全自动荧光免疫分析仪GSPTM检测新生儿葡萄糖-6-磷酸脱氢酶酶活性性能及切值建立  

The enzyme activity performance of glucose-6-phosphate dehydrogenase of the newborn measured by genetic screening processor testing system and the establishment of its cut-off value

作　　者：李霞[1] 何玲[1] 罗业超 厉玉姣[1] LI Xia;HE Ling;LUO Ye Chao;LI Yujiao(Changsha Maternal and Child Health Care Hospital, Hunan Province, 410007)

机构地区：[1]湖南省长沙市妇幼保健院,410007

出　　处：《中国计划生育学杂志》2021年第9期1987-1990,共4页Chinese Journal of Family Planning

摘　　要：目的:评估全自动荧光免疫分析仪GSPTM测定新生儿干血斑中葡萄糖-6-磷酸脱氢酶(G-6-PD)酶活性的检测性能,建立GSPTM应用于长沙地区新生儿G-6-PD缺乏症筛查的切值。方法:利用试剂盒标准品(6个浓度)5次检测并绘制标准曲线,随曲线附带检测3个浓度的标准品以及试剂盒自带高、低水平质控品。计算GSPTM检测体系的精密度、正确度及线性范围。通过检测13767例新生儿血片样本确定样本浓度分布百分位数,结合29例G-6-PD阳性样本检测结果绘制ROC曲线确立筛查切值。结果:GSPTM检测体系批内、批间变异系数分别为2.0%~3.1%、0.8%~3.6%,均优于厂家提供的数据(3.4%、3.9%)。低、高水平质控品浓度均值(15.7U/dl、58.6U/dl)均处允许范围。线性标本(标准品)检测值和理论值建立的线性方程为y=1.0612x-0.836,R2=0.999。GSPTM检测结果与传统1420检测平台测定结果具有线性相关性,两相关变量Spearson系数为0.999,P=0.000。参考样本浓度百分位数分析及ROC曲线,初步确立筛查切值为21.0U/dl。结论:GSPTM检测体系对新生儿干血片G-6-PD酶活测定性能符合筛查实验要求,可应用于新生儿G-6-PD缺乏症筛查,本次筛查切值21.0U/dL。Objective:To evaluate the enzyme activity performance of glucose-6-phosphate dehydrogenase(G6PD)in dried blood specimens of the newborn measured by genetic screening processor testing system(GSPTM),and to establish the cut-off value of newborns screening of G-6-PD dehydrogenase deficiency by GSPTM in Changsha area.Methods:5 times of detections were conducted by standards of the kit(6 concentrations)for drawing standard curve,and with the standard curve,the detection of three concentrations of standards and the high and low level quality products in kit were also conducted.The precision,accuracy,and linear range of the detection system by GSPTM were calculated.ROC curve was drawn for establishing the cut-off value based on 13767 newborn blood samples and 29 positive samples of G6PD.Results:The within-run and between-run coefficient of variability by GSPTM were 2.0%-3.1%and 0.8%-3.6%,respectively,which were superior to those(3.4%and 3.9%)provided by the manufacturer.The mean concentrations of the high and low level quality products were 15.7U/dL and 58.6U/dL,respectively,and which were all in allowed range.The equation of the detection value and theoretical value by the linear samples(standards)was y=1.0612x-0.836,R2=0.999.The results by GSPTM were correlated with the results by the traditional 1420 instrument,and which Spearson coefficient was 0.999(P=0.000).The preliminary cut-off value was 21.0U/dL by percentile reference sample concentration and ROC curve analysis.Conclusion:The results of the enzyme activity performance ofG6PD in dried blood specimens of the newborn measured by GSPTM can conforms the requirement,which can be used for the screening of G6PD dehydrogenase deficiency of newborns,and the cut-off value is 21.0U/dL.

关 键 词：新生儿疾病筛查 葡萄糖-6-磷酸脱氢酶缺乏症 全自动荧光免疫分析仪 性能验证 切值 

分 类 号：R446.6[医药卫生—诊断学] R722.1[医药卫生—临床医学]