一种新的细菌性阴道病检测.doc

检验医学 ? 2009 年24卷05期 朱园园 沈佐君 万士林 【摘要】目的 评估一种国内自主利用唾液酸酶法检测细菌性阴道病的临床应用价值。方法 比色法探索研发试剂的最佳反应条件BVBLUE进口试剂盒采用临床标本对BVBLUE、临床现用国产试剂盒三者检测效果同时进行验证临床应用价值。结果 研发试剂在pH 6.037℃10min时与酶标准品达到最佳反应，与BVBLUE相比，检出限相同时研发试剂底物用量仅为BVBLUE的1/2.78。临床实验中研发试剂与BVBLUE对细菌性阴道病的检测效果差无显著性意义,符合率96%BV blue对细菌性阴道病的检测效果差别有显著性意义，符合率65%。 结论 研发试剂可以达到与BVBLUE相同的检出效果，成本可信度高快速方便，更有利于在临床推广使用。 【关键词】神经氨酸酶；阴道病, 细菌性 and clinical research of a new reagent detecting bacterial vaginosis ZHU Yuan-yuan*, SHEN Zuo-jun，WAN Shi-lin. *Anhui Provincial Hospital affiliated to Anhui Medical University , Anhui Provincial Center of Clinical Laboratory, Hefei 230001,China. Corresponding author：SHEN Zuo-jun, Email: shenzuojun@163.com 【Abstract】Objective To evaluate the diagnostic value of a new reagent developed by domestic institution detecting bacterial vaginosis with sialidase. Methods Explore the condition of the new reagent by colorimetric method, then use clinical examples to verify its reliability and another domestic kit’s with U.S. BVBLUE kit as criteria. Results The new reagent reacted best to standard sialidase at 37℃, 10min in solution of pH6.0. At the same minimum detection limit, the usage of substrate in new reagent was 1/2.78 times of BVBLUE kit’s. In clinical trials, there had no significant difference between new reagent and BVblue kit,the coincidence was up to 96% . Whereas significant difference was detected between another domestic kit and BVBLUE kit, the coincidence was only 65%. Conclusions The new reagent can be made to have the same characteristics as BVBLUE kit, such as quickness, convenience, reliability, but decreased cost greatly. It will have more wide market than other kits in China. 【Key words】Neuraminidase; Vaginosis, Bacterial 细菌性阴道病（Bacterial vaginosis，BV）是阴道内乳酸杆菌大量减少而厌氧菌群如普雷沃菌属、动弯杆菌阴道加德纳菌及支原体等大量繁殖，同时伴有阴道分泌物性质改变的一组综合征。BV与早产、自发流产、子宫内膜炎、输卵管炎、继发性不孕等多种妇产科疾病密切相关[12]，患者对和性传播疾病的易感性增加[34] 。世界范围内其感染率约为5％51％[4]。BV的实验室诊断金标准为Amsel法[]，其成本低廉，但指标易受到主客观因素多种干扰，尽管后人发展出了多胺检测卡、革蓝染色评分检测线索细胞等改良方法，仍存在耗时长、操作繁琐等缺点，不利于临床快速诊