Diabetes Antibody Standardization Program. First evaluation of assays for autoantibodies to IA-2beta.

M. Schlosser; P. Mueller; P. Achenbach; V. Lampasona; P. Bingley; Frans Gorus; Joeri De Grijse; P. Goubert

Diabetes Antibody Standardization Program. First evaluation of assays for autoantibodies to IA-2beta.

M. Schlosser, P. Mueller, P. Achenbach, V. Lampasona, P. Bingley, Frans Gorus, Joeri De Grijse, P. Goubert

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Abstract

OBJECTIVE Autoantibodies to IA-2beta (IA-2betaA) are important risk markers of type 1 diabetes. We report the first Diabetes Antibody Standardization Program (DASP) evaluation of IA-2beta A assays.

RESEARCH DESIGN AND METHODS Thirteen laboratories from nine countries received coded sera from 50 patients with newly diagnosed type 1 diabetes and 100 healthy blood donors. IA-2betaA results were analyzed using receiver operating characteristic (ROC) curves. Concordance of antibody levels was compared using counts per minute (cpm), local and standard curve-derived common units.

RESULTS Median laboratory-assigned sensitivity was 47% (interquartile range [IQR] 45-51), specificity 98% (IQR 95-99), adjusted sensitivity at 95% specificity 50% (IQR 49-53), and area under the ROC curve 0.70 (IQR 0.69-0.73). Use of common IA-2?A units improved concordance between assays compared with local units and cpm (P <0.0001).

CONCLUSIONS IA-2betaA assays in multiple laboratories worldwide achieved good concordance and high specificity for type 1 diabetes. IA-2betaA are suitable for inclusion in autoantibody testing for risk assessment in prediabetes.

Original language	English
Pages (from-to)	2410-2412
Number of pages	3
Journal	Diabetes Care
Volume	34
Publication status	Published - 10 Aug 2011

Keywords

diabetes
antibody

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@article{329a336920714701bebddb9ef3101c3c,

title = "Diabetes Antibody Standardization Program. First evaluation of assays for autoantibodies to IA-2beta.",

abstract = "OBJECTIVE Autoantibodies to IA-2beta (IA-2betaA) are important risk markers of type 1 diabetes. We report the first Diabetes Antibody Standardization Program (DASP) evaluation of IA-2beta A assays. RESEARCH DESIGN AND METHODS Thirteen laboratories from nine countries received coded sera from 50 patients with newly diagnosed type 1 diabetes and 100 healthy blood donors. IA-2betaA results were analyzed using receiver operating characteristic (ROC) curves. Concordance of antibody levels was compared using counts per minute (cpm), local and standard curve-derived common units. RESULTS Median laboratory-assigned sensitivity was 47% (interquartile range [IQR] 45-51), specificity 98% (IQR 95-99), adjusted sensitivity at 95% specificity 50% (IQR 49-53), and area under the ROC curve 0.70 (IQR 0.69-0.73). Use of common IA-2?A units improved concordance between assays compared with local units and cpm (P <0.0001). CONCLUSIONS IA-2betaA assays in multiple laboratories worldwide achieved good concordance and high specificity for type 1 diabetes. IA-2betaA are suitable for inclusion in autoantibody testing for risk assessment in prediabetes.",

keywords = "diabetes, antibody",

author = "M. Schlosser and P. Mueller and P. Achenbach and V. Lampasona and P. Bingley and Frans Gorus and {De Grijse}, Joeri and P. Goubert",

year = "2011",

month = aug,

day = "10",

language = "English",

volume = "34",

pages = "2410--2412",

journal = "Diabetes Care",

issn = "0149-5992",

publisher = "American Diabetes Association Inc.",

}

TY - JOUR

T1 - Diabetes Antibody Standardization Program. First evaluation of assays for autoantibodies to IA-2beta.

AU - Schlosser, M.

AU - Mueller, P.

AU - Achenbach, P.

AU - Lampasona, V.

AU - Bingley, P.

AU - Gorus, Frans

AU - De Grijse, Joeri

AU - Goubert, P.

PY - 2011/8/10

Y1 - 2011/8/10

N2 - OBJECTIVE Autoantibodies to IA-2beta (IA-2betaA) are important risk markers of type 1 diabetes. We report the first Diabetes Antibody Standardization Program (DASP) evaluation of IA-2beta A assays. RESEARCH DESIGN AND METHODS Thirteen laboratories from nine countries received coded sera from 50 patients with newly diagnosed type 1 diabetes and 100 healthy blood donors. IA-2betaA results were analyzed using receiver operating characteristic (ROC) curves. Concordance of antibody levels was compared using counts per minute (cpm), local and standard curve-derived common units. RESULTS Median laboratory-assigned sensitivity was 47% (interquartile range [IQR] 45-51), specificity 98% (IQR 95-99), adjusted sensitivity at 95% specificity 50% (IQR 49-53), and area under the ROC curve 0.70 (IQR 0.69-0.73). Use of common IA-2?A units improved concordance between assays compared with local units and cpm (P <0.0001). CONCLUSIONS IA-2betaA assays in multiple laboratories worldwide achieved good concordance and high specificity for type 1 diabetes. IA-2betaA are suitable for inclusion in autoantibody testing for risk assessment in prediabetes.

AB - OBJECTIVE Autoantibodies to IA-2beta (IA-2betaA) are important risk markers of type 1 diabetes. We report the first Diabetes Antibody Standardization Program (DASP) evaluation of IA-2beta A assays. RESEARCH DESIGN AND METHODS Thirteen laboratories from nine countries received coded sera from 50 patients with newly diagnosed type 1 diabetes and 100 healthy blood donors. IA-2betaA results were analyzed using receiver operating characteristic (ROC) curves. Concordance of antibody levels was compared using counts per minute (cpm), local and standard curve-derived common units. RESULTS Median laboratory-assigned sensitivity was 47% (interquartile range [IQR] 45-51), specificity 98% (IQR 95-99), adjusted sensitivity at 95% specificity 50% (IQR 49-53), and area under the ROC curve 0.70 (IQR 0.69-0.73). Use of common IA-2?A units improved concordance between assays compared with local units and cpm (P <0.0001). CONCLUSIONS IA-2betaA assays in multiple laboratories worldwide achieved good concordance and high specificity for type 1 diabetes. IA-2betaA are suitable for inclusion in autoantibody testing for risk assessment in prediabetes.

KW - diabetes

KW - antibody

M3 - Article

SN - 0149-5992

VL - 34

SP - 2410

EP - 2412

JO - Diabetes Care

JF - Diabetes Care

ER -

Diabetes Antibody Standardization Program. First evaluation of assays for autoantibodies to IA-2beta.

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Keywords

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