B族链球菌核酸检测试剂盒临床应用对比评价  

Comparative evaluation on the clinical application of group B streptococcus nucleic acid detection kits

作　　者：赵建萍[1] 林松洋 王雪侠[1] 孙园圆 卢雪 胡明明 ZHAO Jianping;LIN Songyang;WANG Xuexia;SUN Yuanyuan;LU Xue;HU Mingming(Women&Infants Hospital of Zhengzhou,Henan,Zhengzhou 450016,China;A utobio Diagnostics Co.,Ltd.)

机构地区：[1]郑州市妇幼保健院,南郑州450000 [2]郑州安图生物工程股份有限公司

出　　处：《河南预防医学杂志》2022年第7期552-555,共4页Henan Journal of Preventive Medicine

摘　　要：目的 通过对比评价不同厂家B族链球菌(group B streptococcus,GBS)核酸检测试剂盒的临床和实验室应用情况,为B族链球菌的临床检测提供参考。方法 利用A和B两个厂家的B族链球菌核酸检测试剂盒平行检测964例临床收集样本中的GBS DNA,同时检测一例临床高值样本梯度稀释后的系列样本;另外利用A、B、C三个厂家对GBS培养菌株进行梯度稀释检测,统计并对比检测结果。结果 A、B两个厂家核酸检测试剂盒阳性符合率100.0%,阴性符合率99.3%,总符合率99.7%,Kappa值为0.994,结果一致性高;两个厂家试剂盒同时检测来源于同一例、不同倍数稀释后的临床样本,结果显示A厂家试剂盒检测灵敏度要高于B厂家试剂盒约两个数量级。对GBS培养菌株进行检测对比,结果显示A厂家试剂盒的检测灵敏度高于或相同于B厂家试剂盒,C厂家试剂盒灵敏度次之。结论 A厂家的B族链球菌核酸检测试剂盒应用于临床GBS的检测,具有方便快捷、灵敏度高的特点。Objective To comparatively evaluate the clinical and laboratory application of group B streptococcus(GBS) nucleic acid detection kits from different manufacturers, so as to guide for the clinical detection of GBS. Methods Two manufacturers’ nucleic acid detection kits for GBS DNA detection(A kit and B kit) were used to simultaneously detect 964 clinical samples collected, and a series of samples from a clinically high-value sample after gradient dilution. In addition, A kit, B kit, and C kit were used to detect the cultured strains of GBS by gradient dilution, and the test results were compared and statistically analyzed. Results The consistency rate of positive detection results with the nucleic acid test kits from A kit and B kit was 100.0%,the consistency rate of negative detection results was 99.3%, the overall consistency rate was 99.7%, and the Kappa value was 0.994. The results were highly consistent. A kit and B kit were used to test samples of different gradient concentrations simultaneously, and the results showed that the detection sensitivity of A kit was two orders of magnitude higher than that of B kit. The comparison of standard and clinical cultured strains showed that the detection sensitivity of A kit was higher or the same as that of B kit, and the sensitivity of C kit was lowest. Conclusions A kit for GBS nucleic acid detection can be applied to the detection of clinical GBS, which is convenient and quick, as well as high-sensitivity.

关 键 词：B族链球菌 核酸检测 荧光PCR 

分 类 号：R33[医药卫生—人体生理学]