Zhang Xiaoyan, Zhang Shishi, Wang Wei, He Falin, Zhong Kun, Yuan Shuai, Wang Zhiguo
Clin Lab. 2016 Dec 1;62(12):2437-2441. doi: 10.7754/Clin.Lab.2016.160416.
To investigate the current status of IQC practice of neonatal screening in China.
The IQC data of Phe and TSH testing were collected. Coefficient of variations (CVs) and cumulative CVs of every month in 2014 were compared with the 1/3 and 1/4 TEa.
Of the 219 laboratories, the return rates ranged from 71.23% to 89.95% of 12 months in 2014. The rates of CVs for 2 lots less than 1/3 TEa were 60.27% and 68.78% (Phe), 67.05% and 65.68% (TSH); less than 1/4 TEa were 32.10% and 35.99% (Phe), 32.35% and 27.55% (TSH); rates of cumulative CVs less than 1/3 TEa were 57.89% and 65.98% (Phe), 61.21% and 60.93% (TSH); less than 1/4 TEa were 29.61% and 30.74% (Phe), 27.48% and 22.41% (TSH).
The testing capabilities and performances of neonatal screening laboratories can be objectively evaluated by the quality specifications of acceptable imprecision.
调查中国新生儿筛查室内质量控制（IQC）的实施现状。
收集苯丙氨酸（Phe）和促甲状腺激素（TSH）检测的IQC数据。将2014年各月的变异系数（CVs）和累积CVs与1/3和1/4允许误差（TEa）进行比较。
在219家实验室中，2014年12个月的回报率在71.23%至89.95%之间。2个批次的CVs小于1/3 TEa的比例分别为60.27%和68.78%（Phe），67.05%和65.68%（TSH）；小于1/4 TEa的比例分别为32.10%和35.99%（Phe），32.35%和27.55%（TSH）；累积CVs小于1/3 TEa的比例分别为57.89%和65.98%（Phe），61.21%和60.93%（TSH）；小于1/4 TEa的比例分别为29.61%和30.74%（Phe），27.48%和22.41%（TSH）。
通过可接受不精密度的质量规范可客观评估新生儿筛查实验室的检测能力和性能。
