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Clinical Chemistry 0: clinchem.2004.031799v1, 2004; 10.1373/clinchem.2004.031799
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Received on January 21, 2004
Accepted on May 4, 2004

Endocrinology and Metabolism

Evaluation of Two Nonisotopic Immunoassays for Determination of Glutamic Acid Decarboxylase and Tyrosine Phosphatase Autoantibodies in Serum

Xavier Palomer 1, Dídac Mauricio 2, José Rodríguez-Espinosa 3, Edgar Zapico 3, Carme Mayoral 3, Francesc González-Sastre 4, Alberto de Leiva 5, Francisco Blanco-Vaca 6*

1 Institut de Recerca
2 Serveis d'Endocrinologia, Institut Universitari Parc Taulí, Sabadell, Spain
3 Bioquímica, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
4 Bioquímica, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, and Universitat Autònoma de Barcelona, Barcelona, Spain
5 Serveis d'Endocrinologia, and Universitat Autònoma de Barcelona, Barcelona, Spain
6 Institut de Recerca, and Bioquímica, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

* To whom correspondence should be addressed. E-mail: fblancova{at}hsp.santpau.es.

Background: Autoantibodies for the 65-kDa form of glutamic acid decarboxylase (GAD65) and protein tyrosine phosphatase-like protein (IA-2) are measured for risk prediction and diagnosis of autoimmune diabetes mellitus. There is a lack of adequate nonisotopic alternatives to the most widely used method for both autoantibodies, which is a radiobinding assay (RBA).

Methods: We compared two commercially available immunoassays, an ELISA and a time-resolved immunofluorometric assay (TR-IFMA), with RBA.

Results: We found excellent agreement between the RBA and ELISA for measurement of GAD65 autoantibodies (GADAs); they showed comparable analytical precision in the cutoff range and achieved similar diagnostic specificity. The ELISA identified more GADA-positive individuals among patients with new-onset type 1 diabetes than did the RBA [89% (95% confidence interval, 78-95%), vs 71% (58-82%); P <0.03]. For IA-2 autoantibodies (IA-2As), only the TR-IFMA achieved analytical performance and diagnostic accuracy comparable to that of the RBA. These results with the GADA ELISA and IA-2A TR-IFMA were consistent with those obtained blindly in the Diabetes Antibody Standardization Program 2003. The performance of the GADA TR-IFMA and IA-2A ELISA was unsatisfactory, and these tests were not subjected to clinical evaluation.

Conclusions: The GADA ELISA and IA-2A TR-IFMA behave comparably with RBA and are thus suitable for use in the clinical laboratory.


The following articles in journals at HighWire Press have cited this article:


Home page
 Diabetes CareHome page
A. de Leiva, D. Mauricio, and R. Corcoy
Diabetes-Related Autoantibodies and Gestational Diabetes
Diabetes Care, July 1, 2007; 30(Supplement_2): S127 - S133.
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