探讨在GSP分析仪上进行新生儿先天性甲低TSH筛查切值设定的意义  

To explore the significance of setting the TSH cut-off value in screening for congenital hypothyroidism with GSP

作　　者：梁睿[1] 陈锐 钟裕恒 吴学威 欧锦留 黄湘 LIANG Rui;CHEN Rui;ZHONG Yu-heng;WU Xue-wei;OU Jin-liu;HUANG Xiang(Prenatal Diagnosis Center,Boai Hospital of Zhongshan,Guangdong Zhongshan 528400,China;The Second School of Clinical Medicine,Southern Medical University,Guangzhou 510000)

机构地区：[1]中山市博爱医院产前诊断中心,广东中山528400 [2]南方医科大学第二临床医学院,广州510000 [3]佛山市妇幼保健院产前诊断中心,广东佛山528000

出　　处：《中国优生与遗传杂志》2020年第10期1252-1254,共3页Chinese Journal of Birth Health & Heredity

基　　金：国家自然科学基金(81101534);中山市科技计划重大项目(2016B1009);中山市医学科研项目(2018J125)。

摘　　要：目的探讨中山地区使用全自动荧光免疫分析仪(GSP)进行新生儿先天性甲状腺功能减低症(CH)筛查时促甲状腺激素(TSH)切值设定的意义,以指导后续的筛查工作。方法收集中山地区2017年5月11日至2018年12月在我院新生儿疾病筛查中心用全自动荧光免疫分析仪检测的81 827例新生儿干血斑标本中的TSH值,分别采用百分位数法和应试者操作特征曲线(ROC曲线)法计算切值,并对不同切值下确诊患儿的数据进行分析。结果中山地区新生儿TSH值呈正偏态分布,百分位数法计算的最佳切值P99为8.13 mIU/L,ROC曲线法计算的最佳切值为9.30 mIU/L,灵敏度为1,特异性为0.995,约登指数0.995,曲线下面积为0.999,99% CI为0.998-0.999 mIU/L。结论根据百分位数法和ROC曲线法算出的最佳切值,结合本地区实际情况,本研究认为使用GSP分析仪进行中山市新生儿TSH筛查时选用8.50 mIU/L的切值为较为合适。Objective:To explore the significance of setting the TSH cut-off value of thyroid stimulating hormone(TSH)in congenital hypothyroidism(CH)screening using Genetic Screening Processor(GSP)in Zhongshan,so as to guide the follow-up screening work.Methods:Collect 81 827 cases of neonatal TSH values in dried blood sample,from May 11,2017 to December 2018 in our hospital neonatal disease screening center,the data was analyzed using the percentile method and the receiver operating characteristic curve(ROC curve)to study the optimal cut-off value,then analyzed the data of positive samples and CH samples under the different values.Results:TSH values of neonates in Zhongshan area were positively skewed,P99 calculated by the percentile method was 8.13 mIU/L,the optimal cut-off value calculated by ROC curve method was 9.30 mIU/L,the sensitivity was 1,the specificity was 0.995,the youdan index was 0.995,the area under the curve was 0.999,and the 99%CI was 0.998-0.999 mIU/L.Conclusion:According to the optimal cut-off value calculated by percentile method and ROC curve method,and combined with the actual situation in this region,this study believes that 8.50 mIU/L cut-off value is more appropriate when using Genetic Screening Processor to screen newborn TSH in Zhongshan.

关 键 词：中山地区 先天性甲状腺功能减低症 促甲状腺激素切值 全自动荧光免疫分析仪 

分 类 号：R722.1[医药卫生—儿科]