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目的通过分析1235 AutoDELFIA在新生儿甲状腺功能低下症的筛查情况,评价其使用情况。方法用1235AutoDELFIA对162 600例新生儿血样进行甲状腺功能低下症筛查,分析实验结果及质控数据。结果筛查出可疑阳性3300例,电话召回3065例,召回率92.88%;召回后确诊甲状腺功能低下症101例,高TSH血症165例,确诊率8.68%,甲低发病率1/1610。质控在控率95.23%,总体变异系数9.65%。结论 1235 AutoDELFIA稳定性、均一性良好,可用于新生儿疾病筛查。
Objective To evaluate the use of 1235 AutoDELFIA in the screening of neonatal hypothyroidism. Methods A total of 162 600 newborn blood samples were screened by 1235 AutoDELFIA for hypothyroidism. The experimental results and quality control data were analyzed. Results 3300 suspicious positive patients were screened, 3065 were recalled by telephone, and the recall rate was 92.88%. 101 cases of hypothyroidism were diagnosed after the recall, 165 cases of hypercholesteremia, the diagnosis rate was 8.68%, and the prevalence of hypothyroidism was 1/1610. Quality control rate of 95.23%, the overall coefficient of variation of 9.65%. Conclusion The 1235 AutoDELFIA has good stability and good homogeneity, which can be used in neonatal screening.