A profile of the FDA-approved and CE/IVD-marked Aptima Mycoplasma genitalium assay (Hologic) and key priorities in the management of M. genitalium infections

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.

KEYWORDS:

• Cervicitis
• molecular diagnostics
• nucleic acid amplification test (NAAT)
• sexually transmitted infection
• transcription-mediated amplification
• urethritis

Article highlights

• M.genitalium infections are prevalent and exceedingly difficult to manage due to limited etiological diagnostics and high prevalence of AMR.

• Validated, appropriate and quality-assured NAATs for detection of M.genitalium, combined with macrolide-resistance testing, are imperative for adequate management.

• The FDA-approved and CE/IVD-marked Aptima M.genitalium assay (Hologic) on the automated, flexible and high-throughput Panther platform (Hologic), has an excellent sensitivity and specificity.

• The Aptima M.genitalium assay offers a simple, rapid, and appropriate M. genitaliumdiagnostics, which can easily be combined with simultaneous detection of C. trachomatis, N. gonorrhoeaeandT. vaginalis.

• Macrolide resistance-guided sequential treatment, initiated with doxycycline presumptive therapy, should be implemented for M. genitaliuminfections.

• Dual antimicrobial therapy, novel antimicrobials and, ideally, a vaccine may become essential.

Acknowledgments

We are grateful to Damon Getman (Hologic Inc., San Diego, CA, USA) for providing figures of the TC, TMA, and HPA included in the Aptima MG assay.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.