Abstract: Objective To carry out the current status of internal quality control by statistical analysis of the Internal Quality Control(IQC) data of neonatal screening in 2011, which including phenylalanine (Phe) and thyrotropin-stimulating hormone (TSH). Methods After collecting the internal quality control information and data (raw data, manufacturers information, control rules, lots, numbers of results, coefficient variations of data under control, coefficient of variations of cumulative data under control, methods, instrument manufacturers and models, reagents) of Phe and TSH testing from the external quality control software, coefficient variations of every month and long time duration of Phe and TSH internal quality control had been calculated and analyzed, then comparing with the one third and one forth of acceptable total error (10% and 7.5%) in order to evaluate whether could satisfy the provided quality requirements. Results The return rates of IQC Results ranged from 61.78% to 91.62% of 12 months in 2011, 84.86% for average.There were 80 (49%) laboratories select 1_2S or 1_3S for quality control rules while the remaining (51%) use Westgard multi-rules.The totally rates of CVs of Phe and TSH (2 lots) less than 1/3 TEa were 54.63% and 64.54% (Phe), 58.25% and 62.35% (TSH) respectively; less than 1/4 TEa were 29.14% and 34.48% (Phe), 27.70% and 28.08% (TSH) respectively; for cumulative data the CVs less than 1/3 TEa were 53.20% and 59.12% (Phe), 57.47% and 56.21% (TSH) respectively; less than 1/4 TEa were 26.46% and 28.12% (Phe), 25.64% and 25.87% (TSH) respectively.The most laboratories did not reach the acceptable imprecision level and most of them should improve their precision performances. Conclusion The testing capabilities and performances of neonatal screening laboratories of Phe and TSH can be objectively evaluated by the quality specifications of acceptable imprecision (less than 1/3 TEa or 1/4 TEa) and more work should be done to improve the testing quality of neonatal laboratories in China.

Key words: phenylalanine, thyrotropin-stimulating hormone, internal quality control, coefficient variations of IQC

摘要： 目的 通过对2011全年新生儿疾病筛查实验室苯丙氨酸(phenylalanine, Phe)和促甲状腺素(thyrotropin-stimulating hormone, TSH)室内质量控制(internal quality control, IQC)数据的统计分析, 了解目前我国筛查实验室开展IQC工作的情况。方法 利用室间质量评价活动中收集IQC数据, 上报信息包括Phe和TSH室内质控的原始数据、质控物生产厂家、质控规则、质控物批号、质控结果的个数, 在控数据变异系数、累积在控数据的变异系数、方法学原理、仪器厂家和型号, 所用试剂等相关数据。通过对2011年Phe和TSH每个月份和长期累积的室内质控数据变异系数的监测和数据统计分析, 与室内允许不精密度<1/3TEa(10%)、<1/4TEa (7.5%)进行比较, 以评价各检测项目是否满足规定的质量要求。结果 2011年1-12月份筛查实验室室内质控数据总体回报率为61.78%~91.62%, 全年平均回报率为84.86%。在质控规则选择上, 其中有80家实验室(49%)选择了1_2S或1_3S质控规则;86家实验室(51%)选择了Westgard多规则质控方法。全年12个月Phe和TSH(批号1和批号2)当月在控数据变异系数满足<1/3TEa的实验室平均百分比分别为54.63%和64.54%(Phe), 58.25%和62.35%(TSH);满足<1/4TEa的分别为29.14%和34.48%, 27.70%和28.08%。其累积在控数据变异系数满足<1/3TEa的实验室平均百分比分别为53.20%和59.12%(Phe), 57.47%和56.21%(TSH);满足<1/4TEa的分别为26.46%和28.12%, 25.64%和25.87%。大多数实验室对于满足允许不精密度要求的所占的比例较低, 实验室应在精密度性能上需进一步提高。结论 以允许不精密度(<1/3TEa、<1/4TEa)的质量规范作为新生儿筛查遗传代谢病(Phe、TSH)室内质控不精密度的评判准则, 能客观的了解筛查实验室的检测水平。通过不断提高实验室工作质量, 推动质量改进工作。

关键词: 苯丙氨酸, 促甲状腺素, 室内质量控制, 室内变异系数