Year : 2015 | Volume
: 5 | Issue : 1 | Page : 1-
Blood test to help diagnose type 1 diabetes approved by Food and Drug Administration
Department of Pharmacology, Adesh Institute of Medical Sciences and Research, Bathinda, Punjab, India
Department of Pharmacology, Adesh Institute of Medical Sciences and Research, Bathinda, Punjab
|How to cite this article:|
Mahajan R. Blood test to help diagnose type 1 diabetes approved by Food and Drug Administration.Int J App Basic Med Res 2015;5:1-1
|How to cite this URL:|
Mahajan R. Blood test to help diagnose type 1 diabetes approved by Food and Drug Administration. Int J App Basic Med Res [serial online] 2015 [cited 2021 Sep 19 ];5:1-1
Available from: https://www.ijabmr.org/text.asp?2015/5/1/1/149215
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.  The lack of insulin leads to increased blood and urine glucose and produces classical symptoms of diabetes like polyuria, polydipsia and weight loss, etc.  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.  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. 
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.  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.
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|4||Brooks M. FDA clears blood test to help diagnose type 1 diabetes. Medscape Medical News, August 21, 2014. Available from: http://www.medscape.com/viewarticle/830243?src=wnl_int_edit_tp10 and uac=134696SR. [Last accessed on 2014 Sep 22].|
|5||FDA News Release. FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes. Press Announcements. August 20, 2014. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm410830.htm. [Last accessed on 2014 Sep 22].|