2011～2013年中孕期母血清产前筛查室内质量控制结果分析

Analysis on the results of internal quality control in maternal serum prenatal screening during the second trimester of pregnancy from 2011 to 2013

目的：分析2011～2013年我国中孕期母血清产前筛查室内质量控制情况。方法：收集2011～2013年参加卫生部临床检验中心室间质评参评单位回报的室内质量控制信息,将变异系数与1/3TEa（10%）、1/4TEa（7.5%）以及行业标准（5%）进行比较,得到满足各标准实验室的比例,从而分析我国产前筛查的室内质量控制情况。结果：80%以上的实验室精密度都能达到1/3TEa的标准,达到1/4TEa标准的实验室比例略有降低（占66.18%～90.52%）,而达到我国行业标准的仅有一半左右（36.45%～68.68%）,而各个项目的精密度水平也略有差异,游离beta-hCG和雌三醇的变异系数较大。结论：各项目的室内质量控制精密度水平离我国行业标准还有很大差距,各实验室应建立严格的室内质量控制制度,积极参与室内质量控制数据实验室间比对,提高产前筛查项目的精密度水平。

Objective： To analyze the results of internal quality control（ IQC） in maternal serum prenatal screening during the second trimester of pregnancy from 2011 to 2013 in China. Methods： The results of IQC reported by the laboratories which participated in external quality assessment（ EQA） of National Center for Clinical Laboratories（ NCCL） from 2011 to 2013 were collected,then the coefficient of variation was compared with 1 /3TEa（ 10%）,1 /4TEa（ 7. 5%） and health industry standard（ 5%）. The proportion of laboratories meeting the standards were obtained to analyze IQC situation in China. Results： More than 80% of the participant laboratories could achieve1 /3Tea standards,66. 18%- 90. 52% of the participant laboratories could achieve 1 /4TEa standards. However,only 36. 45%- 68. 68% of the participant laboratories could achieve health industry standards. The precision levels of slight difference between each project varied,the coefficients of variation of free beta- hCG and estriol were large. Conclusion： There is a big gap in the coefficient of variation between the IQC showed by the study and health industry standard. Laboratories should establish strict IQC system,participate in inter- laboratory comparison and improve the precision of maternal prenatal screening.