figure 1 stratification of diabetes risk a. Based on Numbers of Autoantibodies b. Based on Autoantibody Combination developing T1D. When an effective way to reintroduce tolerance in autoimmune diabetes becomes available, high-quality, high-throughput autoantibody tests will be essential <strong>for</strong> identifying individuals who can benefit from such treatment. Future therapeutic intervention trials <strong>for</strong> disease will need to consider the characteristics of the population and assay per<strong>for</strong>mance in screening <strong>for</strong> the disease. These strategies will likely evolve as researchers devise new interventions and develop new tests. Two early intervention trials <strong>for</strong> which recruitment was based on ICA and/or IAA have already proven the efficacy of islet autoantibodies <strong>for</strong> T1D prediction (18, 19). Researchers have also used the presence of IAA, GADA, and IA-2A as a criterion <strong>for</strong> recruiting individuals into prevention studies and <strong>for</strong> identifying initiation of autoimmunity in natural history studies of T1D, such as the The Environmental Determinants of Diabetes in the Young (TEDDY) Study. CLN REFERENCES 1. CDC Diabetes Fact Sheet, 2007, (http:// www.cdc.gov/diabetes/pubs/factsheet07. htm). 2. Naik RG, Brooks-Worrell BM, Palmer J. Latent autoimmune diabetes in adults. J Clin Endocrinol Metab 2009; 94:4635– 4644. 3. Zimmet PZ. The pathogenesis and prevention of diabetes in adults: genes, autoimmunity, and demography. Diabetes Care 10 CliniCal laboratory news <strong>oCtoBeR</strong> <strong>2010</strong> c. Based on IA-2A Epitopes stratification of diabetes risk in islet autoantibody (iaa, gada, and/or ia-2a)-positive first-degree relatives of t1d patients (n = 180) based on autoantibody number (a), target antigen specificity (b), and ia-2a reactivity against ia-2β (c). Reprinted with permission from The <strong>American</strong> Diabetes <strong>Association</strong>. Copyright 2004, from Diabetes 2004;53:384–392. 1995;18:1050–1064. 4. Eisenbarth GS. Type 1 diabetes mellitus. A chronic autoimmune disease. N Engl J Med 1986;314:1360–1368. 5. Taplin CE, Barker JM. Autoantibodies in type 1 diabetes. Autoimmunity 2008;41: 11–18. 6. Bottazzo GF, Florin-Christensen A, Doniach D. Islet-cell antibodies in diabetes mellitus with autoimmune polyendocrine deficiencies. Lancet 1974;304:1279–1283. 7. Palmer JP, Asplin CM, Clemons P, et al. Insulin antibodies in insulin-dependent diabetics be<strong>for</strong>e insulin treatment. Science 1983;222:1337–1339. 8. Baekkeskov S, Aanstoot HJ, Christgau S, et al. Identification of the 64K autoantigen in insulin-dependent diabetes as the GABA-synthesizing enzyme glutamic acid decarboxylase. Nature 1990;347:151–156. 9. Payton MA, Hawkes CJ, Christie MR. Relationship of the 37,000- and 40,000- Mr tryptic fragments of islet antigens in insulin-dependent diabetes to the protein tyrosine phosphatase-like molecule IA-2 (ICA512). J Clin Invest 1995;96:1506–1511. 10. Wenzlau JM, Moua O, Sarkar SA, et al. S1C30A8 is a major target of humoral autoimmunity in type 1 diabetes and a predictive marker in prediabetes. Ann NY Acad Sci 2008;1150:256–259. 11. Torn C, Mueller PW, Schlosser M, et al. Diabetes Antibody Standardization Program: evaluation of assays <strong>for</strong> autoantigens to glutamic acid decarboxylase and islet antigen-2. Diabetologia 2008;1:846–852. 12. Mire-Sluis AR, Gaines Das R, Lernmark A. The World Health Organization International Collaborative Study <strong>for</strong> islet cell antibodies. Diabetologia 2000;43:1282– 1292. 13. Achenbach P, Schlosser M, Williams AJK, et al. Combined testing of antibody titer and affinity improves insulin autoantibody measurement: Diabetes Autoantibody Standardization Program. Clin Immunol 2007;122:85–90. 14. Burbelo PD, Groot S, Dalakas MC, et al. High definition profiling of autoantibodies to glutamic acid decarboxylases GAD65/ GAD67 in stiff-person syndrome. Biochem Biophys Res Commun 2008;366:1–7. 15. Bonifacio E, Yu L, Williams AK, et al. Harmonization of glutamic acid decarboxylase and islet antigen-2 autoantibody assays <strong>for</strong> National Institute of Diabetes Digestive and Kidney Diseases consortia. J Clin Endocrinol Metab <strong>2010</strong>;95:3360–3367. 16. Bingley PJ. <strong>Clinical</strong> applications of diabetes antibody testing. J Clin Endocrinol Metab <strong>2010</strong>;95:25–33. 17. Achenbach P, Warncke K, Reiter J, et al. Stratification of type 1 diabetes risk on the basis of islet autoantibody characteristics. Diabetes 2004;53:384–392. 18. Bingley PJ, Gale EAM. The European Nicotinamide Diabetes Intervention Trial (ENDIT) Group, Diabetologia. Progression to type 1 diabetes in islet cell antibody- positive relatives in the European Neicotinamide Diabetes Intervention Trial: the role of additional immune, genetic and metabolic markers of risk. 2006;49:881–890. 19. Orban T, Sosenko JM, Cutherbertson D, et al. For the Diabetes Prevention Trial- Type 1 Study Group. Pancreatic islet autoantibodies as predictors of type 1 diabetes in the Diabetes Prevention Trial-Type1, Diabetes Care. 2009;32:2269–2274. Patricia W. Mueller, PhD, is chief of the Molecular Risk Assessment Laboratory at the Centers <strong>for</strong> Disease Control and Prevention, Atlanta, Ga. Address all correspondence to: pwm2@cdc.gov. Peter Achenbach, MD, is a physician and clinical scientist at the Institute of Diabetes Research, Helmholtz Center, Munich, Germany. Vito Lampasona is a senior scientist at the Center of Genomics, Bioin<strong>for</strong>matics, and Biostatistics, San Raffaele Scientific Institute, Milan, Italy. Michael Schlosser is a senior scientist in medical biochemistry and molecular biology, University of Greifswald, Karlsburg, Germany. Alistair J. K. Williams is a research fellow in clinical science at North Bristol, University of Bristol, Bristol, U.K.
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