首页> 中文期刊> 《国际检验医学杂志 》 >桂林地区新生儿先天性甲状腺功能减退症静脉血片筛查实验hTSH切值建立

桂林地区新生儿先天性甲状腺功能减退症静脉血片筛查实验hTSH切值建立

             

摘要

Objective To investigate the distribution of human thyroid stimulation hormone(hTSH) in dried venous blood spots of neonatal screening for congenital hypothyroidism in Guilin ,and establish the hTSH cut‐off value for neonatal screening .Methods We selected 101 817 cases of neonatals with the local household registration from January 2011 to December 2013 ,and collected their venous blood to be made into dried venous blood spots on filter paper ,then the hTSH levels in dried blood spots were deter‐mined for congenital hypothyroidism ,According to screening results ,using the percentile method to calculate the hTSH P50 ,P99 of all the normal neonatals and neonatals that born in different quarters .Results Among 101 817 neonatals who were screened ,101 746 cases of normal neonatals ,71 cases of patients(including 47 cases of patients with CH ,24 cases of patients with high hTSH hy‐perlipidemia) ,the hTSH levels of normal neonatals showing a skewed distribution ,P50 ,P99 were 2 .45 μU/mL ,9 .86 μU/mL .the hTSH levels of the neonatal who were born in different quarters was changed with the change in the quarter ,P50 ,P99 were 2 .15μU/mL ,9 .20 μU/mL in The Spring ;P50 ,P99 were 1 .97 μU/mL ,8 .38 μU/mL in the summer ;P50 ,P99 were 2 .67 μU/mL ,10 .43μU/mL in the autumn ;P50 ,P99 were 2 .90μU/mL ,11 .15μU/mL in the winter .Through the analysis ,although the hTSH cut‐off of capillary blood spots that was used in the local center could be applied to dried venous blood spots ,but not ideal cut‐off value .Even‐tually ,the hTSH P99 9 .20μU /mL in the spring was identified as cut‐off value of dried venous blood spots for routine screening la‐boratory ,which had a sensitivity of 100 .00% ,a specificity of 36 .80% ,the diagnosis rate of 38 .96% ,and no missed phenomena .For the better service ,the hTSH value in the range of 9 .20-20 .00 μU/mL was defined as the boundary region ,and it was the danger region when the hTSH value was higher than 20 .00 μU/mL .Conclusion It is necessary to establish a reasonable hTSH cut‐off value to provide objective evidence for the use of dried venous blood spots of neonatal screening for congenital hypothyroidism ,ac‐cording to the boundary region and the danger region ,the recall chosen a different way ,the development of neonatal screening can be effectively promoted .%目的:了解该地区新生儿先天性甲状腺功能减退症(CH)静脉血片筛查中的人促甲状腺素(hTSH)分布水平,探讨hTSH切值建立。方法2011年1月至2013年12月选择该地户籍的新生儿101817例,采集静脉血制成滤纸干血片,然后,检测血片中hTSH水平进行CH筛查,依据筛查结果,用百分位数法计算全部健康新生儿、不同季度出生的健康新生儿的hTSH的P50、P99值。结果101817例新生儿经筛查健康者101746例,异常者71例(其中CH47例、高促甲状腺素血症24例)。健康新生儿的hTSH水平呈偏态分布,P50、P99值分别为2.45μU/mL、9.86μU/mL。不同季度出生的新生儿的hTSH水平随季度变化而变化,春季P50、P99值分别为2.15μU/mL、9.20μU/mL ;夏季P50、P99值分别为1.97μU/mL、8.38μU/mL ;秋季P50、P99值分别为2.67μU/mL、10.43μU/mL ;冬季 P50、P99值分别为2.90μU/mL、11.15μU/mL。通过分析,认为该中心的末稍血片筛查hT‐S H切值虽然适用于静脉血片筛查,但不是理想切值。最终确定灵敏度为100.00%,特异度为36.80%,诊断符合率为38.96%,无漏诊现象的春季hTSH P99值9.20μU/mL作为静脉血片常规筛查实验切值。为优化服务,进一步将 hTSH值9.20~20.00μU/mL定为边界区,大于20.00μU/mL定为高危区。结论为利用静脉血片进行新生儿CH筛查提供客观的参考依据,有必要建立合理的静脉血片筛查实验 hTSH 切值,根据设定的边界区和高危区,选择不同的召回方式,能有效地促进了新筛工作地发展。

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