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目的:分析2014年全国早孕期母血清产前筛查检验项目室内质量控制情况。方法:收集2014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控信息,将变异系数与1/3TEa(10%)、1/4TEa(7.5%)以及5%进行比较,得到满足各标准实验室的比例,从而分析全国早孕目血清产前筛查检验项目的室内质控情况。结果:80%以上的实验室不精密度都能达到1/3TEa的标准,达到1/4TEa标准的实验室比例略有降低,而不精密度达到5%的仅50%左右。结论:各项目的室内质控精密度水平离国内行业标准还有很大差距,各实验室应建立严格的室内质控制度,提高产前筛查项目的精密度水平。
Objective: To analyze the indoor quality control of prenatal screening test items of maternal serum in early pregnancy in China in 2014. Methods: The indoor quality control information collected in 2014 from the inter-laboratory quality assessment institutes participating in the Clinical Laboratory Center of the Ministry of Health was collected. The coefficient of variation was compared with 1 / 3TEa (10%), 1 / 4TEa (7.5%) and 5% To meet the proportion of the standard laboratory, so as to analyze the national early pregnancy serum prenatal screening test project indoor quality control. RESULTS: More than 80% of laboratory inaccuracies reached the 1 / 3TEa standard, with a slight decrease in the lab ratio of 1 / 4TEa and only about 50% of the 5% inaccuracy. Conclusion: The precision level of indoor quality control in each project is still far from the domestic industry standards. Each laboratory should establish strict quality control system and improve the precision of prenatal screening project.