多中心临床评估一种分子诊断检测方法，以鉴定淋病奈瑟菌感染并检测抗微生物药物耐药性。
Multicentre Clinical Evaluation of a Molecular Diagnostic Assay to Identify Neisseria gonorrhoeae Infection and Detect Antimicrobial Resistance.
机构信息
NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China; School of Global Health, Chinese Center for Tropical Diseases Research, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China; Key Laboratory of Respiratory Disease Pathogenomics, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
出版信息
Int J Antimicrob Agents. 2023 May;61(5):106785. doi: 10.1016/j.ijantimicag.2023.106785. Epub 2023 Mar 13.
OBJECTIVES
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.
目的
淋病奈瑟菌（N. gonorrhoeae）的抗生素耐药性（AMR）对公共卫生构成了紧迫威胁，出现了高度耐药菌株，如 FC428 克隆。本研究旨在评估高分辨率熔解曲线分析淋病奈瑟菌抗生素耐药性（HRM-NG-AMR）在诊断淋病奈瑟菌感染和检测扩展谱头孢菌素和阿奇霉素耐药性方面的性能。
方法
使用多中心收集的 1488 个样本，包括 770 个分离株和 718 个泌尿生殖道拭子，评估 HRM-NG-AMR 检测的性能。通过培养法确认淋病奈瑟菌的存在。采用琼脂稀释法测定受试分离株对抗生素的最小抑菌浓度。
结果
以培养为标准，HRM-NG-AMR 检测淋病奈瑟菌的敏感性为 95.15%（95%置信区间 91.65-97.28），特异性为 96.44%（95%置信区间 94.17-97.89）。在检测 AMR 方面，头孢克肟的特异性为 96.29%（95%置信区间 94.57-97.50），阿奇霉素的特异性为 99.52%（95%置信区间 98.68-99.85）。此外，阿奇霉素的敏感性为 31.34%（95%置信区间 20.87-43.97），头孢曲松的敏感性为 79.10%（95%置信区间 63.52-89.42）。通过检测非镶嵌 penA，确定 672 株淋病奈瑟菌分离株中有 664 株（98.81%）对头孢曲松敏感，有 672 株（91.52%）对头孢克肟敏感。最后，准确鉴定了 40 株带有 penA-60.001 等位基因的基因型 FC428 相关菌株。
结论
HRM-NG-AMR 检测法在检测淋病奈瑟菌感染和预测 AMR 方面表现出良好的诊断性能。本研究旨在评估该检测方法在临床中的应用，以加强 AMR 监测和治疗干预。
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