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Clinical and analytical evaluation of the new Aptima Mycoplasma genitalium assay, with data on M. genitalium prevalence and antimicrobial resistance in M. genitalium in Denmark, Norway and Sweden in 2016
Örebro University, School of Medical Sciences. Örebro University Hospital. World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Microbiology, Örebro University Hospital, Örebro, Sweden.ORCID iD: 0000-0003-1710-2081
Department of Dermatovenereology, Bispebjerg University Hospital, Copenhagen, Denmark.
World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University Hospital, Örebro, Sweden.
Olafia Clinic and National Advisory Unit for Sexually Transmitted Infections, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
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2018 (English)In: Clinical Microbiology and Infection, ISSN 1198-743X, E-ISSN 1469-0691, Vol. 24, no 5, p. 533-539Article in journal (Refereed) Published
Abstract [en]

Objectives: Mycoplasma genitalium (MG) causes urethritis and cervicitis, potentially causing reproductive complications. Resistance in MG to first-line (azithromycin) and second-line (moxifloxacin) treatment has increased. We examined the clinical and analytical performance of the new Conformite Europeene (CE)/in vitro diagnostics (IVD) Aptima Mycoplasma genitalium assay (CE/IVD AMG; Hologic); the prevalence of MG, Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG); and MG resistance to azithromycin and moxifloxacin in Denmark, Norway and Sweden in 2016.

Methods: From February 2016 to February 2017, urogenital and extragenital (only in Denmark) specimens from consecutive attendees at three sexually transmitted disease clinics were tested with the CE/ IVD AMG, the research-use-only MG Alt TMA-1 assay (Hologic), Aptima Combo 2 (CT/NG) assay and a laboratory-developed TaqMan real-time mgpB quantitative real-time PCR (qPCR). Resistance-associated mutations were determined by sequencing. Strains of MG and other mycoplasma species in different concentrations were also tested.

Results: In total 5269 patients were included. The prevalence of MG was 7.2% (382/5269; 4.9-9.8% in the countries). The sensitivity of the CE/IVD AMG, MG Alt TMA-1 and mgpB qPCR ranged 99.13-100%, 99.13 -100% and 73.24-81.60%, respectively, in the countries. The specificity ranged 99.57-99.96%, 100% and 99.69-100%, respectively. The prevalence of resistance-associated mutations for azithromycin and moxifloxacin was 41.4% (120/290; 17.7-56.6%) and 6.6% (18/274; 4.1-10.2%), respectively. Multidrug resistance was found in all countries (2.7%; 1.1-4.2%).

Conclusions: Both transcription-mediated amplification (TMA)-based MG assays had a highly superior sensitivity compared to the mgpB qPCR. The prevalence of MG and azithromycin resistance was high. Validated and quality-assured molecular tests for MG, routine resistance testing of MG-positive samples and antimicrobial resistance surveillance are crucial.

Place, publisher, year, edition, pages
Elsevier, 2018. Vol. 24, no 5, p. 533-539
Keywords [en]
16S rRNA, 23S rRNA, Antimicrobial resistance, Aptima, Azithromycin, Hologic, Moxifloxacin, Mycoplasma genitalium, parC
National Category
Infectious Medicine Microbiology in the medical area
Identifiers
URN: urn:nbn:se:oru:diva-66889DOI: 10.1016/j.cmi.2017.09.006ISI: 000430656300015PubMedID: 28923377Scopus ID: 2-s2.0-85032198941OAI: oai:DiVA.org:oru-66889DiVA, id: diva2:1204459
Note

Funding Agencies:

Örebro County Council Research Committee  

Foundation for Medical Research at Örebro University Hospital, Örebro, Sweden  

Available from: 2018-05-08 Created: 2018-05-08 Last updated: 2018-08-30Bibliographically approved

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Unemo, MatsGolparian, DanielSundqvist, Martin

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