A diagnostic evaluation of a molecular assay used for testing and treating anorectal chlamydia and gonorrhoea infections at the point-of-care in Papua New Guinea
A diagnostic evaluation of a molecular assay used for testing and treating anorectal chlamydia and gonorrhoea infections at the point-of-care in Papua New Guinea
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DOI：
10.1016/j.cmi.2018.08.001
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发表时间：
2019-05-01
影响因子：
14.2
通讯作者：
Kelly-Hanku, A.
中科院分区：
文献类型：
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作者：
Badman, S. G.;Willie, B.;Kelly-Hanku, A.
目的：巴布亚新几内亚是全球性传播感染(STI)发病率最高的国家之一，没有能够准确检测肛门直肠沙眼衣原体(CT)和淋球菌(NG)感染的服务。在这里，我们前瞻性地评估了用于护理点(POC)的分子CT/NG检测的诊断性能，目的是加强肛门直肠性传播感染的筛查和当天的治疗。方法：参加巴布亚新几内亚第一项大规模生物行为研究的男性、变性女性和女性性工作者被纳入并要求提供自行收集的肛门直肠拭子用于POC GeneXpert CT/NG测试。如果阳性，则提供当天的治疗。将随机抽取的396份样品运送到澳大利亚，使用COBA 4800 CT/NG试验(美国加利福尼亚州普莱森顿罗氏分子诊断公司)进行比对。结果：共有326份样品提供了COBA的有效结果，70份样品提供了无效的抑制结果。GeneXpert CT/NG检测沙眼衣原体的阳性符合率为96.7%(95%CI 92.3%~98.9%)，阴性符合率为95.5%(95%CI 91.3%~98.0%)，总符合率为96.0%(95%CI为93.3%~97.8%)；淋球菌的阳性符合率为93.0%(95%CI为86.1%~97.1%)。100.0%(95%CI 98.3%~100.0%)和97.8%(95%CI 95.6%~99.1%)。结论：GeneXpert和Cobas CT/NG检测的总符合率较高，沙眼衣原体符合率为96.0%，淋球菌符合率为97.8%。这项研究数据的结果表明，GeneXpert CT/NG检测适合于在POC检测自收集的肛门直肠标本，并且当天治疗是可行的。(C)2018年欧洲临床微生物学和传染病学会。爱思唯尔有限公司出版。保留所有权利。
Objectives: 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.Methods: 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).Results: 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.Conclusions: 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. (C) 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.