摘要
目的:对制备B族链球菌(GBS)DNA质控物的均匀性和稳定性进行评价。方法:利用混合孕晚期妇女阴道分泌物样本制备阳性质控物以及弱阳性质控物。依据《能力验证样品均匀性和稳定性评价指南》以及《实验室内部研制质量控制样本指南》对所制备质控物的均匀性进行评价,采用线性回归模型对质控物保存条件(-80℃、-20℃、4℃、室温)检测质控物稳定性,评价自制质控品的稳定性以及精密度,绘制室内质控图。结果:阳性质控物与弱阳性质控物均匀性评价结果比较,差异均无统计学意义(P>0.05),表明质控物的均匀性较好;线性回归分析结果显示,随着保存时间的延长质控物循环初始阈值(Ct值)均没有显著性趋向变化(P>0.05),阳性及弱阳性质控物稳定性较好;本批次质控物变异系数(CV)<15%,表面精密度良好。结论:实验室自制B族链球菌DNA质控物具有制备简便、成本低、稳定性及精密度好等优点,可以应用于实验室检测。
Objective:To evaluate the uniformity and stability of the prepared Group B Streptococcus(GBS)DNA quality control material.Methods:Positive and weakly positive quality control materials were prepared using vaginal secretion samples from women in late pregnancy.The homogeneity of the prepared control materials was evaluated according to the Guidelines for Evaluating the Homogeneity and Stability of Proficiency Testing Samples and the Guidelines for In-House Development of Quality Control Samples in Laboratories.A linear regression model was used to test the stability of quality control materials under storage conditions(−80°C,−20 C,4°C,room temperature),and the stability and precision of the self−prepared quality control materials were evaluated.An internal quality control chart was plotted.Results:The differences in uniformity evaluation results between positive control materials and weakly positive control materials were not statistically significant(P>0.05),indicating good uniformity of the control materials.The results of linear regression analysis indicate that cycle threshold(Ct)values for all quality control materials showed no significant trend toward change with extended storage time(P>0.05).Both positive and weakly positive quality control materials demonstrated good stability.The coefficient of variation(CV)for this batch of quality control materials was<15%,indicating good surface precision.Conclusion:The laboratory-prepared B-group streptococcus DNA quality control material offers advantages such as simple preparation,low cost,stability,and good precision,making it suitable for laboratory testing.
作者
李灵
周雪原
王晓华
Li Ling;Zhou Xueyuan;Wang Xiaohua(Departmentof Genetics and Eugenics,Inner Mongolia Autonomous Region Maternal and Child Health Hospital,Hohhot,Inner Mongolia,010020,China)
出处
《黑龙江医学》
2025年第24期2955-2958,共4页
Heilongjiang Medical Journal
关键词
B族链球菌
脱氧核糖核酸
自制质控物
均匀性
稳定性
精密度
Group B streptococcus
DNA
Self-prepared quality control materials
Uniformity
Stability
Precision
