Diabetes Antibody Standardization Program: First evaluation of assays for autoantibodies to IA-2β

Original Research

Diabetes Antibody Standardization Program

¹Department of Medical Biochemistry and Molecular Biology, Research Group of Predictive Diagnostics, University of Greifswald, Karlsburg, Germany
²Institute of Pathophysiology, Research Group of Predictive Diagnostics, University of Greifswald, Karlsburg, Germany
³National Diabetes Laboratory, Centers for Disease Control and Prevention, Atlanta, Georgia
⁴Institute of Diabetes Research, Helmholtz Center Munich, German Research Center for Environmental Health, Neuherberg, Germany
⁵Genomics Unit for the Diagnosis of Human Pathologies, Center for Translational Genomics and Bioinformatics, San Raffaele Scientific Institute, Milan, Italy
⁶Diabetes and Metabolism, School of Clinical Sciences, University of Bristol, Bristol, U.K.

Diabetes Care 2011 Nov; 34(11): 2410-2412. https://doi.org/10.2337/dc11-1161

Table 1

Results for IA-2β autoantibody assays

Laboratory no.	Laboratory-assigned sensitivity (%)	Laboratory-assigned specificity (%)	AUC	95% CI	P value	AS 95 (%)	Results reported	IA-2β clone
109	ND	ND	0.77	0.69–0.87	<0.0001	63	local units	Milan
115	39	98	0.72	0.62–0.82	<0.0001	53	cpm	Milan
116	47	99	0.70	0.60–0.80	<0.0001	53	local units	Milan
118	ND	ND	0.68	0.57–0.79	<0.0001	53	cpm	Milan
120	53	96	0.73	0.63–0.82	<0.0001	55	local units	Milan
121	47	99	0.69	0.58–0.79	<0.0001	49	local units	Milan
126	51	98	0.67	0.55–0.78	0.001	49	local units	Seattle
132	43	99	0.74	0.65–0.83	<0.0001	47	local units	Milan
133	47	99	0.69	0.59–0.80	<0.0001	53	local units	Denver
150	53	94	0.75	0.66–0.84	<0.0001	53	cpm	Milan
153	50	98	0.74	0.65–0.84	<0.0001	52	local units	Milan
213	47	92	0.71	0.61–0.81	<0.0001	47	local units	Milan
504	37	92	0.65	0.55–0.75	0.004	20	local units	Milan