我国新生儿遗传代谢病串联质谱筛查室内质控变异系数分析

Analysis of the coefficients of variation for the internal quality control of newborn inherited metabolic diseases screening with tandem mass spectrometry

目的了解我国串联质谱筛查新生儿遗传代谢病的室内质量控制的变异系数。方法采用基于Web的室间质量评价软件系统,收集于2016年4月参加新生儿遗传代谢病串联质谱筛查全国室间质评项目的 79家实验室的室内质控数据,包括2016年4月2个水平(批号1和批号2)当月和累积的室内质控在控数据的变异系数(CV)。根据1/3室间质量评价限(TEa)和1/4 TEa这2个标准,计算各个项目2个批号质控品的室内质控CV的通过率。结果氨基酸类项目批号1中70%以上实验室的当月在控CV都能满足≤1/3TEa,约50%实验室的当月在控CV能满足≤1/4TEa。批号2中除甲硫氨酸外,其他氨基酸项目满足≤1/3TEa的实验室均超过90%。酰基肉碱类项目批号1中约80%实验室的当月在控CV和70%以上实验室的累积在控CV能满足≤1/3TEa,半数以上实验室的当月在控CV和累积在控CV都能满足≤1/4TEa。批号2中,当月在控CV和累积在控CV满足≤1/3TEa的实验室分别约为90%和80%,满足≤1/4TEa的实验室分别约为80%和60%。结论大多数新生儿遗传代谢病筛查实验室室内质控CV可以满足1/3TEa,但满足1/4TEa的实验室仍相对较少,新生儿遗传代谢病筛查实验室应继续加强室内质量控制,进一步提高其检测质量水平。

Objective To investigate the coefficients of variation（ CVs） of internal quality control（ IQC） for newborn inherited metabolic diseases screening with tandem mass spectrometry. Methods The Web-based external quality assessment（ EQA） system was used to collect the IQC data from 79 laboratories nationwide participated in the EQA project for newborn inherited metabolic diseases screening with tandem mass spectrometry,including the CVs of two levels of IQC materials（ Lots 1 and 2） in April of 2016 and long-term cumulative in-control data. Then,the acceptable rates of CVs were calculated based on the 1 /3TEa and 1 /4Tea criteria. Results In amino acid items of Lot 1,more than 70% of laboratories met the 1 /3TEa criteria and about 50% of laboratories met the 1 /4TEa criteria.In amino acid items of Lot 2 except for methionine,more than 90% of laboratories met the 1 /3TEa criteria. In acyl carnitine items of Lot1,the laboratories which CVs in April of 2016 and cumulative CVs met the 1 /3TEa criteria accounted for about 80% and more than 70%,respectively,and the laboratories met the 1 /4TEa criteria accounted for more than 50%. As for Lot 2,the laboratories which CVs in April of 2016 and cumulative CVs met the 1 /3TEa criteria accounted for about 90% and 80%,respectively,and the laboratories met the1 /4TEa criteria accounted for about 80% and 60%,respectively. Conclusion The IQC CVs in most laboratories for newborn inherited metabolic diseases screening may meet the 1 /3TEa criteria,but relatively less laboratories meet the 1 /4TEa criteria,indicating that the laboratories for newborn inherited metabolic diseases screening should continue to improve the IQC and the detection quality.