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目的分析2013年河南省新生儿苯丙酮尿症(PKU)筛查结果并对三种(Lab、丰华、PE)筛查试剂进行质量评估。方法采用荧光分析法检测滤纸血片中苯丙氨酸(phe)浓度。结果郑州大学第三附属医院于2013年共筛查新生儿1030748例,全年确诊HPA患儿151例(1/6826),男77例,女74例;对2013年3月--12月不同厂家的室内质控数据和筛查数据进行了统计,Lab、丰华和PE的低值质控和高值质控的批内变异系数分别为11.79%和10.17%,11.10%和7.72%,12.85%和12.49%;其中Lab试剂筛查新生儿432197例确诊57例,丰华试剂281522例新生儿确诊36例,PE试剂151853例新生儿确诊16例,经χ2检验统计,三种试剂统计的HPA确诊阳性数无明显差异。结论河南省PKU发病率居国内较高水平,Lab、丰华和PE三种试剂质量是稳定的,均可用于PKU筛查。
Objective To analyze the screening results of neonatal phenylketonuria (PKU) in Henan Province in 2013 and evaluate the quality of three screening reagents (Lab, Fenghua, PE). Methods The concentration of phenylalanine (phe) in filter paper was determined by fluorescence analysis. Results In 2013, a total of 1030748 newborns were screened in the Third Affiliated Hospital of Zhengzhou University. 151 cases (1/6826) were diagnosed with HPA in the whole year, including 77 males and 74 females. For March-December 2013, The laboratory indoor quality control data and screening data were statistically analyzed. The intra-assay CV of Lab, Fenghua and PE were 11.79% and 10.17%, 11.10% and 7.72%, 12.85 % And 12.49% respectively. Among them, 577 newborns were screened with 432197 neonates, 361522 newborns with Fenghua reagent, 16 newborns with 151853 PE reagents, andχ2 test showed that HPA No significant difference in the number of positive diagnosis. Conclusion The incidence of PKU in Henan Province ranks high in China. The quality of Lab, Fenghua and PE is stable and can be used in PKU screening.