Dataset Information

Prevalence of Mycoplasma genitalium and Antibiotic Resistance-Associated Mutations in Patients at a Sexually Transmitted Infection Clinic in Iceland, and Comparison of the S-DiaMGTV and Aptima Mycoplasma genitalium Assays for Diagnosis.

ABSTRACT: Mycoplasma genitalium is prevalent among attendees in sexually transmitted infection (STI) clinics, and therapy is hampered by rapidly rising levels of resistance to azithromycin and moxifloxacin. In this study, we evaluated, for the first time in Iceland, the prevalence of M. genitalium and azithromycin and moxifloxacin resistance-associated mutations and assessed the diagnostic performance of the CE/in vitro diagnosis (IVD)-marked S-DiaMGTV (Diagenode Diagnostics) versus the U.S. FDA/CE/IVD-approved Aptima MG (AMG; Hologic) for M. genitalium detection. From October 2018 to January 2019, urine and vaginal swabs were provided by male and female attendees at Iceland's only STI clinic. Specimens were tested with S-DiaMGTV and AMG, and resistance-associated mutations were determined by 23S rRNA gene and parC sequencing. Demographic and clinical data were collected from patient records. M. genitalium prevalence was 9.3% overall; 7.7% (38/491) among male and 10.9% (53/487) among female participants. Azithromycin and moxifloxacin resistance-associated mutations were found in 57.0% (45/79) and 0.0% (0/80) of evaluable specimens, respectively. Sensitivity was 72.5% and 100%, and specificity was 99.9% and 100% for S-DiaMGTV and AMG, respectively. No association was found between M. genitalium and symptoms of urethritis in men. Prevalence rates for M. genitalium and azithromycin resistance-associated genes in Iceland are among the highest reported in Europe. The significantly higher sensitivity of AMG over that of S-DiaMGTV can have important clinical implications. More information is urgently needed to clarify the significance of false-negative results obtained with S-DiaMGTV and other similarly performing widely used real-time PCR methods for diagnosis and management of this sexually transmitted infection.

SUBMITTER: Hilmarsdottir I

PROVIDER: S-EPMC7448636 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Prevalence of Mycoplasma genitalium and Antibiotic Resistance-Associated Mutations in Patients at a Sexually Transmitted Infection Clinic in Iceland, and Comparison of the S-DiaMGTV and Aptima Mycoplasma genitalium Assays for Diagnosis.

Hilmarsdóttir Ingibjörg I Arnardóttir Eva Mjöll EM Jóhannesdóttir Elísabet Reykdal ER Valsdóttir Freyja F Golparian Daniel D Hadad Ronza R Vigfússon Hannes Bjarki HB Unemo Magnus M

Journal of clinical microbiology 20200824 9

Mycoplasma genitalium is prevalent among attendees in sexually transmitted infection (STI) clinics, and therapy is hampered by rapidly rising levels of resistance to azithromycin and moxifloxacin. In this study, we evaluated, for the first time in Iceland, the prevalence of M. genitalium and azithromycin and moxifloxacin resistance-associated mutations and assessed the diagnostic performance of the CE/in vitro diagnosis (IVD)-marked S-DiaMGTV (Diagenode Diagnostics) versus t ...[more]

PMID: 32611793

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Project description:BackgroundMycoplasma genitalium is very difficult to grow in culture but has been more able to be studied for disease associations since the advent of research molecular amplification assays. Polymerase chain reaction (PCR) and other molecular assays have demonstrated an association with adverse disease outcomes, such as urethritis or nongonococcal urethritis in men and adverse reproductive sequelae in women-for example, cervicitis, endometritis, and pelvic inflammatory disease (PID), including an association with risk for human immunodeficiency virus. The lack of commercially available diagnostic assays has limited widespread routine testing. Increasing reports of high rates of resistance to azithromycin detected in research studies have heightened the need available commercial diagnostic assays as well as standardized methods for detecting resistance markers. This review covers available molecular methods for the diagnosis of M. genitalium and assays to predict the antibiotic susceptibility to azithromycin.MethodsA PubMed (US National Library of Medicine and National Institutes of Health) search was conducted for literature published between 2000 and 2016, using the search terms Mycoplasma genitalium, M. genitalium, diagnosis, and detection.ResultsEarly PCR diagnostic tests focused on the MPa adhesion gene and the 16S ribosomal RNA gene. Subsequently, a transcription-mediated amplification assay targeting ribosomes was developed and widely used to study the epidemiology of M. genitalium. Newer methods have proliferated and include quantitative PCR for organism load, AmpliSens PCR, PCR for the pdhD gene, a PCR-based microarray for multiple sexually transmitted infections, and multiplex PCRs. None yet are cleared by the Food and Drug Administration in the United States, although several assays are CE marked in Europe. As well, many research assays, including PCR, gene sequencing, and melt curve analysis, have been developed to detect the 23S ribosomal RNA gene mutations that confer resistance to azithromycin. One recently developed assay can test for both M. genitalium and azithromycin resistance mutations at the same time.ConclusionsIt is recommended that more commercial assays to both diagnose this organism and guide treatment choices should be developed and made available through regulatory approval. Research is needed to establish the cost-effectiveness of routine M. genitalium testing in symptomatic patients and screening in all individuals at high risk of acquiring and transmitting sexually transmitted infections.

Dataset Information

Prevalence of Mycoplasma genitalium and Antibiotic Resistance-Associated Mutations in Patients at a Sexually Transmitted Infection Clinic in Iceland, and Comparison of the S-DiaMGTV and Aptima Mycoplasma genitalium Assays for Diagnosis.

Publications

Prevalence of Mycoplasma genitalium and Antibiotic Resistance-Associated Mutations in Patients at a Sexually Transmitted Infection Clinic in Iceland, and Comparison of the S-DiaMGTV and Aptima Mycoplasma genitalium Assays for Diagnosis.

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