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Second- and third-generation commercial Neisseria gonorrhoeae screening assays and the ongoing issues of false-positive results and confirmatory testing.
European Journal of Clinical Microbiology & Infectious Diseases ( IF 4.5 ) Pub Date : 2020-08-07 , DOI: 10.1007/s10096-020-04004-5
Todd M Pryce 1 , Valerie J Hiew 1 , Erin J Haygarth 1 , David M Whiley 2
Affiliation  

Supplementary nucleic acid amplification tests for Neisseria gonorrhoeae (NG) are widely used to circumvent specificity problems often associated with extragenital sites. This study was prompted by our observations and concerns from local sexual health physicians over increased discrepancies between Roche cobas 4800 CT/NG (c4800) and our in-house supplementary NG-PCR (NG-duplex) for oropharyngeal samples, when compared with Abbott RealTime CT/NG (m2000) performed prior. Here, we investigated these differences. Three banks of NG-positive samples were used. Bank 1 (n = 344) were screened using m2000. Banks 2 (n = 344) and 3 (n = 400) were screened using c4800. Remnant nucleic acids from all banks were tested using NG-duplex as part of routine testing. Bank 2 samples were further tested using m2000, some selectively tested using Cepheid Xpert CT/NG. Bank 3 samples were further tested using cobas CT/NG (cobas 6800 system). Confirmatory rates were significantly (p < 0.0001) higher for m2000 compared with c4800, with oropharyngeal samples the key difference. However, we also showed that our NG-duplex failed to confirm some true-positive NG samples. Using an expanded gold standard, confirmatory rates for m2000 and c4800 exceeded 90% for all anatomical sites with the exception of c4800 for oropharyngeal specimens at 78%. The observed discrepancies were due to a combination of c4800 producing false-positive results for oropharyngeal samples as well as sensitivity issues related to the NG-duplex assay. The data highlight the ongoing need for NG supplemental nucleic acid testing for oropharyngeal samples but also emphasise the need for careful selection of supplementary methods.



中文翻译:

第二代和第三代商用淋病奈瑟菌筛查分析以及持续存在的假阳性结果和验证性检测问题。

淋病奈瑟菌(NG)的补充核酸扩增试验被广泛用于规避通常与外生殖器部位相关的特异性问题。与 Abbott RealTime 相比,Roche cobas 4800 CT/NG (c4800) 和我们内部的口咽样本补充 NG-PCR (NG-duplex) 之间的差异增加,引发了我们的观察和当地性健康医生的担忧,从而促成了这项研究之前进行过 CT/NG (m2000)。在这里,我们调查了这些差异。使用了三个 NG 阳性样品库。银行 1 ( n  = 344) 使用 m2000 进行筛选。银行 2 ( n  = 344) 和 3 ( n = 400) 使用 c4800 进行筛选。作为常规检测的一部分,使用 NG-duplex 对来自所有银行的残余核酸进行了检测。Bank 2 样本使用 m2000 进行了进一步测试,其中一些样本使用 Cepheid Xpert CT/NG 进行了选择性测试。Bank 3 样本使用 cobas CT/NG(cobas 6800 系统)进一步测试。确证率显着 ( p < 0.0001) 与 c4800 相比,m2000 更高,口咽样本是关键差异。然而,我们还表明我们的 NG-duplex 未能确认某些真正阳性的 NG 样本。使用扩展的金标准,除口咽标本的 c4800 为 78% 外,所有解剖部位的 m2000 和 c4800 的确认率均超过 90%。观察到的差异是由于 c4800 对口咽样本产生假阳性结果以及与 NG 双链检测相关的敏感性问题的组合。这些数据强调了对口咽样本进行 NG 补充核酸检测的持续需求,但也强调了仔细选择补充方法的必要性。

更新日期:2020-08-08
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