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目的探讨四川省新生儿疾病筛查中心实验室先天性甲状腺功能减低症(CH)筛查切值,减少漏诊率,降低假阳性率。方法对四川省新生儿疾病筛查中心片区市县2011至2012年活产婴儿出生72小时并充分哺乳6次后取其足跟血,采用时间分辨荧光免疫法检测血中促甲状腺激素(TSH)浓度。结果 2011至2012年度共测定525 941例标本,其TSH浓度呈偏态分布,其中正常新生儿人数为525 554,确诊CH患儿230例,高TSH血症患儿157例。当筛查切值定为8.0mIU/L和定为8.9mIU/L时,灵敏度x~2=10.188,P<0.05;特异度x~2=458.460,P<0.05,制定出四川省新生儿疾病筛查中心实验室时间分辨荧光免疫法筛查CH参考切值为8.0mIU/L。结论四川省新生儿疾病筛查中心制定的CH筛查切值是适宜的、有依据的,为更大规模开展的新生儿CH筛查提供了决策依据。
Objective To investigate the cut value of congenital hypothyroidism (CH) screening in neonatal screening center of Sichuan Province to reduce the rate of misdiagnosis and reduce the false positive rate. Methods The hematopoietic growth hormone (TSH) in blood was detected by time-resolved fluorescence immunoassay after 72 hours of birth and full lactation in cities and counties of Sichuan Province from 2011-2012. concentration. Results A total of 525 941 specimens were determined from 2011 to 2012, and their TSH concentrations were skewed. Among them, 525 554 were normal newborns, 230 were diagnosed as CH, and 157 were hypercholesterolemic. Sensitivity x ~ 2 = 10.188, P <0.05; specificity x ~ 2 = 458.460, P <0.05, when the screening cut-off value was 8.0mIU / L and 8.9mIU / L, Screening center laboratory time-resolved fluorescence immunoassay screening CH reference cut value of 8.0mIU / L. Conclusions The CH screening cut-off value established by Sichuan Neonatal Disease Screening Center is appropriate and validated, which provides a basis for decision-making on CH screening of newborns on a larger scale.