2014年早孕期母血清产前筛查检验项目室内质控结果调查与分析

Investigation and analysis on internal quality control results of maternal serum prenatal screening project during the first trimester of pregnancy in 2014

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 internal quality control（ IQC） results of maternal serum prenatal screening project during the first trimester of pregnancy in 2014. Methods： IQC information was collected in 2014,then the coefficient of variation was compared with1 /3TEa（ 10%）,1 /4TEa（ 7. 5%） and 5%. The proportions of laboratories meeting the standards were obtained,IQC situation of maternal serum prenatal screening project during the first trimester of pregnancy in China was analyzed. Results： The imprecision of more than 80%of the participant laboratories achieved 1 /3Tea standard,the proportion of participant laboratories with imprecision achieving 1 /4TEa standard decreased slightly,the imprecision of only 50% of the participant laboratories achieved 5%. Conclusion： There is a big gap in IQC precision between maternal serum prenatal screening project and national industry standard. Laboratories should establish strict IQC system and improve IQC precision of maternal serum prenatal screening project.