摘要
目的对全自动荧光免疫分析仪(GSP)检测干血片葡萄糖-6-磷酸脱氢酶(G6PD)的性能进行验证,并初步建立该方法筛查葡萄糖-6-磷酸脱氢酶缺乏症(G6PDd)的cut-off值。方法前期确定验证方案,对试剂盒自带标准品B、D、E 3个浓度的标本,L、H两个浓度的质控品及试剂盒自带标准品B、C、D、E、F 5个浓度标本进行GSP系统的精密度、正确度和线性范围的验证。采用GSP和目前临床常规使用的Victor2D 1420型荧光免疫分析仪(半自动荧光免疫分析仪)同步检测2742例新生儿干血片G6PD水平,比较两种仪器结果,并使用百分位数分布及受试者工作特征(ROC)曲线初步建立中山市博爱医院产前诊断中心GSP筛查G6PDd时G6PD水平的cut-off值。结果应用GSP检测G6PD时,批内变异系数分别为2.09%、1.54%和1.90%,总变异系数分别为3.08%、1.72%和2.12%,分别小于厂家声明的3.40%和3.90%;质控浓度L的25份标本的测量总均值与靶值的相对偏差为3.84%,质控浓度H的25份标本的测量总均值与靶值的相对偏差为3.44%;5个浓度标本的检测值和理论值的线性回归方程为Y=1.0082 X+0.0125,决定系数(R^(2))为0.9991,R^(2)>0.995,线性相关性良好。标本总体P_(5)的G6PD水平为20.10 U/dL。两种仪器的一致性良好。结论GSP应用于中山市新生儿G6PD检测中,精密度、准确度、线性范围均达到了厂家声明的检测性能,可常规用于新生儿G6PDd筛查。该中心初步采用的GSP新生儿G6PDd筛查的cut-off值为20.10 U/dL。
Objective To verify the performance of Genetic Screening Processor(GSP)for determination of glucose-6-phosphate dehydrogenase(G6PD)in dried blood spots.The cut-off value of glucose-6-phosphate dehydrogenase deficiency(G6PDd)screening by this method was established.Methods The validation scheme was determined in the early stage,and the precision,accuracy and linear range of GSP system were verified for samples with B,D and E concentrations,quality control products with L and H concentrations and linear samples with B,C,D,E,F 5 concentrations of kits.GSP analyzer and Victor2D 1420 fluorescence immunoassay(semi-automatic analyzer)were used to detect G6PD level in blood of 2742 neonates.The results of the two instruments were compared.Furthermore,percentile method and Receiver Operating Characteristic(ROC)curve was used to establish the optimal cut-off value of G6PD level in dried blood spots of G6PDd screened by GSP analyzer in Prenatal Diagnosis Center,Boai Hospital Affiliated to Southern Medical University.Results When GSP was used to detect G6PD,the coefficient of variation in batch were 2.09%,1.54%and 1.90%,and the total coefficient of variation were 3.08%,1.72%and 2.12%respectively,which were lower than 3.40%and 3.90%claimed by manufacturers.The relative deviation between the total mean of measurement and the target value of 25 samples of quality control concentration L was 3.84%,and that of 25 samples of quality control concentration H was 3.44%.The linear regression equation of tested values and theoretical values of 5 linear specimens was Y=1.0082 X+0.0125,the R^(2) was 0.9991,R^(2)>0.995,indicating good linear correlation.The G6PD level at the 5.0 percentile was 20.10 U/dL.The two instruments had good consistency.Conclusion GSP is used in the detection of G6PD in neonatal screening of in Zhongshan city,its precision,accuracy,linear range have reached the detection performance declared by the manufacturer,and it could be routinely used in the screening of neonatal G6PDd.The cut-off of GSP neonatal G6PDd scre
作者
魏庆玲
梁睿
李冬秀
陈伟荣
吴学威
黄湘
WEI Qingling;LIANG Rui;LI Dongxiu;CHEN Weirong;WU Xuewei;HUANG Xiang(The Second School of Clinical Medicine,Southern Medical University,Guangzhou,Guangdong 510000,China;Prenatal Diagnosis Center,Boai Hospital Affiliated to Southern Medical University,Zhongshan,Guangdong 528400,China;Prenatal Diagnostic Center,Foshan Maternal and Child Health Hospital Affiliated to Southern Medical University,Foshan,Guangdong 528000,China)
出处
《检验医学与临床》
CAS
2022年第14期1926-1929,共4页
Laboratory Medicine and Clinic
基金
广东省中山市科技计划重大项目(2016B1009)。
