Tsuruoka Naoki, Uzawa Yutaka, Kikuchi Ken, Ohtsuka Hiroki, Todome Yuko, Ohkuni Hisashi
Department of Clinical Laboratory, Tokyo Women's Medical University, School of Medicine.
Kansenshogaku Zasshi. 2008 Jul;82(4):317-21. doi: 10.11150/kansenshogakuzasshi1970.82.317.
The Gonogen II test for rapid identification of Neisseria gonorrhoeae (Gonococcus, GC) was evaluated. The test is based on a colorimetric reaction with monoclonal antibody to GC outer membrane protein 1. Of the 50 clinical isolates of GC, 49 isolates tested positive and only one strain tested negative. Other Neisseria. spp, H. influenzae, H. parainfluenzae, E. corrodens, M. catarrhalis, and A. baumannii showed negative test results. Non-Neisseriae. spp, such as S. aureus. P. aeruginosa, E. faecalis, and E. coli also showed negative test results. No cross-reactivity was found between GC and other Neisseriae. spp or non-Neisseriae. spp. In a mixed suspension of GC and all of non-Neisseriae. spp as mentioned above, the GonoGen II test was positive. The specificity and sensitivity of the test for the identification of GC were 98% and 100%. The minimum limit of detection of GC was > or = 1 x 10(5) cfu/mL. Decision making based on the test result is possible within 10 minutes. These findings also suggest that the test does not require pure GC. The GonoGen II test appears to be a reliable, quick and easy-to-use assay, and also to not require viable GC. Thus GonoGen II is shown to be a very useful test for the identification of GC.
对用于快速鉴定淋病奈瑟菌（淋球菌，GC）的Gonogen II试验进行了评估。该试验基于与GC外膜蛋白1单克隆抗体的比色反应。在50株GC临床分离株中，49株检测呈阳性，仅1株检测呈阴性。其他奈瑟菌属、流感嗜血杆菌、副流感嗜血杆菌、啮蚀艾肯菌、卡他莫拉菌和鲍曼不动杆菌检测结果均为阴性。非奈瑟菌属，如金黄色葡萄球菌、铜绿假单胞菌、粪肠球菌和大肠埃希菌检测结果也为阴性。GC与其他奈瑟菌属或非奈瑟菌属之间未发现交叉反应。在GC与上述所有非奈瑟菌属的混合悬液中，Gonogen II试验呈阳性。该试验鉴定GC的特异性和敏感性分别为98%和100%。GC的最低检测限为≥1×10⁵ cfu/mL。可在10分钟内根据试验结果做出决策。这些发现还表明该试验不需要纯的GC。Gonogen II试验似乎是一种可靠、快速且易于使用的检测方法，并且不需要活的GC。因此，Gonogen II被证明是一种用于鉴定GC的非常有用的试验。
