全自动荧光免疫分析仪用于深圳新生儿筛查苯丙氨酸检测的性能验证

Performance verification analysis of genetic screening processor to test phenylalanine of dried blood spot

目的对全自动荧光免疫分析仪(Genetic Screening Processor,GSP)用于深圳新生儿筛查,检测滤纸干血片(dried blood spot,DBS)中苯丙氨酸(Phe)的性能进行验证分析和评价。方法采用试剂盒自带L、H两浓度水平质控品,美国疾病预防控制中心(the Centers for Disease Control and Prevention,CDC)新生儿筛查室间质评标本,试剂盒自带6个线性标本,进行GSP系统的精密度、正确度和线性范围的验证,通过检测362例新生儿疾病筛查标本,与目前临床常用的茚三酮荧光法进行比对。结果应用GSP检测Phe时,批内变异系数分别为5.23%和4.81%,总变异系数分别为8.00%和4.43%,均小于厂家声称值7.5%和8.5%;美国CDC新生儿筛查室间质评四个标本,其赋值均在偏移的验证区间内;6个线性标本的检测值和理论值的线性回归方程为:y=1.3236x-0.4258,r2=0.9952,r2 >0.995,认为线性范围符合要求;GSP与茚三酮荧光法的一致性较好(Kappa值为0.91,P<0.001),检测结果相关性良好(r值为0.75,P<0.001)。结论GSP应用于深圳新生儿筛查Phe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,比对结果的一致性、相关性良好,GSP可用于深圳新生儿筛查Phe含量的检测。

Objective:To verify and evaluate the performance of Genetic Screening Processor(GSP)to test phenylalanine(Phe)of dried blood spot(DBS)in Shenzhen neonatal screening. Methods:It use that two levels of quality control of the test kit,including L and H,the quality control specimen from newborn screening quality assurance program of the U.S.Centers for Disease Control and Prevention(CDC),6 linear specimen from the test kit. the precision,accuracy and linear range of the GSP system are verified. It was compare with the common method(Ninhydrin fluorescence method)by detecting 362 case of neonatal disease screening. Results:When detecting Phe by GSP,the variation coefficient of the batch was 5.23% and 4.81% respectively,and the total variation coefficient was 8.00% and 4.43% respectively,both less than the manufacturer claimed 7.5% and 8.5%. The assignment of Four specimens from newborn screening quality assurance program of the U.S. CDC are in the validation of offset range. The linear regression equation of the test value and theoretical value for 6 linear specimen is:y = 1.3236 x-0.4258,r^2 = 0.9952,r^2 >0.995,the linear range is expected. The consistency between GSP and ninhydrin fluorescence method was better(Kappa value was 0.91,P<0.001),and the correlation between the test results was good(r=0.75,P<0.001). Conclusion:GSP is used to detect the Phe of DBS in Shenzhen neonatal screening,the precision,accuracy and linear range reach the detection performance declared by the manufacturer,and the consistency and correlation of the result is good,and the GSP can be used to detect Phe in Shenzhen neonatal screening.