Infectious Diseases Section, Department of Medicine, Verona University Hospital, Verona, Italy.
WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Verona University Hospital, Verona, Italy.
BMC Infect Dis. 2024 Feb 29;24(Suppl 1):224. doi: 10.1186/s12879-024-09042-4.
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections have increased globally. Asymptomatic infections represent a significant risk of long-term complications. Men who have sex with men (MSM) are disproportionally affected, underscoring the need to offer screening programmes to this population. CT/NG Point of Care Testing (POCT) constitutes a strategic tool to improve the continuum of STI care, however extensive real-life evaluations amongst at risk populations are lacking. The aim of this study is to estimate the GeneXpert CT/NG assay performance and usability for CT and NG at genital and extragenital sites for screening amongst MSM.
This study was a multi-site sexual health clinic-based evaluation (Italy, Malta and Peru) with consecutive enrolment. A first void urine sample (divided in two aliquots), two oropharyngeal and two anorectal swabs were collected for each study participant. One specimen set (one for each anatomical site) was tested with the dual index test (Cepheid) at the clinics by the healthcare staff, the other set with FDA/CE approved Nucleic Acid Amplification Tests (NAATs) at the laboratory. Clinical sites and reference laboratories participated in an internal and external quality control programme. Sensitivity, specificity, positive and negative likelihood ratios, positive and negative predictive values for each anatomical site were estimated using a meta-analytic approach.
One thousand seven hundred two MSM were recruited across all clinical sites for a total of 5049 biological specimens. NG and CT were respectively detected in 274 and 287 of samples. Overall, the NG POCT sensitivity and specificity was 91.43% and 99.75% in urine (LR + 372.80, LR- 0.09), 89.68% and 99.55% in rectal specimens (LR + 197.30, LR- 0.10) and 75.87% and 98.77% at the pharynx respectively (LR + 61.94, LR- 0.24). The CT component of the POCT sensitivity was 84.82% and specificity 99.63% in urine (LR + 228.68, LR- 0.15), 78.07% and 99.19% respectively on rectal site (LR + 96.23, LR-0.22), 67.79% and 99.88% respectively at pharyngeal site (LR + 554.89, LR- 0.32). 95.95% of MSM reported to be willing to wait for POCT results and no provider reported difficulties in terms of performance or interpretation of the results of the Xpert CT/NG.
Rapid turnaround time, ease of use and high acceptability make the Xpert CT/NG testing system a strategic tool for increasing testing frequency, reaching those not yet tested and offering the possibility of immediate treatment if needed. The assay showed good negative likelihood ratios and confirms its use to rule out CT/NG infections. Sensitivity varied across sites and pathogens. Periodic staff training at the testing sites should be mandatory.
沙眼衣原体（CT）和淋病奈瑟菌（NG）感染在全球范围内呈上升趋势。无症状感染是导致长期并发症的一个重大风险。男男性行为者（MSM）受影响不成比例，这凸显了向这一人群提供筛查计划的必要性。CT/NG 即时检测（POCT）是改善性传播感染护理连续性的战略工具，然而，在高危人群中缺乏广泛的实际生活评估。本研究旨在评估 GeneXpert CT/NG 检测在筛查 MSM 生殖器和非生殖器部位 CT 和 NG 方面的性能和可用性。
这是一项在意大利、马耳他和秘鲁三地性健康诊所进行的基于多中心的评估（意大利、马耳他和秘鲁），采用连续入组的方法。每位研究参与者采集第一份晨尿样本（分为两份等分）、两份口咽拭子和两份肛拭子。一组标本（每个解剖部位各一组）由临床医护人员在诊所使用双索引检测（Cepheid）进行检测，另一组标本在实验室使用经 FDA/CE 批准的核酸扩增检测（NAATs）进行检测。临床和参考实验室都参加了内部和外部质量控制计划。使用荟萃分析方法估计每个解剖部位的敏感性、特异性、阳性和阴性似然比、阳性和阴性预测值。
共有 1720 名 MSM 在所有临床地点共招募了 5049 份生物样本。在这些样本中，NG 和 CT 的检出率分别为 274 例和 287 例。总体而言，NG POCT 的敏感性和特异性在尿样中分别为 91.43%和 99.75%（LR+372.80，LR-0.09），在直肠标本中分别为 89.68%和 99.55%（LR+197.30，LR-0.10），在咽拭子中分别为 75.87%和 98.77%（LR+61.94，LR-0.24）。POCT 的 CT 组件在尿样中的敏感性为 84.82%，特异性为 99.63%（LR+228.68，LR-0.15），在直肠部位的敏感性为 78.07%，特异性为 99.19%（LR+96.23，LR-0.22），在咽拭子中的敏感性为 67.79%，特异性为 99.88%（LR+554.89，LR-0.32）。95.95%的 MSM 表示愿意等待 POCT 结果，没有提供者报告该检测在性能或结果解释方面存在困难。快速的周转时间、易于使用和高接受性使 Xpert CT/NG 检测系统成为增加检测频率、覆盖尚未接受检测人群以及提供即时治疗可能性的战略工具。该检测方法的阴性似然比良好，证实了其用于排除 CT/NG 感染的用途。敏感性在不同地点和病原体之间存在差异。应强制要求在检测点对工作人员进行定期培训。
