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 essentia

Cite: Shipitsyna E. , Unemo M.
A profile of the FDA-approved and CE/IVD-marked AptimaMycoplasma genitaliumassay (Hologic) and key priorities in the management ofM. genitaliuminfections
Expert Review of Molecular Diagnostics. 2020. V.20. N11. P.1063-1074. DOI: 10.1080/14737159.2020.1842198 WOS Scopus РИНЦ OpenAlex

Dates:

Published online:

Jun 16, 2022

Identifiers:

Web of science:	WOS:000583431700001
Scopus:	eid_2-s2.0-85094908935
Elibrary:	45179364
OpenAlex:	W3094105307

Citing:

DB	Citing
OpenAlex	9
Web of science	7

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