Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. 2020 List of human papillomavirus assays Suitable for primary cervical cancer screening

    Publikation: Bidrag til tidsskriftReviewForskningpeer review

  2. Repeated introduction and spread of the MRSA clone t304/ST6 in Northern Europe

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Invasive aspergillosis in patients with severe COVID-19 pneumonia

    Publikation: Bidrag til tidsskriftLetterForskningpeer review

Vis graf over relationer

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 CE/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 extra-genital (only in Denmark) specimens from consecutive attendees at three STD 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 qPCR. Resistance-associated mutations were determined by sequencing. Strains of MG and other mycoplasma species in different concentrations were also tested.

RESULTS: Totally, 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 between 99.13-100%, 99.13-100%, and 73.24-81.60%, respectively, in the countries. The specificity ranged between 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 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.

OriginalsprogEngelsk
TidsskriftClinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
Vol/bind24
Udgave nummer5
Sider (fra-til)533-539
ISSN1198-743X
DOI
StatusUdgivet - 1 maj 2018

ID: 51696660