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EDITORIAL
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

Date of Web Publication13-Jan-2015

Correspondence Address:
Rajiv Mahajan
Department of Pharmacology, Adesh Institute of Medical Sciences and Research, Bathinda, Punjab
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-516X.149215

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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

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 2020 May 31];5:1. Available from: http://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. [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.

 
   References Top

1.
Cihakova D. Type 1 Diabetes Mellitus. Johns Hopkins Medical Institutions. Available from: http://www.autoimmune.pathology.jhmi.edu/diseases.cfm?systemID=3 and DiseaseID=23. [Last accessed on 2014 Sep 22].  Back to cited text no. 1
    
2.
Cooke DW, Plotnick L. Type 1 diabetes mellitus in pediatrics. Pediatr Rev 2008;29:374-84.  Back to cited text no. 2
    
3.
American Diabetes Association. Type 1 diabetes. Available from: http://www.diabetes.org/diabetes-basics/type-1/. [Last accessed on 2014 Sep 22].  Back to cited text no. 3
    
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].  Back to cited text no. 4
    
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].  Back to cited text no. 5
    



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