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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
Department of Medical Microbiology, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology, St. Petersburg, Russia.
Örebro University, School of Medical Sciences. Örebro University Hospital. WHO Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine.ORCID iD: 0000-0003-1710-2081
2020 (English)In: Expert Review of Molecular Diagnostics, ISSN 1473-7159, E-ISSN 1744-8352, Vol. 20, no 11, p. 1063-1074Article in journal (Refereed) Published
Abstract [en]

INTRODUCTION: (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.

Place, publisher, year, edition, pages
Expert Reviews Ltd. , 2020. Vol. 20, no 11, p. 1063-1074
Keywords [en]
Cervicitis, molecular diagnostics, nucleic acid amplification test (NAAT), sexually transmitted infection, transcription-mediated amplification, urethritis
National Category
Infectious Medicine
Identifiers
URN: urn:nbn:se:oru:diva-86801DOI: 10.1080/14737159.2020.1842198ISI: 000583431700001PubMedID: 33095669Scopus ID: 2-s2.0-85094908935OAI: oai:DiVA.org:oru-86801DiVA, id: diva2:1479244
Available from: 2020-10-26 Created: 2020-10-26 Last updated: 2020-12-21Bibliographically approved

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