Centre for Women's Infectious Diseases, The Royal Women's Hospital, Parkville, VIC, Australia.
Molecular Microbiology Research Group, Murdoch Children's Research Institute, Parkville, VIC, Australia.
J Med Microbiol. 2021 Jan;70(1). doi: 10.1099/jmm.0.001271.
is a sexually transmitted pathogen with increasing resistance to first- and second-line antimicrobials. The 'near-patient test' ResistancePlus MG FleXible (SpeeDx) detects plus four macrolide resistance mutations (MRMs), facilitating same-day patient follow up. This assay has not been assessed on freshly collected samples. Our goal was to evaluate the performance of the ResistancePlus MG FleXible test against the standard of care open platform test. ResistancePlus MG FleXible (analysed on the Cepheid GeneXpert platform) was evaluated on freshly collected samples and compared to the standard of care open platform test ResistancePlus MG (SpeeDx) analysed on the LightCycler 480 II (Roche). For 270 valid tests, ResistancePlus MG FleXible yielded a high positive per cent agreement (PPA) of 94.1% [96/102; 95 % confidence interval (CI): 87.6-97.8 %] and negative per cent agreement (NPA) of 95.2% (160/168; 95 % CI: 90.8-97.9%) for detection compared to the reference assay (kappa for test concordance of 0.89; 95 % CI: 0.83-0.95). Performance was similar across different sample types. For the detection of MRMs, ResistancePlus MG FleXible had a PPA of 97.1% (66/68; 95% CI: 89.8-99.6) and NPA of 78.6% (22/28; 95 % CI: 59.0-91.7), with test comparison kappa of 0.79 (95 % CI: 0.65-0.93). Notably, of six discordant results (i.e. determined to be wild type by the reference assay), five were positive for MRMs by Sanger sequencing, indicating that the ResistancePlus MG FleXible assay has an improved performance for mutation detection. ResistancePlus MG FleXible had comparable test performance for detection as the open platform assay, with improved detection of MRMs. The ResistancePlus MG FleXible 'near-patient' assay can deliver a rapid result to expedite appropriate treatment.
是一种性传播病原体，对一线和二线抗菌药物的耐药性日益增加。“床边即时检测”ResistancePlus MG FleXible（SpeeDx）检测 加上四种大环内酯类耐药突变（MRMs），便于当天对患者进行随访。该检测尚未在新采集的样本上进行评估。我们的目标是评估 ResistancePlus MG FleXible 检测与标准护理开放式平台检测的性能。ResistancePlus MG FleXible（在 Cepheid GeneXpert 平台上分析）在新采集的样本上进行评估，并与标准护理开放式平台检测 ResistancePlus MG（SpeeDx）在 LightCycler 480 II（罗氏）上进行比较。对于 270 个有效测试，ResistancePlus MG FleXible 的高阳性百分比一致率（PPA）为 94.1%[96/102；95%置信区间（CI）：87.6-97.8%]，阴性百分比一致率（NPA）为 95.2%（160/168；95%CI：90.8-97.9%）用于检测与参考检测相比（一致性检测的 Kappa 值为 0.89；95%CI：0.83-0.95）。不同样本类型的性能相似。对于 MRMs 的检测，ResistancePlus MG FleXible 的 PPA 为 97.1%（66/68；95%CI：89.8-99.6），NPA 为 78.6%（22/28；95%CI：59.0-91.7），检测比较 Kappa 值为 0.79（95%CI：0.65-0.93）。值得注意的是，在六个不一致的结果中（即参考检测确定为野生型），有五个通过 Sanger 测序检测到 MRMs 呈阳性，这表明 ResistancePlus MG FleXible 检测在突变检测方面具有更好的性能。ResistancePlus MG FleXible 在 检测方面与开放式平台检测具有相当的检测性能，并且对 MRMs 的检测有所提高。ResistancePlus MG FleXible“床边”即时检测可快速获得结果，以加快适当的治疗。
