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目的:对苏州市2007年1月到2010年3月新生儿先天性甲状腺功能减低症(congenital hypothyroidism,CH)筛查工作进行统计,探讨初筛实验中筛查切值的设定与筛查效率的相关性。方法:对出生72 h经充分哺乳后的新生儿采集足跟血滤纸标本,采用时间分辨荧光免疫法(DELEFIA)Perkin.Elmer试剂盒检测滤纸干血斑中促甲状腺素(TSH)浓度。采用百分位数法确定切值,并应用SPSS软件—ROC曲线(受试者工作特征曲线)分析筛查切值。结果:新生儿筛查TSH检测水平呈偏态分布,平均值为2.27μU/ml,中位数值为2.74μU/ml,正常新生儿99%百分位数值为9.20μU/ml。初筛值为0～5μU/ml者占89.77%,其中0.00～0.99、1.00～1.99、2.00～2.99、3.00～3.99和4.00～4.99μU/ml者分别占15.16%、27.68%、23.37%、15.20%和8.56%。有0.7%的受检者初筛TSH在8.00～8.99μU/ml之间。按照切值为9μU/ml,复查率为1.38%。一共确诊206例CH患儿,CH发生率1/1 219,尚无漏诊报道。在确诊患儿中42.23%的初筛测定值在9～20μU/ml。结论:苏州市新生儿中CH的发生率高于全国平均水平。筛查切值9.0μU/ml较适合苏州人群,对于临界切值的样本根据质控值与筛查阳性率作2次选择。
Objective: To investigate the screening of congenital hypothyroidism (CH) in neonates from January 2007 to March 2010 in Suzhou City, and discuss the setting of screening cut-off value and the screening efficiency in screening experiments Relevance. Methods: Heel blood filter paper samples were collected from neonates who were fully breast-fed at 72 h after birth. The TSH concentrations in dried blood spots of filter paper were measured by DELEFIA Perkin Elmer kit. The cut-off value was determined using the percentile method, and the cut-off value was analyzed using the SPSS software-ROC curve (subject work characteristic curve). Results: The level of TSH in neonatal screening was skewed, with an average of 2.27μU / ml, a median of 2.74μU / ml and a normal 99% percentile of 9.20μU / ml. The primary screening value was 0 ~ 5μU / ml, accounting for 89.77%, of which 0.00 ~ 0.99, 1.00 ~ 1.99, 2.00 ~ 2.99, 3.00 ~ 3.99 and 4.00 ~ 4.99μU / ml accounted for 15.16%, 27.68%, 23.37%, 15.20 % And 8.56%. There were 0.7% of the subjects screening TSH in the 8.00 ~ 8.99μU / ml between. According to the cut value of 9μU / ml, the review rate was 1.38%. A total of 206 cases diagnosed CH children, CH incidence of 1/219, no missed diagnosis. In the diagnosed children 42.23% of the initial screening test value of 9 ~ 20μU / ml. Conclusion: The incidence of CH in neonates in Suzhou is higher than the national average. Screening cut value 9.0μU / ml is more suitable for Suzhou population, for the cut-off value of the sample according to the quality control value and screening positive rate for 2 times.