Kirby Institute, UNSW Sydney, NSW, Australia.
Sexual and Reproductive Health Unit, Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
Clin Microbiol Infect. 2019 May;25(5):623-627. doi: 10.1016/j.cmi.2018.08.001. Epub 2018 Aug 11.
Papua New Guinea has among the highest prevalences of sexually transmissible infections (STIs) globally with no services able to accurately test for anorectal Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections. Here we prospectively evaluated the diagnostic performance of a molecular CT/NG assay used at the point-of-care (POC) with the aim of enhancing anorectal STI screening and same-day treatment.
Men who have sex with men, transgender women and female sex workers taking part in Papua New Guinea's first large-scale biobehavioural study were enrolled and asked to provide a self-collected anorectal swab for POC GeneXpert CT/NG testing. Same-day treatment was offered if positive. A convenience sample of 396 unique and randomly selected samples were transported to Australia for comparison using the Cobas 4800 CT/NG test (Roche Molecular Diagnostics, Pleasanton, CA, USA).
A total of 326 samples provided valid results by Cobas whereas 70 samples provided invalid results suggesting inhibition. The positive, negative and overall percentage agreements of GeneXpert CT/NG for the detection of C. trachomatis were 96.7% (95% CI 92.3%-98.9%), 95.5% (95% CI 91.3%-98.0%) and 96.0% (95% CI 93.3%-97.8%), and for N. gonorrhoeae were 93.0% (95% CI 86.1%-97.1%), 100.0% (95% CI 98.3%-100.0%) and 97.8% (95% CI 95.6%-99.1%), respectively.
The overall rate of agreement between the GeneXpert and Cobas CT/NG assays was high with 96.0% for C. trachomatis and 97.8% for N. gonorrhoeae. Results from this study data suggest that the GeneXpert CT/NG assay is suitable for testing self-collected anorectal specimens at the POC and that same-day treatment was feasible.
巴布亚新几内亚的性传播感染（STIs）患病率在全球范围内处于最高水平，尚无任何服务能够准确检测肛门直肠沙眼衣原体（CT）和淋病奈瑟菌（NG）感染。在这里，我们前瞻性地评估了一种用于即时护理（POC）的分子 CT/NG 检测的诊断性能，旨在加强肛门直肠 STI 筛查和当天治疗。
参与巴布亚新几内亚首次大规模生物行为研究的男男性行为者、跨性别女性和性工作者被招募，并被要求提供自我采集的肛门直肠拭子进行 POC GeneXpert CT/NG 检测。如果检测结果阳性，则提供当天的治疗。从 396 个独特且随机选择的样本中，采集了 326 个有有效结果的样本，并通过罗氏分子诊断公司（美国加利福尼亚州普莱森顿）的 Cobas 4800 CT/NG 测试进行了比较。
共有 326 个样本通过 Cobas 提供了有效结果，而 70 个样本提供了无效结果提示抑制。GeneXpert CT/NG 检测 C. trachomatis 的阳性、阴性和总符合率分别为 96.7%（95%CI 92.3%-98.9%）、95.5%（95%CI 91.3%-98.0%）和 96.0%（95%CI 93.3%-97.8%），检测 N. gonorrhoeae 的阳性、阴性和总符合率分别为 93.0%（95%CI 86.1%-97.1%）、100.0%（95%CI 98.3%-100.0%）和 97.8%（95%CI 95.6%-99.1%）。
GeneXpert 和 Cobas CT/NG 检测之间的总一致性率很高，C. trachomatis 为 96.0%，N. gonorrhoeae 为 97.8%。这项研究的数据表明，GeneXpert CT/NG 检测适用于即时护理点采集的自我采集肛门直肠标本，并且可以实现当天治疗。
