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目的建立A群链球菌抗原检测试剂盒(胶体金法)质控参考品,并进行初步检测。方法从国家医学细菌保藏管理中心库存标准菌株中筛选出10株A群链球菌和10株非A群链球菌进行菌落形态、菌型、生物学特性及16s r RNA鉴定;并确定菌液浓度测定方法。结果选择了10株不同来源的A群链球菌作为阳性参考菌株,10株同属不同群或寄生部位与A群链球菌相同的其他种属菌株作为阴性参考菌株。经16s r RNA基因序列比对,所选参比菌株与相应的模式株相似度均在99%以上。平板计数结果明显低于显微计数法,不同人员分别对32份菌液进行显微计数的结果差异无统计学意义(P=0.310)。结论建立了A群链球菌抗原检测试剂盒(胶体金法)质控参考菌株,并确立了显微计数法作为确定参考菌液浓度的方法,为今后相关参考品的制备奠定了基础。
Objective To establish a group A streptococcal antigen test kit (colloidal gold method) quality control reference, and conduct a preliminary test. Methods 10 strains of streptococcus group A and 10 strains of non-group A streptococcus were screened from the stock standard strains of the National Center for Medical Bacteriostasis for colony morphology, bacteria, biological characteristics and 16s rRNA identification; and determination of bacterial concentration method. Results 10 strains of Streptococcus group A from different origins were selected as positive reference strains and 10 strains of other species belonging to different groups or the same as group A streptococci were selected as negative reference strains. The 16s rRNA gene sequence alignment, the selected reference strains and the corresponding model strains were more than 99% similarity. The results of plate counting were significantly lower than those of the microscopic counting method. There was no significant difference in the results of micro-counting of 32 samples (P = 0.310). Conclusion A group A streptococcal antigen detection kit (colloidal gold method) quality control reference strains were established, and the establishment of a micro-count method as a reference bacteria concentration method for the preparation of the relevant reference materials in the future laid the foundation.