2006年连云港市新生儿先天性甲状腺功能减低症筛查及质量评估

Screening and Evaluation on Neonatal Congenital Hypothyroidism in Lianyungang City in 2006

[目的]分析连云港市新生儿先天性甲状腺功能减低症（CH）筛查结果并对两种（PE和丰华）筛查试剂进行质量评估。[方法]采用时间分辨荧光免疫法检测滤纸血斑中TSH浓度。[结果]2006年筛查新生儿59128例，确诊CH患儿24例（1／2464），其中PE试剂确诊10例（1／2840），丰华试剂确诊14例（1／2199）；差异无统计学意义（P〉O．05）；丰华10个批次变异系数在7．48％～13．80％，PE为4．15％～10．70％；99％百分位数，丰华为9．14％，PE为6．95％。[结论]连云港市CH发病率居国内平均水平，患儿呈散发性分布，扩大筛查范围是发现CH患儿的唯一有效手段。国产丰华试剂质量是稳定的，可用于CH筛查。

[Objective] To analyze the results of screening of neonatal congenital hypothyroidism（CH）, evaluate the quality of two screening reagents. [Methods]The concentration of TSH of the blood in filter paper was tested with temporal resolution fluorescent immunoassay （TRFIA）. [Results]59 128 newborns heel blood specimens were screened. 24 cases（1/2 464） were diagnosed as congenital hypothyroidism（CH）,of them 10（1/2 840） were diagnosed with PE reagent, and 14（1/2 199） were diagnosed with Fenghua reagent. There was no difference. （P〉0.05）. The coefficient of variation of the 10 batches of Fenghua was from 7.48% to 13.80% , PE was from 4.15% to 10.70%. Fenghua was 9. 14% ,and PE was 6.95% about 99 % percentile. [Conclusion]The incidence of CH in Lianyungang was at the mean level in our country with sporadic cases. The only effective way to find out the cases of CH was large screening. The quality of Fenghua reagent made in China was stable,it can be used for neonatal screening.