探讨A群链球菌抗原检测试剂盒质控参考品的建立及初步检测研究  

To Explore the Establishment and Preliminary Detection of the Reference Substance for Quality Control of Group A Streptococcus Antigen Detection Kit

作　　者：赵艳争[1] 陈凯[1] 王学菊[1] ZHAO Yan-zheng;CHEN Kai;WANG Xue-ju(Tianjin Beichen Hospital,Tianjin 300134)

机构地区：[1]天津市北辰医院,天津300134

出　　处：《中国医疗器械信息》2022年第3期35-37,共3页China Medical Device Information

基　　金：天津市北辰区卫健系统科技项目(课题名称:A群β型链球菌蛋白质抗原M酶联免疫检测方法的建立,课题编号:SHGY-2020032)。

摘　　要：目的:探究A群链球菌抗原检测试剂盒质控参考品的建立及初步检测。方法:选取2019年11月~2020年12月本院8份样本为阳性参考组,已通过A群β型链球菌定性培养鉴定其阳性。选取同期本院体检中心获取的8例与阳性参考组年龄、性别结构相似的健康人群作为对照组(A群β型链球菌定性培养鉴定其阴性)。分析菌型、菌落形态、生物学特性,实施16S rRNA鉴定,对菌液浓度的测定方法进行测定。结果:对比两组样本的16S rRNA基因序列,相应模式株的相似度超过99%。对比显微计数法、平板计数法,平板计数更低,P<0.05,有统计学意义。不同工作人员对菌液实施显微计数,结果比较差异统计学意义不存在,P>0.05。结论:A族链球菌抗原试剂盒可建立质控参考菌株,并以显微计数法为参考菌液浓度方法,具有显著价值,奠定了参考品制备的基础。Objective:To explore the establishment and preliminary detection of reference materials for quality control of group A Streptococcus antigen detection kit.Methods:8 samples from our hospital from November 2019 to December 2020 were selected.Group Aβstreptococcus was identified as positive by qualitative culture.8 cases obtained from physical examination center of our hospital with similar age and gender structure as the patient group were selected.(Group Aβstreptococcus was negative by qualitative culture).The bacterial type,colony morphology and biological characteristics were analyzed,16S rRNA identification was carried out,and the determination method of bacterial liquid concentration was determined.Results:Comparing the 16S rRNA gene sequences of the two groups,the similarity of corresponding type strains was over 99%.Compared with the microscopic counting method and the plate counting method,the plate counting method was lower,and the difference was statistically significant(P<0.05).There was no statistical difference between the results of microscopic counting of bacterial liquid by different workers(P>0.05).Conclusion:Group A streptococcal antigen kit can establish reference strains for quality control.And the microscopic counting method was used as the reference method for the concentration of bacterial liquid.It has significant value and lays the foundation for reference preparation.

关 键 词：A族链球菌 显微计数法 平板计数法 菌液浓度 参考菌株 

分 类 号：R378.1[医药卫生—病原生物学]