Abstract：
OBJECTIVE: Antimicrobial resistance (AMR) in Neisseria gonorrhoeae (N. gonorrhoeae) is an urgent threat to public health, with the emergence of highly resistant strains such as the FC428 clone. This study aimed to evaluate the high-resolution melting assay of N. gonorrhoeae AMR (HRM-NG-AMR) for diagnosing N. gonorrhoeae infection and detecting extended-spectrum cephalosporins and azithromycin resistance.
METHODS: A multicentre collection of 1488 samples, including 770 isolates and 718 urogenital swabs, was used to evaluate the performance of the HRM-NG-AMR assay. The presence of N. gonorrhoeae was confirmed by culture. Minimum inhibitory concentrations of antibiotics against the tested isolates were determined using the agar dilution method.
RESULTS: Regarding N. gonorrhoeae identification, HRM-NG-AMR had a sensitivity of 95.15% (95% CI 91.65-97.28) and a specificity of 96.44% (95% CI 94.17-97.89) using culture as standard. Regarding AMR detection, the specificity ranged from 96.29% (95% CI 94.57-97.50) for cefixime to 99.52% (95% CI 98.68-99.85) for azithromycin. Additionally, the sensitivity ranged from 31.34% (95% CI 20.87-43.97) for azithromycin to 79.10% (95% CI 63.52-89.42) for ceftriaxone. It was determined that 664 of 672 (98.81%) and 615 of 672 (91.52%) N. gonorrhoeae isolates were susceptible to ceftriaxone and cefixime, respectively, by detecting non-mosaic penA. Lastly, 40 genotypic FC428-related strains with the penA-60.001 allele were accurately identified.
CONCLUSIONS: The HRM-NG-AMR assay showed promising diagnostic performance for detecting N. gonorrhoeae infection and predicting AMR. This study aimed to evaluate the application of this assay in the clinical setting to enhance AMR surveillance and treatment intervention.
METHODS: A multicentre collection of 1488 samples, including 770 isolates and 718 urogenital swabs, was used to evaluate the performance of the HRM-NG-AMR assay. The presence of N. gonorrhoeae was confirmed by culture. Minimum inhibitory concentrations of antibiotics against the tested isolates were determined using the agar dilution method.
RESULTS: Regarding N. gonorrhoeae identification, HRM-NG-AMR had a sensitivity of 95.15% (95% CI 91.65-97.28) and a specificity of 96.44% (95% CI 94.17-97.89) using culture as standard. Regarding AMR detection, the specificity ranged from 96.29% (95% CI 94.57-97.50) for cefixime to 99.52% (95% CI 98.68-99.85) for azithromycin. Additionally, the sensitivity ranged from 31.34% (95% CI 20.87-43.97) for azithromycin to 79.10% (95% CI 63.52-89.42) for ceftriaxone. It was determined that 664 of 672 (98.81%) and 615 of 672 (91.52%) N. gonorrhoeae isolates were susceptible to ceftriaxone and cefixime, respectively, by detecting non-mosaic penA. Lastly, 40 genotypic FC428-related strains with the penA-60.001 allele were accurately identified.
CONCLUSIONS: The HRM-NG-AMR assay showed promising diagnostic performance for detecting N. gonorrhoeae infection and predicting AMR. This study aimed to evaluate the application of this assay in the clinical setting to enhance AMR surveillance and treatment intervention.
摘要：
目的：淋病奈瑟菌的耐药性（AMR）是对公众健康的紧迫威胁，随着FC428克隆等高水平抗性菌株的出现。本研究旨在评估淋病奈瑟菌AMR（HRM-NG-AMR）的高分辨率熔解试验，以诊断淋病奈瑟菌感染并检测超广谱头孢菌素和阿奇霉素耐药性。
方法：为了评估HRM-NG-AMR测定的性能，我们采用了1488个样本的多中心采集，包括770个分离株和718个泌尿生殖器拭子.淋病奈瑟菌的存在通过培养证实。使用琼脂稀释法确定抗生素对测试分离物的最小抑制浓度。
结果：关于淋病奈瑟菌的鉴定，HRM-NG-AMR的灵敏度为95.15%(95%置信区间[CI]，91.65-97.28）和使用培养作为标准的96.44％（95％CI，94.17-97.89）的特异性。关于AMR检测，头孢克肟的特异性为96.29%(95%CI,94.57~97.50),阿奇霉素的特异性为99.52%(95%CI,98.68~99.85).此外,阿奇霉素的敏感性为31.34%(95%CI,20.87-43.97),头孢曲松的敏感性为79.10%(95%CI,63.52-89.42).我们确定98.81％（664/672）和91.52％（615/672）的淋病奈瑟菌分离株对头孢曲松和头孢克肟敏感，分别,通过检测非马赛克penA。最后,准确鉴定了40株具有penA-60.001等位基因的基因型FC428相关菌株。
结论：HRM-NG-AMR检测在检测淋病奈瑟菌感染和预测AMR方面显示出良好的诊断性能。研究旨在评估该测定在临床环境中的应用，以增强AMR监测和治疗干预。
方法：为了评估HRM-NG-AMR测定的性能，我们采用了1488个样本的多中心采集，包括770个分离株和718个泌尿生殖器拭子.淋病奈瑟菌的存在通过培养证实。使用琼脂稀释法确定抗生素对测试分离物的最小抑制浓度。
结果：关于淋病奈瑟菌的鉴定，HRM-NG-AMR的灵敏度为95.15%(95%置信区间[CI]，91.65-97.28）和使用培养作为标准的96.44％（95％CI，94.17-97.89）的特异性。关于AMR检测，头孢克肟的特异性为96.29%(95%CI,94.57~97.50),阿奇霉素的特异性为99.52%(95%CI,98.68~99.85).此外,阿奇霉素的敏感性为31.34%(95%CI,20.87-43.97),头孢曲松的敏感性为79.10%(95%CI,63.52-89.42).我们确定98.81％（664/672）和91.52％（615/672）的淋病奈瑟菌分离株对头孢曲松和头孢克肟敏感，分别,通过检测非马赛克penA。最后,准确鉴定了40株具有penA-60.001等位基因的基因型FC428相关菌株。
结论：HRM-NG-AMR检测在检测淋病奈瑟菌感染和预测AMR方面显示出良好的诊断性能。研究旨在评估该测定在临床环境中的应用，以增强AMR监测和治疗干预。
