ABSTRACT

Introduction

Mycoplasma genitalium (MG) causes frequently asymptomatic STIs. MG prevalence figures are lacking and management is complicated by the lack of etiological diagnostics and high antimicrobial resistance in many countries. Appropriately validated, quality-assured, and FDA-approved MG diagnostic assays have been lacking.

Areas covered

The clinical and analytical performance characteristics of the Aptima® MG assay, the first FDA-approved MG nucleic acid amplification test (NAAT), are summarized. Key priorities in the management and control of MG infections are also discussed.

Expert opinion

Highly sensitive, specific, and quality-assured MG NAATs, e.g. the Aptima MG assay on the automated and flexible Panther® platform, are imperative to improve the management and control of MG infections internationally. This testing, combined with macrolide-resistance testing (not yet available on the Panther platform), offers a rapid, high-throughput, and appropriate diagnosis of MG. Macrolide resistance-guided sequential treatment needs to be implemented for MG infections. Dual antimicrobial therapy, novel antimicrobials and, ideally, a vaccine may become essential.

中文翻译：

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FDA 批准和 CE/IVD 标记的 Aptima 生殖支原体检测 (Hologic) 的概况以及管理生殖支原体感染的关键优先事项

摘要

介绍

生殖支原体(MG) 经常导致无症状的性传播感染。许多国家缺乏病原学诊断方法和高抗菌素耐药性，因此缺乏 MG 患病率数据，管理变得复杂。缺乏经过适当验证、有质量保证和 FDA 批准的 MG 诊断分析。

覆盖区域

总结了 Aptima® MG 检测的临床和分析性能特征，这是第一个 FDA 批准的 MG 核酸扩增测试 (NAAT)。还讨论了管理和控制 MG 感染的关键优先事项。

专家意见

高度敏感、特异性和质量有保证的 MG NAAT，例如自动化和灵活 Panther® 平台上的 Aptima MG 检测，对于改善国际上 MG 感染的管理和控制势在必行。该测试与大环内酯抗性测试（Panther 平台上尚未提供）相结合，可提供快速、高通量和适当的 MG 诊断。需要对MG感染实施大环内酯类耐药指导的序贯治疗。双重抗菌疗法、新型抗菌药物以及理想情况下的疫苗可能变得必不可少。