Evaluation of Six Commercial Nucleic Acid Amplification Tests for Detection of Neisseria gonorrhoeae and Other Neisseria Species
Evaluation of Six Commercial Nucleic Acid Amplification Tests for Detection of Neisseria gonorrhoeae and Other Neisseria Species
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DOI：
10.1128/jcm.01217-11
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发表时间：
2011-10-01
影响因子：
9.4
通讯作者：
Tapsall, John
中科院分区：
文献类型：
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作者：
Tabrizi, Sepehr N.;Unemo, Magnus;Tapsall, John
生殖器外样本中淋病奈瑟菌的分子检测可能会由于与脑膜炎奈瑟菌或脑膜炎奈瑟菌的交叉反应而导致假阳性结果。本研究检查了450个特征性临床培养分离株，包括216个N。淋病分离株和234株非淋球菌奈瑟菌属（n = 218）和16株其他密切相关的细菌，6个商业核酸扩增试验（NAAT）。检测的6种NAAT为Gen-Probe APTIMA COMBO 2和APTIMA GC、Roche COBAS Amplicor CT/NG和COBAS 4800 CT/NG检测、BD ProbeTec GC Qx扩增DNA检测和Abbott RealTime CT/NG检测。除COBAS Amplicor CT/NG检测（未检出4株（1.9%）分离株）外，所有检测试剂均显示所有N.淋病分离株（n = 216）。在检查的234个非淋球菌分离株中，由于交叉反应，所有检测的初始结果均显示出一些假阳性结果。具体而言，COBAS Amplicor和ProbeTec检测显示假阳性结果的数量最多，分别检测到33（14.1%）和26（11%）株非淋球菌奈瑟菌分离株。在首次检测中，APTIMA COMBO 2、APTIMA GC、Abbott RealTime和Roche COBAS 4800显示较低水平的交叉反应，分别有5个（2.1%）、4个（1.7%）、2个（1%）和2个（1%）分离株显示低水平阳性。使用新鲜培养的菌落对这9株非淋球菌分离株进行复检后，APTIMA COMBO 2、Abbott RealTime或COBAS 4800检测均未呈阳性。总之，COBAS Amplicor和ProbeTec检测显示大量假阳性结果，而其余NAAT仅显示零星的低水平假阳性结果。确认N的补充试验。淋病NAAT仍然推荐用于所有检测样本，特别是来自生殖器外部位的样本。
Molecular detection of Neisseria gonorrhoeae in extragenital samples may result in false-positive results due to cross-reaction with commensal Neisseria species or Neisseria meningitidis. This study examined 450 characterized clinical culture isolates, comprising 216 N. gonorrhoeae isolates and 234 isolates of nongonococcal Neisseria species (n = 218) and 16 isolates of other closely related bacteria, with six commercial nucleic acid amplification tests (NAATs). The six NAATs tested were Gen-Probe APTIMA COMBO 2 and APTIMA GC, Roche COBAS Amplicor CT/NG and COBAS 4800 CT/NG tests, BD ProbeTec GC Qx amplified DNA assay, and Abbott RealTime CT/NG test. All assays except COBAS Amplicor CT/NG test where four (1.9%) isolates were not detected showed a positive result with all N. gonorrhoeae isolates (n = 216). Among the 234 nongonococcal isolates examined, initial results from all assays displayed some false-positive results due to cross-reactions. Specifically, the COBAS Amplicor and ProbeTec tests showed the highest number of false-positive results, detecting 33 (14.1%) and 26 (11%) nongonococcal Neisseria isolates, respectively. On the first testing, APTIMA COMBO 2, APTIMA GC, Abbott RealTime, and Roche COBAS 4800 showed lower level of cross-reactions with five (2.1%), four (1.7%), two (1%), and two (1%) of the isolates showing low-level positivity, respectively. Upon retesting of these nine nongonococcal isolates using freshly cultured colonies, none were positive by the APTIMA COMBO 2, Abbott RealTime, or COBAS 4800 test. In conclusion, the COBAS Amplicor and ProbeTec tests displayed high number of false-positive results, while the remaining NAATs showed only sporadic low-level false-positive results. Supplementary testing for confirmation of N. gonorrhoeae NAATs remains recommended with all samples tested, in particular those from extragenital sites.