荧光酶免疫法在先天性甲状腺功能低下症筛查中的应用

FEIA in neonatal hypothyroidism screening

目的 探讨荧光酶免疫法 (FEIA)在新生儿甲状腺功能低下症筛查中的实用性。方法对FEIA方法测定滤纸干血片促甲状腺激素 (TSH)含量进行方法学检测 ,同时与酶联免疫吸附法(ELISA)和免疫放射法 (IRMA)相比较 ,并检测 1794例新生儿TSH正常水平及筛查切值 (cutoff)。结果 该方法最低检测限为 4.14mIU/L ,批内平均变异系数 (CV)为 0 .0 8,批间平均变异系数 (CV)为0 .11,高、中、低 3个浓度的平均重现率为 96 .4% ,实验结果与目前国内筛查使用的ELISA法和IRMA法高度相关 (r=0 .96 98和 0 .975 6 )。筛查切值建议定为 12mIU/L。结论 FEIA方法适用于新生儿甲状腺功能低下症的疾病筛查 ,其设备亦可用于筛查苯丙酮尿症。

Objective To discuss the availability of fluorescent enzyme immunoassay (FEIA) in neonatal diseases screening. Methods FEIA was used to detect the content of TSH in filter paper dried blood spot samples FEIA was compared with ELISA and IRMA. The normal level of TSH 1 794 neonatal and the cut off value of screening were measured. Results The minimum test limit of FEIA was 4.14 mIU/L, and the average CV within the group was 0.08 and between the groups was 0.11 respectively. The average rate of recovery of high, medium and low concentration was 96.4%. The results of FEIA was correlated with those of ELISA and IRMA ( r = 0.969 and 0.975). The cut off value of screening was 12 mIU/L.Conclusion FEIA can be applied to simultaneously screen hypothyroidism and PKU in meonats.