Abstract
Objective To investigate the current situation of islet autoantibodies detection in China, and to evaluate assay proficiency to improve the diagnosis and classification of autoimmune diabetes. Methods Islet autoantibodies questionnaire was sent to 20 members of National Clinical Research Center for Metabolic Diseases in April 2015. In accordance with international standardization of islet autoantibodies program, sera of 50 patients with newly diagnosed type 1 diabetes, 100 healthy controls were blindly numbered and assayed in three core units using radioligand assay. The area under the receiver operating characteristic curve (ROC) (AUC) was applied to evaluate the sensitivity and specificity, as well as the consistency of the results. Mann-Whitney U test was used to compare the WHO values of type 1 diabetes mellitus and healthy volunteers autoantibodies. Linear correlation analysis was applied to evaluate the correlation of 3-lab results after converting into WHO standard unit. Results (1) All of 20 hospitals carried out the detection of glutamic acid decarboxyase antibody (GADA), and 7 hospitals detect GADA+ protein tyrosinephosphate antibody(IA-2A) paralelly (35%); The detection methods included immunoblotting (30%), chemiluminescence (20%), enzyme-linked immunosorbent assay (20%), radioimmunoassay (15%) and radioligand assay (15%). (2) Among three core units, sensitivity for GADA detection ranged from 72% to 80%, while specificity ranged from 95% to 100%; sensitivity for IA-2A detection ranged from 38% to 58% with the specificity from 98% to 100%. The ROC analysis showed that the AUC of GADA was 0.897-0.935, of IA-2A was 0.716-0.749. The consistency of GADA detection among three units was 92.7%, of IA-2A was 92%. Conclusion Islet autoantibodies detection in Chinese hospitals need to be standardized. Radioligand assay is recommended for centralized detection of islet autoantibodies in China. Key words: Diabetes mellitus, type 1; Standardization; Glutamic acid decarboxylase antibody; Autoantibodies to tyrosine phosphatase-like protein
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