两种细菌性阴道病诊断试剂盒性能的比较  

Comparison on the performance of two kinds of experimental diagnostic reagent kits for bacterialvaglnosis

作　　者：陈颖婷[1] 高云龙[1] 吴新忠[1] 郑智明[1] 

机构地区：[1]广东省中医院检验科,广州510120

出　　处：《国际医药卫生导报》2012年第10期1507-1509,共3页International Medicine and Health Guidance News

摘　　要：目的比较华今生物科技有限公司和珠海迪尔生物工程有限公司的细菌性阴道病f唾液酸酶法）检测试剂盒的性能。方法随机选取100例疑为细菌性阴道病fBV）的妇女，于阴道后穹窿取3份分泌物标本，分别采用Amsel法、华今生物科技诊断试剂盒和珠海迪尔快速诊断试剂盒进行BV检测，以Amsel法的检测结果为标准，分别比较两种试剂盒的检测结果与Amsel法的符合率。结果100例阴道分泌物标本中99例为有效标本，其中34例被Arosel法诊断为BV，华今生物科技诊断试剂盒和珠海迪尔快速诊断试剂盒与Amsel法的符合率分别为90．9％和81．8％，华今生物科技诊断试剂盒的符合率高于珠海迪尔快速诊断试剂盒；此外，华今生物科技诊断试剂盒（6．2％）的假阳性率也低于珠海迪尔快速诊断试剂盒（12．3％）。结论华今生物科技诊断试剂盒操作简便、快速可靠，能够快速诊断BV，具有较好的临床应用前景。Objective To compare the performance and value of two reagent kits used for the diagnositic bacte- rial vaginosis （BV） from Huajin Biological Technology Co., LTD and Zhuhai Deer Biological Engineering Co., LTD. Meth- ods 100 women with suspected BV were recruited. BV was detected at the same time by Amsel method by using Huajin diagnostic reagent kit and Zhuhai diagnostic reagent kit respectively. The testing result of Amsel method was used for confirmed diagnosis of BV. The coincidence rates of the testing results of two reagent kits compared with the criteria of Amsel method were evaluated.Results 34 cases were confirmed BV by Amsel method among 99 validated samples. The coincidence rates of Huajin diagnostic reagent kit and Zhuhai diagnostic reagent kit were 90.9% and 81.8% respectively, showing that the former was significantly higher than the latter. In addition, the false positive rate of Zhuhai diagnostic reagent kit （12.3%） was significantly higher than that of Huajin diagnostic reagent kit （6.2%）.Conclusion Huajin diagnostic reagent kit should be a better tool for diagnosing BV with the character of rapidity, convenience and low false positive rate, with a better prospect.

关 键 词：细菌性阴道病 诊断试剂 

分 类 号：R711.3[医药卫生—妇产科学]