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首页> 外文期刊>Sexually Transmitted Infections >Is confirmatory testing of Roche cobas 4800 CT/NG test Neisseria gonorrhoeae positive samples required? Comparison of the Roche cobas 4800 CT/NG test with an opa/pap duplex assay for the detection of N gonorrhoeae
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Is confirmatory testing of Roche cobas 4800 CT/NG test Neisseria gonorrhoeae positive samples required? Comparison of the Roche cobas 4800 CT/NG test with an opa/pap duplex assay for the detection of N gonorrhoeae

机译：是否需要对Roche cobas 4800 CT / NG测试淋病奈瑟氏球菌阳性样品进行确认性测试？罗氏cobas 4800 CT / NG测试与不透明/巴氏双联体检测法检测淋病奈瑟菌的比较

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Objectives: Recently marketed nucleic acid amplification tests (NAAT) for the detection of Neisseria gonorrhoeae (NG) have improved specificity over previous generation assays. A study to assess the necessity for confirmation of Roche cobas 4800 NG positive samples was undertaken by the Public Health Wales Microbiology Molecular Diagnostic Unit in Cardiff. Methods: Classical NG culture identification was compared to cobas 4800 (DR-9), opacity (opa) gene and porA pseudogene (pap) results. Confirmatory NAATs (opa/pap) were performed prospectively for 120 cobas 4800 NG positive urogenital and extragenital samples. Retrospective supplementary NAAT and sequence analysis of additional cobas 4800 NG positive extragenital samples was also carried out. Results: 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 cobas 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. Conclusions: Molecular tests could be used for culture confirmation where available. Roche cobas 4800 Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) CT/NG gonorrhoea diagnosis is superior to culture with urogenital and rectal positives not requiring confirmation. Roche cobas 4800 oropharyngeal NG detection findings warrant further prospective study of routine confirmatory testing accounting for its cost and clinical usefulness.
机译：目的：最近上市的用于检测淋病奈瑟氏球菌（NG）的核酸扩增试验（NAAT）比以前的测定具有更高的特异性。卡迪夫的公共卫生威尔士微生物分子诊断部门进行了一项研究，以评估确认Roche cobas 4800 NG阳性样品的必要性。方法：将经典的NG培养物鉴定结果与cobas 4800（DR-9），不透明度（opa）基因和porA假基因（pap）结果进行比较。前瞻性对120例cobas 4800 NG阳性泌尿生殖器和生殖器样本进行了验证性NAAT（opa / pap）。还进行了回顾性补充NAAT和其他cobas 4800 NG阳性生殖器外样本的序列分析。结果：在188个经典鉴定的临床NG分离株中，在所有3个分子靶标中都鉴定出184个为NG。仅通过2个分子靶标检测到两个分离株。另外2个分离株是培养假阳性。结合前瞻性和回顾性测试的结果，cobas 4800 NG对泌尿生殖器，直肠和口咽样品的检测灵敏度和阴性预测值为100％。所有样品类型的特异性均大于99.7％。泌尿生殖道和直肠标本的阳性预测值分别为96.0％和96.4％，口咽标本的阳性预测值为88.6％。结论：分子检测可以用于培养的确认。罗氏cobas 4800沙眼衣原体/淋病奈瑟菌（CT / NG）CT / NG淋病的诊断优于无需确认的泌尿生殖道和直肠阳性的培养。罗氏cobas 4800口咽NG的检测结果值得对常规验证性测试进行进一步的前瞻性研究，考虑到其成本和临床实用性。

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