NYtor BV, Nijmegen.
From the Infectious Diseases, Public Health Service (PHS) of Amsterdam.
Sex Transm Dis. 2020 Apr;47(4):238-242. doi: 10.1097/OLQ.0000000000001141.
Absence of rapid antimicrobial resistance testing of Neisseria gonorrhoeae (Ng) hinders personalized antibiotic treatment. To enable rapid ciprofloxacin prescription, a real-time polymerase chain reaction (PCR) for simultaneous detection of Ng and fluoroquinolone resistance-associated gyrA-S91F mutation was evaluated.
Analytical NG quantitative PCR kit (NYtor BV) performance was assessed on 50 Ng transcription-mediated amplification (TMA)-negative and 100 Ng TMA-positive samples. To assess clinical use, 200 samples were prospectively analyzed, in parallel to routine diagnostic tests. Also, 50 urine, 50 anal, 50 pharyngeal, and 50 vaginal Ng TMA-positive samples were retrospectively analyzed. To assess if patients carried strains with different ciprofloxacin sensitivity at different anatomical locations, 50 urine/anal or vaginal/anal sample pairs collected during a single visit were analyzed.
The NG quantitative PCR kit showed 97% sensitivity and 100% specificity for Ng detection and 92% sensitivity and 99% specificity for gyrA-S91F detection. Relative to TMA results, 85% Ng detection sensitivity and 99% specificity were found. Regarding the 200 prospectively analyzed clinical samples, 13 were Ng positive, of which 10 were also tested for antibiotic susceptibility by culture. The kit showed concordance for GyrA-S91F detection in 9 of 10 samples. Ng was detected in 96% and 94% of vaginal and urine TMA-positive samples, in 84% of anal samples and only in 22% of pharyngeal samples. Discordant ciprofloxacin sensitivity was found for 2 of 26 characterized urine/anal sample pairs.
The NG quantitative polymerase chain reaction (qPCR) kit can be implemented in diagnostic testing for vaginal, urine, and anal Ng TMA-positive samples to enable rapid prescription of oral ciprofloxacin.
淋病奈瑟菌（Ng）缺乏快速的抗生素耐药性检测，阻碍了个体化抗生素治疗。为了能够快速开具环丙沙星处方，我们评估了一种用于同时检测 Ng 和氟喹诺酮类药物耐药相关的 gyrA-S91F 突变的实时聚合酶链反应（PCR）。
评估了 50 份 Ng 转录介导扩增（TMA）阴性和 100 份 Ng TMA 阳性样本的 NYtor BV 分析性 Ng 定量 PCR 试剂盒性能。为了评估临床应用，前瞻性分析了 200 份样本，与常规诊断检测同时进行。此外，回顾性分析了 50 份尿液、50 份肛门、50 份咽和 50 份阴道 Ng TMA 阳性样本。为了评估患者在不同解剖部位是否携带不同的对环丙沙星敏感性的菌株，分析了在单次就诊时收集的 50 份尿液/肛门或阴道/肛门样本对。
Ng 定量 PCR 试剂盒对 Ng 检测的敏感性为 97%，特异性为 100%，对 gyrA-S91F 检测的敏感性为 92%，特异性为 99%。与 TMA 结果相比，Ng 检测的敏感性为 85%，特异性为 99%。关于 200 份前瞻性分析的临床样本，13 份为 Ng 阳性，其中 10 份也通过培养进行了抗生素敏感性测试。试剂盒在 10 份样本中的 9 份中对 GyrA-S91F 检测的一致性。在阴道 TMA 阳性样本中，96%和 94%的样本检测到 Ng，在尿 TMA 阳性样本中，94%和 94%的样本检测到 Ng，在肛门样本中，84%的样本检测到 Ng，而在咽样本中，仅 22%的样本检测到 Ng。对 26 对特征化的尿液/肛门样本对进行了不一致的环丙沙星敏感性检测。
Ng 定量聚合酶链反应（qPCR）试剂盒可用于阴道、尿液和肛门 Ng TMA 阳性样本的诊断检测，以实现口服环丙沙星的快速处方。
