University of Alabama at Birmingham, Birmingham, Alabama, USA
Indiana University School of Medicine, Indianapolis, Indiana, USA.
J Clin Microbiol. 2019 Mar 28;57(4). doi: 10.1128/JCM.01996-18. Print 2019 Apr.
The clinical performance of the Cobas CT/NG assay on the Cobas 6800/8800 systems (Cobas) for the detection of and was established in a multisite, prospective collection study using male and female urogenital specimens; supportive data from archived specimens were also included. The results obtained with the Cobas assay were compared with the patient infected status derived from a combination of U.S. Food and Drug Administration-approved nucleic acid amplification tests to determine the sensitivity and specificity of detection from each sample type. The sensitivity of Cobas for the detection of in female specimens was 95.6% (95% confidence interval [CI], 92.4% to 97.4%) for urine; 98.6% (95% CI, 95.2% to 99.6%) and 99.2% (95% CI, 95.4% to 99.9%) for clinician- and self-collected vaginal swab specimens, respectively; 93.3% (95% CI, 89.6% to 95.7%) for endocervical swabs; and 92.5% (95% CI, 88.7% to 95.1%) for cervical swab samples in PreservCyt. The specificity for the detection of was ≥98.8% for all female sample types. Sensitivity and specificity estimates of Cobas for the detection of in male urine samples were 100% (96.8% to 100.0%) and 99.7% (95% CI, 99.2% to 99.9%), respectively. The sensitivity of Cobas for the detection of in female specimens was 94.8% (95% CI, 89.6% to 97.4%) for urine; 100.0% (95% CI, 87.9% to 100.0%) and 100.0% (95% CI, 87.9% to 100.0%) for clinician- and self-collected vaginal swab specimens, respectively; 97.0% (95% CI, 91.5% to 99.0%) for endocervical swabs; and 96.6% (95% CI, 90.6% to 98.8%) for cervical samples in PreservCyt; the specificity for all female sample types was >99.0%. The sensitivity and specificity of Cobas for detecting in male urine were 100.0% (95% CI, 95.8% to 100.0%) and 99.5% (95% CI, 98.8% to 99.8%), respectively. Fully automated assays help fill the clinical need for a sensitive, high-throughput screening tool to aid public health efforts to control and infections.
科宝 CT/NG 检测试剂盒（科宝）在科宝 6800/8800 系统上对 和 的临床性能是通过一项多中心前瞻性采集研究确立的，该研究使用了男性和女性泌尿生殖标本；也包括了来自存档标本的支持性数据。使用科宝检测试剂盒获得的结果与源自美国食品和药物管理局批准的核酸扩增检测的患者感染状态进行了比较，以确定每种样本类型的检测灵敏度和特异性。科宝检测女性标本中 的灵敏度为：尿液样本为 95.6%（95%置信区间[CI]，92.4%至 97.4%）；临床医生和自我采集的阴道拭子样本分别为 98.6%（95%CI，95.2%至 99.6%）和 99.2%（95%CI，95.4%至 99.9%）；宫颈拭子样本为 93.3%（95%CI，89.6%至 95.7%）；宫颈刷样本在 PreservCyt 中为 92.5%（95%CI，88.7%至 95.1%）。所有女性样本类型检测 的特异性均≥98.8%。科宝检测男性尿液样本中 的灵敏度估计值为 100%（96.8%至 100.0%），特异性为 99.7%（95%CI，99.2%至 99.9%）。科宝检测女性标本中 的灵敏度为：尿液样本为 94.8%（95%CI，89.6%至 97.4%）；临床医生和自我采集的阴道拭子样本分别为 100.0%（95%CI，87.9%至 100.0%）和 100.0%（95%CI，87.9%至 100.0%）；宫颈拭子样本为 97.0%（95%CI，91.5%至 99.0%）；在 PreservCyt 中为 96.6%（95%CI，90.6%至 98.8%）；所有女性样本类型的特异性均>99.0%。科宝检测男性尿液中 的灵敏度和特异性分别为 100.0%（95%CI，95.8%至 100.0%）和 99.5%（95%CI，98.8%至 99.8%）。全自动检测有助于满足临床对灵敏、高通量筛查工具的需求，以支持公共卫生努力，控制 和 的感染。
