目的:建立新型冠状病毒质控品体系，为以荧光PCR法为原理的新型冠状病毒核酸检测及其试剂盒的性能评价提供可靠的质控物质。方法:将新型冠状病毒毒株原液10倍梯度稀释得到浓度依次为10n 6、10n 5、10n 4、10n 3、10n 2拷贝/ml的5组阳性质控品，进行核酸提取和荧光定量PCR检测n Ct值，计算n Ct值的均值、标准差、变异系数、变化趋势，对质控品进行均一性和稳定性评价。n 结果:在本实验5个浓度梯度内，n Ct值与质控品浓度成线性相关。均一性评价中，各浓度组质控品的变异系数分别为4.60%、2.67%、2.22%、2.04%和2.50%。稳定性评价中，在4 ℃保存条件下的质控品的检测结果不随时间延长而改变。n 结论:建立的新型冠状病毒质控品在4 ℃保存条件下均一性和稳定性好，可用于新型冠状病毒核酸检测及相关试剂盒的性能评价。“,”Objective:To establish quality control products for 2019-nCoV detection, and provide reliable control materials for the quality evaluations of the 2019-nCoV detection kit based on fluorescence PCR.Methods:Virus strain was diluted to concentrations of 10n 6, 10n 5, 10n 4, 10n 3, 10n 2 copies/ml which were used as positive control products. The mean value, standard deviation, coefficient of variability (CV) and tendency of the Ct values were calculated. The homogeneity and stability of the quality control products were tested.n Results:Within the concentration gradients, n Ct value and concentration of the control products were linearly related. In homogeneity test, the CVs of the quality control products with concentrations of 10n 6, 10n 5, 10n 4, 10n 3, 10n 2 and 0 copies/ml were 4.60%, 2.67%, 2.22%, 2.04% and 2.50% respectively. In stability test, there was no significant linear trend with extended test time at 4 ℃.n Conclusion:Evaluations of homogeneity and stability indicated that the quality control products were established successfully. And the products can be used for evaluation of 2019-nCoV detection kit based on fluorescence PCR.