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• W2163572562 abstract "<h3>Objectives</h3> Recently marketed nucleic acid amplification tests (NAAT) for the detection of <i>Neisseria gonorrhoeae</i> (NG) have improved specificity over previous generation assays. A study to assess the necessity for confirmation of Roche <b>cobas</b> 4800 NG positive samples was undertaken by the Public Health Wales Microbiology Molecular Diagnostic Unit in Cardiff. <h3>Methods</h3> Classical NG culture identification was compared to <b>cobas</b> 4800 (<i>DR-9</i>), opacity (<i>opa</i>) gene and <i>porA</i> pseudogene (<i>pap</i>) results. Confirmatory NAATs (<i>opa</i>/<i>pap</i>) were performed prospectively for 120 <b>cobas</b> 4800 NG positive urogenital and extragenital samples. Retrospective supplementary NAAT and sequence analysis of additional <b>cobas</b> 4800 NG positive extragenital samples was also carried out. <h3>Results</h3> Of the 188 classically identified clinical NG isolates, 184 were identified as NG in all 3 molecular targets. Two isolates were only detected by 2 molecular targets. A further 2 isolates were culture false-positives. Combining the results from prospective and retrospective testing, the sensitivity and negative predictive value for <b>cobas</b> 4800 NG detection for urogenital, rectal and oropharyngeal samples was 100%. Specificity for all sample types was greater than 99.7%. Positive predictive value was 96.0% and 96.4% for urogenital and rectal specimens, respectively, and 88.6% for oropharyngeal samples. <h3>Conclusions</h3> Molecular tests could be used for culture confirmation where available. Roche <b>cobas</b> 4800 <i>Chlamydia trachomatis/Neisseria gonorrhoeae</i> (CT/NG)CT/NG gonorrhoea diagnosis is superior to culture with urogenital and rectal positives not requiring confirmation. Roche <b>cobas</b> 4800 oropharyngeal NG detection findings warrant further prospective study of routine confirmatory testing accounting for its cost and clinical usefulness." @default.
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• W2163572562 date "2014-03-20" @default.
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• W2163572562 title "Is confirmatory testing of Roche<b>cobas</b>4800 CT/NG test<i>Neisseria gonorrhoeae</i>positive samples required? Comparison of the Roche<b>cobas</b>4800 CT/NG test with an<i>opa</i>/<i>pap</i>duplex assay for the detection of<i>N gonorrhoeae</i>" @default.
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• W2163572562 doi "https://doi.org/10.1136/sextrans-2013-051410" @default.
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