中国胰岛自身抗体检测标准化计划报告：检测方法调查及准确性评估

China Islet Autoantibody Standardization Program： methodology investigation and accuracy assessment

目的调查我国医院胰岛自身抗体检测开展情况，启动检测标准化评估工作。 方法2015年4月向国家代谢性疾病临床医学研究中心20家核心成员单位发放胰岛自身抗体检测情况调查表。选择采用放射配体法的3家核心成员单位，发放盲法编号的50例新诊断1型糖尿病和100名健康人的血清样本。经WHO标准品换算结果后，采用受试者工作特征曲线（ROC）下面积（AUC）评价检测敏感性和特异性及结果判定的一致性。曼-惠特尼U检验比较T1DM与健康人的自身抗体WHO值，直线相关分析评价各实验室结果换算成WHO标准单位后的相关性。 结果（1）回报结果的20家医院均开展了谷氨酸脱羧酶抗体（GADA）检测，其中7家单位同时开展了蛋白酪氨酸磷酸酶抗体（IA-2A）检测（35%）；检测方法包括免疫印迹法（30%）、化学发光法（20%）、酶联免疫吸附法（20%）、放射免疫法（15%）和放射配体法（15%）。（2）采用放射配体法的3家单位，检测GADA敏感性72%~80%，特异性95%~100%；检测IA-2A敏感性38%~58%，特异性98%~100%；受试者工作特征曲线分析显示，曲线下面积GADA为0.897~0.935，IA-2A为0.716~0.749；检测GADA一致性为92.7%，IA-2A一致性为92%。 结论我国医院胰岛自身抗体检测亟需标准化。放射配体法可作为现阶段我国胰岛自身抗体中心化检测的推荐方法。

ObjectiveTo investigate the current situation of islet autoantibodies detection in China, and to evaluate assay proficiency to improve the diagnosis and classification of autoimmune diabetes. MethodsIslet 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%. ConclusionIslet autoantibodies detection in Chinese hospitals need to be standardized. Radioligand assay is recommended for centralized detection of islet autoantibodies in China.