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.
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 Conformité Européene (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.
['Unemo|M|M|', 'Salado-Rasmussen|K|K|', 'Hansen|M|M|', 'Olsen|A O|AO|', 'Falk|M|M|', 'Golparian|D|D|', 'Aasterød|M|M|', 'Ringlander|J|J|', 'Nilsson|C Stezckó|CS|', 'Sundqvist|M|M|', 'Schønning|K|K|', 'Moi|H|H|', 'Westh|H|H|', 'Jensen|J S|JS|']
D000293:Adolescent D000328:Adult D000368:Aged D000900:Anti-Bacterial Agents D003718:Denmark D024881:Drug Resistance, Bacterial D005260:Female D006801:Humans D008297:Male D008826:Microbial Sensitivity Tests D008875:Middle Aged D058889:Molecular Typing D009175:Mycoplasma Infections D045704:Mycoplasma genitalium D009664:Norway D011159:Population Surveillance D015995:Prevalence D012336:RNA, Ribosomal, 16S D012338:RNA, Ribosomal, 23S D012680:Sensitivity and Specificity D013548:Sweden D055815:Young Adult
Aptima Mycoplasma genitalium Antimicrobial resistance Azithromycin Moxifloxacin Hologic 16S rRNA 23S rRNA parC