一种检测细菌性阴道病方法的建立及临床评价  

Establishment and clinical evaluation of a new method to detect bacterial vaginosis

作　　者：朱园园[1] 沈佐君[1] 万士林[2] 

机构地区：[1]安徽医科大学附属省立医院安徽省临床检验中心,安徽合肥230001 [2]美国哥伦比亚大学内外科医学会病理和细胞生物学系,纽约10032

出　　处：《检验医学》2009年第5期350-354,共5页Laboratory Medicine

基　　金：安徽省人才开发资金资助项目(2005Z040)

摘　　要：目的评估一种国内自主建立利用唾液酸酶检测细菌性阴道病（BV）方法的临床应用价值。方法比色法探索研发试剂与酶标准品的最佳反应条件,包括底物溶液的pH值和反应的最适温度及时间。采用研发试剂、BV BLUE、临床现用国产试剂盒对临床标本进行检测,判断研发试剂的临床应用价值。结果研发试剂在pH值6.0-6.2、37℃10 min时与酶标准品达到最佳反应,与BV BLUE相比,检出限相同时研发试剂底物用量仅为BV BLUE的1/2.78。临床实验中,研发试剂与BV BLUE对BV的检测效果差异无统计学意义（P=1.000,Kappa=0.905）,符合率为96%。而国产试剂盒与BV BLUE对BV的检测效果差异有统计学意义（P=0.000,Kappa=0.362）,符合率为65%。结论研发试剂可以达到与BV BLUE相同的检出效果,其快速、方便、可信度高且成本较低,优于国内类似产品,更有利于在临床推广和使用。Objective To evaluate the diagnostic value of a new domestic method with sialidase for detection of bacterial vaginosis （BV）. Methods The optimal reaction conditions of the new reagent catalyzed by standard sialidase were explored according to eolorimetric results, including pH, reacting temperature and time. Then we used clinical examples to verify the reliability of the new method as compared with the present domestic kit and imported BV BLUE kit. Results The new method reacted optimally at 37 ℃, 10 min in solution of pH 6.0-6.2. At the same detection limit, the dosage of substrate in new reagent was 1/2.78 of BV BLUE kit. In clinical evaluation, there was no significant difference of detection effect between new reagent and BV BLUE kit and the coincidence rate was up to 96% （ P = 1.000,Kappa =0.905）. Whereas significant difference was found between another domestic kit and BV BLUE kit with the coincidence rate of 65% （ P = 0. 000,Kappa = 0. 362）. Conclusions The new method has the same characteristics as BV BLUE kit, such as quickness, convenience, reliability, but decreased cost. It is better than an other similar domestic kit and suitable for clinical use in China.

关 键 词：阴道病 细菌 唾液酸酶 

分 类 号：R446.5[医药卫生—诊断学]