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评估 SpeeDx 公司的 ResistancePlus GC 检测法对淋病奈瑟菌中环丙沙星耐药性的分子检测。

Evaluation of the molecular detection of ciprofloxacin resistance in Neisseria gonorrhoeae by the ResistancePlus GC assay (SpeeDx).

机构信息

Scottish Bacterial Sexually Transmitted Infections Reference Laboratory, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.

Scottish Bacterial Sexually Transmitted Infections Reference Laboratory, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom; School of Medicine, University of St Andrews, United Kingdom.

出版信息

Diagn Microbiol Infect Dis. 2021 Apr;99(4):115262. doi: 10.1016/j.diagmicrobio.2020.115262. Epub 2020 Nov 12.

Abstract

There is growing concern due to the emergence of multidrug resistance in Neisseria gonorrhoeae. A rapid molecular test which guides and provides antimicrobial susceptibility knowledge prior to start of treatment is needed. This study evaluated the clinical performance of the ResistancePlus GC assay compared to in-house PCR and antimicrobial susceptibility results for ciprofloxacin resistance. Samples were selected from a range of sites with corresponding cultures isolated from the same patient episode. The ResistancePlus GC assay displayed high sensitivity for N. gonorrhoeae detection (98.5%) and gyrA detection (97.1%). There was high agreement (98.9%) between the ResistancePlus GC assay and culture phenotype. Mixed population testing showed that the assay was able to detect resistance in a sample containing a minority variant of 27% resistant. The ResistancePlus GC assay performed well and could be used to provide a clinically relevant indication of ciprofloxacin susceptibility for the treatment of gonorrhoea.

摘要

由于淋病奈瑟菌出现了多药耐药性,人们越来越关注这一问题。目前需要一种快速的分子检测方法,在开始治疗前指导并提供抗菌药物敏感性知识。本研究评估了 ResistancePlus GC 检测与本地 PCR 及针对环丙沙星耐药性的抗菌药物敏感性检测结果的临床性能。从不同的采样点选择样本,这些样本均来自同一患者的同一感染部位的培养物。ResistancePlus GC 检测对淋病奈瑟菌的检测具有很高的灵敏度(98.5%)和 gyrA 检测的灵敏度(97.1%)。ResistancePlus GC 检测与培养表型之间具有很高的一致性(98.9%)。混合群体检测表明,该检测方法能够检测出少数变异体占 27%的耐药样本中的耐药性。ResistancePlus GC 检测的性能良好,可用于为淋病的治疗提供环丙沙星敏感性的临床相关指示。

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