新型B族链球菌胶体金免疫层析试纸条的临床应用评价

目的 探讨新型B族链球菌(GBS)胶体金免疫层析试纸条的临床检测效果。方法 选取202份女性的阴道或宫颈棉拭子标本,采用新型检测试剂与对照试剂作对比,进行临床应用评价。结果 新型试剂最低检出浓度为10⁵ CFU/ml,5～8 min内即可观察结果; 与对照试剂相比,考核试剂灵敏度更好,显色时间更短; 检测的202份临床标本中,与对照试剂相比,197例样本检测结果一致,其余5例样本检测结果不符,阳性符合率达97.5%,阴性符合率达97.54%,总符合率为97.52%,Kappa值0.948,一致性分析表明新型试剂与对照试剂具有很好的一致性。结论 该新型试剂能有效的辅助诊断B族链球菌感染,具有较高的临床应用价值。

Clinical Application of Novel Colloidal Gold Immunochromatographic Test Strip for Group B Streptococci

Objective To explore the effect of a novel colloidal gold immunochromatographic test strip for detection of group B streptococci(GBS).Methods A total of 202 cases of swab of vagina or neck of uterus were collected,and they were detected by novel strip and control strip to evaluate their clinical applications.Results Sensitivity of novel strip was about 10⁵ CFU/ml and the detection time was about 5 to 8 minutes,and it showed better sensitivity and shorter detectiontime compared with control strip.In the 202 cases of clinical samples,the detection results of 197 cases were in consistent with the control strip,however,the detection results of 5 cases were not in consistent.The positive coincidencerate and negative coincidence rate were 97.5% and 97.54% respectively,and the total coincidence rate and Kappa value were 97.52% and 0.948 respectively.The consistency test showed no significant difference between this strip and control strip.Conclusion This method was a effective technology for diagnosing of infection caused by GBS,and had high value in clinical application.