中国新生儿筛查实验室外部质量评估国家计划

National Program for External Quality Assessment of Chinese Newborn Screening Laboratories.

作者信息

Du Yuxuan, Wang Wei, Liu Jiali, Zhang Zhixin, Zhao Zhen, He Falin, Yuan Shuai, Wang Zhiguo

机构信息

National Center for Clinical Laboratories, Beijing Hospital, Beijing 100730, China;

National Center of Gerontology, Beijing Hospital, Beijing 100730, China.

出版信息

Int J Neonatal Screen. 2020 May 9;6(2):38. doi: 10.3390/ijns6020038. eCollection 2020 Jun.

DOI:10.3390/ijns6020038

PMID:33073031

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7422995/

Abstract

OBJECTIVES

To analyze the coefficient of variation (CV) of external quality assessment (EQA) in Chinese newborn screening (NBS) laboratories.

METHOD

EQA's robust CV was analyzed by the Clinet-EQA evaluation system.

RESULTS

Participating laboratories of the EQA program increased annually. There was more than a 11-fold increase in phenylalanine (Phe) and thyroid stimulating hormone (TSH). It has shown a declining robust CV, which has tended to level off in recent years. The interquartile range (IQR) of Phe and TSH's robust CV has decreased from 15.5% to 1.5% and from 22.8% to 1.8%, respectively. Compared to bacterial inhibition assay (BIA), the robust CV of Phe has been shown to be relatively reduced in the fluorescence assay and quantitative enzymatic assay (QEA). The robust CV by ELISA was relatively unstable compared to DELFIA and FEIA. In addition, the robust CVs of glucose-6-phosphate dehydrogenase (G6PD) and 17-alpha-hydroxy progesterone (17-OHP) by Genetic Screening Processor (GSP) were lower than other systems. The median of robust CV by non-derivatized MS/MS (Fenghua) in Phe and free carnitine were around 2.2-4.7% and 2.6-5.2%.

CONCLUSION

Neonatal screening has developed rapidly in China and the majority of participant laboratories had satisfactory performance for the quantitative results.

摘要

目的

分析中国新生儿筛查（NBS）实验室外部质量评估（EQA）的变异系数（CV）。

方法

采用Clinet-EQA评估系统分析EQA的稳健CV。

结果

参与EQA计划的实验室逐年增加。苯丙氨酸（Phe）和促甲状腺激素（TSH）增加了11倍多。其稳健CV呈下降趋势，近年来趋于平稳。Phe和TSH的稳健CV的四分位间距（IQR）分别从15.5%降至1.5%，从22.8%降至1.8%。与细菌抑制试验（BIA）相比，荧光法和定量酶法（QEA）中Phe的稳健CV相对降低。与DELFIA和FEIA相比，ELISA法的稳健CV相对不稳定。此外，基因筛查处理器（GSP）检测葡萄糖-6-磷酸脱氢酶（G6PD）和17-α-羟孕酮（17-OHP）的稳健CV低于其他系统。非衍生化串联质谱法（Fenghua）检测Phe和游离肉碱的稳健CV中位数分别在2.2-4.7%和2.6-5.2%左右。