhmi.edu/diseases.cfm?systemID=3 and DiseaseID=23 .
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- 4.Brooks M. FDA clears blood test to help diagnose type 1 diabetes. Medscape Medical News. 2014. Aug 21, [Last accessed on 2014 Sep 22]. Available from: http://www.medscape.com/viewarticle/830243?src=wnl_int_edit_tp10 and uac=134696SR .
- 5.FDA News Release. FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes. Press Announcements. 2014. Aug 20, [Last accessed on 2014 Sep 22]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm410830.htm .