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
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
2020-10-262020-10-262020-12-21Bibliographically approved