ECE2024 Poster Presentations Diabetes, Obesity, Metabolism and Nutrition (130 abstracts)
Evaluation of a new prototype ELISA for the detection of autoantibodies against IA2 in patients with type 1 diabetes mellitus
Skander Elleuche 1 , Gia-Gia Hò 1 , Alexander Kühnl 1 , Malgorzata Baranowska-Dell 2 , Kai Masur 3,4 , Petra Augstein 5,6 , Sandra Saschenbrecker 1 , Christian Probst 1 , Lars Komorowski 1 , Kersten Dieckmann 1 & Cornelia Dähnrich 1
1Institute for Experimental Immunology, affiliated to Euroimmun Medizinische Labordiagnostika AG, Lübeck, Germany; 2Department of General, Visceral, Thoracic, and Vascular Surgery, Research Group of Predictive Diagnostics, University Medical Center Greifswald, Greifswald, Germany; 3Leibniz Institute for Plasma Science and Technology (INP Greifswald), Greifswald, Germany; 4Diabetes Competence Centre Karlsburg (KDK), Karlsburg, Germany; 5Institute of Diabetes "Gerhardt Katsch", Karlsburg, Germany; 6Department for Diabetology, Klinikum Karlsburg, Heart and Diabetes Center Karlsburg, Karlsburg, Germany
Introduction: Autoantibodies against insulinoma-associated antigen-2 (anti-IA2) are an important marker for diagnosis and prediction of new-onset type 1 diabetes mellitus (T1DM). Here we report on a new prototype Anti-IA2 ELISA with shorter total incubation time (3h15min) compared to the established EUROIMMUN Anti-IA2 ELISA (minimum 17h40min). The study evaluates the performance of the prototype assay.
Methods: The clinical performance of the prototype ELISA was evaluated using a sensitivity panel comprising sera from 32 patients with suspected T1DM and 111 patients with confirmed T1DM, and a specificity panel consisting of sera from 50 suspected cases each of connective tissue disease and celiac disease, and from 210 healthy donors. For method comparison, 32 samples from suspected T1DM cases and a subset of 100 samples from confirmed T1DM patients were additionally analyzed using the established EUROIMMUN Anti-IA2 ELISA and the Medipan CentAK anti-IA2 M radioimmunoassay (RIA), respectively.
Results: The clinical sensitivity of the prototype ELISA amounted to 73.4% (105/143) at a specificity of 99.4% (308/310). Method comparison revealed a sensitivity of the prototype of 93.3% (28/30) referring to the established ELISA and 93.8% (61/65) referring to the RIA, while the overall agreement was 90.6% (29/32, ELISA) and 90.0% (90/100, RIA).
Conclusions: The results suggest that the new Anti-IA2 ELISA will be a valuable tool in supporting the serodiagnosis of T1DM. Reducing the processing time to a few hours minimizes the time required for laboratory testing, reinforcing the prototype’s suitability to replace the established ELISA. Additionally, the new assay enables easier automation in conjunction with other ELISA with similar timelines on EUROIMMUN Analyzer I or EUROLabWorkstation ELISA.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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