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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 quality control of maternal serum prenatal screening in China from 2011 to 2013. Methods: The indoor quality control information collected from participating laboratories in the clinical laboratory of the Ministry of Health from 2011 to 2013 was collected. The coefficient of variation was compared with 1 / 3TEa (10%), 1 / 4TEa (7.5%) and industry standard %) Were compared to get the proportion of each standard laboratory to analyze the prenatal screening of indoor quality control. Results: More than 80% of laboratory precision could reach 1 / 3TEa standard. The proportion of laboratories reaching 1 / 4TEa standard slightly decreased (66.18% -90.52%), while only about half of the industry standards in China (36.45% -68.68%), while the precision of each item was slightly different. The coefficient of variation of free beta-hCG and estriol was larger. Conclusion: The precision level of indoor quality control in each project is still far from the industry standard in our country. Each laboratory should establish strict indoor quality control system and actively participate in inter-laboratory comparison of indoor quality control data to improve prenatal screening The level of precision of the project.