Preparation and Eualuation of Group B Streptococcus DNA Quality Control Material
Li Ling
Zhou Xueyuan
Wang Xiaohua
Abstract：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℃,-20 ℃,4 ℃,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.
Keywords：Group B streptococcusDNASelf-prepared quality control materialsUniformityStabilityPrecision
Publication Date：2025-12-25
Online Publishing Date：2025-12-31(First online date of this platform, not the publication date of the document)
Pages：4( 2955-2958 )