GSP分析仪检测新生儿苯丙氨酸参考限的建立

The Establishment of the Reference Limit for Detecting Neonatal Phenylalanine by Genetic Screening Processor

目的探讨河南地区使用全自动荧光免疫分析仪(Genetic Screening Processor,GSP)检测新生儿高苯丙氨酸血症(hyperphenylalaninemia,HPA)的筛查指标血苯丙氨酸(phenylalanine,Phe)水平时其参考限的建立。方法采用GSP分析仪和目前临床常规使用的Victor2D 1420型荧光免疫分析仪(半自动分析仪)同步检测6204例新生儿血Phe水平并对其进行比较,使用百分位数法建立GSP分析仪筛查HPA时血Phe水平的参考限。结果 GSP分析仪和Victor2D 1420型荧光免疫分析仪对新生儿血Phe水平的检测结果呈显著正线性相关( r =0.393, P <0.001),但成对样本检测结果差异具有统计学意义( t =74.764, P <0.001);GSP分析仪检测血Phe水平时参考限为2.10 mg/dL。结论使用不同仪器设备检测血Phe水平时应分别建立其参考限;GSP分析仪检测时的参考限为2.10 mg/dL,以指导河南地区后续的HPA筛查工作。

Objective To establish the reference limit of blood phenylalanine(Phe)concentration in neonatal hyperphenylalaninemia(HPA)by using Genetic Screening Processor(GSP)in Henan area. Methods The blood Phe concentration in 6,204 neonates was synchronously detected with Victor2D 1420 fluorescent immunoanalyzer(semi- automatic analyzer)which was used in daily clinical practice and GSP.The data was analyzed and the reference limit of blood Phe concentration was established by percentile method through screening neonatal HPA. Results The results of blood Phe concentration in newborn detected by GSP and Victor2D 1420 fluorescence immunoanalyzer,respectively,were linearly correlated( r =0.393, P <0.001).But there was a significant difference between two groups( t =74.764, P <0.001)and the reference limit of blood Phe concentration in newborn detected by GSP was 2.10mg/dL. Conclusion The reference limits of blood Phe concentration should be established respectively when using different devices.The reference limit of blood Phe concentration in newborn detected by GSP is 2.10mg/dL,which provides a guide for the subsequent screening for HPA in Henan area.