Ota K V, Tamari I E, Smieja M, Jamieson F, Jones K E, Towns L, Juzkiw J, Richardson S E
Hospital for Sick Children, Toronto, Ontario, Canada.
Sex Transm Infect. 2009 Jun;85(3):182-6. doi: 10.1136/sti.2008.034140. Epub 2009 Jan 6.
This study compared the sensitivity and specificity of culture and two nucleic acid amplification tests (NAATs): the BD Probetec ET system (PT) and the Aptima Combo 2 (AC2) in detecting Neisseria gonorrhoeae (GC) and Chlamydia trachomatis (CT) in pharyngeal and rectal specimens.
Male subjects were prospectively recruited at an MSM clinic in Toronto, Canada. Pharyngeal and rectal specimens were obtained for GC and CT culture, PT and AC2. Urine was also obtained for PT. A true positive was defined as: (1) positive culture, (2) positive PT and AC2 at the same site or (3) a single positive NAAT and detection of the same organism by any method at another site.
248 subjects were recruited. The prevalence of pharyngeal GC was 8.1%, rectal GC 11.7%, pharyngeal CT 2.0% and rectal CT 7.7%. The sensitivity of culture for pharyngeal GC and CT was 0%; 41.4% for rectal GC and 21.1% for rectal CT. The sensitivity of PT for pharyngeal GC, rectal GC, pharyngeal CT and rectal CT was 95.0%, 93.1%, 80.0% and 94.7%, respectively. The sensitivity of AC2 was 95.0% for pharyngeal GC and 100% at all other sites. Specificity was consistently above 98%.
PT and AC2 detected GC and CT with superior sensitivity compared to culture. They detected 73 pharyngeal or rectal GC and CT infections compared to 16 by culture, using a rigorous gold standard. NAATs should be the method of choice for the detection of GC and CT in extragenital sites in men who have sex with men.
本研究比较了培养法与两种核酸扩增检测方法(NAATs):BD Probetec ET系统(PT)和Aptima Combo 2(AC2)在检测咽拭子和直肠拭子中淋病奈瑟菌(GC)和沙眼衣原体(CT)方面的敏感性和特异性。
在加拿大多伦多的一家男男性行为者诊所前瞻性招募男性受试者。采集咽拭子和直肠拭子用于GC和CT培养、PT检测及AC2检测。同时采集尿液用于PT检测。真阳性定义为:(1)培养阳性;(2)同一部位PT和AC2均为阳性;或(3)单个NAAT阳性且另一部位通过任何方法检测到相同病原体。
共招募248名受试者。咽GC患病率为8.1%,直肠GC为11.7%,咽CT为2.0%,直肠CT为7.7%。培养法检测咽GC和CT的敏感性为0%;直肠GC为41.4%,直肠CT为21.1%。PT检测咽GC、直肠GC、咽CT和直肠CT的敏感性分别为95.0%、93.1%、80.0%和94.7%。AC2检测咽GC的敏感性为95.0%,其他所有部位均为100%。特异性始终高于98%。
与培养法相比,PT和AC2检测GC和CT具有更高的敏感性。采用严格的金标准,它们检测出73例咽或直肠GC和CT感染,而培养法仅检测出16例。核酸扩增检测应作为男男性行为者生殖器外部位GC和CT检测的首选方法。