11种新生儿苯丙氨酸检测试剂盒质量分析

目的：对11种新生儿苯丙氨酸检测试剂盒质量状况进行分析评价。方法：以国际新生儿筛查组织的第四代新生儿筛查参考品及自制精密度质控品为样品，选用11种新生儿苯丙氨酸检测试剂盒进行检测，方法涉及茚三酮-荧光法、酶显色法、串联质谱法。对每个试剂盒的准确度、线性、检测下限、批内精密度及批间精密度性能指标进行分析评价。结果：所有试剂盒线性达到较好的质量水平，检测下限均在1.0 mg·dL^-1以下，然而，准确度指标偏差较大，尤其是对最低浓度参考品的准确度的测定，其中，只有6个试剂盒的6个浓度点偏差均在15%以内；国产试剂盒对国际新生儿筛查参考品的测定较进口试剂盒具有较小的偏差；除一家试剂盒批内精密度相对标准偏差大于15%外，其他批内精密度及批间精密度均低于10%；串联质谱法试剂盒相比较本研究所使用的其他2种方法试剂盒具有较低的检测下限，但对参考品测定的相对偏差表现较高趋势。结论：新生儿苯丙氨酸检测试剂盒质量参差不齐，部分产品尚存在质量方面的问题。

Objective:To evaluate the quality of eleven kinds of neonatal phenylalanine detection kits.Methods:The fourth generation reference for neonatal screening from the International Society for Newborn Screening and precision control materials prepared in-house were used to evaluate eleven kinds of neonatal phenylalanine detection kits. Three methods were adopted in this study, including ninhydrin-fluorometric assay, enzymatic colorimetric assay and tandem mass spectrometry assay.The performance indicators, such as accuracy, linearity, limit of detection (LOD), within-batch precision and between-batch precision for each detection kit were analyzed and evaluated.Results:The linearity of all kits was good, with the minimal LOD lower than 1.0 mg·dL^-1.However, the relative deviation (RD) for accuracy was high, especially at the lowest concentration of the reference. The six concentration points of only six kits had RD less than 15%.The domestic kits for the detection of the international reference for neonatal screening showed a lower relative deviation than that of the imported kits. The relative standard deviation (RSD) for within-batch precision and between-batch precision of the kits were lower than 10% except for one kit, whose within-batch precision was higher than 15%.The LOD of tandem mass spectrometry assay kits was lower than that of the other two kinds of method kits used in this study, but the RD for measurement of reference showed a higher trend.Conclusion:The quality of neonatal phenylalanine detection kits is varied, and the quality issues still exist in some products.

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