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目的 对比分析两种酶法苯丙氨酸定量检测试剂盒的性能,为行业标准制定和临床应用提供参考.方法 分别对两种试剂盒进行外观检查,线性、特异性、空白限、准确度和精密度验证,以及临床样本验证.结果 两种苯丙氨酸定量检测试剂盒外观和物理检查符合要求,两种试剂盒线性回归系数均高于标准要求.试剂盒A检测特异性质控品的检测浓度为0.49 mg/dL,试剂盒B检测特异性质控品的检测浓度为0.89 mg/dL,均小于各自的临界值,满足拟定标准要求.试剂盒B的准确性略差于拟定标准要求.试剂盒A、B的空白限分别为0.5589 mg/dL和0.9452 mg/dL,均不大于拟定标准要求的1.0 mg/dL.两种试剂盒的精密度均满足拟定标准要求,临床样本检测相关性较好(r=0.9903).结论 两种试剂盒均能满足拟定标准要求,基本符合临床需要.“,”Objective To verify the quality standard for quantitative determination of neonatal phenylalanine kit and provide reference for clinical application. Methods The quantitative determination of neonatal phenylalanine kit manufactured by two representative manufacturers were inspected, and then verified for linearity, minimum detection limit, accuracy, precision specificity and clinical application validation. Results The two kits were compared, and the linear regression coefficient of two kits was determined. The detection concentration of the kit A for specific test substance was 0.49 mg/dL and that of the kit B was 0.89 mg/dL;both were less than the respective critical values, meeting the requirements of the proposed standard. The kit B had a slightly inappropriate accuracy. Kit limit of blank for A and B were 0.5589 mg/dL and 0.9452 mg/dL, resoectively, and were not greater than that of formulate standards of 1.0 mg/dL. The precision of the two kits could satisfy the requirements of standards ,and had better correlation for clinical samples (r=0.9903). Conclusion Both kits could meet the demand of standards, and in line with the clinical need.