【摘要】 目的研究一种酶法淋球菌快检试剂盒性能。方法用培养法和酶法淋球菌快检试剂盒同时检测4262例河南省疾病预防控制中心2013年5月至2014年12月接收的临床分泌物标本,以淋球菌琼脂平板培养结合巧克力色血琼脂平板补充培养为对照。结果酶法淋球菌快检试剂盒灵敏度96.15%(50/52),特异性98.72%(4156/4210),阳性预测值48.08%(50/104),阴性预测值99.95%(4156/4158)。P=3.68E-12<0.05,与参比方法相比,差异有统计学意义。结论酶法淋球菌快检试剂盒已经是临床性能较好、操作简单的淋球菌快检试剂,有必要进一步扩大临床研究,为临床推广提供数据。更多还原

【Abstract】 Objective To evaluate the clinical performance of an enzymatic Neisseria gonorrhoeae kit. Methods Totally4262 cases clinical secretions were detected by enzymatic Neisseria gonorrhoeae kit,meanwhile,all the samples above were streak plating in Neisseria gonorrhoeae agar plates complementing with chocolate blood agar plates for comparison.Results Among the 4262 cases,the sensitivity and specificity of enzymatic Neisseria gonorrhoeae kit were 96. 15%( 50 /52) and 98. 72%( 4156 /4210),respectively. The positive predictive value and negative predictive value were48. 08%( 50 /104) and 99. 95%( 4156 /4158),respectively. P = 3. 68E-12 < 0. 05,compared with the reference method,there was statistically significant difference between them. Conclusion Although the difference was statistically significant,the enzymatic Neisseria gonorrhoeae kit offered a better quick test method because of its better clinical performance and simply operation. To provide much more data for clinical promotion,it is necessary to expand clinical research.更多还原