Optimization and Clinical Evaluation of an Automated Commercial Analyte-Specific Reagent Assay for
            <i>Mycoplasmoides genitalium</i>
            Macrolide Resistance Detection in Primary Clinical Specimens

Munson, Erik; Zapp, Amanda; Moore, J. B.; Lavey, Stephen C; Russell, H.; Munson, Kimber L.; Martín, Irene

doi:10.1128/jcm.00335-23

Cited by 2 publications

(1 citation statement)

References 46 publications

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“…While certain therapeutic regimens were effective to varying degrees in treating infection by this bacterium, this report, chronicling therapeutic intervention failure at a high frequency, is illustrative of the incorporation of drug-resistant M. genitalium onto the CDC "Watch List" for antibiotic resistance threats in the United States 30 and can be extrapolated to other areas of public health and clinical patient management. On-site M. genitalium macrolide resistance determination, with one example being molecular analyte-specific reagent assays under development for commercial use, 31 could prevent failed therapeutic interventions and limit post-infection complications.…”

Section: Discussionmentioning

confidence: 99%

Mycoplasmoides genitaliumMacrolide Resistance Detection is Needed in University Settings

Lavey,

Cassel,

Munson

2024

Clin Med Res

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Background: Mycoplasmoides genitalium remains a difficult sexually-transmitted infection (STI) to manage due to its potential for antimicrobial resistance and post-infection sequelae. University students are especially vulnerable, as this demographic has the highest rate of STI in the United States. As a result, investigating prevalence rates and therapeutic outcomes in this population is essential to minimize future impact of M. genitalium. The purpose of this study was to investigate a university student population for M. genitalium distribution and treatment outcome. Design:Retrospective chart-review of university health clinic attendees, augmented by laboratory detection of M. genitalium following therapeutic intervention.Methods: A total of 1617 student encounters at a midwestern United States university health clinic over a 28-month interval from November 2017 through February 2020 were analyzed for M. genitalium and Chlamydia trachomatis positivity rates and prevalence. Detection of these sexually-transmitted pathogens occurred by commercial RNA amplification testing. Chart review was focused on participant outcomes following initial M. genitalium detection and therapeutic intervention.Results: C. trachomatis positivity and prevalence rates were 7.05% and 9.00%, respectively, while analogous rates for M. genitalium were 7.05% and 6.51%, respectively. An average of 1.83 positive results was generated from participants infected with M. genitalium at any time, with an average of 1.17 positive results for C. trachomatis (P < 0.0002). For students treated with azithromycin, 30.3% generated a negative M. genitalium result upon follow-up, with 1g daily and 2-day 500mg dosing regimens demonstrating less efficacy than a 4-day 250mg regimen or moxifloxacin. Conclusion:Data indicate a need for molecular M. genitalium macrolide resistance determination from primary specimens in the university setting.

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Section: Discussionmentioning

confidence: 99%

Mycoplasmoides genitaliumMacrolide Resistance Detection is Needed in University Settings

Lavey,

Cassel,

Munson

2024

Clin Med Res

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Mycoplasmoides genitalium nucleic acid semi-quantitation and molecular macrolide resistance detection via automated assays: gender and specimen source considerations

Munson,

Moore,

Krueger

et al. 2024

J Clin Microbiol

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A laboratory-developed test (LDT) using analyte-specific reagents has been optimized on a commercial platform to detect macrolide resistance-associated mutations (MRM) in 23S rRNA from Mycoplasmoides genitalium from primary clinical specimens. In this study, MRM-LDT was applied to a multi-specimen source study set. One thousand four hundred ninety-five primary specimens testing positive for M. genitalium by commercial transcription-mediated amplification (TMA) were initially titered by the TMA assay using serial 10-fold dilutions to semi-quantitate target nucleic acid burden. Primary specimens were then processed for MRM detection using the MRM-LDT. Findings were stratified by gender and specimen source. The mean log 10 target nucleic acid titer of a TMA-positive specimen was 3.51 (median 3; range 0–10). Male specimens ( n = 1145) demonstrated a mean log 10 M. genitalium TMA titer of 3.67; that value observed in 350 female specimens was 2.98 ( P < 0.0001). The MRM-LDT detection rate (88.7%) from specimens with log 10 M. genitalium TMA titers ≥ 4 was increased over specimens with log 10 titers ≤ 1 (4.5%; P < 0.0002). In females, MRM-LDT was positive from 51.3% of vaginal swab and 34.7% of urine specimens ( P = 0.01). In males, MRM-LDT was positive from 65.0% of rectal swab and 55.7% of urine specimens ( P = 0.002). Differences were also observed in log 10 M. genitalium TMA titers as a function of specimen source. M. genitalium macrolide resistance rates among multiple specimen sources, as determined by MRM-LDT, are high in the United States and can be consistent with target nucleic acid burden within the primary specimen. Caveats experienced within subgroupings support MRM reflex testing on primary M. genitalium -positive specimens. IMPORTANCE First-line macrolide treatment failure is of increasing concern with Mycoplasmoides genitalium in multiple settings. Recent sexually-transmitted infection treatment guidelines from the United States Centers for Disease Control and Prevention have predicated therapeutic approaches on the availability of a macrolide resistance/susceptibility result from a primary clinical specimen. In this report, we investigate potential correlation between macrolide resistance mutation detection rates (identified by a molecular amplified laboratory-developed test) and transcription-mediated amplification-based rRNA target semi-quantitation. Data reveal that rRNA semi-quantitation and laboratory-developed test detection rate differences exist as a function of gender and specimen source. These data can guide providers in proper specimen selection not only for the laboratory diagnosis of M. genitalium but also macrolide resistance mutation determination from primary clinical specimens.

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Optimization and Clinical Evaluation of an Automated Commercial Analyte-Specific Reagent Assay for Mycoplasmoides genitalium Macrolide Resistance Detection in Primary Clinical Specimens

Cited by 2 publications

References 46 publications

Mycoplasmoides genitaliumMacrolide Resistance Detection is Needed in University Settings

Mycoplasmoides genitaliumMacrolide Resistance Detection is Needed in University Settings

Mycoplasmoides genitalium nucleic acid semi-quantitation and molecular macrolide resistance detection via automated assays: gender and specimen source considerations

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