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目的 评估全自动荧光免疫分析仪GSPTM检测17α-羟孕酮(17α-OHP)的分析性能,并初步建立应用于先天性肾上腺皮质增生症(CAH)筛查的17α-OHP切值.方法 通过检测试剂盒自带标准品B/D/E-个浓度、试剂盒自带高、低水平质控品,和试剂盒自带的A-E六个浓度的标准品,分析GSPTM系统的精密度、正确度和线性范围.检测临床新生儿血片样本3063例,以99.5％百分位数的17 α-OHP水平暂定为初始切值.结果 GSPTM筛查系统检测B/D/E中17α-OHP批内变异系数为3.98％～5.97％,均小于厂家声明的8.7％;批间变异系数为4.32％～ 8.52％,均小于厂家声明的9.2％.GSPTM系统检测的低、高质控品浓度平均值分别为20.65 nmol/L和140.67 nmol/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=1.1196x-1.7049,相关系数的平方(R2)为0.9998.GSPTM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=0.615,P＜0.001.GSPTM筛查系统检测结果99.5百分位数的17 α-OHP水平为15.50nmol/L.结论 GSPTM系统对17α-OHP的定量性能符合厂家声明的要求,应用于新生儿CAH筛查是可行的.本中心初步采用的GSPTM筛查新生儿CAH的17α-OHP切值为15.50nmol/L.“,”Objective:To evaluate the performance of genetic screening processor (GSPTM) in the measurement of 17α-OH-progesterone (17α-OHP),and establish the newborn 17α-OHP cut-off value for congenital adrenal hyperplasia (CAH).Methods:The precision,accuracy and linearity were evaluated by testing samples of standards,and controls.A series of 3063 sample were tested by GSPTM,and the initial 17α-OHP cut-off value was set at 99.5 percentile of newborn 17α-OHP.Results:The within-run coefficient of variation (CV) for 17α-OHP ranged from 3.98％～5.97％,and all of them were less than 8.7％ declared by GSPTM manufacture.The total CV for 17α-OHP ranged from 4.32％～8.52％,and all of them were less than 9.2％ declared by GSPTM manufacture.The 17α-OHP results of low and high controls tested by GSPTM were 20.65 nmol/L and 140.67 nmol/L and all of them were with the accepted range.The equation of observed 17α-OHP level by expected level was y=1.1196x -1.7049,and the correlation coefficient (R2) was 0.9998.The 17α-OHP level by GSPTM showed a strong positive correlation with that by DELFIA 1235,Spearman r=0.615,P＜0.001.The 99.5 percentile of newborn 17α-OHP level was 15.50 nmol/L.Conclusions:Due to with a good performance on 17α-OHP measurement,GSPTM was considered as a feasible method for CAH screening.The initial 17α-OHP cut-off value for CAH was 15.50 nmol/L in our newborn screening center.