全自动荧光免疫分析仪筛查贵州地区新生儿先天性甲状腺功能减退症的性能验证及切值设定

Performance verification and cut value set of neonatal congenital hypothyroidism in Guizhou area screened using automatic fluorescence immunoanalyzer

目的利用全自动荧光免疫分析仪(GSP)检测先天性甲状腺功能减退症(CH)患儿促甲状腺激素(TSH)水平,评估GSP性能,建立贵州地区CH新生儿应用GSP筛查TSH的切值。方法选取2021年1—12月的149045例新生儿为研究对象,通过对GSP配套试剂盒滤纸干血片标本进行检测,计算GSP的精密度和正确度。检测5个浓度的线性样本,计算GSP线性。应用多因素分析,确定影响干血片中TSH的主要因素。采集新生儿足跟血,使用TSH测定试剂盒检测干血片中的TSH,采用百分位数法确定TSH切值。结果149045例新生儿筛查CH可疑阳性3704例,共确诊117例CH,其中六盘水确诊33例,黔东南确诊41例,黔西南确诊13例,铜仁确诊16例,省直14例,总确诊率1/1274。在性别、季节、地区3个因素中,TSH值受季节影响最大。确定TSH阳性切值8.00μU/ml。结论GSP系统对TSH检测的定量性能可以达到实验室要求,应用于新生儿CH筛查是可行的,综合地区、性别、季节各因素,切值定在8.00μU/ml。

Objective To detect the levels of thyroid stimulating hormone(TSH)in children with congenital hypothyroidism(CH)using automatic fluorescence immunoanalyzer(GSP),evaluate performance of CSP,and establish the cut value of TSH in CSP screening of CH neonates in Guizhou area.Methods A total of 149045 neonates from January to December in 2021 were selected as study objects.The precision and accuracy of CSP were calculated by measuring the dried blood samples of GSP and neonatal phenylalanine kit.The linear samples of 5 concentrations were detected to calculate the linearity of CSP.Multi-factor analysis was performed to determine the main factors affecting TSH in dry blood tablets.Neonatal heel blood was collected,TSH in dry blood samples was detected by GSP thyrotropin assay kit,and TSH cut value was determined by percentile method.Results Among 149045 neonates,3704 cases were suspected of positive CH,and 117 cases were diagnosed as CH,including 33 cases in Liupanshui,41 cases in southeast of Guizhou Province,13 cases in southwest of Guizhou Province,16 cases in Tongren,14 cases in provincial hospital,the total diagnostic rate was 1/1274.Among three factors(gender,season,region),the impact of season on TSH levels was the highest.The positive cut value of TSH was 8.O0μU/ml.Conclusion The quantitative performance of GSP system for TSH detection can meet the requirements of the laboratory,and it is feasible to be used in neonatal CH screening.The cut value is set at 8.00μU/ml considering the factors of region,gender and season.