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目的评估全自动荧光免疫分析仪(Genetic Screening Processor,GSP~(TM))检测促甲状腺素的性能,并建立筛查新生儿促甲状腺素的切值。方法通过检测试剂盒自带标准品B/C/E 3个浓度样本、试剂盒自带高、低水平质控品,和Perkin Elmer公司的制备的6个浓度的线性样本,分析GSP~(TM)系统的精密度、正确度和线性范围。通过检测已经确诊的3261例新生儿疾病筛查标本(甲减患儿129例和正常对照3132例),运用受试者工作特征(ROC)曲线法建立本中心筛查新生儿促甲状腺素的初始切值。结果 GSP~(TM)筛查系统批内变异系数为4.59%~6.83%,均小于厂家声明的8.3%;批间变异系数为6.60%~7.46%,均小于厂家声明的8.5%。GSP~(TM)系统检测的高、低质控品浓度平均值分别为60.29μU/m L和14.63μU/m L,都在试剂盒声明的允许范围之内。线性标本的检测值和理论值的线性方程为y=0.8905x+1.1286,相关系数的平方(R2)为0.99961。GSP~(TM)系统TSH测定浓度值与1235系统的测定值之间呈现显著的正相关,Spearman r=0.772,P<0.001。ROC曲线下面积为0.999,P<0.001.TSH水平为7.13μU/m L时,Youden系数的值最大为0.998,灵敏度为100%,特异度为98.8%。结论GSP~(TM)系统对TSH的定量性能符合厂家声明的要求,应用于新生儿TSH水平筛查是可行的。本中心建立的GSP~(TM)筛查新生儿TSH的切值为7.13μU/m L。
OBJECTIVE: To evaluate the performance of thyroid stimulating hormone (GSP-TM) by automatic fluorescence immunoassay analyzer (GSP-TM) and establish the screening value of thyrotropin in neonates. Methods Three concentrations of B / C / E standard samples were obtained from the kit. The kit was supplied with high and low quality control samples and 6 linear samples prepared by Perkin Elmer. System precision, accuracy and linearity range. By detecting 3261 neonatal screening samples (129 hypothyroid children and 3132 normal controls), the initial screening of neonatal thyrotropin using the ROC curve was established. Cut value. Results The coefficient of variation (CV) of GSP ~ (TM) screening system was 4.59% ~ 6.83%, both of which were less than 8.3% of the manufacturer’s declaration. The coefficient of variation among lots was 6.60% ~ 7.46%, all less than 8.5% of the manufacturer’s declaration. The average concentrations of high and low quality control products detected by GSP-TM system were 60.29μU / m L and 14.63μU / m L, respectively, all within the allowable range of the kit statement. The linear equation for the linear and theoretical values of the linear sample is y = 0.8905x + 1.1286, and the square of the correlation coefficient (R2) is 0.99961. There was a significant positive correlation between the measured concentration of TSH in GSP TM system and the measured value of 1235 system, Spearman r = 0.772, P <0.001. The area under the ROC curve was 0.999, P <0.001. The maximum value of the Youden coefficient was 0.998 with a sensitivity of 100% and a specificity of 98.8% for a TSH level of 7.13 μU / mL. Conclusion The quantitative performance of TSH in GSP TM system meets the requirements of manufacturer’s declaration. It is feasible to screen TSH in neonates. The center established GSP ~ (TM) screening TSH newborn cut-off value of 7.13μU / m L.