检测细菌性阴道病干化学法的建立及评价

Establishment and evaluation of a dry chemical method to detect bacterial vaginosis

利用肉眼观察反应产物颜色的变化探讨研发试剂与酶标准品的最佳反应条件,在pH值6.2,37℃,15 min,MSTT为10μg时,研发干片与酶标准品达到最佳反应。临床实验中,将研发试剂、细菌性阴道病(BV)BLUE、国产试剂盒分别对临床标本进行对比检测,研发试剂与BV BLUE对BV的检测效果差异无统计学意义,符合率为97%。而国产A试剂盒与BV BLUE对BV的检测效果差异有统计学意义(P<0.01,χ2=0.390,r=0.42),符合率仅为67%。

To discuss the best reacting conditions between developed chemicals and standard enzymes with macroscopic observation. The result showed the best reacting conditions was pH 6.2, 37℃, 15 rains and MSTT 10 μg. In clinical experiment, clinical samples were contrasted and measured by employing the developed chemical reagent, BV BLUE and the existing homemade clinical testing kit. The developed reagent and BV BLUE had no statistic significance in detecting BV,the coincidence rate was 97%. In contrast, the homemade clinical testing kit had statistic significance （P 〈0. 01 ,X20. 390, r =0. 42）, the coincidence rate of 67%.